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.

Funding source and primary outcome changes in clinical trials registered on ClinicalTrials.gov are associated with the reporting of a statistically significant primary outcome: a cross-sectional study.

PubMed

Ramagopalan, Sreeram V; Skingsley, Andrew P; Handunnetthi, Lahiru; Magnus, Daniel; Klingel, Michelle; Pakpoor, Julia; Goldacre, Ben

2015-01-01

We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3%) had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome .  Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

A model-based correction for outcome reporting bias in meta-analysis.

PubMed

Copas, John; Dwan, Kerry; Kirkham, Jamie; Williamson, Paula

2014-04-01

It is often suspected (or known) that outcomes published in medical trials are selectively reported. A systematic review for a particular outcome of interest can only include studies where that outcome was reported and so may omit, for example, a study that has considered several outcome measures but only reports those giving significant results. Using the methodology of the Outcome Reporting Bias (ORB) in Trials study of (Kirkham and others, 2010. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. British Medical Journal 340, c365), we suggest a likelihood-based model for estimating the effect of ORB on confidence intervals and p-values in meta-analysis. Correcting for bias has the effect of moving estimated treatment effects toward the null and hence more cautious assessments of significance. The bias can be very substantial, sometimes sufficient to completely overturn previous claims of significance. We re-analyze two contrasting examples, and derive a simple fixed effects approximation that can be used to give an initial estimate of the effect of ORB in practice.

Clinical Trial Registries Are of Minimal Use for Identifying Selective Outcome and Analysis Reporting

ERIC Educational Resources Information Center

Norris, Susan L.; Holmer, Haley K.; Fu, Rongwei; Ogden, Lauren A.; Viswanathan, Meera S.; Abou-Setta, Ahmed M.

2014-01-01

Objective: This study aimed to examine selective outcome reporting (SOR) and selective analysis reporting (SAR) in randomized controlled trials (RCTs) and to explore the usefulness of trial registries for identifying SOR and SAR. Study Design and Setting: We selected one "index outcome" for each of three comparative effectiveness reviews…

Alternatives to Traditional EMS Dispatch and Transport: A Scoping Review of Reported Outcomes.

PubMed

Jensen, Jan L; Carter, Alix J E; Rose, Jennifer; Visintini, Sarah; Bourdon, Emmanuelle; Brown, Ryan; McVey, Jennifer; Travers, Andrew H

2015-09-01

Emergency medical services (EMS) programs, which provide an alternative to traditional EMS dispatch or transport to the emergency department (ED), are becoming widely implemented. This scoping review identified and catalogued all outcomes used to measure such alternative EMS programs. Data Source Broad systematized bibliographic and grey literature searches were conducted. Study Selection Inclusion criteria were 911 callers/EMS patients, reported on alternatives to traditional EMS dispatch OR traditional EMS transport to the ED, and reported an outcome measure. Data Extraction The reports were categorized as either alternative to dispatch or to EMS transport, and outcome measures were categorized and described. Data Synthesis The bibliographic search retrieved 13,215 records, of which 34 articles met the inclusion criteria, with an additional 10 added from reference list hand-searching (n=44 included). In the grey literature search, 31 websites were identified, from which four met criteria and were retrieved (n=4 included). Fifteen reports (16 studies) described alternatives to EMS dispatch, and 33 reports described alternatives to EMS transport. The most common outcomes reported in the alternatives to EMS dispatch reports were service utilization and decision accuracy. Twenty-four different specific outcomes were reported. The most common outcomes reported in the alternatives to EMS transport reports were service utilization and safety, and 50 different specific outcomes were reported. Numerous outcome measures were identified in reports of alternative EMS programs, which were catalogued and described. Researchers and program leaders should achieve consensus on uniform outcome measures, to allow benchmarking and improve comparison across programs.

Optimal functional outcome measures for assessing treatment for Dupuytren’s disease: a systematic review and recommendations for future practice

PubMed Central

2013-01-01

Background Dupuytren's disease of the hand is a common condition affecting the palmar fascia, resulting in progressive flexion deformities of the digits and hence limitation of hand function. The optimal treatment remains unclear as outcomes studies have used a variety of measures for assessment. Methods A literature search was performed for all publications describing surgical treatment, percutaneous needle aponeurotomy or collagenase injection for primary or recurrent Dupuytren’s disease where outcomes had been monitored using functional measures. Results Ninety-one studies met the inclusion criteria. Twenty-two studies reported outcomes using patient reported outcome measures (PROMs) ranging from validated questionnaires to self-reported measures for return to work and self-rated disability. The Disability of Arm, Shoulder and Hand (DASH) score was the most utilised patient-reported function measure (n=11). Patient satisfaction was reported by eighteen studies but no single method was used consistently. Range of movement was the most frequent physical measure and was reported in all 91 studies. However, the methods of measurement and reporting varied, with seventeen different techniques being used. Other physical measures included grip and pinch strength and sensibility, again with variations in measurement protocols. The mean follow-up time ranged from 2 weeks to 17 years. Conclusions There is little consistency in the reporting of outcomes for interventions in patients with Dupuytren’s disease, making it impossible to compare the efficacy of different treatment modalities. Although there are limitations to the existing generic patient reported outcomes measures, a combination of these together with a disease-specific questionnaire, and physical measures of active and passive individual joint Range of movement (ROM), grip and sensibility using standardised protocols should be used for future outcomes studies. As Dupuytren’s disease tends to recur following treatment as well as extend to involve other areas of the hand, follow-up times should be standardised and designed to capture both short and long term outcomes. PMID:23575442

Interprofessional education for delirium care: a systematic review.

PubMed

Sockalingam, Sanjeev; Tan, Adrienne; Hawa, Raed; Pollex, Heather; Abbey, Susan; Hodges, Brian David

2014-07-01

Recent delirium prevention and treatment guidelines recommend the use of an interprofessional team trained and competent in delirium care. We conducted a systematic review to identify the evidence for the value of interprofessional delirium education programs on learning outcomes. We searched several databases and the grey literature. Studies describing an education intervention, involving two or more healthcare professions and reporting on at least one learning outcome as classified by Kirkpatrick's evaluation framework were included in this review. Ten out of 633 abstracts reviewed met the study inclusion criteria. Several studies reported on more than one learning outcome. Two studies focused on learner reactions to interprofessional delirium education; three studies focused on learning outcomes (e.g. delirium knowledge); six studies focused on learner behavior in practice; and six studies reported on learning results (e.g. patient outcomes), mainly changes in delirium rates post-intervention. Studies reporting changes in patient outcomes following the delirium education intervention used an interprofessional practice (IPP) intervention in combination with interprofessional education (IPE). Our review of the limited evidence suggests that IPE programs may influence team and patient outcomes in delirium care. More systematic studies of the effectiveness of interprofessional delirium education interventions are needed.

Patient-reported outcome measures in burning mouth syndrome - a review of the literature.

PubMed

Ni Riordain, R; McCreary, C

2013-04-01

Oral Diseases (2013) 19, 230-235 This review aims to investigate the patient-reported outcomes currently used in the burning mouth syndrome literature and to explore whether any standardisation of such measures has taken place. Electronic databases were searched for all types of burning mouth syndrome studies using patient-reported outcome measures. Studies were selected by predefined inclusion criteria. Copies of the papers obtained were thoroughly reviewed. A study-specific data extraction form was used, allowing papers to be reviewed in a standardised manner. The initial literature search yielded a total of 173 citations, 43 of which were deemed suitable for inclusion in this study. Symptom severity and symptomatic relief were reported as a patient-reported outcome measure in 40 of the studies and quantified most commonly using a visual analogue scale. Quality of life was reported in 13 studies included in this review. Depression and/or anxiety was reported in 14 of the studies. As is evident from the variety of questionnaires and instruments used in the evaluation of the impact of burning mouth syndrome on patients' lives, no standardisation of patient outcomes has yet been achieved. © 2012 John Wiley & Sons A/S.

Standardising the reporting of outcomes in gastric cancer surgery trials: protocol for the development of a core outcome set and accompanying outcome measurement instrument set (the GASTROS study).

PubMed

Alkhaffaf, Bilal; Glenny, Anne-Marie; Blazeby, Jane M; Williamson, Paula; Bruce, Iain A

2017-08-09

Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Whilst surgery is the mainstay of curative treatment, it is associated with significant risks. Surgical strategies for treating gastric cancer should be based on evidence from systematic reviews of well-designed randomised controlled trials. However, inconsistencies in the reporting of outcomes from these trials makes evidence synthesis unreliable. We present a protocol for an international consensus study to develop a standardised set of outcomes and measurement tools - a 'core outcome set' (COS) - to be used by all future trials examining therapeutic surgical interventions for gastric cancer. The GASTROS study aims to standardise the reporting of outcomes in gastric cancer surgery trials through an international consensus process of key stakeholders including health care professionals and patients. The first of three stages in the study will identify a 'long-list' of potentially important outcomes to be prioritised. These will be extracted from a systematic review of relevant academic literature and patient interviews. Stage 2 will comprise an eDelphi survey which will consider the views of patients, nurse specialists and surgeons to prioritise the most important outcomes. A meeting of stakeholder representatives will ratify the COS. Stage 3 will focus on identifying appropriate instruments to measure the prioritised outcomes by means of quality assessment of available measurement instruments and stakeholder consultation. This study aims to standardise the reporting of outcomes in future trials examining therapeutic surgical interventions for gastric cancer. It is anticipated that standardisation of outcome reporting in these surgical effectiveness trials will enhance the evidence base for clinical practice. Highlighting outcomes of greatest importance to patients will ensure that their perspectives are central to research in this field.

Survivorship and functional outcomes of patellofemoral arthroplasty: a systematic review.

PubMed

van der List, J P; Chawla, H; Zuiderbaan, H A; Pearle, A D

2017-08-01

Historically poor results of survivorship and functional outcomes of patellofemoral arthroplasty (PFA) have been reported in the setting of isolated patellofemoral osteoarthritis. More recently, however, fairly good results of PFA were reported, but the current status of PFA outcomes is unknown. Therefore, a systematic review was performed to assess overall PFA survivorship and functional outcomes. A search was performed using PubMed, Embase and Cochrane systems, and the registries were searched. Twenty-three cohort studies and one registry reported survivorship using Kaplan-Meier curve, while 51 cohort studies reported functional outcomes of PFA. Twelve studies were level II studies, while 45 studies were level III or IV studies. Heterogeneity was mainly seen in type of prosthesis and year the cohort started. Nine hundred revisions in 9619 PFAs were reported yielding 5-, 10-, 15- and 20-year PFA survivorships of 91.7, 83.3, 74.9 and 66.6 %, respectively, and an annual revision rate of 2.18. Functional outcomes were reported in 2587 PFAs with an overall score of 82.2 % of the maximum score. KSS and Knee Function Score were 87.5 and 81.6 %, respectively. This systematic review showed that fairly good results of PFA survivorship and functional outcomes were reported at short- and midterm follow-up in the setting of isolated patellofemoral osteoarthritis. Heterogeneity existed mainly in prosthesis design and year the cohort started. These results provide a clear overview of the current status of PFA in the setting of isolated patellofemoral osteoarthritis. IV.

Variation of clinical outcomes used in glaucoma randomised controlled trials: a systematic review.

PubMed

Ismail, Rehab; Azuara-Blanco, Augusto; Ramsay, Craig R

2014-04-01

In randomised clinical trials (RCTs) the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. The purpose of this review is to identify different clinical outcomes reported in glaucoma trials. We conducted a systematic review of glaucoma RCTs. A sample or selection of glaucoma trials were included bounded by a time frame (between 2006 and March 2012). Only studies in English language were considered. All clinical measured and reported outcomes were included. The possible variations of clinical outcomes were defined prior to data analysis. Information on reported clinical outcomes was tabulated and analysed using descriptive statistics. Other data recorded included type of intervention and glaucoma, duration of the study, defined primary outcomes, and outcomes used for sample size calculation, if nominated. The search strategy identified 4323 potentially relevant abstracts. There were 315 publications retrieved, of which 233 RCTs were included. A total of 967 clinical measures were reported. There were large variations in the definitions used to describe different outcomes and their measures. Intraocular pressure was the most commonly reported outcome (used in 201 RCTs, 86%) with a total of 422 measures (44%). Safety outcomes were commonly reported in 145 RCTs (62%) whereas visual field outcomes were used in 38 RCTs (16%). There is a large variation in the reporting of clinical outcomes in glaucoma RCTs. This lack of standardisation may impair the ability to evaluate the evidence of glaucoma interventions.

Standardised outcomes in nephrology - Haemodialysis (SONG-HD): study protocol for establishing a core outcome set in haemodialysis.

PubMed

Tong, Allison; Manns, Braden; Hemmelgarn, Brenda; Wheeler, David C; Tugwell, Peter; Winkelmayer, Wolfgang C; van Biesen, Wim; Crowe, Sally; Kerr, Peter G; Polkinghorne, Kevan R; Howard, Kirsten; Pollock, Carol; Hawley, Carmel M; Johnson, David W; McDonald, Stephen P; Gallagher, Martin P; Urquhart-Secord, Rachel; Craig, Jonathan C

2015-08-19

Chronic kidney disease is a significant contributor to mortality and morbidity worldwide, and the number of people who require dialysis or transplantation continues to increase. People on dialysis are 15 times more likely to die than the general population. Dialysis is also costly, intrusive, and time-consuming and imposes an enormous burden on patients and their families. This escalating problem has spurred a proliferation of trials in dialysis, yet health and quality of life remain poor. The reasons for this are complex and varied but are attributable in part to problems in the design and reporting of studies, particularly outcome selection. Problems related to outcomes include use of unvalidated surrogates, outcomes of little or no relevance to patients, highly variable outcome selection limiting comparability across studies, and bias in reporting outcomes. The aim of the Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) study is to establish a core outcome set for haemodialysis trials, to improve the quality of reporting, and the relevance of trials conducted in people on haemodialysis. SONG-HD is a five-phase project that includes the following: a systematic review to identify outcomes that have been reported in haemodialysis systematic reviews and trials; nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choices; qualitative stakeholder interviews with patients, caregivers, clinicians, researchers, and policy makers to elicit individual values and perspectives on outcomes for haemodialysis trials; a three-round Delphi survey with stakeholder groups to distil and generate a prioritised list of core outcomes; and a consensus workshop to establish a core outcome set for haemodialysis trials. Establishing a core outcome set to be consistently measured and reported in haemodialysis trials will improve the integrity, transparency, usability, and contribution of research relevant to patients requiring haemodialysis; ensure that outcomes of relevance to all stakeholders are consistently reported across trials; and mitigate against outcome reporting bias. Ultimately, patients will be more protected from potential harm, patients and clinicians will be better able to make informed decisions about treatment, and researchers and policy makers will be more able to maximise the value of research to the public.

Variations in reporting of outcomes in randomized trials on diet and physical activity in pregnancy: A systematic review.

PubMed

Rogozińska, Ewelina; Marlin, Nadine; Yang, Fen; Dodd, Jodie M; Guelfi, Kym; Teede, Helena; Surita, Fernanda; Jensen, Dorte M; Geiker, Nina R W; Astrup, Arne; Yeo, SeonAe; Kinnunen, Tarja I; Stafne, Signe N; Cecatti, Jose G; Bogaerts, Annick; Hauner, Hans; Mol, Ben W; Scudeller, Tânia T; Vinter, Christina A; Renault, Kristina M; Devlieger, Roland; Thangaratinam, Shakila; Khan, Khalid S

2017-07-01

Trials on diet and physical activity in pregnancy report on various outcomes. We aimed to assess the variations in outcomes reported and their quality in trials on lifestyle interventions in pregnancy. We searched major databases without language restrictions for randomized controlled trials on diet and physical activity-based interventions in pregnancy up to March 2015. Two independent reviewers undertook study selection and data extraction. We estimated the percentage of papers reporting 'critically important' and 'important' outcomes. We defined the quality of reporting as a proportion using a six-item questionnaire. Regression analysis was used to identify factors affecting this quality. Sixty-six randomized controlled trials were published in 78 papers (66 main, 12 secondary). Gestational diabetes (57.6%, 38/66), preterm birth (48.5%, 32/66) and cesarian section (60.6%, 40/66), were the commonly reported 'critically important' outcomes. Gestational weight gain (84.5%, 56/66) and birth weight (87.9%, 58/66) were reported in most papers, although not considered critically important. The median quality of reporting was 0.60 (interquartile range 0.25, 0.83) for a maximum score of one. Study and journal characteristics did not affect quality. Many studies on lifestyle interventions in pregnancy do not report critically important outcomes, highlighting the need for core outcome set development. © 2017 Japan Society of Obstetrics and Gynecology.

Lower Anogenital Tract Disease Therapy Outcomes, COMET, and CROWN: Call for Research Submissions.

PubMed

Andrews, Jeffrey

2015-10-01

There is a problem of inconsistent and inappropriate outcome selection for research studies. We can improve the relevance of research results for women and for their physicians and clinicians by encouraging researchers to critically evaluate outcome measures, and use valid, appropriate, standardized measures. To this purpose, and to facilitate synthesis of the evidence, outcomes reported by clinical studies should be standardized for different disease conditions through the development of core outcome sets (COS). There is an international effort for reaching consensus on outcome measures and establishing COS that represent agreed-upon standardized collections of outcome measures that will be reported in all studies within a clinical area. Across clinical specialties, the Core Outcome Measures in Effectiveness Trials (COMET) initiative launched in 2010. In 2014, the editors of women's health journals answered the challenge of COMET and formed the Core Outcomes in Women's Health initiative. The Journal of Lower Genital Tract Diseases is a participating member of the Core Outcomes in Women's Health consortium. There is broad inconsistency in outcome measures and reporting in the field of lower anogenital tract diseases. No core outcome sets currently exist. Suggested target conditions in anogenital disease are vulvar dermatoses, cervical intraepithelial neoplasia, and vulvodynia. Investigators are encouraged to conduct secondary systematic research to determine previously reported primary outcome measures and suggest domains for COS. Core Outcomes in Women's health initiative and COMET encourage the formation of consensus panels of stakeholders (researchers, health care providers, patients, and others) to recommend outcome domains and COS and then publish their report.

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

PubMed Central

Ahn, Rosa; Woodbridge, Alexandra; Abraham, Ann; Saba, Susan; Korenstein, Deborah; Madden, Erin; Boscardin, W John

2017-01-01

Objective To examine the association between the presence of individual principal investigators’ financial ties to the manufacturer of the study drug and the trial’s outcomes after accounting for source of research funding. Design Cross sectional study of randomized controlled trials (RCTs). Setting Studies published in “core clinical” journals, as identified by Medline, between 1 January 2013 and 31 December 2013. Participants Random sample of RCTs focused on drug efficacy. Main outcome measure Association between financial ties of principal investigators and study outcome. Results A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers’ fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9). Conclusions Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base. PMID:28096109

Evidence on the Effectiveness of Water, Sanitation, and Hygiene (WASH) Interventions on Health Outcomes in Humanitarian Crises: A Systematic Review.

PubMed

Ramesh, Anita; Blanchet, Karl; Ensink, Jeroen H J; Roberts, Bayard

2015-01-01

Water, sanitation, and hygiene (WASH) interventions are amongst the most crucial in humanitarian crises, although the impact of the different WASH interventions on health outcomes remains unclear. To examine the quantity and quality of evidence on WASH interventions on health outcomes in humanitarian crises, as well as evaluate current evidence on their effectiveness against health outcomes in these contexts. A systematic literature review was conducted of primary and grey quantitative literature on WASH interventions measured against health outcomes in humanitarian crises occurring from 1980-2014. Populations of interest were those in resident in humanitarian settings, with a focus on acute crisis and early recovery stages of humanitarian crises in low and middle-income countries. Interventions of interest were WASH-related, while outcomes of interest were health-related. Study quality was assessed via STROBE/CONSORT criteria. Results were analyzed descriptively, and PRISMA reporting was followed. Of 3963 studies initially retrieved, only 6 published studies measured a statistically significant change in health outcome as a result of a WASH intervention. All 6 studies employed point-of-use (POU) water quality interventions, with 50% using safe water storage (SWS) and 35% using household water treatment (HWT). All 6 studies used self-reported diarrhea outcomes, 2 studies also reported laboratory confirmed outcomes, and 2 studies reported health treatment outcomes (e.g. clinical admissions). 1 study measured WASH intervention success in relation to both health and water quality outcomes; 1 study recorded uptake (use of soap) as well as health outcomes. 2 studies were unblinded randomized-controlled trials, while 4 were uncontrolled longitudinal studies. 2 studies were graded as providing high quality evidence; 3 studies provided moderate and 1 study low quality evidence. The current evidence base on the impact of WASH interventions on health outcomes in humanitarian crises is extremely limited, and numerous methodological limitations limit the ability to determine associative, let alone causal, relationships.

Evidence on the Effectiveness of Water, Sanitation, and Hygiene (WASH) Interventions on Health Outcomes in Humanitarian Crises: A Systematic Review

PubMed Central

Ramesh, Anita; Blanchet, Karl; Ensink, Jeroen H. J.; Roberts, Bayard

2015-01-01

Background Water, sanitation, and hygiene (WASH) interventions are amongst the most crucial in humanitarian crises, although the impact of the different WASH interventions on health outcomes remains unclear. Aim To examine the quantity and quality of evidence on WASH interventions on health outcomes in humanitarian crises, as well as evaluate current evidence on their effectiveness against health outcomes in these contexts. Methods A systematic literature review was conducted of primary and grey quantitative literature on WASH interventions measured against health outcomes in humanitarian crises occurring from 1980–2014. Populations of interest were those in resident in humanitarian settings, with a focus on acute crisis and early recovery stages of humanitarian crises in low and middle-income countries. Interventions of interest were WASH-related, while outcomes of interest were health-related. Study quality was assessed via STROBE/CONSORT criteria. Results were analyzed descriptively, and PRISMA reporting was followed. Results Of 3963 studies initially retrieved, only 6 published studies measured a statistically significant change in health outcome as a result of a WASH intervention. All 6 studies employed point-of-use (POU) water quality interventions, with 50% using safe water storage (SWS) and 35% using household water treatment (HWT). All 6 studies used self-reported diarrhea outcomes, 2 studies also reported laboratory confirmed outcomes, and 2 studies reported health treatment outcomes (e.g. clinical admissions). 1 study measured WASH intervention success in relation to both health and water quality outcomes; 1 study recorded uptake (use of soap) as well as health outcomes. 2 studies were unblinded randomized-controlled trials, while 4 were uncontrolled longitudinal studies. 2 studies were graded as providing high quality evidence; 3 studies provided moderate and 1 study low quality evidence. Conclusion The current evidence base on the impact of WASH interventions on health outcomes in humanitarian crises is extremely limited, and numerous methodological limitations limit the ability to determine associative, let alone causal, relationships. PMID:26398228

The influence of patient factors on patient-reported outcomes of orthopedic surgery involving implantable devices: a systematic review.

PubMed

Waheeb, Androu; Zywiel, Michael G; Palaganas, Marvilyn; Venkataramanan, Viji; Davis, Aileen M

2015-02-01

Recent evidence suggests that patient factors can influence response to medical and surgical treatment and may play an under-recognized role in predicting treatment outcomes. However, the current state of knowledge concerning potential associations following orthopedic surgery in particular is unclear. The purpose of the present study was to systematically review current literature to investigate the currently known associations between pre-operative patient factors and patient-reported outcomes following orthopedic surgery. A systematic review was performed of the PubMed database to identify original studies that investigated the relationships between one or more patient factors and patient-reported outcomes of primary orthopedic surgical procedures involving implantation of a medical device. A total of 10,174 records were identified, with 83 studies included in the final review. The most commonly assessed patient factors included age, sex, and body mass index (BMI), reported in 63%, 55%, and 48% of studies, respectively. The only other patient factors identified were socioeconomic status and race, both of which were assessed in a single study. Considerable heterogeneity was observed in the methods used to stratify subjects by patient factors, patient-reported outcome constructs assessed, and follow-up intervals. Only 10% of studies performed appropriate sample size or power calculations, only 51% used methodologies to control for potentially confounding factors, and 6% assessed responder status. Overall, variable and conflicting findings were seen. While female sex and increasing BMI did appear to be associated with worse absolute outcomes, these differences did not appear to be maintained when differences in baseline status were considered. No clear associations between age and outcomes were identified. The present understanding of these relationships between patient factors and patient-reported outcomes following orthopedic surgery is limited. There is a need for further studies using high-quality methodology, consistent stratification of participants based on patient factors, accepted patient-reported outcome constructs, and appropriate assessment of responder status. Copyright © 2014 Elsevier Inc. All rights reserved.

Role of tear location on outcomes of open primary repair of the anterior cruciate ligament: A systematic review of historical studies.

PubMed

van der List, Jelle P; DiFelice, Gregory S

2017-10-01

The general opinion is that outcomes of open primary repair of the anterior cruciate ligament (ACL) in the historical literature were disappointing. Since good outcomes of primary repair of proximal tears have recently been reported, we aimed to assess the role of tear location on open primary repair outcomes in the historical literature. All studies reporting outcomes of open primary ACL repair published between the inception of PubMed, Embase and Cochrane and 2000 were identified. Studies were included if tear location was reported. Outcome scores, return to sports, stability examinations, failures and patient satisfaction were collected and reviewed in the total study cohort and in a subgroup of studies treating only proximal tears. Spearman correlation analysis was performed between the percentage of proximal tears in the studies and all outcomes. Twenty-nine studies were included reporting outcomes of open primary in 1457 patients of which 72% had proximal and 23% midsubstance tears. Mean age was 30years, 65% were males, and mean follow-up was 3.6years. Good outcomes were noted in the total cohort, and excellent outcomes were noted following repair of proximal tears. Positive correlation was found between the percentage proximal tears in the studies and percentage satisfied patients (p=0.010). Tear location seems to have played a role on the outcomes of open primary ACL repair. Outcomes of open primary repair in patients with proximal tears were excellent, which confirms there may be a potential role for primary repair as treatment for proximal ACL tears. Copyright © 2017 Elsevier B.V. All rights reserved.

Twenty-Year Systematic Review of the Hip Pathology, Risk Factors, Treatment, and Clinical Outcomes in Artistic Athletes-Dancers, Figure Skaters, and Gymnasts.

PubMed

Bolia, Ioanna; Utsunomiya, Hajime; Locks, Renato; Briggs, Karen; Philippon, Marc J

2018-01-01

To identify (1) the predominant level of evidence of the clinical studies regarding the hip pathology, risk factors, treatment, and clinical outcomes in artistic athletes (dancers, figure skaters, and gymnasts) (2) the most commonly reported hip pathology, risk factors, treatments, and clinical outcomes in dancers, figure skaters, and gymnasts. To conduct this systematic review PubMed, EMBASE, and Scopus databases were searched for relevant studies and pertinent data were collected from the eligible articles. Included were studies which reported hip injuries in artistic athletes, the risk factors, treatment, and/or the clinical outcomes. We excluded case reports or irrelevant studies. No meta-analysis was performed because of study heterogeneity. The methodical index for nonrandomized studies (MINORS) criteria were used for quality control. Thirty-eight studies were included in the analysis. The mean MINORS score was 13.6 ± 4.6 points indicating fair quality of evidence of the included articles. The predominant level of evidence was level IV. Chondrolabral pathology and muscle injuries were the most commonly reported pathologies. We found only 2 risk factor analysis studies; however, many studies reported risk correlation between artistic sports or imaging findings and hip pathology. Treatment strategies were reported in only 7 studies, clinical outcomes are significantly underreported. Chondrolabral pathology was the most commonly reported hip pathology in artistic athletes, however, prospective cohort studies are necessary to really understand these injuries and their associated risk factors. The lack of clinical outcomes is significant and future data collection is required to assess the effectiveness of the various treatments.

Outcome Reporting Bias in Government-Sponsored Policy Evaluations: A Qualitative Content Analysis of 13 Studies

PubMed Central

2016-01-01

The reporting of evaluation outcomes can be a point of contention between evaluators and policy-makers when a given reform fails to fulfil its promises. Whereas evaluators are required to report outcomes in full, policy-makers have a vested interest in framing these outcomes in a positive light–especially when they previously expressed a commitment to the reform. The current evidence base is limited to a survey of policy evaluators, a study on reporting bias in education research and several studies investigating the influence of industry sponsorship on the reporting of clinical trials. The objective of this study was twofold. Firstly, it aimed to assess the risk of outcome reporting bias (ORB or ‘spin’) in pilot evaluation reports, using seven indicators developed by clinicians. Secondly, it sought to examine how the government’s commitment to a given reform may affect the level of ORB found in the corresponding evaluation report. To answer these questions, 13 evaluation reports were content-analysed, all of which found a non-significant effect of the intervention on its stated primary outcome. These reports were systematically selected from a dataset of 233 pilot and experimental evaluations spanning three policy areas and 13 years of government-commissioned research in the UK. The results show that the risk of ORB is real. Indeed, all studies reviewed here resorted to at least one of the presentational strategies associated with a risk of spin. This study also found a small, negative association between the seniority of the reform’s champion and the risk of ORB in the evaluation of that reform. The publication of protocols and the use of reporting guidelines are recommended. PMID:27690131

COS-STAR: a reporting guideline for studies developing core outcome sets (protocol).

PubMed

Kirkham, Jamie J; Gorst, Sarah; Altman, Douglas G; Blazeby, Jane; Clarke, Mike; Devane, Declan; Gargon, Elizabeth; Williamson, Paula R

2015-08-22

Core outcome sets can increase the efficiency and value of research and, as a result, there are an increasing number of studies looking to develop core outcome sets (COS). However, the credibility of a COS depends on both the use of sound methodology in its development and clear and transparent reporting of the processes adopted. To date there is no reporting guideline for reporting COS studies. The aim of this programme of research is to develop a reporting guideline for studies developing COS and to highlight some of the important methodological considerations in the process. The study will include a reporting guideline item generation stage which will then be used in a Delphi study. The Delphi study is anticipated to include two rounds. The first round will ask stakeholders to score the items listed and to add any new items they think are relevant. In the second round of the process, participants will be shown the distribution of scores for all stakeholder groups separately and asked to re-score. A final consensus meeting will be held with an expert panel and stakeholder representatives to review the guideline item list. Following the consensus meeting, a reporting guideline will be drafted and review and testing will be undertaken until the guideline is finalised. The final outcome will be the COS-STAR (Core Outcome Set-STAndards for Reporting) guideline for studies developing COS and a supporting explanatory document. To assess the credibility and usefulness of a COS, readers of a COS development report need complete, clear and transparent information on its methodology and proposed core set of outcomes. The COS-STAR guideline will potentially benefit all stakeholders in COS development: COS developers, COS users, e.g. trialists and systematic reviewers, journal editors, policy-makers and patient groups.

Reporting and handling missing outcome data in mental health: a systematic review of Cochrane systematic reviews and meta-analyses.

PubMed

Spineli, Loukia M; Pandis, Nikolaos; Salanti, Georgia

2015-06-01

The purpose of the study was to provide empirical evidence about the reporting of methodology to address missing outcome data and the acknowledgement of their impact in Cochrane systematic reviews in the mental health field. Systematic reviews published in the Cochrane Database of Systematic Reviews after January 1, 2009 by three Cochrane Review Groups relating to mental health were included. One hundred ninety systematic reviews were considered. Missing outcome data were present in at least one included study in 175 systematic reviews. Of these 175 systematic reviews, 147 (84%) accounted for missing outcome data by considering a relevant primary or secondary outcome (e.g., dropout). Missing outcome data implications were reported only in 61 (35%) systematic reviews and primarily in the discussion section by commenting on the amount of the missing outcome data. One hundred forty eligible meta-analyses with missing data were scrutinized. Seventy-nine (56%) of them had studies with total dropout rate between 10 and 30%. One hundred nine (78%) meta-analyses reported to have performed intention-to-treat analysis by including trials with imputed outcome data. Sensitivity analysis for incomplete outcome data was implemented in less than 20% of the meta-analyses. Reporting of the techniques for handling missing outcome data and their implications in the findings of the systematic reviews are suboptimal. Copyright © 2014 John Wiley & Sons, Ltd.

Can UK NHS research ethics committees effectively monitor publication and outcome reporting bias?

PubMed

Begum, Rasheda; Kolstoe, Simon

2015-07-25

Publication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service (NHS) research ethics committee to monitor both types of reporting bias. As part of an internal audit we accessed research ethics database records for studies submitting an end of study declaration to the Hampshire A research ethics committee (formerly Southampton A) between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications. Out of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32%. Original Research Ethics Committee (REC) applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 (57%) of the published studies. This study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research.

The reporting of functional outcome instruments in the Journal of Orthopaedic Trauma over a 5-year period.

PubMed

Horwitz, Daniel S; Richard, Raveesh D; Suk, Michael

2014-01-01

Orthopaedic journals, such as the Journal of Orthopaedic Trauma, frequently publish studies reporting functional outcome instruments, but little information has been provided regarding the validity and overall strength of these instruments. This study analyzes the trends in reported functional outcome instruments in articles published in the Journal of Orthopaedic Trauma over a 5-year period and examines the utilization rate, "overall" strength, and validity of these functional outcome instruments for the populations being studied. Articles that were published in the Journal of Orthopaedic Trauma from January 2006 to December 2010 were reviewed, and each article was assigned to 1 of 4 different categories, based on the subspecialty focus and body region. The total number of articles reporting the use of functional outcome instruments, articles with at least 1 functional outcome instrument found in the AO Handbook, and the total number of functional outcome instruments reported were recorded. Each functional outcome instrument was assigned to 1 of 3 categories (generic, nonvalidated, validated), and each validated instrument was also examined to determine whether the category of interest for which it was used was one in which it was previously validated in. A total of 171 articles (34%) of the articles initially reviewed met the inclusion criteria. The average number of articles per year that reported functional outcome instruments was 56% (range, 47%-65%), and the average number of articles that reported at least 1 validated outcome instrument was 51% (range, 44%-61%). The average percentage of validated scores that were appropriately used within the category of interest was 23% (range, 13%-41%). Even though the 56% utilization rate of functional outcome instruments in The Journal of Orthopaedic Trauma is much higher than other journals, it is still low given the importance of measuring and attaining excellent functional outcomes. It is clear that future effort should be given to validating outcome measures for correct evaluation of orthopaedic trauma patients.

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.

Outcomes of online support and resources for cancer survivors: a systematic literature review.

PubMed

Hong, Yan; Peña-Purcell, Ninfa C; Ory, Marcia G

2012-03-01

This study aims to review systematically the available literature on health outcomes of online cancer support and resources. We searched major databases with the following selection criteria: (1) empirical study on use of online support or resources by cancer survivors, (2) reporting effects or outcomes of online support or resources, (3) focusing on adult cancer survivors, and (4) peer-reviewed articles published by 2010. A total of 24 studies (37 articles) were included in the review. Most studies were focused on breast cancer survivors and had small sample sizes. Fifteen studies employed a cross-sectional design including eight qualitative studies. Only five studies used pre-post design, and four employed RCT design. The outcome measures have focused on psychosocial effects; most studies reported positive effects, although none of the RCT studies reported significant outcomes. Existing studies of online cancer support and resources have demonstrated preliminary but inconclusive evidence for positive outcomes. We call for additional studies with rigorous study designs and the inclusion of more diverse participants and cancer conditions. Connecting diverse cancer survivors to culturally appropriate, evidence-based online support and resources is a strategy to enhance health outcomes. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

The impact of patient support programs on adherence, clinical, humanistic, and economic patient outcomes: a targeted systematic review

PubMed Central

Ganguli, Arijit; Clewell, Jerry; Shillington, Alicia C

2016-01-01

Background Patient support programs (PSPs), including medication management and counseling, have the potential to improve care in chronic disease states with complex therapies. Little is known about the program’s effects on improving clinical, adherence, humanistic, and cost outcomes. Purpose To conduct a targeted review describing medical conditions in which PSPs have been implemented; support delivery components (eg, face-to-face, phone, mail, and internet); and outcomes associated with implementation. Data sources MEDLINE – 10 years through March 2015 with supplemental handsearching of reference lists. Study selection English-language trials and observational studies of PSPs providing at minimum, counseling for medication management, measurement of ≥1 clinical outcome, and a 3-month follow-up period during which outcomes were measured. Data extraction Program characteristics and related clinical, adherence, humanistic, and cost outcomes were abstracted. Study quality and the overall strength of evidence were reviewed using standard criteria. Data synthesis Of 2,239 citations, 64 studies met inclusion criteria. All targeted chronic disease processes and the majority (48 [75%]) of programs offered in-clinic, face-to-face support. All but 9 (14.1%) were overseen by allied health care professionals (eg, nurses, pharmacists, paraprofessionals). Forty-one (64.1%) reported at least one significantly positive clinical outcome. The most frequent clinical outcome impacted was adherence, where 27 of 41 (66%) reported a positive outcome. Of 42 studies measuring humanistic outcomes (eg, quality of life, functional status), 27 (64%) reported significantly positive outcomes. Only 15 (23.4%) programs reported cost or utilization-related outcomes, and, of these, 12 reported positive impacts. Conclusion The preponderance of evidence suggests a positive impact of PSPs on adherence, clinical and humanistic outcomes. Although less often measured, health care utilization and costs are also reduced following PSP implementation. Further research is needed to better quantify which support programs, delivery methods, and components offer the greatest value for any particular medical condition. PMID:27175071

Review of Adult Electrical Burn Injury Outcomes Worldwide: An Analysis of Low-Voltage vs High-Voltage Electrical Injury.

PubMed

Shih, Jessica G; Shahrokhi, Shahriar; Jeschke, Marc G

The aims of this article are to review low-voltage vs high-voltage electrical burn complications in adults and to identify novel areas that are not recognized to improve outcomes. An extensive literature search on electrical burn injuries was performed using OVID MEDLINE, PubMed, and EMBASE databases from 1946 to 2015. Studies relating to outcomes of electrical injury in the adult population (≥18 years of age) were included in the study. Forty-one single-institution publications with a total of 5485 electrical injury patients were identified and included in the present study. Fourty-four percent of these patients were low-voltage injuries (LVIs), 38.3% high-voltage injuries (HVIs), and 43.7% with voltage not otherwise specified. Forty-four percentage of studies did not characterize outcomes according to LHIs vs HVIs. Reported outcomes include surgical, medical, posttraumatic, and others (long-term/psychological/rehabilitative), all of which report greater incidence rates in HVI than in LVI. Only two studies report on psychological outcomes such as posttraumatic stress disorder. Mortality rates from electrical injuries are 2.6% in LVI, 5.2% in HVI, and 3.7% in not otherwise specified. Coroner's reports revealed a ratio of 2.4:1 for deaths caused by LVI compared with HVI. HVIs lead to greater morbidity and mortality than LVIs. However, the results of the coroner's reports suggest that immediate mortality from LVI may be underestimated. Furthermore, on the basis of this analysis, we conclude that the majority of studies report electrical injury outcomes; however, the majority of them do not analyze complications by low vs high voltage and often lack long-term psychological and rehabilitation outcomes after electrical injury indicating that a variety of central aspects are not being evaluated or assessed.

Detecting gait abnormalities after concussion or mild traumatic brain injury: A systematic review of single-task, dual-task, and complex gait.

PubMed

Fino, Peter C; Parrington, Lucy; Pitt, Will; Martini, Douglas N; Chesnutt, James C; Chou, Li-Shan; King, Laurie A

2018-05-01

While a growing number of studies have investigated the effects of concussion or mild traumatic brain injury (mTBI) on gait, many studies use different experimental paradigms and outcome measures. The path for translating experimental studies for objective clinical assessments of gait is unclear. This review asked 2 questions: 1) is gait abnormal after concussion/mTBI, and 2) what gait paradigms (single-task, dual-task, complex gait) detect abnormalities after concussion. Data sources included MEDLINE/PubMed, Scopus, Web of Science, and Cumulative Index to Nursing and Allied Health Literature (CINAHL) accessed on March 14, 2017. Original research articles reporting gait outcomes in people with concussion or mTBI were included. Studies of moderate, severe, or unspecified TBI, and studies without a comparator were excluded. After screening 233 articles, 38 studies were included and assigned to one or more sections based on the protocol and reported outcomes. Twenty-six articles reported single-task simple gait outcomes, 24 reported dual-task simple gait outcomes, 21 reported single-task complex gait outcomes, and 10 reported dual-task complex gait outcomes. Overall, this review provides evidence for two conclusions: 1) gait is abnormal acutely after concussion/mTBI but generally resolves over time; and 2) the inconsistency of findings, small sample sizes, and small number of studies examining homogenous measures at the same time-period post-concussion highlight the need for replication across independent populations and investigators. Future research should concentrate on dual-task and complex gait tasks, as they showed promise for detecting abnormal locomotor function outside of the acute timeframe. Additionally, studies should provide detailed demographic and clinical characteristics to enable more refined comparisons across studies. Copyright © 2018 Elsevier B.V. All rights reserved.

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.

PubMed

Ahn, Rosa; Woodbridge, Alexandra; Abraham, Ann; Saba, Susan; Korenstein, Deborah; Madden, Erin; Boscardin, W John; Keyhani, Salomeh

2017-01-17

 To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding.  Cross sectional study of randomized controlled trials (RCTs).  Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013.  Random sample of RCTs focused on drug efficacy.  Association between financial ties of principal investigators and study outcome.  A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9).  Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base. 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.

Use of patient-reported outcome measures in foot and ankle research.

PubMed

Hunt, Kenneth J; Hurwit, Daniel

2013-08-21

In the orthopaedic literature, there is a wide range of clinical outcome measurement tools that have been used in evaluating foot and ankle procedures, disorders, and outcomes, with no broadly accepted consensus as to which tools are preferred. The purpose of this study was to determine the frequency and distribution of the various outcome instruments used in the foot and ankle literature, and to identify trends for use of these instruments over time. We conducted a systematic review of all original clinical articles reporting on foot and/or ankle topics in six orthopaedic journals over a ten-year period (2002 to 2011). All clinical patient-reported outcome rating instruments used in these articles were recorded, as were study date, study design, clinical topic, and level of evidence. A total of 878 clinical foot and ankle articles that used at least one patient-reported outcome measure were identified among 16,513 total articles published during the ten-year period. There were 139 unique clinical outcome scales used, and the five most popular scales (as a percentage of foot/ankle outcome articles) were the American Orthopaedic Foot & Ankle Society (AOFAS) scales (55.9%), visual analog scale (VAS) for pain (22.9%), Short Form-36 (SF-36) Health Survey (13.7%), Foot Function Index (FFI) (5.5%), and American Academy of Orthopaedic Surgeons (AAOS) outcomes instruments (3.3%). The majority of articles described Level-IV studies (70.1%); only 9.4% reported Level-I studies. A considerable variety of outcome measurement tools are used in the foot and ankle clinical literature, with a small proportion used consistently. The AOFAS scales continue to be used at a high rate relative to other scales that have been validated. Data from the present study underscore the need for a paradigm shift toward the use of consistent, valid, and reliable outcome measures for studies of foot and ankle procedures and disorders. It is not clear which existing validated outcome instruments will emerge as widely used and clinically meaningful. These data support the need for a paradigm shift toward the consistent use of valid and reliable outcome measures for foot and ankle clinical research.

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.

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer.

PubMed

Waters, Aoife Mi; Tudur Smith, Catrin; Young, Bridget; Jones, Terry M

2014-05-13

The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be 'cherry-picked', such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013).

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer

PubMed Central

2014-01-01

Background The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be ‘cherry-picked’, such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. Methods/Design This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. Discussion A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. Trials and registration This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013). PMID:24885068

Hand therapist use of patient report outcome (PRO) in practice: a survey study.

PubMed

Valdes, Kristin; MacDermid, Joy; Algar, Lori; Connors, Brian; Cyr, Lisa M; Dickmann, Sharon; Lucado, Ann M; Naughton, Nancy

2014-01-01

The purpose of this survey was to gain greater insight into hand therapists' use of Patient Report Outcome (PRO) measures. An 11-question survey that evaluated therapists' perceptions, preferences, and patterns of use of patient report outcome measures was sent to members of ASHT. A total of 633 ASHT members participated in the survey study. A large majority of participants (92%) responded affirmatively to using a PRO measure in practice. The DASH was reported as the most frequently used measure (90%). The majority of therapists (84%) discuss the results of the outcome measurement score with their patients. Of the participants who use more than one outcome measure, 44% report that this allows them to better establish their patient's functional and physical limitations. The findings in this study suggest that a large percentage of hand therapists are currently including a PRO measure in their hand therapy practice. Copyright © 2014 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Medication adherence in randomized controlled trials evaluating cardiovascular or mortality outcomes in dialysis patients: A systematic review.

PubMed

Murali, Karumathil M; Mullan, Judy; Chen, Jenny H C; Roodenrys, Steven; Lonergan, Maureen

2017-01-31

Medication non-adherence is common among renal dialysis patients. High degrees of non-adherence in randomized controlled trials (RCTs) can lead to failure to detect a true treatment effect. Cardio-protective pharmacological interventions have shown no consistent benefit in RCTs involving dialysis patients. Whether non-adherence contributes to this lack of efficacy is unknown. We aimed to investigate how medication adherence and drug discontinuation were assessed, reported and addressed in RCTs, evaluating cardiovascular or mortality outcomes in dialysis patients. Electronic database searches were performed in MEDLINE, EMBASE & Cochrane CENTRAL for RCTs published between 2005-2015, evaluating self-administered medications, in adult dialysis patients, which reported clinical cardiovascular or mortality endpoints, as primary or secondary outcomes. Study characteristics, outcomes, methods of measuring and reporting adherence, and data on study drug discontinuation were analyzed. Of the 642 RCTs in dialysis patients, 22 trials (12 placebo controlled), which included 19,322 patients, were eligible. The trialed pharmacological interventions included anti-hypertensives, phosphate binders, lipid-lowering therapy, cardio-vascular medications, homocysteine lowering therapy, fish oil and calcimimetics. Medication adherence was reported in five trials with a mean of 81% (range: 65-92%) in the intervention arm and 84.5% (range: 82-87%) in the control arm. All the trials that reported adherence yielded negative study outcomes for the intervention. Study-drug discontinuation was reported in 21 trials (mean 33.2%; 95% CI, 22.0 to 44.5, in intervention and 28.8%; 95% CI, 16.8 to 40.8, in control). Trials with more than 20% study drug discontinuation, more often yielded negative study outcomes (p = 0.018). Non-adherence was included as a contributor to drug discontinuation in some studies, but the causes of discontinuation were not reported consistently between studies, and non-adherence was listed under different categories, thereby potentiating the misclassification of adherence. Reporting of medication adherence and study-drug discontinuation in RCTs investigating cardiovascular or mortality endpoints in dialysis patients are inconsistent, making it difficult to compare studies and evaluate their impact on outcomes. Recommendations for consistent reporting of non-adherence and causes of drug discontinuation in RCTs will therefore help to assess their impact on clinical outcomes.

The impact of social services interventions in developing countries: a review of the evidence of impact on clinical outcomes in people living with HIV.

PubMed

Bateganya, Moses H; Dong, Maxia; Oguntomilade, John; Suraratdecha, Chutima

2015-04-15

Social service interventions have been implemented in many countries to help people living with HIV (PLHIV) and household members cope with economic burden as a result of reduced earning or increased spending on health care. However, the evidence for specific interventions-economic strengthening and legal services-on key health outcomes has not been appraised. We searched electronic databases from January 1995 to May 2014 and reviewed relevant literature from resource-limited settings on the impact of social service interventions on mortality, morbidity, retention in HIV care, quality of life, and ongoing HIV transmission and their cost-effectiveness. Of 1685 citations, 8 articles reported the health impact of economic strengthening interventions among PLHIV in resource-limited settings. None reported on legal services. Six of the 8 studies were conducted in sub-Saharan Africa: 1 reported on all 5 outcomes and 2 reported on 4 and 2 outcomes, respectively. The remaining 5 reported on 1 outcome each. Seven studies reported on quality of life. Although all studies reported some association between economic strengthening interventions and HIV care outcomes, the quality of evidence was rated fair or poor because studies were of low research rigor (observational or qualitative), had small sample size, or had other limitations. The expected impact of economic strengthening interventions was rated as high for quality of life but uncertain for all the other outcomes. Implementation of economic strengthening interventions is expected to have a high impact on the quality of life for PLHIV but uncertain impact on mortality, morbidity, retention in care, and HIV transmission. More rigorous research is needed to explore the impact of more targeted intervention components on health outcomes.

An overview of reviews evaluating the effectiveness of financial incentives in changing healthcare professional behaviours and patient outcomes.

PubMed

Flodgren, Gerd; Eccles, Martin P; Shepperd, Sasha; Scott, Anthony; Parmelli, Elena; Beyer, Fiona R

2011-07-06

There is considerable interest in the effectiveness of financial incentives in the delivery of health care. Incentives may be used in an attempt to increase the use of evidence-based treatments among healthcare professionals or to stimulate health professionals to change their clinical behaviour with respect to preventive, diagnostic and treatment decisions, or both. Financial incentives are an extrinsic source of motivation and exist when an individual can expect a monetary transfer which is made conditional on acting in a particular way. Since there are numerous reviews performed within the healthcare area describing the effects of various types of financial incentives, it is important to summarise the effectiveness of these in an overview to discern which are most effective in changing health professionals' behaviour and patient outcomes. To conduct an overview of systematic reviews that evaluates the impact of financial incentives on healthcare professional behaviour and patient outcomes. We searched the Cochrane Database of Systematic Reviews (CDSR) (The Cochrane Library); Database of Abstracts of Reviews of Effectiveness (DARE); TRIP; MEDLINE; EMBASE; Science Citation Index; Social Science Citation Index; NHS EED; HEED; EconLit; and Program in Policy Decision-Making (PPd) (from their inception dates up to January 2010). We searched the reference lists of all included reviews and carried out a citation search of those papers which cited studies included in the review. We included both Cochrane and non-Cochrane reviews of randomised controlled trials (RCTs), controlled clinical trials (CCTs), interrupted time series (ITSs) and controlled before and after studies (CBAs) that evaluated the effects of financial incentives on professional practice and patient outcomes, and that reported numerical results of the included individual studies. Two review authors independently extracted data and assessed the methodological quality of each review according to the AMSTAR criteria. We included systematic reviews of studies evaluating the effectiveness of any type of financial incentive. We grouped financial incentives into five groups: payment for working for a specified time period; payment for each service, episode or visit; payment for providing care for a patient or specific population; payment for providing a pre-specified level or providing a change in activity or quality of care; and mixed or other systems. We summarised data using vote counting. We identified four reviews reporting on 32 studies. Two reviews scored 7 on the AMSTAR criteria (moderate, score 5 to 7, quality) and two scored 9 (high, score 8 to 11, quality). The reported quality of the included studies was, by a variety of methods, low to moderate. Payment for working for a specified time period was generally ineffective, improving 3/11 outcomes from one study reported in one review. Payment for each service, episode or visit was generally effective, improving 7/10 outcomes from five studies reported in three reviews; payment for providing care for a patient or specific population was generally effective, improving 48/69 outcomes from 13 studies reported in two reviews; payment for providing a pre-specified level or providing a change in activity or quality of care was generally effective, improving 17/20 reported outcomes from 10 studies reported in two reviews; and mixed and other systems were of mixed effectiveness, improving 20/31 reported outcomes from seven studies reported in three reviews. When looking at the effect of financial incentives overall across categories of outcomes, they were of mixed effectiveness on consultation or visit rates (improving 10/17 outcomes from three studies in two reviews); generally effective in improving processes of care (improving 41/57 outcomes from 19 studies in three reviews); generally effective in improving referrals and admissions (improving 11/16 outcomes from 11 studies in four reviews); generally ineffective in improving compliance with guidelines outcomes (improving 5/17 outcomes from five studies in two reviews); and generally effective in improving prescribing costs outcomes (improving 28/34 outcomes from 10 studies in one review). Financial incentives may be effective in changing healthcare professional practice. The evidence has serious methodological limitations and is also very limited in its completeness and generalisability. We found no evidence from reviews that examined the effect of financial incentives on patient outcomes.

An overview of reviews evaluating the effectiveness of financial incentives in changing healthcare professional behaviours and patient outcomes

PubMed Central

Flodgren, Gerd; Eccles, Martin P; Shepperd, Sasha; Scott, Anthony; Parmelli, Elena; Beyer, Fiona R

2014-01-01

Background There is considerable interest in the effectiveness of financial incentives in the delivery of health care. Incentives may be used in an attempt to increase the use of evidence-based treatments among healthcare professionals or to stimulate health professionals to change their clinical behaviour with respect to preventive, diagnostic and treatment decisions, or both. Financial incentives are an extrinsic source of motivation and exist when an individual can expect a monetary transfer which is made conditional on acting in a particular way. Since there are numerous reviews performed within the healthcare area describing the effects of various types of financial incentives, it is important to summarise the effectiveness of these in an overview to discern which are most effective in changing health professionals’ behaviour and patient outcomes. Objectives To conduct an overview of systematic reviews that evaluates the impact of financial incentives on healthcare professional behaviour and patient outcomes. Methods We searched the Cochrane Database of Systematic Reviews (CDSR) (The Cochrane Library); Database of Abstracts of Reviews of Effectiveness (DARE); TRIP; MEDLINE; EMBASE; Science Citation Index; Social Science Citation Index; NHS EED; HEED; EconLit; and Program in Policy Decision-Making (PPd) (from their inception dates up to January 2010). We searched the reference lists of all included reviews and carried out a citation search of those papers which cited studies included in the review. We included both Cochrane and non-Cochrane reviews of randomised controlled trials (RCTs), controlled clinical trials (CCTs), interrupted time series (ITSs) and controlled before and after studies (CBAs) that evaluated the effects of financial incentives on professional practice and patient outcomes, and that reported numerical results of the included individual studies. Two review authors independently extracted data and assessed the methodological quality of each review according to the AMSTAR criteria. We included systematic reviews of studies evaluating the effectiveness of any type of financial incentive. We grouped financial incentives into five groups: payment for working for a specified time period; payment for each service, episode or visit; payment for providing care for a patient or specific population; payment for providing a pre-specified level or providing a change in activity or quality of care; and mixed or other systems. We summarised data using vote counting. Main results We identified four reviews reporting on 32 studies. Two reviews scored 7 on the AMSTAR criteria (moderate, score 5 to 7, quality) and two scored 9 (high, score 8 to 11, quality). The reported quality of the included studies was, by a variety of methods, low to moderate. Payment for working for a specified time period was generally ineffective, improving 3/11 outcomes from one study reported in one review. Payment for each service, episode or visit was generally effective, improving 7/10 outcomes from five studies reported in three reviews; payment for providing care for a patient or specific population was generally effective, improving 48/69 outcomes from 13 studies reported in two reviews; payment for providing a pre-specified level or providing a change in activity or quality of care was generally effective, improving 17/20 reported outcomes from 10 studies reported in two reviews; and mixed and other systems were of mixed effectiveness, improving 20/31 reported outcomes from seven studies reported in three reviews. When looking at the effect of financial incentives overall across categories of outcomes, they were of mixed effectiveness on consultation or visit rates (improving 10/17 outcomes from three studies in two reviews); generally effective in improving processes of care (improving 41/57 outcomes from 19 studies in three reviews); generally effective in improving referrals and admissions (improving 11/16 outcomes from 11 studies in four reviews); generally ineffective in improving compliance with guidelines outcomes (improving 5/17 outcomes from five studies in two reviews); and generally effective in improving prescribing costs outcomes (improving 28/34 outcomes from 10 studies in one review). Authors’ conclusions Financial incentives may be effective in changing healthcare professional practice. The evidence has serious methodological limitations and is also very limited in its completeness and generalisability. We found no evidence from reviews that examined the effect of financial incentives on patient outcomes. PMID:21735443

Literature review of outcome parameters used in studies of Geriatric Fracture Centers.

PubMed

Liem, I S L; Kammerlander, C; Suhm, N; Kates, S L; Blauth, M

2014-02-01

A variety of multidisciplinary treatment models have been described to improve outcome after osteoporotic hip fractures. There is a tendency toward better outcomes after implementation of the most sophisticated model with a shared leadership for orthopedic surgeons and geriatricians; the Geriatric Fracture Center. The purpose of this review is to evaluate the use of outcome parameters in published literature on the Geriatric Fracture Center evaluation studies. A literature search was performed using Medline and the Cochrane Library to identify Geriatric Fracture Center evaluation studies. The outcome parameters used in the included studies were evaluated. A total of 16 outcome parameters were used in 11 studies to evaluate patient outcome in 8 different Geriatric Fracture Centers. Two of these outcome parameters are patient-reported outcome measures and 14 outcome parameters were objective measures. In-hospital mortality, length of stay, time to surgery, place of residence and complication rate are the most frequently used outcome parameters. The patient-reported outcomes included activities of daily living and mobility scores. There is a need for generally agreed upon outcome measures to facilitate comparison of different care models.

Integrating Learning Outcome Typologies for HRD: Review and Current Status

ERIC Educational Resources Information Center

Lim, Doo Hun; Yoon, Seung Won; Park, Sunyoung

2013-01-01

This study reports the result of literature review in regards to learning outcome studies and presents a framework that integrates content types with learning outcomes. Analysis of learning outcome studies between 1992 and 2006 using the ERIC database indicated that most empirical studies have assessed the learning outcome at lower levels of…

A Systematic Review of the Unintended Consequences of Clinical Interventions to Reduce Adverse Outcomes.

PubMed

Manojlovich, Milisa; Lee, Soohee; Lauseng, Deborah

2016-12-01

This is a systematic review of the literature on unintended consequences of clinical interventions to reduce falls, catheter-related urinary tract infection, and vascular catheter-related infections in hospitalized patients. A systematic search of the literature was conducted in CINAHL and PubMed. We developed a screening tool and a two-stage screening process to identify relevant articles. Nine articles met inclusion criteria, and of those, 8 reported on interventions to reduce patient falls. Four studies reported a positive, unexpected benefit; 3 studies reported a negative, unexpected detriment; and 4 reported a perverse effect (different from what was expected). Three studies reported both positive and perverse effects arising from the intervention. In 4 of the studies, despite fall prevention interventions, patients fell while trying to get to the bathroom, suggesting that interventions to reduce one adverse outcome (i.e., CAUTI) may be associated with another outcome (i.e., patient falls). In some cases, there were positive outcomes for those who implemented and/or evaluated interventions. We encourage colleagues to collect and report data on possible unintended consequences of their interventions to allow a fuller picture of the relationship between intervention and all outcomes to emerge.

[Pelargonium sidoides in acute bronchitis - Health-related quality of life and patient-reported outcome in adults receiving EPs 7630 treatment].

PubMed

Matthys, Heinrich; Lizogub, Victor G; Funk, Petra; Malek, Fathi A

2010-12-01

Health-related quality of life (HRQL) and patient-reported outcome (PRO) have become important outcome parameters for the evaluation of medical treatment within clinical trials and, furthermore, to evaluate efficiency in clinical practice. We therefore report further exploratory results of an already reported dose-finding study with EPs 7630 tablets, now focussing on HRQL and PRO. A total of 406 adults with acute bronchitis were randomly assigned to one of four parallel treatment groups (placebo, 30 mg, 60 mg or 90 mg EPs 7630 daily). HRQL and PRO were assessed by questionnaires as secondary outcome measures at each study visit or daily in the patient's diary. At day 7, the patient-reported outcome measures were significantly more improved in all the three EPs 7630 groups compared to placebo (EQ-5D and EQ VAS, SF-12: physical score, impact of patient's sickness, duration of activity limitation, patient-reported treatment outcome, satisfaction with treatment). In conclusion, a statistically significant and clinically relevant improvement of HRQL/PRO compared to placebo was shown in all the three EPs 7630 groups.

Patient-Reported Outcomes and Total Health Care Expenditure in Prediction of Patient Satisfaction: Results From a National Study.

PubMed

Hung, Man; Zhang, Weiping; Chen, Wei; Bounsanga, Jerry; Cheng, Christine; Franklin, Jeremy D; Crum, Anthony B; Voss, Maren W; Hon, Shirley D

2015-01-01

Health care quality is often linked to patient satisfaction. Yet, there is a lack of national studies examining the relationship between patient satisfaction, patient-reported outcomes, and medical expenditure. The aim of this study is to examine the contribution of physical health, mental health, general health, and total health care expenditures to patient satisfaction using a longitudinal, nationally representative sample. Using data from the 2010-2011 Medical Expenditure Panel Survey, analyses were conducted to predict patient satisfaction from patient-reported outcomes and total health care expenditures. The study sample consisted of adult participants (N=10,157), with sampling weights representative of 233.26 million people in the United States. The results indicated that patient-reported outcomes and total health care expenditure were associated with patient satisfaction such that higher physical and mental function, higher general health status, and higher total health care expenditure were associated with higher patient satisfaction. We found that patient-reported outcomes and total health care expenditure had a significant relationship with patient satisfaction. As more emphasis is placed on health care value and quality, this area of research will become increasingly needed and critical questions should be asked about what we value in health care and whether we can find a balance between patient satisfaction, outcomes, and expenditures. Future research should apply big data analytics to investigate whether there is a differential effect of patient-reported outcomes and medical expenditures on patient satisfaction across different medical specialties.

Towards core outcome set (COS) development: a follow-up descriptive survey of outcomes in Cochrane reviews.

PubMed

Wuytack, Francesca; Smith, Valerie; Clarke, Mike; Williamson, Paula; Gargon, Elizabeth

2015-05-19

A core outcome set (COS) can address problems of outcome heterogeneity and outcome reporting bias in trials and systematic reviews, including Cochrane reviews, helping to reduce waste. One of the aims of the international Core Outcome Measures in Effectiveness Trials (COMET) Initiative is to link the development and use of COS with the outcomes specified and reported in Cochrane reviews, including the outcomes listed in the summary of findings (SoF) tables. As part of this work, an earlier exploratory survey of the outcomes of newly published 2007 and 2011 Cochrane reviews was performed. This survey examined the use of COS, the variety of specified outcomes, and outcome reporting in Cochrane reviews by Cochrane Review Group (CRG). To examine changes over time and to explore outcomes that were repeatedly specified over time in Cochrane reviews by CRG, we conducted a follow-up survey of outcomes in 2013 Cochrane reviews. A descriptive survey of outcomes in Cochrane reviews that were first published in 2013. Outcomes specified in the methods sections and reported in the results section of the Cochrane reviews were examined by CRG. We also explored the uptake of SoF tables, the number of outcomes included in these, and the quality of the evidence for the outcomes. Across the 50 CRGs, 375 Cochrane reviews that included at least one study specified a total of 3142 outcomes. Of these outcomes, 32 % (1008) were not reported in the results section of these reviews. For 23 % (233) of these non-reported outcomes, we did not find any reason in the text of the review for this non-report. Fifty-seven percent (216/375) of reviews included a SoF table. The proportion of specified outcomes that were reported in Cochrane reviews had increased in 2013 (68 %) compared to 2007 (61 %) and 2011 (65 %). Importantly, 2013 Cochrane reviews that did not report specified outcomes were twice as likely to provide an explanation for why the outcome was not reported. There has been an increased uptake of SoF tables in Cochrane reviews. Outcomes that were repeatedly specified in Cochrane reviews by CRG in 2007, 2011, and 2013 may assist COS development.

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.

Observational Park-based Physical Activity Studies: A Systematic Review of the Literature

PubMed Central

Joseph, Rodney P.; Maddock, Jay E.

2016-01-01

This article reports the outcomes of a systematic review of observational park-based physical activity (PA) studies. Five electronic databases and the Active Living Research website were searched in July 2015 to identify relevant articles. Studies were included if they: a) reported observational data collected at outdoor park-based settings during free living conditions, b) reported results of a park audit, c) included PA as an outcome measure of the park audit, and d) were published after 1990 in English-language peer-review journals. Thirty-two articles, reporting outcomes of 26 unique studies, met inclusion criteria for review. Most studies (n=20, 87%) had cross-sectional or non-interventional study designs, while 6 (23%) employed quasi-experimental designs. Studies were predominately conducted in the U.S. (n=19, 76%). The median number of park users across studies was 4,558 (Range= 815 to 76,632). Approximately half (51%) of all park users were female. Eighty-one percent of studies (n=21) reported PA outcomes for individuals of all ages, while 4 studies (15%) reported PA outcomes for children only and 1 study (4%) for adults only. Moderate-to-vigorous physical activity (MVPA) of park users ranged from 31% to 85% (Median=55.0%). Studies conducted in the U.S. reported a slightly higher median number of park-users engaging in MVPA than those outside the U.S. (60.5% vs. 52.8%). Fifteen studies examined gender differences in MVPA. Among these, 12 (87%) reported more males engaging in MVPA than females. Results of this review highlight the need for innovative strategies to promote MVPA among park users and to increase park use among children. PMID:27311337

Observational Park-based physical activity studies: A systematic review of the literature.

PubMed

Joseph, Rodney P; Maddock, Jay E

2016-08-01

This article reports the outcomes of a systematic review of observational park-based physical activity (PA) studies. Five electronic databases and the Active Living Research website were searched in July 2015 to identify relevant articles. Studies were included if they: a) reported observational data collected at outdoor park-based settings during free living conditions, b) reported results of a park audit, c) included PA as an outcome measure of the park audit, and d) were published after 1990 in English-language peer-review journals. Thirty-two articles, reporting outcomes of 26 unique studies, met inclusion criteria for review. Most studies (n=20, 87%) had cross-sectional or non-interventional study designs, while 6 (23%) employed quasi-experimental designs. Studies were predominately conducted in the U.S. (n=19, 76%). The median number of park users across studies was 4558 (Range=815 to 76,632). Approximately half (51%) of all park users were female. Eighty-one percent of studies (n=21) reported PA outcomes for individuals of all ages, while 4 studies (15%) reported PA outcomes for children only and 1 study (4%) for adults only. Moderate-to-vigorous physical activity (MVPA) of park users ranged from 31% to 85% (Median=55.0%). Studies conducted in the U.S. reported a slightly higher median number of park-users engaging in MVPA than those outside the U.S. (60.5% vs. 52.8%). Fifteen studies examined gender differences in MVPA. Among these, 12 (87%) reported more males engaging in MVPA than females. Results of this review highlight the need for innovative strategies to promote MVPA among park users and to increase park use among children. Copyright © 2016 Elsevier Inc. All rights reserved.

Quality of reporting of outcomes in phase III studies of pulmonary tuberculosis: a systematic review.

PubMed

Bonnett, Laura Jayne; Ken-Dror, Gie; Davies, Geraint Rhys

2018-02-21

Despite more than 60 years of clinical trials, tuberculosis (TB) still causes a high global burden of mortality and morbidity. Treatment currently requires multiple drugs in combination, taken over a prolonged period. New drugs are needed to shorten treatment duration, prevent resistance and reduce adverse events. However, to improve on current methodology in drug development, a more complete understanding of the existing clinical evidence base is required. A systematic review was undertaken to summarise outcomes reported in phase III trials of patients with newly diagnosed pulmonary TB. A systematic search of databases (PubMed, MEDLINE, EMBASE, CENTRAL and LILACs) was conducted on 30 November 2017 to retrieve relevant peer-reviewed articles. Reference lists of included studies were also searched. This systematic review considered all reported outcomes. Of 248 included studies, 229 considered "on-treatment" outcomes whilst 148 reported "off-treatment" outcomes. There was wide variation and ambiguity in the definition of reported outcomes, including their relationship to treatment and in the time points evaluated. Additional challenges were observed regarding the analysis approach taken (per protocol versus intention to treat) and the varying durations of "intensive" and "continuation" phases of treatment. Bacteriological outcomes were most frequently reported but radiological and clinical data were often included as an implicit or explicit component of the overall definition of outcome. Terminology used to define long-term outcomes in phase III trials is inconsistent, reflecting evolving differences in protocols and practices. For successful future cumulative meta-analysis, the findings of this review suggest that greater availability of individual patient data and the development of a core outcome set would be desirable. In the meantime, we propose a simple and logical approach which should facilitate combination of key evidence and inform improvements in the methodology of TB drug development and clinical trials.

Systematic Review of Soft Tissue Alterations and Esthetic Outcomes Following Immediate Implant Placement and Restoration of Single Implants in the Anterior Maxilla.

PubMed

Khzam, Nabil; Arora, Himanshu; Kim, Paul; Fisher, Anthony; Mattheos, Nikos; Ivanovski, Saso

2015-12-01

The aim of this review is to assess the outcome of single-tooth immediate implant placement and restoration (IPR) in the maxillary anterior region, with a particular emphasis on soft tissue and esthetic outcomes. An electronic search in Medline, EBSCOhost, and Ovid (PubMed) was performed to identify studies that reported on soft tissue outcomes following immediate placement and restoration of implants in the maxillary esthetic region with a mean follow-up of ≥1 year. Nineteen studies on single implants inserted immediately into fresh extraction sockets and provisionally restored in the maxillary esthetic region were included. Soft tissue changes were found to be acceptable, with most studies reporting mean gingival recession of 0.27 ± 0.38 mm and mean papillary height loss of 0.23 ± 0.27 mm after follow-up of ≥1 year. Advanced buccal recession (>1 mm) occurred in 11% of cases. Long-term follow-up studies (>2 years) reported that the interdental papillae, in particular, showed a tendency to rebound over time. The few studies that reported on patient-centered outcomes showed a high level of patient satisfaction with the outcomes of IPR treatment. The IPR protocol resulted in generally acceptable soft tissue and esthetic outcomes, with suboptimal results reported in ≈11% of low-risk cases. Factors such as preoperative tissue biotype or use of a flap or connective tissue graft did not significantly influence soft tissue and esthetic outcomes. Long-term prospective controlled clinical trials are necessary to identify factors that may influence the esthetic outcomes associated with IPR.

Outcomes After Shoulder and Elbow Injury in Baseball Players: Are We Reporting What Matters?

PubMed

Makhni, Eric C; Saltzman, Bryan M; Meyer, Maximilian A; Moutzouros, Vasilios; Cole, Brian J; Romeo, Anthony A; Verma, Nikhil N

2017-02-01

Return to play, as well as time to return to play, are the most important metrics considered by athletes when attempting to make treatment decisions after injury. However, the consistency of reporting of these metrics in the scientific literature is unknown. To investigate patterns of outcomes reporting in the medical literature of shoulder and elbow injuries in active baseball players. Systematic review. A systematic review of literature published within the past 10 years was performed to identify all recent clinical studies focusing on shoulder and elbow injuries in baseball players across all levels. Review articles, case reports, and laboratory/biomechanical studies were all excluded. A total of 49 studies were included for review. The majority of studies were either level 3 or level 4 evidence (96%). In total, 71% of studies reported on rates of return to preinjury level of play, whereas 31% of studies reported on time to return to preinjury level of play. Only 47% of studies reported on both rate and time of return to preinjury level of play. A minority of studies (8%) reported patient satisfaction rates. Finally, 27 different subjective and patient-reported outcomes were reported, and none of these appeared in more than 14% of all studies. Time to return to preinjury level of play is inadequately reported in studies of shoulder and elbow injury in baseball players. Similarly, satisfaction rates and scores are underreported. Finally, the significant variability of subjective and patient-reported outcomes utilized may undermine the ability of clinicians to accurately compare results from different studies.

Does source of funding and conflict of interest influence the outcome and quality of spinal research?

PubMed

Amiri, Amir Reza; Kanesalingam, Kavitha; Cro, Suzie; Casey, Adrian T H

2014-02-01

There has been longstanding controversy surrounding the influence of funding source on the conduct and outcome of medical research. In 2011, a systematic review of the use of recombinant bone morphogenetic protein-2 revealed underreporting of unfavorable outcomes in some industry-sponsored trials. We hypothesize that Industrial funding and the presence of potential conflict of interest will be associated with low levels of evidence (LOE) and greater proportions of favorable outcomes in spinal research. The aim of this study is to investigate the association between funding source and potential conflict of interest on the LOE and study outcome in the current spinal research. Systematic review of all the spinal publications in five leading spinal, orthopedics, neurosurgery, and general medical journals during 2010 (print and online). Supplements were included. Outcome and the LOE of research papers. Two reviewers independently assessed all publications. Commentaries, editorials, letters, open operating theatres, case reports, narrative reviews, and study protocols were excluded. The self-reported potential conflict of interest and type of funding was extracted from each paper. Funding type was classified as foundation, industry, public, intramural, multiple (including industry), multiple (without industry), and unfunded. The outcome of each study was classified as favorable, unfavorable, equivocal, or not applicable. Clinical publications were ranked using the LOE guidelines produced by the Oxford Center for Evidence-Based Medicine. Overall, 1356 papers were analyzed, out of which 864 were suitable for LOE grading. There was good interobserver reliability for assignment of LOE grade, κ=0.897 (p<.01) and study outcome κ=0.804 (p<.01). A significant association was found between LOE and source of funding (p<.01). Industry-funded studies had the greatest proportion of level IV evidence (65%). There was a significant association between the funding source and study outcome (p=.01). The proportion of industry-funded studies with favorable outcomes (88%) was higher than that of publicly and foundation-funded studies (73% and 74%, respectively). The associated odds ratio for reporting favorable outcomes in industry-funded studies compared with studies with public and foundation funding was 2.7 (95% confidence interval [CI], 1.4-5.3), and 2.6 (95% CI, 1.3-5.2), respectively. A significant association between LOE and study outcome (p<.01) was also identified. Level I studies had the highest proportions of unfavorable (14%) and equivocal (23%) outcomes. Level IV studies had the highest proportion of favorable outcome (85%). There was no association between self-reported conflict of interest and LOE (p=.83) or study outcome (p=.25). We demonstrated a significant association between source of funding, study outcome, and LOE in spinal research. A large proportion of industry funded research was shown to provide level IV evidence and report favorable outcome. Copyright © 2014 Elsevier Inc. All rights reserved.

Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data.

PubMed

Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich

2013-10-01

Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as "completely reported" or "incompletely reported." For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically significant for all types of outcomes. The main limitation of our study is that our sample is not representative because only CSRs provided voluntarily by pharmaceutical companies upon request could be assessed. In addition, the sample covered only a limited number of therapeutic areas and was restricted to randomized controlled trials investigating drugs. In contrast to CSRs, publicly available sources provide insufficient information on patient-relevant outcomes of clinical trials. CSRs should therefore be made publicly available. Please see later in the article for the Editors' Summary.

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

A review of temporal effects and outcome predictors in substance abuse treatment studies with long-term follow-ups. Preliminary results and methodological issues.

PubMed

McKay, J R; Weiss, R V

2001-04-01

This article is an initial report from a review of alcohol and drug treatment studies with follow-ups of 2 years or more. The goals of the review are to examine the stability of substance use outcomes and the factors that moderate or mediate these outcomes. Results from 12 studies that generated multiple research reports are presented, and methodological problems encountered in the review are discussed. Substance use outcomes at the group level were generally stable, although moderate within-subject variation in substance use status over time was observed. Of factors assessed at baseline, psychiatric severity was a significant predictor of outcome in the highest percentage of reports, although the nature of the relationship varied. Stronger motivation and coping at baseline also consistently predicted better drinking outcomes. Better progress while in treatment, and the performance of pro-recovery behaviors and low problem severity in associated areas following treatment, consistently predicted better substance use outcomes.

Developing core economic outcome sets for asthma studies: a protocol for a systematic review.

PubMed

Hounsome, Natalia; Fitzsimmons, Deborah; Phillips, Ceri; Patel, Anita

2017-08-11

Core outcome sets are standardised lists of outcomes, which should be measured and reported in all clinical studies of a specific condition. This study aims to develop core outcome sets for economic evaluations in asthma studies. Economic outcomes include items such as costs, resource use or quality-adjusted life years. The starting point in developing core outcome sets will be conducting a systematic literature review to establish a preliminary list of reporting items to be considered for inclusion in the core outcome set. We will conduct literature searches of peer-reviewed studies published from January 1990 to January 2017. These will include any comparative or observational studies (including economic models) and systematic reviews reporting economic outcomes. All identified economic outcomes will be tabulated together with the major study characteristics, such as population, study design, the nature and intensity of the intervention, mode of data collection and instrument(s) used to derive an outcome. We will undertake a 'realist synthesis review' to analyse the identified economic outcomes. The outcomes will be summarised in the context of evaluation perspectives, types of economic evaluation and methodological approaches. Parallel to undertaking a systematic review, we will conduct semistructured interviews with stakeholders (including people with personal experience of asthma, health professionals, researchers and decision makers) in order to explore additional outcomes which have not been considered, or used, in published studies. The list of outcomes generated from the systematic review and interviews with stakeholders will form the basis of a Delphi survey to refine the identified outcomes into a core outcome set. The review will not involve access to individual-level data. Findings from our systematic review will be communicated to a broad range of stakeholders including clinical guideline developers, research funders, trial registries, ethics committees and other regulators. © 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.

Long-Term Outcomes of ADHD: A Systematic Review of Self-Esteem and Social Function.

PubMed

Harpin, V; Mazzone, L; Raynaud, J P; Kahle, J; Hodgkins, P

2016-04-01

To compare the long-term self-esteem and social function outcomes of individuals with untreated and treated ADHD across childhood, adolescence, and adulthood. A systematic search of 12 databases was performed to identify peer-reviewed, primary research articles, published January 1980 to December 2011, reporting long-term self-esteem and/or social function outcomes (≥2 years; life consequences distinct from symptoms) of individuals with untreated or treated ADHD. Overall, 127 studies reported 150 outcomes. Most outcomes were poorer in individuals with untreated ADHD versus non-ADHD controls (57% [13/23] for self-esteem; 73% [52/71] for social function). A beneficial response to treatment (pharmacological, nonpharmacological, and multimodal treatments) was reported for the majority of self-esteem (89% [8/9]) and social function (77% [17/22]) outcomes. Untreated ADHD was associated with poorer long-term self-esteem and social function outcomes compared with non-ADHD controls. Treatment for ADHD was associated with improvement in outcomes; however, further long-term outcome studies are needed. © The Author(s) 2013.

The Impact of Generic Substitution on Health and Economic Outcomes: A Systematic Review.

PubMed

Gothe, H; Schall, I; Saverno, K; Mitrovic, M; Luzak, A; Brixner, D; Siebert, U

2015-08-01

Generic drugs are considered therapeutically equivalent to their original counterparts and lower in acquisition costs. However, the overall impact of generic substitution (GS) on global clinical and economic outcomes has not been conclusively evaluated. To test whether (1) generics and original products yield the same health outcomes, and (2) generic therapies save economic resources versus original therapies. We performed a systematic literature review in Medline, Embase, and the Cochrane Database of Systematic Reviews to identify original studies that examine clinical or economic outcomes of GS. After standardized data extraction, reported outcomes were categorized as supporting or rejecting the hypotheses. Each reported outcome was assessed and accounted for supporting and opposing GS. One publication could provide multiple outcome comparisons. We included 40 studies across ten therapeutic areas. Fourteen studies examined patients on de novo therapy; 24 studies investigated maintenance drug therapy, and two studies considered both settings. Overall, 119 outcome comparisons were examined. Of 97 clinical outcome comparisons, 67% reported no significant difference between generic drugs and their off-patent counterparts. Of 22 economic comparisons, 64% suggested that GS increased costs. Consequently, hypothesis (1) was supported but hypothesis (2) was not. We found no major differences among studies that investigated clinical outcomes with de novo or maintenance therapy. The review suggests that clinical effects are similar after GS. However, economic savings are not guaranteed. More systematic research comparing clinical and economic outcomes with or without GS is needed to inform policy on the use of generic substitution.

Systematic Review of Programs Treating High-Need and High-Cost People With Multiple Chronic Diseases or Disabilities in the United States, 2008–2014

PubMed Central

Bleich, Sara N.; Sherrod, Cheryl; Chiang, Anne; Boyd, Cynthia; Wolff, Jennifer; DuGoff, Eva; Salzberg, Claudia; Anderson, Keely; Leff, Bruce

2015-01-01

Introduction Finding ways to provide better and less expensive health care for people with multiple chronic conditions or disability is a pressing concern. The purpose of this systematic review was to evaluate different approaches for caring for this high-need and high-cost population. Methods We searched Medline for articles published from May 31, 2008, through June 10, 2014, for relevant studies. Articles were considered eligible for this review if they met the following criteria: included people with multiple chronic conditions (behavioral or mental health) or disabilities (2 or more); addressed 1 or more of clinical outcomes, health care use and spending, or patient satisfaction; and compared results from an intervention group with a comparison group or baseline measurements. We extracted information on program characteristics, participant characteristics, and significant (positive and negative) clinical findings, patient satisfaction, and health care use outcomes. For each outcome, the number of significant and positive results was tabulated. Results Twenty-seven studies were included across 5 models of care. Of the 3 studies reporting patient satisfaction outcomes, 2 reported significant improvements; both were randomized controlled trials (RCTs). Of the 14 studies reporting clinical outcomes, 12 reported improvements (8 were RCTs). Of the 13 studies reporting health care use and spending outcomes, 12 reported significant improvements (2 were RCTs). Two models of care — care and case management and disease management — reported improvements in all 3 outcomes. For care and case management models, most improvements were related to health care use. For the disease management models, most improvements were related to clinical outcomes. Conclusions Care and case management as well as disease management may be promising models of care for people with multiple chronic conditions or disabilities. More research and consistent methods are needed to understand the most appropriate care for these high-need and high-cost patients. PMID:26564013

Systematic Review of Programs Treating High-Need and High-Cost People With Multiple Chronic Diseases or Disabilities in the United States, 2008-2014.

PubMed

Bleich, Sara N; Sherrod, Cheryl; Chiang, Anne; Boyd, Cynthia; Wolff, Jennifer; DuGoff, Eva; Chang, Eva; Salzberg, Claudia; Anderson, Keely; Leff, Bruce; Anderson, Gerard

2015-11-12

Finding ways to provide better and less expensive health care for people with multiple chronic conditions or disability is a pressing concern. The purpose of this systematic review was to evaluate different approaches for caring for this high-need and high-cost population. We searched Medline for articles published from May 31, 2008, through June 10, 2014, for relevant studies. Articles were considered eligible for this review if they met the following criteria: included people with multiple chronic conditions (behavioral or mental health) or disabilities (2 or more); addressed 1 or more of clinical outcomes, health care use and spending, or patient satisfaction; and compared results from an intervention group with a comparison group or baseline measurements. We extracted information on program characteristics, participant characteristics, and significant (positive and negative) clinical findings, patient satisfaction, and health care use outcomes. For each outcome, the number of significant and positive results was tabulated. Twenty-seven studies were included across 5 models of care. Of the 3 studies reporting patient satisfaction outcomes, 2 reported significant improvements; both were randomized controlled trials (RCTs). Of the 14 studies reporting clinical outcomes, 12 reported improvements (8 were RCTs). Of the 13 studies reporting health care use and spending outcomes, 12 reported significant improvements (2 were RCTs). Two models of care - care and case management and disease management - reported improvements in all 3 outcomes. For care and case management models, most improvements were related to health care use. For the disease management models, most improvements were related to clinical outcomes. Care and case management as well as disease management may be promising models of care for people with multiple chronic conditions or disabilities. More research and consistent methods are needed to understand the most appropriate care for these high-need and high-cost patients.

Reporting and Methodology of Multivariable Analyses in Prognostic Observational Studies Published in 4 Anesthesiology Journals: A Methodological Descriptive Review.

PubMed

Guglielminotti, Jean; Dechartres, Agnès; Mentré, France; Montravers, Philippe; Longrois, Dan; Laouénan, Cedric

2015-10-01

Prognostic research studies in anesthesiology aim to identify risk factors for an outcome (explanatory studies) or calculate the risk of this outcome on the basis of patients' risk factors (predictive studies). Multivariable models express the relationship between predictors and an outcome and are used in both explanatory and predictive studies. Model development demands a strict methodology and a clear reporting to assess its reliability. In this methodological descriptive review, we critically assessed the reporting and methodology of multivariable analysis used in observational prognostic studies published in anesthesiology journals. A systematic search was conducted on Medline through Web of Knowledge, PubMed, and journal websites to identify observational prognostic studies with multivariable analysis published in Anesthesiology, Anesthesia & Analgesia, British Journal of Anaesthesia, and Anaesthesia in 2010 and 2011. Data were extracted by 2 independent readers. First, studies were analyzed with respect to reporting of outcomes, design, size, methods of analysis, model performance (discrimination and calibration), model validation, clinical usefulness, and STROBE (i.e., Strengthening the Reporting of Observational Studies in Epidemiology) checklist. A reporting rate was calculated on the basis of 21 items of the aforementioned points. Second, they were analyzed with respect to some predefined methodological points. Eighty-six studies were included: 87.2% were explanatory and 80.2% investigated a postoperative event. The reporting was fairly good, with a median reporting rate of 79% (75% in explanatory studies and 100% in predictive studies). Six items had a reporting rate <36% (i.e., the 25th percentile), with some of them not identified in the STROBE checklist: blinded evaluation of the outcome (11.9%), reason for sample size (15.1%), handling of missing data (36.0%), assessment of colinearity (17.4%), assessment of interactions (13.9%), and calibration (34.9%). When reported, a few methodological shortcomings were observed, both in explanatory and predictive studies, such as an insufficient number of events of the outcome (44.6%), exclusion of cases with missing data (93.6%), or categorization of continuous variables (65.1%.). The reporting of multivariable analysis was fairly good and could be further improved by checking reporting guidelines and EQUATOR Network website. Limiting the number of candidate variables, including cases with missing data, and not arbitrarily categorizing continuous variables should be encouraged.

Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review

PubMed Central

Malhotra, Aneil; Banning, Adrian P; Jenkinson, Crispin

2010-01-01

Objectives To systematically assess the type of outcomes selected and the prevalence of patient reported outcomes in contemporary cardiovascular trials and to quantify any misuse or underuse of patient reported outcomes using a specially developed tool that would allow estimation of the relevance of such outcomes to clinical decision making. Design Systematic review. Data sources Medline and Embase. Study selection Randomised controlled trials of the treatment for or prevention of cardiovascular disease published in 10 leading general medical and cardiology journals from January 2005 to December 2008. Results Primary outcomes were patient important (death, morbidity, or patient reported outcomes) in only 93 of 413 trials (23%, SE 2%), whereas another 92 (22%, SE 2%) combined these outcomes with other less important ones into a composite. Sixty five trials (16%; SE 2%) used at least one instrument to measure patient reported outcomes, mostly in trials where such information would have been important or crucial for clinical decision making (52 trials). Patient reported outcomes were judged to be of little incremental value to a large number of, mostly explanatory, cardiovascular trials (152 trials). However, many trials in which patient reported outcomes would have been important or crucial for clinical decision making did not report such outcomes (122 of 174 trials, 70%). These included several trials that primarily aimed to improve symptoms or functional status, trials that tested interventions with a considerable potential for causing harm (mainly bleeding) that were not meaningfully measured, and trials with composite outcomes that were dominated by outcomes of questionable importance to patients. Conclusions Despite a continued rise in the reporting of patient reported outcomes with no evidence for their misuse in more recent cardiovascular trials, they seem to be still underused once their relevance to clinical decision making has been taken into account. This was largely explained by inappropriate use of composite outcomes and inadequate measurement of harms. PMID:21041324

A Systematic Review of Palliative Care Intervention Outcomes and Outcome Measures in Low-Resource Countries.

PubMed

Potts, Maryellen; Cartmell, Kathleen B; Nemeth, Lynne; Bhattacharjee, Gautam; Qanungo, Suparna

2018-05-01

To meet the growing need for palliative care in low-resource countries, palliative care programs should be evidence based and contextually appropriate. This study was conducted to synthesize the current evidence to guide future programmatic and research efforts. This systematic review evaluated palliative care outcome measures, outcomes, and interventions in low-resource countries. After title searches, abstracts and full-text articles were screened for inclusion. Data were extracted to report on intervention models, outcome measures used, and intervention outcomes. Eighteen papers were reviewed, reporting on interventions conducted across nine low-resource countries. These interventions evaluated home-based palliative care models; a community-managed model; palliative care integrated with hospitals, hospices, or HIV clinics; and models focused on patients' self-management. Three studies were randomized controlled trials. Other studies used nonrandomized trials, cohort studies, mixed methods, pre-post test evaluation, cost-accounting evaluation, and cross-sectional surveys. Thirteen studies measured physical outcomes, 10 using multidimensional instruments. Nine studies measured psychological outcomes, eight using multidimensional instruments. Nine studies measured social outcomes, seven using multidimensional instruments. Nine studies measured outcomes across multiple domains. Across outcomes evaluated, results were reported in the direction of benefit associated with palliative care interventions. Many palliative care intervention models exist to serve patients in low-resource countries. Yet, limited high-quality evidence from low-resource countries is available to document intervention outcomes. Rigorous experimental studies and greater measurement of multidimensional aspects of palliative care are needed to advance the science of palliative care in low-resource settings. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Pharmacists' interventions on clinical asthma outcomes: a systematic review.

PubMed

Garcia-Cardenas, Victoria; Armour, Carol; Benrimoj, Shalom I; Martinez-Martinez, Fernando; Rotta, Inajara; Fernandez-Llimos, Fernando

2016-04-01

The objective of this systematic review was to evaluate the impact of pharmacists' interventions on clinical asthma outcomes on adult patients and to identify the outcome indicators used.PubMed, Scopus, Web of Science and Scielo were searched. Studies addressing pharmacists' interventions on adult asthma patients reporting clinical asthma outcomes were incorporated.11 clinical outcomes were identified in 21 studies. 10 studies measured the impact of the intervention on asthma control. Randomised controlled trials (RCT) and non-RCTs found positive results in percentages of controlled patients and Asthma Control Questionnaire (ACQ) scores. Discordant results were found for Asthma Control Test results. Asthma severity was assessed in four studies. One RCT found a significant decrease in the percentage of severe patients; two non-RCTs found significant improvements in severity scores. 11 studies reported pulmonary function indicators, showing inconsistent results. Eight studies measured asthma symptoms; three RCTs and four non-RCTs showed significant improvements.RCTs and non-RCTs generated similar results for most outcomes. Based on the evidence generated by RCTs, pharmacists' have a positive impact on the percentage of controlled patients, ACQ scores, severity and symptoms. Future research should report using the core outcome set of indicators established for asthma (PROSPERO CRD42014007019). Copyright ©ERS 2016.

Validated Outcomes in the Grafting of Autologous Fat to the Breast: The VOGUE Study. Development of a Core Outcome Set for Research and Audit.

PubMed

Agha, Riaz A; Pidgeon, Thomas E; Borrelli, Mimi R; Dowlut, Naeem; Orkar, Ter-Er K; Ahmed, Maziyah; Pujji, Ojas; Orgill, Dennis P

2018-05-01

Autologous fat grafting is an important part of the reconstructive surgeon's toolbox when treating women affected by breast cancer and subsequent tumor extirpation. The debate over safety and efficacy of autologous fat grafting continues within the literature. However, work performed by the authors' group has shown significant heterogeneity in outcome reporting. Core outcome sets have been shown to reduce heterogeneity in outcome reporting. The authors' goal was to develop a core outcome set for autologous fat grafting in breast reconstruction. The authors published their protocol a priori. A Delphi consensus exercise among key stakeholders was conducted using a list of outcomes generated from their previous work. These outcomes were divided into six domains: oncologic, clinical, aesthetic and functional, patient-reported, process, and radiologic. In the first round, 55 of 78 participants (71 percent) completed the Delphi consensus exercise. Consensus was reached on nine of the 13 outcomes. The clarity of the results and lack of additional suggested outcomes deemed further rounds to be unnecessary. The VOGUE Study has led to the development of a much-needed core outcome set in the active research front and clinical area of autologous fat grafting. The authors hope that clinicians will use this core outcome set to audit their practice, and that researchers will implement these outcomes in their study design and reporting of autologous fat grafting outcomes. The authors encourage journals and surgical societies to endorse and encourage use of this core outcome set to help refine the scientific quality of the debate, the discourse, and the literature. Therapeutic, V.

Complex Relationships Among Masculine Norms and Health/Well-Being Outcomes: Correlation Patterns of the Conformity to Masculine Norms Inventory Subscales.

PubMed

Gerdes, Zachary T; Levant, Ronald F

2018-03-01

The Conformity to Masculine Norms Inventory (CMNI) is a widely used multidimensional scale. Studies using the CMNI most often report only total scale scores, which are predominantly associated with negative outcomes. Various studies since the CMNI's inception in 2003 using subscales have reported both positive and negative outcomes. The current content analysis examined studies ( N = 17) correlating the 11 subscales with 63 criterion variables across 7 categories. Most findings were consistent with past research using total scale scores that reported negative outcomes. For example, conformity to masculine norms has been inversely related to help-seeking and positively correlated with concerning health variables, such as substance use. Nonetheless, past reliance on total scores has obscured the complexity of associations with the CMNI in that 30% of the findings in the present study reflected positive outcomes, particularly for health promotion. Subscales differed in their relationships with various outcomes: for one subscale they were predominantly positive, but six others were mostly negative. The situational and contextual implications of conformity to masculine norms and their relationships to positive and negative outcomes are discussed.

Risky Business: Talking with Your Patients About Cyberbullying and Sexting.

PubMed

Englander, Elizabeth K

2018-04-01

This article reviews cyberbullying and sexting research and presents new research exploring relatively neglected areas of cyberbullying and cell phone ownership among children and outcomes following sexting in college. Two samples are studied: 4584 elementary school children and 1332 college freshman. Findings include: owning a cell phone increased the risk of becoming involved in cyberbullying in grades 3, 4, and 5; and, of college freshman who sexted, 61% reported no outcomes, 19% reported negative outcomes, 13% reported positive outcomes, and 7% reported mixed outcomes. This information may be useful when considering discussing these digital technology risks with patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Cell assisted lipotransfer in breast augmentation and reconstruction: A systematic review of safety, efficacy, use of patient reported outcomes and study quality.

PubMed

Arshad, Zeeshaan; Karmen, Lindsey; Choudhary, Rajan; Smith, James A; Branford, Olivier A; Brindley, David A; Pettitt, David; Davies, Benjamin M

2016-12-01

Cell assisted lipotransfer serves as a novel technique for both breast reconstruction and breast augmentation. This systematic review assesses the efficacy, safety and use of patient reported outcome measures in studies involving cell assisted lipotransfer. We also carry out an objective assessment of study quality focussing on recruitment, follow-up and provide an up-to-date clinical trial landscaping analysis. Key electronic databases were searched according to PRISMA guidelines and pre-defined inclusion and exclusion criteria. Two independent reviewers examined the retrieved publications and performed data extraction. 3980 publications were identified. Following screening, 11 studies were included for full review, representing a total of 336 patients with a follow-up time ranging from six to 42 months. A degree of variation was noted in graft retention and reported satisfaction levels, although there were only three comparative studies with conflicting results. Complications occurred at a rate of 37%. Additionally, there was a paucity of objective outcomes assessments (e.g. 3D assessment modalities or validated patient reported outcome measures) in the selected studies. Cell assisted lipotransfer is a surgical technique that is currently employed sparingly within the plastic & reconstructive surgery community. Presently, further technical and outcome standardization is required, in addition to rigorous randomized controlled trials and supporting long-term follow-up data to better determine procedural safety and efficacy. Routine use of more objective outcome measures, particularly 3D assessments and validated patient reported outcome measures, will also help facilitate wider clinical adoption and establish procedural utility.

Autograft versus nonirradiated allograft tissue for anterior cruciate ligament reconstruction: a systematic review.

PubMed

Mariscalco, Michael W; Magnussen, Robert A; Mehta, Divyesh; Hewett, Timothy E; Flanigan, David C; Kaeding, Christopher C

2014-02-01

An autograft has traditionally been the gold standard for anterior cruciate ligament reconstruction (ACLR), but the use of allograft tissue has increased in recent years. While numerous studies have demonstrated that irradiated allografts are associated with increased failure rates, some report excellent results after ACLR with nonirradiated allografts. The purpose of this systematic review was to determine whether the use of nonirradiated allograft tissue is associated with poorer outcomes when compared with autografts. Patients undergoing ACLR with autografts versus nonirradiated allografts will demonstrate no significant differences in graft failure risk, laxity on postoperative physical examination, or differences in patient-oriented outcome scores. Systematic review. A systematic review was performed to identify prospective or retrospective comparative studies (evidence level 1, 2, or 3) of autografts versus nonirradiated allografts for ACLR. Outcome data included graft failure based on clinical findings and instrumented laxity, postoperative laxity on physical examination, and patient-reported outcome scores. Studies were excluded if they did not specify whether the allograft had been irradiated. Quality assessment and data extraction were performed by 2 examiners. Nine studies comparing autografts and nonirradiated allografts were included. Six of the 9 studies compared bone-patellar tendon-bone (BPTB) autografts with BPTB allografts. Two studies compared hamstring tendon autografts to hamstring tendon allografts, and 1 study compared hamstring tendon autografts to tibialis anterior allografts. The mean patient age in 7 of 9 studies ranged from 24.5 to 32 years, with 1 study including only patients older than 40 years and another not reporting patient age. The mean follow-up duration was 24 to 94 months. Six of 9 studies reported clinical graft failure rates, 8 of 9 reported postoperative instrumented laxity measurements, 7 of 9 reported postoperative physical examination findings, and all studies reported patient-reported outcome scores. This review demonstrated no statistically significant difference between autografts and nonirradiated allografts in any outcome measure. No significant differences were found in graft failure rate, postoperative laxity, or patient-reported outcome scores when comparing ACLR with autografts to nonirradiated allografts in this systematic review. These findings apply to patients in their late 20s and early 30s. Caution is advised when considering extrapolation of these findings to younger, more active cohorts.

Assessment of the reporting of quality and outcome measures in hepatic resections: a call for 90-day reporting in all hepatectomy series

PubMed Central

Egger, Michael E; Ohlendorf, Joanna M; Scoggins, Charles R; McMasters, Kelly M; Martin, Robert C G

2015-01-01

Background The aim of this paper is to assess the current state of quality and outcomes measures being reported for hepatic resections in the recent literature. Methods Medline and PubMed databases were searched for English language articles published between 1 January 2002 and 30 April 2013. Two examiners reviewed each article and relevant citations for appropriateness of inclusion, which excluded papers of liver donor hepatic resections, repeat hepatectomies or meta-analyses. Data were extracted and summarized by two examiners for analysis. Results Fifty-five studies were identified with suitable reporting to assess peri-operative mortality in hepatic resections. In only 35% (19/55) of the studies was the follow-up time explicitly stated, and in 47% (26/55) of studies peri-operative mortality was limited to in-hospital or 30 days. The time period in which complications were captured was not explicitly stated in 19 out of 28 studies. The remaining studies only captured complications within 30 days of the index operation (8/28). There was a paucity of quality literature addressing truly patient-centred outcomes. Conclusion Quality outcomes after a hepatic resection are inconsistently reported in the literature. Quality outcome studies for a hepatectomy should report mortality and morbidity at a minimum of 90 days after surgery. PMID:26228262

Moving the Needle: Simulation's Impact on Patient Outcomes.

PubMed

Cox, Tiffany; Seymour, Neal; Stefanidis, Dimitrios

2015-08-01

This review investigates the available literature that addresses the impact simulator training has on patient outcomes. The authors conducted a comprehensive literature search of studies reporting outcomes of simulation training and categorized studies based on the Kirkpatrick model of training evaluation. Kirkpatrick level 4 studies reporting patient outcomes were identified and included in this review. Existing evidence is promising, demonstrating patient benefits as a result of simulation training for central line placement, obstetric emergencies, cataract surgery, laparoscopic inguinal hernia repair, and team training. Copyright © 2015 Elsevier Inc. All rights reserved.

Vascular Access Outcomes Reported in Maintenance Hemodialysis Trials: A Systematic Review.

PubMed

Viecelli, Andrea K; O'Lone, Emma; Sautenet, Benedicte; Craig, Jonathan C; Tong, Allison; Chemla, Eric; Hooi, Lai-Seong; Lee, Timmy; Lok, Charmaine; Polkinghorne, Kevan R; Quinn, Robert R; Vachharajani, Tushar; Vanholder, Raymond; Zuo, Li; Irish, Ashley B; Mori, Trevor A; Pascoe, Elaine M; Johnson, David W; Hawley, Carmel M

2018-03-01

Many randomized controlled trials have been performed with the goal of improving outcomes related to hemodialysis vascular access. If the reported outcomes are relevant and measured consistently to allow comparison of interventions across trials, such trials can inform decision making. This study aimed to assess the scope and consistency of vascular access outcomes reported in contemporary hemodialysis trials. Systematic review. Adults requiring maintenance hemodialysis. All randomized controlled trials and trial protocols reporting vascular access outcomes identified from ClinicalTrials.gov, Embase, MEDLINE, and the Cochrane Kidney and Transplant Specialized Register from January 2011 to June 2016. Any hemodialysis-related intervention. The frequency and characteristics of vascular access outcome measures were analyzed and classified. From 168 relevant trials, 1,426 access-related outcome measures were extracted and classified into 23 different outcomes. The 3 most common outcomes were function (136 [81%] trials), infection (63 [38%]), and maturation (31 [18%]). Function was measured in 489 different ways, but most frequently reported as "mean access blood flow (mL/min)" (37 [27%] trials) and "number of thromboses" (30 [22%]). Infection was assessed in 136 different ways, with "number of access-related infections" being the most common measure. Maturation was assessed in 44 different ways at 15 different time points and most commonly characterized by vein diameter and blood flow. Patient-reported outcomes, including pain (19 [11%]) and quality of life (5 [3%]), were reported infrequently. Only a minority of trials used previously standardized outcome definitions. Restricted sampling frame for feasibility and focus on contemporary trials. The reporting of access outcomes in hemodialysis trials is very heterogeneous, with limited patient-reported outcomes and infrequent use of standardized outcome measures. Efforts to standardize outcome reporting for vascular access are critical to optimizing the comparability, reliability, and value of trial evidence to improve outcomes for patients requiring hemodialysis. Copyright © 2017 National Kidney Foundation, Inc. All rights reserved.

Student Self-Reported Learning Outcomes of Field Trips: The pedagogical impact

NASA Astrophysics Data System (ADS)

Lavie Alon, Nirit; Tal, Tali

2015-05-01

In this study, we used the classification and regression trees (CART) method to draw relationships between student self-reported learning outcomes in 26 field trips to natural environments and various characteristics of the field trip that include variables associated with preparation and pedagogy. We wished to examine the extent to which the preparation for the field trip, its connection to the school curriculum, and the pedagogies used, affect students' self-reported outcomes in three domains: cognitive, affective, and behavioral; and the extent the students' socioeconomic group and the guide's affiliation affect students' reported learning outcomes. Given that most of the field trips were guide-centered, the most important variable that affected the three domains of outcomes was the guide's storytelling. Other variables that showed relationships with self-reported outcomes were physical activity and making connections to everyday life-all of which we defined as pedagogical variables. We found no significant differences in student self-reported outcomes with respect to their socioeconomic group and the guide's organizational affiliation.

Review of adult electrical burn injury outcomes worldwide: An analysis of low- voltage versus high-voltage electrical injury

PubMed Central

Shih, Jessica G; Shahrokhi, Shahriar; Jeschke, Marc G

2016-01-01

Objective To review low-voltage versus high-voltage electrical burn complications in adults, and to identify novel areas that are not recognized to improve outcomes. Methods An extensive literature search on electrical burn injuries was performed using OVID Medline, PubMed and EMBASE databases from 1946–2015. Studies relating to outcomes of electrical injury in the adult population (≥18 years of age) were included in the study. Results Forty-one single-institution publications with a total of 5485 electrical injury patients were identified and included in the present study. 18.0% of these patients were low-voltage injuries (LVI), 38.3% high-voltage injuries (HVI) and 43.7% with voltage not otherwise specified (NOS). Forty-four percent of studies did not characterize outcomes according to low versus high-voltage injuries. Reported outcomes include surgical, medical, post-traumatic, and other (long-term/psychological/rehabilitative), all of which report greater incidence rates in HVI compared to LVI. Only two studies report on psychological outcomes such as post-traumatic stress disorder. Mortality from electrical injuries are 2.6% in LVI, 5.2% in HVI and 3.7% in NOS. Coroner’s reports reveal a ratio of 2.4:1 for deaths caused by low-voltage injury compared to high voltage-injury. Conclusions High-voltage injuries lead to greater morbidity and mortality than low-voltage injuries. However, the results of the coroner’s reports suggest that immediate mortality from low-voltage injury may be underestimated. Furthermore, based on the data of this analysis we conclude that the majority of studies report electrical injury outcomes, however, the majority of them do not analyze complications by low versus high voltage and often lack long-term psychological and rehabilitation outcomes post-electrical injury indicating that a variety of central aspects are not being evaluated or assessed. PMID:27359191

Concordance Between Self-Reported Childhood Maltreatment Versus Case Record Reviews for Child Welfare–Affiliated Adolescents: Prevalence Rates and Associations With Outcomes

PubMed Central

Negriff, Sonya; Schneiderman, Janet U.; Trickett, Penelope K.

2017-01-01

The present study used data from an ongoing longitudinal study of the effects of maltreatment on adolescent development to (1) describe rates of maltreatment experiences obtained from retrospective self-report versus case record review for adolescents with child welfare–documented maltreatment histories, (2) examine self-reported versus child welfare–identified maltreatment in relation to mental health and risk behavior outcomes by maltreatment type, and (3) examine the association between the number of different types of maltreatment and mental health and risk behavior outcomes. Maltreatment was coded from case records using the Maltreatment Case Record Abstraction Instrument (MCRAI) and participants were asked at mean age = 18.49 about childhood maltreatment experiences using the Comprehensive Trauma Interview (CTI). Results showed that an average of 48% of maltreatment found by the MCRAI for each type of maltreatment were unique cases not captured by the CTI, whereas an average of 40% self-reported maltreatment (CTI) was not indicated by the MCRAI. Analyses with outcomes showed generally, self-reported maltreatment, regardless of concordance with MCRAI, was related to the poorest outcomes. The difference in associations with the outcomes indicates both self-report and case record review data may have utility depending on the outcomes being assessed. PMID:27777329

Patient-Reported Outcomes and Total Health Care Expenditure in Prediction of Patient Satisfaction: Results From a National Study

PubMed Central

Zhang, Weiping; Chen, Wei; Bounsanga, Jerry; Cheng, Christine; Franklin, Jeremy D; Crum, Anthony B; Voss, Maren W; Hon, Shirley D

2015-01-01

Background Health care quality is often linked to patient satisfaction. Yet, there is a lack of national studies examining the relationship between patient satisfaction, patient-reported outcomes, and medical expenditure. Objective The aim of this study is to examine the contribution of physical health, mental health, general health, and total health care expenditures to patient satisfaction using a longitudinal, nationally representative sample. Methods Using data from the 2010-2011 Medical Expenditure Panel Survey, analyses were conducted to predict patient satisfaction from patient-reported outcomes and total health care expenditures. The study sample consisted of adult participants (N=10,157), with sampling weights representative of 233.26 million people in the United States. Results The results indicated that patient-reported outcomes and total health care expenditure were associated with patient satisfaction such that higher physical and mental function, higher general health status, and higher total health care expenditure were associated with higher patient satisfaction. Conclusions We found that patient-reported outcomes and total health care expenditure had a significant relationship with patient satisfaction. As more emphasis is placed on health care value and quality, this area of research will become increasingly needed and critical questions should be asked about what we value in health care and whether we can find a balance between patient satisfaction, outcomes, and expenditures. Future research should apply big data analytics to investigate whether there is a differential effect of patient-reported outcomes and medical expenditures on patient satisfaction across different medical specialties. PMID:27227131

The effectiveness of social marketing in global health: a systematic review.

PubMed

Firestone, Rebecca; Rowe, Cassandra J; Modi, Shilpa N; Sievers, Dana

2017-02-01

Social marketing is a commonly used strategy in global health. Social marketing programmes may sell subsidized products through commercial sector outlets, distribute appropriately priced products, deliver health services through social franchises and promote behaviours not dependent upon a product or service. We aimed to review evidence of the effectiveness of social marketing in low- and middle-income countries, focusing on major areas of investment in global health: HIV, reproductive health, child survival, malaria and tuberculosis. We searched PubMed, PsycInfo and ProQuest, using search terms linking social marketing and health outcomes for studies published from 1995 to 2013. Eligible studies used experimental or quasi-experimental designs to measure outcomes of behavioural factors, health behaviours and/or health outcomes in each health area. Studies were analysed by effect estimates and for application of social marketing benchmark criteria. After reviewing 18 974 records, 125 studies met inclusion criteria. Across health areas, 81 studies reported on changes in behavioural factors, 97 studies reported on changes in behaviour and 42 studies reported on health outcomes. The greatest number of studies focused on HIV outcomes (n = 45) and took place in sub-Saharan Africa (n = 67). Most studies used quasi-experimental designs and reported mixed results. Child survival had proportionately the greatest number of studies using experimental designs, reporting health outcomes, and reporting positive, statistically significant results. Most programmes used a range of methods to promote behaviour change. Programmes with positive, statistically significant findings were more likely to apply audience insights and cost-benefit analyses to motivate behaviour change. Key evidence gaps were found in voluntary medical male circumcision and childhood pneumonia. Social marketing can influence health behaviours and health outcomes in global health; however evaluations assessing health outcomes remain comparatively limited. Global health investments are needed to (i) fill evidence gaps, (ii) strengthen evaluation rigour and (iii) expand effective social marketing approaches. © The Author 2016. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine.

Child and adult outcomes of chronic child maltreatment.

PubMed

Jonson-Reid, Melissa; Kohl, Patricia L; Drake, Brett

2012-05-01

To describe how child maltreatment chronicity is related to negative outcomes in later childhood and early adulthood. The study included 5994 low-income children from St Louis, including 3521 with child maltreatment reports, who were followed from 1993-1994 through 2009. Children were 1.5 to 11 years of age at sampling. Data include administrative and treatment records indicating substance abuse, mental health treatment, brain injury, sexually transmitted disease, suicide attempts, and violent delinquency before age 18 and child maltreatment perpetration, mental health treatment, or substance abuse in adulthood. Multivariate analysis controlled for potential confounders. Child maltreatment chronicity predicted negative childhood outcomes in a linear fashion (eg, percentage with at least 1 negative outcome: no maltreatment = 29.7%, 1 report = 39.5%, 4 reports = 67.1%). Suicide attempts before age 18 showed the largest proportionate increase with repeated maltreatment (no report versus 4+ reports = +625%, P < .0001). The dose-response relationship was reduced once controls for other adverse child outcomes were added in multivariate models of child maltreatment perpetration and mental health issues. The relationship between adult substance abuse and maltreatment report history disappeared after controlling for adverse child outcomes. Child maltreatment chronicity as measured by official reports is a robust indicator of future negative outcomes across a range of systems, but this relationship may desist for certain adult outcomes once childhood adverse events are controlled. Although primary and secondary prevention remain important approaches, this study suggests that enhanced tertiary prevention may pay high dividends across a range of medical and behavioral domains.

Patient Reported Outcomes in Preoperative and Postoperative Patients with Hypospadias.

PubMed

Keays, Melise A; Starke, Nathan; Lee, Simon C; Bernstein, Ira; Snodgrass, Warren T; Bush, Nicol C

2016-04-01

Current outcome tools for hypospadias have limited focus on the caregiver or patient perspective of important patient centered outcomes. In this study we collaborated with patients, caregivers, and lay and medical experts to develop and pilot a patient reported outcome measure for hypospadias. We developed a patient reported outcome measure based on systematic review of the literature and focus group input. The patient reported outcome measure was piloted in caregivers for boys younger than 8 years and in patients older than 8 years who presented for urology consultation before meeting with the surgeon. Patients were classified with uncorrected hypospadias, successful repair or failed repair based on the presence or absence of complications (fistula, diverticulum, meatal stenosis/stricture, greater than 30-degree recurrent curvature, glans dehiscence and/or skin reoperation). A patient reported outcome measure was developed and administered to 347 patients and/or caregivers-proxies, including 105 uncorrected cases, 162 successful repair cases and 80 failed cases. Satisfaction with appearance was highest in those with successful hypospadias repair compared to failed repair and uncorrected hypospadias (93% vs 77% and 67%, respectively). Voiding symptoms such as spraying or a deviated stream were highest in failed and uncorrected cases (39% and 37%, respectively). Overall dissatisfaction with voiding was highest for uncorrected hypospadias and failed repair compared to successful cases (54% and 47%, respectively, vs 15%). The evaluation of patient and caregiver-proxy reported outcomes in preoperative and postoperative patients with hypospadias allows for the quantification of benefits derived from hypospadias repair and may ultimately represent the gold standard outcome measure for hypospadias. This pilot study identified preliminary patient centered themes and demonstrated the feasibility of administering hypospadias patient reported outcome measures in clinical practice. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

What impact does nursing care left undone have on patient outcomes? Review of the literature.

PubMed

Recio-Saucedo, Alejandra; Dall'Ora, Chiara; Maruotti, Antonello; Ball, Jane; Briggs, Jim; Meredith, Paul; Redfern, Oliver C; Kovacs, Caroline; Prytherch, David; Smith, Gary B; Griffiths, Peter

2018-06-01

Systematic review of the impact of missed nursing care on outcomes in adults, on acute hospital wards and in nursing homes. A considerable body of evidence supports the hypothesis that lower levels of registered nurses on duty increase the likelihood of patients dying on hospital wards, and the risk of many aspects of care being either delayed or left undone (missed). However, the direct consequence of missed care remains unclear. Systematic review. We searched Medline (via Ovid), CINAHL (EBSCOhost) and Scopus for studies examining the association of missed nursing care and at least one patient outcome. Studies regarding registered nurses, healthcare assistants/support workers/nurses' aides were retained. Only adult settings were included. Because of the nature of the review, qualitative studies, editorials, letters and commentaries were excluded. PRISMA guidelines were followed in reporting the review. Fourteen studies reported associations between missed care and patient outcomes. Some studies were secondary analyses of a large parent study. Most of the studies used nurse or patient reports to capture outcomes, with some using administrative data. Four studies found significantly decreased patient satisfaction associated with missed care. Seven studies reported associations with one or more patient outcomes including medication errors, urinary tract infections, patient falls, pressure ulcers, critical incidents, quality of care and patient readmissions. Three studies investigated whether there was a link between missed care and mortality and from these results no clear associations emerged. The review shows the modest evidence base of studies exploring missed care and patient outcomes generated mostly from nurse and patient self-reported data. To support the assertion that nurse staffing levels and skill mix are associated with adverse outcomes as a result of missed care, more research that uses objective staffing and outcome measures is required. Although nurses may exercise judgements in rationing care in the face of pressure, there are nonetheless adverse consequences for patients (ranging from poor experience of care to increased risk of infection, readmissions and complications due to critical incidents from undetected physiological deterioration). Hospitals should pay attention to nurses' reports of missed care and consider routine monitoring as a quality and safety indicator. © 2017 The Authors. Journal of Clinical Nursing Published by John Wiley & Sons Ltd.

Outcome Measures Used to Report Kidney Function in Studies Investigating Surgical Management of Kidney Tumours: A Systematic Review.

PubMed

Ellis, Robert J; Cho, Yeoungjee; Del Vecchio, Sharon J; McStea, Megan; Morais, Christudas; Coombes, Jeff S; Wood, Simon T; Gobe, Glenda C; Francis, Ross S

2018-05-01

Most practice decisions relevant to preserving kidney function in patients managed surgically for kidney tumours are driven by observational studies. A wide range of outcome measures are used in these studies, which reduces comparability and increases the risk of reporting bias. To comprehensively and succinctly describe the outcomes used to evaluate kidney function in studies evaluating surgical management of kidney tumours. Electronic search of the PubMed database was conducted to identify studies with at least one measure of kidney function in patients managed surgically for kidney tumours, published between January 2000 and September 2017. Abstracts were initially screened for eligibility. Full texts of articles were then evaluated in more detail for inclusion. A narrative synthesis of the evidence was conducted. A total of 312 studies, involving 127905 participants, were included in this review. Most were retrospective (n=274) studies and conducted in a single centre (n=264). Overall, 78 unique outcome measures were identified, which were grouped into six outcome categories. Absolute postoperative kidney function (n=187), relative kidney function (n=181), and postoperative chronic kidney disease (n=131) were most frequently reported. Kidney function was predominantly quantified using estimated glomerular filtration rate or creatinine clearance (n=255), most using the modification of diet in renal disease equation (n=182). Only 70 studies provided rationale for specific outcome measures used. There is significant variability in the reporting and quantification of kidney function in studies evaluating patients managed surgically for kidney tumours. A standardised approach to measuring and reporting kidney function will increase the effectiveness of outcomes reported and improve relevance of research findings within a clinical context. Although we know that the removal of a kidney can reduce kidney function, clinical significance of various approaches is a matter of debate. This article demonstrates significant variability in the way kidney function was reported across all studies of patients with kidney cancer undergoing surgery, indicating a need for standardisation. Copyright © 2018 European Association of Urology. All rights reserved.

Revision Hip Arthroscopy: A Systematic Review of Diagnoses, Operative Findings, and Outcomes.

PubMed

Cvetanovich, Gregory L; Harris, Joshua D; Erickson, Brandon J; Bach, Bernard R; Bush-Joseph, Charles A; Nho, Shane J

2015-07-01

To determine indications for, operative findings of, and outcomes of revision hip arthroscopy. A systematic review was registered with PROSPERO and performed based on PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Therapeutic clinical outcome studies reporting the indications for, operative findings of, and outcomes of revision hip arthroscopy were eligible for inclusion. All study-, patient-, and hip-specific data were extracted and analyzed. The Modified Coleman Methodology Score was used to assess study quality. Five studies were included (348 revision hip arthroscopies; 333 patients; mean age, 31.4 ± 4.2 years; 60% female patients). All 5 studies were either Level III or IV evidence. The surgeon performing revision hip arthroscopy was the same as the primary hip surgeon in only 25% of cases. The mean time between primary and revision hip arthroscopy was 27.8 ± 7.0 months (range, 2 to 193 months). Residual femoroacetabular impingement was the most common indication for and operative finding of revision hip arthroscopy (81% of cases). The most commonly reported revision procedures were femoral osteochondroplasty (24%) and acetabuloplasty (18%). The modified Harris Hip Score was used in all 5 analyzed studies, with significant (P < .05) improvements observed in all 5 studies (weighted mean, 56.8 ± 3.6 preoperatively v 72.0 ± 8.3 at final follow-up [22.4 ± 9.8 months]; P = .01). Other patient-reported outcomes (Non-Arthritic Hip Score, Hip Outcome Score, 33-item International Hip Outcome Tool, Short Form 12) showed significant improvements but were not used in all 5 analyzed studies. After revision hip arthroscopy, subsequent reported operations were hip arthroplasty in 11 patients and re-revision hip arthroscopy in 8 patients (5% total reoperation rate). Revision hip arthroscopy is most commonly performed for residual femoroacetabular impingement, with statistically significant and clinically relevant improvements shown in multiple patient-reported clinical outcome scores at short-term follow-up. The reoperation rate after revision hip arthroscopy is 5% within 2 years, including further arthroscopy or conversion to hip arthroplasty. Level IV, systematic review of Level III and IV studies. Copyright © 2015 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Serum uric acid levels and multiple health outcomes: umbrella review of evidence from observational studies, randomised controlled trials, and Mendelian randomisation studies.

PubMed

Li, Xue; Meng, Xiangrui; Timofeeva, Maria; Tzoulaki, Ioanna; Tsilidis, Konstantinos K; Ioannidis, John PA; Campbell, Harry; Theodoratou, Evropi

2017-06-07

Objective  To map the diverse health outcomes associated with serum uric acid (SUA) levels. Design  Umbrella review. Data sources  Medline, Embase, Cochrane Database of Systematic Reviews, and screening of citations and references. Eligibility criteria  Systematic reviews and meta-analyses of observational studies that examined associations between SUA level and health outcomes, meta-analyses of randomised controlled trials that investigated health outcomes related to SUA lowering treatment, and Mendelian randomisation studies that explored the causal associations of SUA level with health outcomes. Results  57 articles reporting 15 systematic reviews and144 meta-analyses of observational studies (76 unique outcomes), 8 articles reporting 31 meta-analyses of randomised controlled trials (20 unique outcomes), and 36 articles reporting 107 Mendelian randomisation studies (56 unique outcomes) met the eligibility criteria. Across all three study types, 136 unique health outcomes were reported. 16 unique outcomes in meta-analyses of observational studies had P<10 -6 , 8 unique outcomes in meta-analyses of randomised controlled trials had P<0.001, and 4 unique outcomes in Mendelian randomisation studies had P<0.01. Large between study heterogeneity was common (80% and 45% in meta-analyses of observational studies and of randomised controlled trials, respectively). 42 (55%) meta-analyses of observational studies and 7 (35%) meta-analyses of randomised controlled trials showed evidence of small study effects or excess significance bias. No associations from meta-analyses of observational studies were classified as convincing; five associations were classified as highly suggestive (increased risk of heart failure, hypertension, impaired fasting glucose or diabetes, chronic kidney disease, coronary heart disease mortality with high SUA levels). Only one outcome from randomised controlled trials (decreased risk of nephrolithiasis recurrence with SUA lowering treatment) had P<0.001, a 95% prediction interval excluding the null, and no large heterogeneity or bias. Only one outcome from Mendelian randomisation studies (increased risk of gout with high SUA levels) presented convincing evidence. Hypertension and chronic kidney disease showed concordant evidence in meta-analyses of observational studies, and in some (but not all) meta-analyses of randomised controlled trials with respective intermediate or surrogate outcomes, but they were not statistically significant in Mendelian randomisation studies. Conclusion  Despite a few hundred systematic reviews, meta-analyses, and Mendelian randomisation studies exploring 136 unique health outcomes, convincing evidence of a clear role of SUA level only exists for gout and nephrolithiasis. 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.

Developing, implementing and disseminating a core outcome set for neonatal medicine.

PubMed

Webbe, James; Brunton, Ginny; Ali, Shohaib; Duffy, James Mn; Modi, Neena; Gale, Chris

2017-01-01

In high resource settings, 1 in 10 newborn babies require admission to a neonatal unit. Research evaluating neonatal care involves recording and reporting many different outcomes and outcome measures. Such variation limits the usefulness of research as studies cannot be compared or combined. To address these limitations, we aim to develop, disseminate and implement a core outcome set for neonatal medicine. A steering group that includes parents and former patients, healthcare professionals and researchers has been formed to guide the development of the core outcome set. We will review neonatal trials systematically to identify previously reported outcomes. Additionally, we will specifically identify outcomes of importance to parents, former patients and healthcare professionals through a systematic review of qualitative studies. Outcomes identified will be entered into an international, multi-perspective eDelphi survey. All key stakeholders will be invited to participate. The Delphi method will encourage individual and group stakeholder consensus to identify a core outcome set. The core outcome set will be mapped to existing, routinely recorded data where these exist. Use of a core set will ensure outcomes of importance to key stakeholders, including former patients and parents, are recorded and reported in a standard fashion in future research. Embedding the core outcome set within future clinical studies will extend the usefulness of research to inform practice, enhance patient care and ultimately improve outcomes. Using routinely recorded electronic data will facilitate implementation with minimal addition burden. Core Outcome Measures in Effectiveness Trials (COMET) database: 842 (www.comet-initiative.org/studies/details/842).

A systematic review of the impact of volume of surgery and specialization on patient outcome.

PubMed

Chowdhury, M M; Dagash, H; Pierro, A

2007-02-01

Volume of surgery and specialization may affect patient outcome. Articles examining the effects of one or more of three variables (hospital volume of surgery, surgeon volume and specialization) on outcome (measured by length of hospital stay, mortality and complication rate) were analysed. Reviews, opinion articles and observational studies were excluded. The methodological quality of each study was assessed, a correlation between the variables analysed and the outcome accepted if it was significant. The search identified 55,391 articles published between 1957 and 2002; 1075 were relevant to the study, of which 163 (9,904,850 patients) fulfilled the entry criteria. These 163 examined 42 different surgical procedures, spanning 13 surgical specialities. None were randomized and 40 investigated more than one variable. Hospital volume was reported in 127 studies; high-volume hospitals had significantly better outcomes in 74.2 per cent of studies, but this effect was limited in prospective studies (40 per cent). Surgeon volume was reported in 58 studies; high-volume surgeons had significantly better outcomes in 74 per cent of studies. Specialization was reported in 22 studies; specialist surgeons had significantly better outcomes than general surgeons in 91 per cent of studies. The benefit of high surgeon volume and specialization varied in magnitude between specialities. High surgeon volume and specialization are associated with improved patient outcome, while high hospital volume is of limited benefit. Copyright (c) 2007 British Journal of Surgery Society Ltd.

Comparative effectiveness studies examining patient-reported outcomes among children with cleft lip and/or palate: a systematic review.

PubMed

Ranganathan, Kavitha; Vercler, Christian J; Warschausky, Seth A; MacEachern, Mark P; Buchman, Steven R; Waljee, Jennifer F

2015-01-01

Health care policy makers are increasingly encouraging comparative effectiveness research. Little is known regarding comparative studies among children with cleft lip and/or palate. Cleft lip and/or palate profoundly influences self-perception and social functioning, and patient-reported outcomes provide a unique perspective on the success of reconstruction. The purpose of this study was to systematically review the literature regarding patient-reported outcomes among patients with cleft lip and/or palate. The authors reviewed articles from MEDLINE, Embase, and PsycInfo that examined the use of patient-reported outcome instruments for cleft lip and/or palate. Studies of patients with cleft lip and/or palate across any age that described the use of patient-completed measures in patient and control populations were included. A research librarian confirmed the search, and two independent, blinded reviewers performed full-text review. The authors identified 1979 articles and selected 30 for inclusion. Forty-two different assessment tools were used to analyze factors such as self-esteem, behavior, and social support. The Strengths and Difficulties Questionnaire was most commonly used (n = 7), followed by the Childhood Experience Questionnaire (n = 5), and the Satisfaction with Appearance survey (n = 4). Barriers to analysis included lack of standardization of survey administration, effect of publication bias, and variations in patient populations between individual studies. Comparative studies of patient-reported outcomes among patients with cleft lip and/or palate are infrequent. Many instruments exist to measure patient-reported outcomes in this population, but no specific standard exists. Identifying efficient and targeted forms of instrument selection and administration will enhance comparative studies among children with cleft lip and/or palate. Diagnostic, III.

Down the Track: TAFE Outcomes for Young People Two Years On

ERIC Educational Resources Information Center

Sherman, Rebecca

2006-01-01

Using results from the 2002 Student Outcomes Survey and a follow-up survey of these students in 2004, this report examines outcomes over time of young people aged 15-24 years who undertook technical and further education (TAFE) training in 2001. The report looks at changes in employment, wages and skill level, further study outcomes and other…

The effects of prenatal cannabis exposure on fetal development and pregnancy outcomes: a protocol.

PubMed

Gunn, Jayleen K L; Rosales, Cecilia B; Center, Katherine E; Nuñez, Annabelle V; Gibson, Steven J; Ehiri, John E

2015-03-13

The effects of exposure to marijuana in utero on fetal development are not clear. Given that the recent legislation on cannabis in the US is likely to result in increased use, there is a need to assess the effects of prenatal cannabis exposure on fetal development and pregnancy outcomes. The objective of this review is to assess the effects of prenatal exposure to cannabis on pregnancy outcomes (including maternal and child outcomes). Major databases will be searched from inception to the latest issue, with the aim of identifying studies that reported the effects of prenatal exposure to cannabis on fetal development and pregnancy outcomes. Two investigators will independently review all titles and abstracts to identify potential articles. Discrepancies will be resolved by repeated review, discussion and consensus. Study quality assessment will be undertaken, using standard protocols. To qualify for inclusion, studies must report at least one maternal or neonatal outcome post partum. Cross-sectional, case-control, cohort and randomised controlled trials published in English will be included. In order to rule out the effects of other drugs that may affect fetal development and pregnancy outcomes, studies will only be included if they report outcomes of prenatal exposure to cannabis while excluding other illicit substances. Data from eligible studies will be extracted, and data analysis will include a systematic review and critical appraisal of evidence, and meta-analysis if data permit. Meta-analysis will be conducted if three or more studies report comparable statistics on the same outcome. The review which will result from this protocol has not already been conducted. Preparation of the review will follow the procedures stated in this protocol, and will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Ethical approval of data will not be required since the review will use data that are already available in the public domain through published articles and other reports. 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.

Farming characteristics and self-reported health outcomes of Irish farmers.

PubMed

van Doorn, D; Richardson, N; Storey, A; Osborne, A; Cunningham, C; Blake, C; McNamara, J

2018-05-17

Irish farmers represent a 'high-risk' group for non-communicable diseases, which, arguably, pose a greater occupational health challenge for farmers. To date, there has been little exploration of the farming characteristics associated with farmers' poor health outcomes. To examine the relationship between farming and male farmers' self-reported health outcomes and to compare the study findings to national health studies to explore which factors specifically are associated with Irish farmers' poorer health outcomes relative to the general population. This cross-sectional survey research used self-reported quantitative data on the health outcomes and health behaviours of male farmers from the South-East of Ireland. Data were entered into SPSS and descriptive and binary regression techniques were used for data analysis. There were 314 participants (99% response rate). Age, full-time farming and dairy farming significantly impacted self-reported health outcomes and health behaviours. There was a high prevalence of self-reported arthritis compared with the national average of Irish males. 'Younger' farmers (<45 years) were more likely to engage in harmful health behaviours such as smoking and 'binge-drinking' one or more times per week. This study identified self-reported patterns of risky lifestyle behaviours among particular subgroups of Irish farmers for whom targeted health interventions are warranted. Interventions are particularly important for younger farmers who may see themselves as invincible and impregnable to ill-health.

Agreement between the results of meta-analyses from case reports and from clinical studies regarding the efficacy of laronidase therapy in patients with mucopolysaccharidosis type I who initiated enzyme replacement therapy in adult age: An example of case reports meta-analyses as an useful tool for evidence-based medicine in rare diseases.

PubMed

Sampayo-Cordero, Miguel; Miguel-Huguet, Bernat; Pardo-Mateos, Almudena; Moltó-Abad, Marc; Muñoz-Delgado, Cecilia; Pérez-López, Jordi

2018-02-01

Case reports might have a prominent role in the rare diseases field, due to the small number of patients affected by one such disease. A previous systematic review regarding the efficacy of laronidase therapy in patients with mucopolysaccharidosis type I (MPS-I) who initiated enzyme replacement therapy (ERT) in adult age has been published. The review included a meta-analysis of 19 clinical studies and the description of eleven case reports. It was of interest to perform a meta-analysis of those case reports to explore the role of such meta-analyses as a tool for evidence-based medicine in rare diseases. The study included all case reports with standard treatment regimen. Primary analysis was the percentage of case reports showing an improvement in a specific outcome. Only when that percentage was statistically higher than 5%, the improvement was confirmed as such. The outcomes that accomplished this criterion were ranked and compared to the GRADE criteria obtained by those same outcomes in the previous meta-analysis of clinical studies. There were three outcomes that had a significant improvement: Urine glycosaminoglycans, liver volume and 6-minute walking test. Positive and negative predictive values, sensitivity and specificity for the results of the meta-analysis of case reports as compared to that of clinical studies were 100%, 88.9%, 75% and 100%, respectively. Accordingly, absolute (Rho=0.82, 95%CI: 0.47 to 0.95) and relative agreement (Kappa=0.79, 95%CI: 0.593 to 0.99) between the number of case reports with improvement in a specific outcome and the GRADE evidence score for that outcome were good. Sensitivity analysis showed that agreement between the meta-analysis of case reports and that of the clinical studies were good only when using a strong confirmatory strategy for outcome improvement in case reports. We found an agreement between the results of meta-analyses from case reports and from clinical studies in the efficacy of laronidase therapy in patients with MPS-I who initiated ERT in adult age. This agreement suggests that combining case reports quantitatively, rather than analyzing them separately or qualitatively, may improve conclusions in the field of rare diseases. Copyright © 2018 Elsevier Inc. All rights reserved.

Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Schlessinger, Daniel I; Iyengar, Sanjana; Yanes, Arianna F; Chiren, Sarah G; Godinez-Puig, Victoria; Chen, Brian R; Kurta, Anastasia O; Schmitt, Jochen; Deckert, Stefanie; Furlan, Karina C; Poon, Emily; Cartee, Todd V; Maher, Ian A; Alam, Murad; Sobanko, Joseph F

2017-07-12

Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinically irrelevant. The outcome heterogeneity and reporting bias of these studies leave clinicians unable to accurately compare studies. Core outcome sets (COSs) are an agreed minimum set of outcomes recommended to be measured and reported in all clinical trials of a given condition or disease. Although COSs are under development for several dermatologic conditions, work has yet to be done to identify core outcomes specific for SCC. Outcome extraction for COS generation will occur via four methods: (1) systematic literature review; (2) patient interviews; (3) other published sources; and (4) input from stakeholders in medicine, pharmacy, and other relevant industries. The list of outcomes will be revaluated by the Measuring PRiority Outcome Variables via Excellence in Dermatologic surgery (IMPROVED) Steering Committee. Delphi processes will be performed separately by expert clinicians and patients to condense the list of outcomes generated. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. At the end of the meeting, members will vote and decide on a final recommended set of core outcomes. The Core Outcome Measures in Effectiveness Trials (COMET) organization and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN) will serve as advisers throughout the COS generation process. Comparison of clinical trials via systematic reviews and meta-analyses is facilitated when investigators study outcomes that are relevant and similar. The aim of this project is to develop a COS to guide use for future clinical trials.

A systematic review assessing non-pharmacological conservative treatment studies for people with non-inflammatory multi-joint pain: clinical outcomes and research design considerations.

PubMed

Comer, C; Smith, T O; Drew, B; Raja, R; Kingsbury, S R; Conaghan, Philip G

2018-03-01

To systematically review the evidence to determine the clinical outcomes and the important methodological quality features of interventional studies on adults with non-inflammatory multi-joint pain (MJP). Systematic search of published and unpublished literature using the databases: AMED, CINAHL, MEDLINE, EMBASE, psycINFO, SPORTDiscus, PEDro, OpenGrey, the EU Clinical Trials Register, World Health Organization International Clinical Trial Registry Platform, ClinicalTrials.gov and the ISRCTN registry (search: inception to 19th October 2017). All papers reporting the clinical outcomes of non-pharmacological interventions for people with non-inflammatory MJP were included. Studies were critically appraised using the Downs and Black Critical Appraisal and the TIDieR reporting checklists. Data were analysed using a Best Evidence Synthesis approach. From 3824 citations, four papers satisfied the eligibility criteria. Three studies reported outcomes from multidisciplinary rehabilitation programmes and one study reported the findings of a spa therapy intervention. All interventions significantly improved pain, function and quality of life in the short-term. There was limited reporting of measures for absenteeism, presenteeism and psychosocial outcomes. The evidence was 'weak', and due to a lack of controlled trials, there is limited evidence to ascertain treatment effectiveness. Design consideration for future trials surround improved reporting of participant characteristics, interventions and the standardisation of core outcome measures. There is insufficient high-quality trial data to determine the effectiveness of treatments for non-inflammatory MJP. Given the significant health burden which this condition presents on both individuals and wider society, developing and testing interventions and accurately reporting these, should be a research priority. Registration PROSPERO (CRD42013005888).

Protocol for the development of a Core Outcome Set (COS) for hemorrhoidal disease: an international Delphi study.

PubMed

van Tol, R R; Melenhorst, J; Dirksen, C D; Stassen, L P S; Breukink, S O

2017-07-01

Over the last decade, many studies were performed regarding treatment options for hemorrhoidal disease. Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes. However, the reported outcome measures are numerous and diverse. The heterogeneity of outcome definition in clinical trials limits transparency and paves the way for bias. The development of a core outcome set (COS) helps minimizing this problem. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease. The aim of this project is to generate a COS regarding the outcome of treatment after hemorrhoidal disease. A Delphi study will be performed by an international steering group healthcare professionals and patients with the intention to create a standard outcome set for future clinical trials for the treatment of hemorrhoidal disease. First, a literature review will be conducted to establish which outcomes are used in clinical trials for hemorrhoidal disease. Secondly, both healthcare professionals and patients will participate in several consecutive rounds of online questionnaires and a face-to-face meeting to refine the content of the COS. Development of a COS for hemorrhoidal disease defines a minimum outcome-reporting standard and will improve the quality of research in the future.

Inequalities in multiple health outcomes by education, sex, and race in 93 US counties: why we should measure them all.

PubMed

Asada, Yukiko; Whipp, Alyce; Kindig, David; Billard, Beverly; Rudolph, Barbara

2014-06-13

Regular reporting of health inequalities is essential to monitoring progress of efforts to reduce health inequalities. While reporting of population health became increasingly common, reporting of a subpopulation group breakdown of each indicator of the health of the population is rarely a standard practice. This study reports education-, sex-, and race-related inequalities in four health outcomes in each of the selected 93 counties in the United States in a systematic and comparable manner. This study is a cross-sectional analysis of large, publicly available data, 2008, 2009, and 2010 Behavioral Risk Factor Surveillance System (BRFSS) Selected Metropolitan/Micropolitan Area Risk Trends (SMART) and 2008, 2009, and 2010 United States Birth Records from the National Vital Statistics System. The study population is American adults older than 25 years of age residing in the selected 93 counties, representing about 30% of the US population, roughly equally covering all geographic regions of the country. Main outcome measures are: (1) Attribute (group characteristic)-specific inequality: education-, sex-, or race-specific inequality in each of the four health outcomes (poor or fair health, poor physical health days, poor mental health days, and low birthweight) in each county; (2) Overall inequality: the average of these three attribute-specific inequalities for each health outcome in each county; and (3) Summary inequality in total morbidity: the weighted average of the overall inequalities across the four health outcomes in each county. The range of inequality across the counties differed considerably by health outcome; inequality in poor or fair health had the widest range and the highest median among inequalities in all health outcomes. In more than 70% of the counties, education-specific inequality was the largest in all health outcomes except for low birthweight. It is feasible to extend population health reporting to include reporting of a subpopulation group breakdown of each indicator of the health of the population at a small jurisdictional level using publicly available data. No single group characteristic or health outcome represents the whole picture of health inequalities in a population. Examining multiple group characteristics and outcomes in a comparable manner is essential in reporting health inequalities.

A Systematic Review of Diuretics in the Medical Management of Ménière's Disease.

PubMed

Crowson, Matthew G; Patki, Aniruddha; Tucci, Debara L

2016-05-01

(1) Review evidence for the use of oral diuretic medications in the management of Ménière's disease. (2) Analyze therapy-related hearing and vertigo outcomes. Literature was obtained through directed searches of MEDLINE, EMBASE, Web of Science, EBSCO Host, Cochrane Reviews, and linked citations through seminal papers. We searched independent electronic databases for articles that reported the use of diuretics in patients with Ménière's disease. All articles of level 4 evidence or higher, per the Oxford Centre for Evidence-Based Medicine, were included with no limit for number of patients, duration of therapy, or follow-up period. Two independent investigators reviewed the articles for inclusion eligibility. Outcomes were tabulated, including subjective or quantitative measures of hearing, tinnitus, vertigo episode frequency, and medication adverse effects. Nineteen articles were included from 1962 to 2012 from 11 countries. Twelve retrospective case series, 4 randomized controlled trials, 2 case-control trials, and 1 prospective case series were identified. Six studies investigated isosorbide; 5, hydrochlorothiazide; 2, acetazolamide; 2, chlorthalidone; and 1 each of betahistine, hydrochlorothiazide, chlorthalidone, acetazolamide, hydrochlorothiazide-triamterene, and nimodipine. Eight (42.1%) studies reported hearing outcomes improvement. Fifteen (79.0%) studies reported vertigo outcomes improvement. Ten (52.6%) studies reported no side effects, and 4 studies (21.1%) reported abdominal discomfort. No significant morbidity or mortality was reported in any study. Multiple low evidence-level studies report that oral diuretic therapy may be beneficial in the medical management of Ménière's disease. Improvement in vertigo episode frequency was consistently reported, with less convincing evidence for improvement in hearing outcomes. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

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.

Long-term Non-Invasive Ventilation in Infants: A Systematic Review and Meta-Analysis.

PubMed

Bedi, Prabhjot K; Castro-Codesal, Maria Luisa; Featherstone, Robin; AlBalawi, Mohammed M; Alkhaledi, Bashar; Kozyrskyj, Anita L; Flores-Mir, Carlos; MacLean, Joanna E

2018-01-01

The use of long-term non-invasive ventilation (NIV) to treat sleep and breathing disorders in children has increased substantially in the last decade; however, less data exist about its use in infants. Given that infants have distinct sleep and breathing patterns when compared to older children, the outcomes of infants on long-term NIV may differ as well. The aim of this study is to systematically review the use and outcomes of long-term NIV in infants. Ovid Medline, Ovid Embase, CINAHL (via EbscoHOST), PubMed, and Wiley Cochrane Library were systematically searched from January 1990 to July 2017. Studies on infants using long-term NIV outside of an acute care setting were included. Data were extracted on study design, population characteristics, and NIV outcomes. A total of 327 studies were full-text reviewed, with final inclusion of 60. Studies were distributed across airway (40%), neuromuscular (28%), central nervous system (10%), cardio-respiratory (2%), and multiple (20%) disease categories. Of the 18 airway studies reporting on NIV outcomes, 13 (72%) reported improvements in respiratory parameters. Of the 12 neuromuscular studies exclusively on spinal muscular atrophy type 1 (SMA1), six (50%) reported decreased hospitalizations and nine (75%) reported on mortality outcomes. Risk of bias was moderate to serious, and quality of the evidence was low to very low for all studies. Most studies had an observational design with no control group, limiting the potential for a meta-analysis. The outcomes reported in studies differed by the disease category being studied. Studies on airway conditions showed improvements in respiratory parameters for infants using NIV. Studies on neuromuscular disorder, which were almost exclusively on SMA1, reported decreased hospitalizations and prolonged survival. Overall, it appears that NIV is an effective long-term therapy for infants. However, the high risk of bias and low quality of the available evidence limited strong conclusions.

Use of Antegrade Continence Enema for the Treatment of Fecal Incontinence and Functional Constipation in Adults: A Systematic Review.

PubMed

Patel, Abhilasha S; Saratzis, Athanasios; Arasaradnam, Ramesh; Harmston, Christopher

2015-10-01

Antegrade continence enema is a proximal colonic stoma that allows antegrade lavage of the colon for the treatment of fecal incontinence and functional constipation. Its role in the treatment of these conditions in adults has not been established. This review aimed to evaluate the clinical response and complications of antegrade continence enema in the adult population. A systematic literature search of MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases from January 1980 to October 2013 was conducted. Studies reporting clinical outcomes of antegrade continence enema in adult patients were considered. Only studies with participants aged 16 years and older were selected. Use of the antegrade continence enema for the treatment of constipation and incontinence in adults was investigated. The primary outcome was the number of patients irrigating their stoma. Secondary outcomes included the incidence of stoma stenosis, assessment of functional outcome, and evaluation of quality of life. Overall, 15 studies were selected, describing outcomes in 374 patients. All of the reports were observational cross-sectional studies, and 4 were prospective. The number of participants still using their stoma ranged from 47% to 100% over a follow-up period of 6 to 55 months. Eleven studies reported achievement of full continence in 33% to 100% of patients. Four studies described functional outcomes, and 7 studies reported a wide range of patient satisfaction. The rate of stoma stenosis varied from 8% to 50%. There were considerable heterogeneities within and across studies. Most studies were of poor quality, as reflected in the Methodological Index for Nonrandomized Studies score. Antegrade continence enema has been reported as an acceptable treatment of both functional constipation and fecal incontinence in adults across several analyses. There is wide variation regarding outcome measures. Larger prospective studies are required to assess the role of antegrade continence enema in the adult population.

Student Outcomes 2009: Data Dictionary. Support Document

ERIC Educational Resources Information Center

National Centre for Vocational Education Research (NCVER), 2009

2009-01-01

This document was produced as an added resource for the report "Outcomes from the Productivity Places Program, 2009." The study reported the outcomes for students who completed their vocational education and training (VET) under the Productivity Places Program (PPP) during 2008. This document presents an alphabetical arrangement of the…

Clinical assessment and patient-reported outcome measures in low-back pain - a survey among primary health care physiotherapists.

PubMed

Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva

2018-05-09

We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by <15%. Advantages in using patient-reported outcome measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of rehabilitation in low-back pain, yellow flags, and other factors need to be taken into the consideration in the assessment which means the use of patient-reported outcome measures in addition to clinical testing. The use of patient-reported outcome measures is an advantage in the clinical reasoning process to enhance the quality of assessment and to educate and motivate the patient. Barriers to use patient-reported outcome measures are mainly lack of time and knowledge, and administrative aspects. Through education or organizational change-work, barriers to the use of patient-reported outcome measures might be changed.

A Review of Quality Measures for Assessing the Impact of Antimicrobial Stewardship Programs in Hospitals

PubMed Central

Akpan, Mary Richard; Ahmad, Raheelah; Shebl, Nada Atef; Ashiru-Oredope, Diane

2016-01-01

The growing problem of antimicrobial resistance (AMR) has led to calls for antimicrobial stewardship programs (ASP) to control antibiotic use in healthcare settings. Key strategies include prospective audit with feedback and intervention, and formulary restriction and preauthorization. Education, guidelines, clinical pathways, de-escalation, and intravenous to oral conversion are also part of some programs. Impact and quality of ASP can be assessed using process or outcome measures. Outcome measures are categorized as microbiological, patient or financial outcomes. The objective of this review was to provide an overview of quality measures for assessing ASP and the reported impact of ASP in peer-reviewed studies, focusing particularly on patient outcomes. A literature search of papers published in English between 1990 and June 2015 was conducted in five databases using a combination of search terms. Primary studies of any design were included. A total of 63 studies were included in this review. Four studies defined quality metrics for evaluating ASP. Twenty-one studies assessed the impact of ASP on antimicrobial utilization and cost, 25 studies evaluated impact on resistance patterns and/or rate of Clostridium difficile infection (CDI). Thirteen studies assessed impact on patient outcomes including mortality, length of stay (LOS) and readmission rates. Six of these 13 studies reported non-significant difference in mortality between pre- and post-ASP intervention, and five reported reductions in mortality rate. On LOS, six studies reported shorter LOS post intervention; a significant reduction was reported in one of these studies. Of note, this latter study reported significantly (p < 0.001) higher unplanned readmissions related to infections post-ASP. Patient outcomes need to be a key component of ASP evaluation. The choice of metrics is influenced by data and resource availability. Controlling for confounders must be considered in the design of evaluation studies to adequately capture the impact of ASP and it is important for unintended consequences to be considered. This review provides a starting point toward compiling standard outcome metrics for assessing ASP. PMID:27025520

Complex Relationships Among Masculine Norms and Health/Well-Being Outcomes: Correlation Patterns of the Conformity to Masculine Norms Inventory Subscales

PubMed Central

Gerdes, Zachary T.; Levant, Ronald F.

2017-01-01

The Conformity to Masculine Norms Inventory (CMNI) is a widely used multidimensional scale. Studies using the CMNI most often report only total scale scores, which are predominantly associated with negative outcomes. Various studies since the CMNI’s inception in 2003 using subscales have reported both positive and negative outcomes. The current content analysis examined studies (N = 17) correlating the 11 subscales with 63 criterion variables across 7 categories. Most findings were consistent with past research using total scale scores that reported negative outcomes. For example, conformity to masculine norms has been inversely related to help-seeking and positively correlated with concerning health variables, such as substance use. Nonetheless, past reliance on total scores has obscured the complexity of associations with the CMNI in that 30% of the findings in the present study reflected positive outcomes, particularly for health promotion. Subscales differed in their relationships with various outcomes: for one subscale they were predominantly positive, but six others were mostly negative. The situational and contextual implications of conformity to masculine norms and their relationships to positive and negative outcomes are discussed. PMID:29219033

A systematic review and development of a classification framework for factors associated with missing patient-reported outcome data.

PubMed

Palmer, Michael J; Mercieca-Bebber, Rebecca; King, Madeleine; Calvert, Melanie; Richardson, Harriet; Brundage, Michael

2018-02-01

Missing patient-reported outcome data can lead to biased results, to loss of power to detect between-treatment differences, and to research waste. Awareness of factors may help researchers reduce missing patient-reported outcome data through study design and trial processes. The aim was to construct a Classification Framework of factors associated with missing patient-reported outcome data in the context of comparative studies. The first step in this process was informed by a systematic review. Two databases (MEDLINE and CINAHL) were searched from inception to March 2015 for English articles. Inclusion criteria were (a) relevant to patient-reported outcomes, (b) discussed missing data or compliance in prospective medical studies, and (c) examined predictors or causes of missing data, including reasons identified in actual trial datasets and reported on cover sheets. Two reviewers independently screened titles and abstracts. Discrepancies were discussed with the research team prior to finalizing the list of eligible papers. In completing the systematic review, four particular challenges to synthesizing the extracted information were identified. To address these challenges, operational principles were established by consensus to guide the development of the Classification Framework. A total of 6027 records were screened. In all, 100 papers were eligible and included in the review. Of these, 57% focused on cancer, 23% did not specify disease, and 20% reported for patients with a variety of non-cancer conditions. In total, 40% of the papers offered a descriptive analysis of possible factors associated with missing data, but some papers used other methods. In total, 663 excerpts of text (units), each describing a factor associated with missing patient-reported outcome data, were extracted verbatim. Redundant units were identified and sequestered. Similar units were grouped, and an iterative process of consensus among the investigators was used to reduce these units to a list of factors that met the guiding principles. The list was organized on a framework, using an iterative consensus-based process. The resultant Classification Framework is a summary of the factors associated with missing patient-reported outcome data described in the literature. It consists of 5 components (instrument, participant, centre, staff, and study) and 46 categories, each with one or more sub-categories or examples. A systematic review of the literature revealed 46 unique categories of factors associated with missing patient-reported outcome data, organized into 5 main component groups. The Classification Framework may assist researchers to improve the design of new randomized clinical trials and to implement procedures to reduce missing patient-reported outcome data. Further research using the Classification Framework to inform quantitative analyses of missing patient-reported outcome data in existing clinical trials and to inform qualitative inquiry of research staff is planned.

A systematic review of outcomes after revision amputation for treatment of traumatic finger amputation

PubMed Central

Yuan, Frank; McGlinn, Evan P.; Giladi, Aviram M.; Chung, Kevin C.

2015-01-01

Background Revision amputations are often the treatment for traumatic finger amputation injuries. However, patient outcomes are inadequately reported, and their impact poorly understood. We performed a systematic review to evaluate outcomes of revision amputations and amputation wound coverage techniques. Methods We searched all available English literature in PubMed and EMBASE for articles reporting outcomes of non-replantation treatments for traumatic finger amputation injuries, including revision amputation, local digital flaps, skin grafting, and conservative treatment. Data extracted were study characteristics, patient demographic data, sensory and functional outcomes, patient-reported outcomes (PROs), and complications. Results 1659 articles were screened, yielding 43 studies for review. Mean static 2-point discrimination (2-PD) was 5.0 ± 1.5 mm (n=23 studies) overall. Mean static 2-PD was 6.1 ± 2.4 mm after local flap procedures and 3.8 ± 0.4 mm after revision amputation. Mean total active motion (TAM) was 93 ± 8% of normal (n=6 studies) overall. Mean TAM was 90 ± 9% of normal after local flap procedures and 95% of normal after revision amputation. 77% of patients report cold intolerance after revision amputation. 91% of patients (217/238) report “satisfactory” or “good/excellent” ratings regardless of treatment. Conclusion Revision amputation and conservative treatments result in better static 2-PD outcomes compared to local flaps. All techniques preserve TAM, although arc of motion is slightly better with revision amputation. Revision amputation procedures are frequently associated with cold intolerance. Patients report “satisfactory,” “good,” or “excellent” ratings in appearance and quality of life with all non-replantation techniques. Level of Evidence III PMID:26111316

The impact of Public Reporting on clinical outcomes: a systematic review and meta-analysis.

PubMed

Campanella, Paolo; Vukovic, Vladimir; Parente, Paolo; Sulejmani, Adela; Ricciardi, Walter; Specchia, Maria Lucia

2016-07-22

To assess both qualitatively and quantitatively the impact of Public Reporting (PR) on clinical outcomes, we carried out a systematic review of published studies on this topic. Pubmed, Web of Science and SCOPUS databases were searched to identify studies published from 1991 to 2014 that investigated the relationship between PR and clinical outcomes. Studies were considered eligible if they investigated the relationship between PR and clinical outcomes and comprehensively described the PR mechanism and the study design adopted. Among the clinical outcomes identified, meta-analysis was performed for overall mortality rate which quantitative data were exhaustively reported in a sufficient number of studies. Two reviewers conducted all data extraction independently and disagreements were resolved through discussion. The same reviewers evaluated also the quality of the studies using a GRADE approach. Twenty-seven studies were included. Mainly, the effect of PR on clinical outcomes was positive. Meta-analysis regarding overall mortality included, in a context of high heterogeneity, 10 studies with a total of 1,840,401 experimental events and 3,670,446 control events and resulted in a RR of 0.85 (95 % CI, 0.79-0.92). The introduction of PR programs at different levels of the healthcare sector is a challenging but rewarding public health strategy. Existing research covering different clinical outcomes supports the idea that PR could, in fact, stimulate providers to improve healthcare quality.

Childhood Sexual Abuse Patterns, Psychosocial Correlates, and Treatment Outcomes among Adults in Drug Abuse Treatment

ERIC Educational Resources Information Center

Boles, Sharon M.; Joshi, Vandana; Grella, Christine; Wellisch, Jean

2005-01-01

This study reports on the effects of having a history of childhood sexual abuse (CSA) on treatment outcomes among substance abusing men and women (N = 2,434) in a national, multisite study of drug treatment outcomes. A history of CSA was reported by 27.2% of the women and 9.2% of the men. Controlling for gender, compared to patients without CSA,…

Standard of treatment and outcomes of adults with lupus nephritis in Africa: a systematic review.

PubMed

Ameh, O I; Kengne, A P; Jayne, D; Bello, A K; Hodkinson, B; Gcelu, A; Okpechi, I G

2016-10-01

Lupus nephritis (LN) is a significant cause of mortality and morbidity in patients with systemic lupus erythematosus (SLE) and the severity of disease has been described to be increased in Africans. Observational studies have been conducted; however, the treatment and outcome of African patients with LN has not been rigorously assessed. We conducted a systematic review of studies selected from a PubMed search of outcome in Africans with biopsy-proven LN from 1 January 1990 to 30 June 2015. Studies that gave information on histology, treatment and outcome of patients were included. Sixteen studies were selected from a search that yielded 302 papers; half were from North Africa, 2/16 (12.5%) were prospective studies and 2/16 (12.5%) were multi-centre studies. The sample size of reported biopsies in the studies ranged from 22 to 246 patients. Only 3/16 (18.8%) studies used more recent criteria for the classification and reporting of renal histology, and proliferative LN (class III and IV) were reported with increased frequency from the studies. For induction therapy, all the studies reported use of corticosteroids while 15/16 (93.8%) of the studies also used cyclophosphamide (CYC) as an induction agent. Overall mortality rates ranged from 7.9% to 34.9% with increased disease activity, kidney failure and infections cited as common causes of mortality. Five-year renal survival was 48-84% while five-year patient survival was 54%-94%. Survival rates were higher for studies reported from North Africa. This analysis highlights diagnostic challenges in LN in Africa and shows that a CYC/glucocorticoid-based regimen remains the standard of treatment for adult patients. The contributions of this therapy to reported outcomes of LN in Africa require further exploration. © The Author(s) 2016.

The effectiveness of regionalization of perinatal care services--a systematic review.

PubMed

Rashidian, A; Omidvari, A H; Vali, Y; Mortaz, S; Yousefi-Nooraie, R; Jafari, M; Bhutta, Z A

2014-10-01

Several reports recommend the implementation of perinatal regionalization for improvements in maternal and neonatal outcomes, while research evidence on the effectiveness of perinatal regionalization has been limited. The interventional studies have been assessed for robust evidence on the effectiveness of perinatal regionalization on improving maternal and neonatal health outcomes. Bibliographic databases of Medline, EMbase, EconLit, HMIC have been searched using sensitive search terms for interventional studies that reported important patient or process outcomes. At least two authors assessed eligibility for inclusion and the risk of biases and extracted data from the included studies. As meta-analysis was not possible, a narrative analysis as well as a 'vote-counting' analysis has been conducted for important outcomes. After initial screenings 53 full text papers were retrieved. Eight studies were included in the review from the USA, Canada and France. Studies varied in their designs, and in the specifications of the intervention and setting. Only three interrupted time series studies had a low risk of bias, of which only one study reported significant reductions in neonatal and infant mortality. Studies of higher risk of bias were more likely to report improvements in outcomes. Implementing perinatal regionalization programs is correlated with improvements in perinatal outcomes, but it is not possible to establish a causal link. Despite several high profile policy statements, evidence of effect is weak. It is necessary to assess the effectiveness of perinatal regionalization using robust research designs in a more diverse range of countries.

Measure Once, Cut Twice – Adding Patient-Reported Outcome Measures to the Electronic Health Record for Comparative Effectiveness Research

PubMed Central

Wu, Albert W.; Kharrazi, Hadi; Boulware, L. Ebony; Snyder, Claire F.

2013-01-01

Objective This paper presents the current state of patient-reported outcome measures, and explains new opportunities for leveraging the recent adoption of electronic health records to expand the application of patient-reported outcomes in both clinical care and comparative effectiveness research. Study Design and Setting Historic developments of patient-reported outcome, electronic health record, and comparative effectiveness research are analyzed in two dimensions: patient-centeredness and digitization. We pose the question: “What needs to be standardized around the collection of patient-reported outcomes in electronic health records for comparative effectiveness research?” Results We identified three converging trends: the progression of patient-reported outcomes toward greater patient centeredness and electronic adaptation; the evolution of electronic health records into personalized and fully digitized solutions; the shift toward patient-oriented comparative effectiveness research. Related to this convergence, we propose an architecture for patient-reported outcome standardization that could serve as a first step toward a more comprehensive integration of patient-reported outcomes with electronic health record for both practice and research. Conclusion The science of patient-reported outcome measurement has matured sufficiently to be integrated routinely into electronic health records and other e-health solutions to collect data on an ongoing basis for clinical care and comparative effectiveness research. Further efforts and ideally coordinated efforts from various stakeholders are needed to refine the details of the proposed framework for standardization. PMID:23849145

A systematic review of the association between family meals and adolescent risk outcomes.

PubMed

Goldfarb, Samantha S; Tarver, Will L; Locher, Julie L; Preskitt, Julie; Sen, Bisakha

2015-10-01

To conduct a systematic review of the literature examining the relationship between family meals and adolescent health risk outcomes. We performed a systematic search of original empirical studies published between January 1990 and September 2013. Based on data from selected studies, we conducted logistic regression models to examine the correlates of reporting a protective association between frequent family meals and adolescent outcomes. Of the 254 analyses from 26 selected studies, most reported a significant association between family meals and the adolescent risk outcome-of-interest. However, model analyses which controlled for family connectedness variables, or used advanced empirical methods to account for family-level confounders, were less likely than unadjusted models to report significant relationships. The type of analysis conducted was significantly associated with the likelihood of finding a protective relationship between family meals and the adolescent outcome-of-interest, yet very few studies are using such methods in the literature. Copyright © 2015 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

A Cross-Sectional Review of Reporting Variation in Postoperative Bowel Dysfunction After Rectal Cancer Surgery.

PubMed

Chapman, Stephen J; Bolton, William S; Corrigan, Neil; Young, Neville; Jayne, David G

2017-02-01

Postoperative bowel dysfunction affects quality of life after sphincter-preserving rectal cancer surgery, but the extent of the problem is not clearly defined because of inconsistent outcome measures used to characterize the condition. The purpose of this study was to assess variation in the reporting of postoperative bowel dysfunction and to make recommendations for standardization in future studies. If possible, a quantitative synthesis of bowel dysfunction symptoms was planned. MEDLINE and EMBASE databases, as well as the Cochrane Library, were queried systematically between 2004 and 2015. The studies selected reported at least 1 component of bowel dysfunction after resection of rectal cancer. The main outcome measures were reporting, measurement, and definition of postoperative bowel dysfunction. Of 5428 studies identified, 234 met inclusion criteria. Widely reported components of bowel dysfunction were incontinence to stool (227/234 (97.0%)), frequency (168/234 (71.8%)), and incontinence to flatus (158/234 (67.5%)). Urgency and stool clustering were reported less commonly, with rates of 106 (45.3%) of 234 and 61 (26.1%) of 234. Bowel dysfunction measured as a primary outcome was associated with better reporting (OR = 3.49 (95% CI, 1.99-6.23); p < 0.001). Less than half of the outcomes were assessed using a dedicated research tool (337/720 (46.8%)), and the remaining descriptive measures were infrequently defined (56/383 (14.6%)). Heterogeneity in the reporting, measurement, and definition of postoperative bowel dysfunction precluded pooling of results and limited interpretation. Considerable variation exists in the reporting, measurement, and definition of postoperative bowel dysfunction. These inconsistencies preclude reliable estimates of incidence and meta-analysis. A broadly accepted outcome measure may address this deficit in future studies.

Systematic Review of Radiation Therapy Toxicity Reporting in Randomized Controlled Trials of Rectal Cancer: A Comparison of Patient-Reported Outcomes and Clinician Toxicity Reporting

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gilbert, Alexandra, E-mail: a.gilbert@leeds.ac.uk; Ziegler, Lucy; Martland, Maisie

The use of multimodal treatments for rectal cancer has improved cancer-related outcomes but makes monitoring toxicity challenging. Optimizing future radiation therapy regimens requires collection and publication of detailed toxicity data. This review evaluated the quality of toxicity information provided in randomized controlled trials (RCTs) of radiation therapy in rectal cancer and focused on the difference between clinician-reported and patient-reported toxicity. Medline, EMBASE, and the Cochrane Library were searched (January 1995-July 2013) for RCTs reporting late toxicity in patients treated with regimens including preoperative (chemo)radiation therapy. Data on toxicity measures and information on toxicity reported were extracted using Quantitative Analyses ofmore » Normal Tissue Effects in the Clinic recommendations. International Society for Quality of Life Research standards on patient-reported outcomes (PROs) were used to evaluate the quality of patient-reported toxicity. Twenty-one RCT publications met inclusion criteria out of 4144 articles screened. All PRO studies reported higher rates of toxicity symptoms than clinician-reported studies and reported on a wider range and milder symptoms. No clinician-reported study published data on sexual dysfunction. Of the clinician-reported studies, 55% grouped toxicity data related to an organ system together (eg “Bowel”), and 45% presented data only on more-severe (grade ≥3) toxicity. In comparison, all toxicity grades were reported in 79% of PRO publications, and all studies (100%) presented individual symptom toxicity data (eg bowel urgency). However, PRO reporting quality was variable. Only 43% of PRO studies presented baseline data, 28% did not use any psychometrically validated instruments, and only 29% of studies described statistical methods for managing missing data. Analysis of these trials highlights the lack of reporting standards for adverse events and reveals the differences between clinician and patient reporting of toxicity. Recommendations for improving the quality of adverse event data collection are provided, with the aim of improving critical appraisal of outcomes for future studies.« less

A quantitative assessment of patient and nurse outcomes of bedside nursing report implementation.

PubMed

Sand-Jecklin, Kari; Sherman, Jay

2014-10-01

To quantify quantitative outcomes of a practice change to a blended form of bedside nursing report. The literature identifies several benefits of bedside nursing shift report. However, published studies have not adequately quantified outcomes related to this process change, having either small or unreported sample sizes or not testing for statistical significance. Quasi-experimental pre- and postimplementation design. Seven medical-surgical units in a large university hospital implemented a blend of recorded and bedside nursing report. Outcomes monitored included patient and nursing satisfaction, patient falls, nursing overtime and medication errors. We found statistically significant improvements postimplementation in four patient survey items specifically impacted by the change to bedside report. Nursing perceptions of report were significantly improved in the areas of patient safety and involvement in care and nurse accountability postimplementation. However, there was a decline in nurse perception that report took a reasonable amount of time after bedside report implementation; contrary to these perceptions, there was no significant increase in nurse overtime. Patient falls at shift change decreased substantially after the implementation of bedside report. An intervening variable during the study period invalidated the comparison of medication errors pre- and postintervention. There was some indication from both patients and nurses that bedside report was not always consistently implemented. Several positive outcomes were documented in relation to the implementation of a blended bedside shift report, with few drawbacks. Nurse attitudes about report at the final data collection were more positive than at the initial postimplementation data collection. If properly implemented, nursing bedside report can result in improved patient and nursing satisfaction and patient safety outcomes. However, managers should involve staff nurses in the implementation process and continue to monitor consistency in report format as well as satisfaction with the process. © 2014 John Wiley & Sons Ltd.

Implementation of learning outcome attainment measurement system in aviation engineering higher education

NASA Astrophysics Data System (ADS)

Salleh, I. Mohd; Mat Rani, M.

2017-12-01

This paper aims to discuss the effectiveness of the Learning Outcome Attainment Measurement System in assisting Outcome Based Education (OBE) for Aviation Engineering Higher Education in Malaysia. Direct assessments are discussed to show the implementation processes that become a key role in the successful outcome measurement system. A case study presented in this paper involves investigation on the implementation of the system in Aircraft Structure course for Bachelor in Aircraft Engineering Technology program in UniKL-MIAT. The data has been collected for five semesters, starting from July 2014 until July 2016. The study instruments used include the report generated in Learning Outcomes Measurements System (LOAMS) that contains information on the course learning outcomes (CLO) individual and course average performance reports. The report derived from LOAMS is analyzed and the data analysis has revealed that there is a positive significant correlation between the individual performance and the average performance reports. The results for analysis of variance has further revealed that there is a significant difference in OBE grade score among the report. Independent samples F-test results, on the other hand, indicate that the variances of the two populations are unequal.

Do women fare worse? A metaanalysis of gender differences in outcome after traumatic brain injury.

PubMed

Farace, E; Alves, W M

2000-01-01

The purpose of this metaanalysis was to investigate possible gender differences in TBI sequelae. The case fatality rates in patients after TBI have previously been shown to be significantly higher in women as compared with men. A quantitative review of published studies of TBI outcome revealed eight studies (20 outcome variables) of TBI in which outcome was reported separately for men and women. Outcome was worse in women than in men for 85% of the measured variables, with an average effect size of -0.15. Although clinical opinion is often that women tend to experience better outcomes than do men after TBI, the opposite pattern was suggested in the results of this metaanalysis. However, this conclusion is limited by the fact that in only a small percentage of the total published reports on TBI outcome was outcome described separately for each sex. A careful, prospective study of sex differences in TBI outcome is clearly needed.

A mixed method pilot study: the researchers' experiences.

PubMed

Secomb, Jacinta M; Smith, Colleen

2011-08-01

This paper reports on the outcomes of a small well designed pilot study. Pilot studies often disseminate limited or statistically meaningless results without adding to the body knowledge on the comparative research benefits. The design a pre-test post-test group parallel randomised control trial and inductive content analysis of focus group transcripts was tested specifically to increase outcomes in a proposed larger study. Strategies are now in place to overcome operational barriers and recruitment difficulties. Links between the qualitative and quantitative arms of the proposed larger study have been made; it is anticipated that this will add depth to the final report. More extensive reporting on the outcomes of pilot studies would assist researchers and increase the body of knowledge in this area.

Concordance Between Self-Reported Childhood Maltreatment Versus Case Record Reviews for Child Welfare-Affiliated Adolescents.

PubMed

Negriff, Sonya; Schneiderman, Janet U; Trickett, Penelope K

2017-02-01

The present study used data from an ongoing longitudinal study of the effects of maltreatment on adolescent development to (1) describe rates of maltreatment experiences obtained from retrospective self-report versus case record review for adolescents with child welfare-documented maltreatment histories, (2) examine self-reported versus child welfare-identified maltreatment in relation to mental health and risk behavior outcomes by maltreatment type, and (3) examine the association between the number of different types of maltreatment and mental health and risk behavior outcomes. Maltreatment was coded from case records using the Maltreatment Case Record Abstraction Instrument (MCRAI) and participants were asked at mean age = 18.49 about childhood maltreatment experiences using the Comprehensive Trauma Interview (CTI). Results showed that an average of 48% of maltreatment found by the MCRAI for each type of maltreatment were unique cases not captured by the CTI, whereas an average of 40% self-reported maltreatment (CTI) was not indicated by the MCRAI. Analyses with outcomes showed generally, self-reported maltreatment, regardless of concordance with MCRAI, was related to the poorest outcomes. The difference in associations with the outcomes indicates both self-report and case record review data may have utility depending on the outcomes being assessed.

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.

Effectiveness of prepregnancy care for women with pregestational diabetes mellitus: protocol for a systematic review of the literature and identification of a core outcomes set using a Delphi survey.

PubMed

Egan, Aoife M; Smith, Valerie; Devane, Declan; Dunne, Fidelma P

2015-08-14

Women with pregnancy complicated by pregestational diabetes experience increased rates of adverse pregnancy outcomes. Prepregnancy care is the targeted support and additional care offered to those women who are planning pregnancy and is associated with improved outcomes. However, there is significant heterogeneity in the outcomes measured and reported in studies evaluating the effects of prepregnancy care, which makes meaningful comparison difficult. The aim of this article is to present a protocol for a study to develop a Core Outcome Set (COS) for trials and other studies evaluating the effectiveness of prepregnancy care for women with pregestational diabetes mellitus. This study will include a systematic review of the literature to identify outcomes that have previously been reported in studies evaluating prepregnancy care for women with pregestational diabetes. We will then prioritise these outcomes from the perspective of key stakeholders, including women with pregestational diabetes as well as clinicians, using a Delphi survey. A final consensus meeting will be held with stakeholders to review and finalise the outcomes. The expectation is that the COS will always be collected and reported in all clinical trials, audits of practice and other forms of research that involve prepregnancy care programs for women with pregestational diabetes. This will facilitate comparing and contrasting of studies and allow for combining of appropriate studies with the ultimate goal of improved patient care.

Interprofessional education: effects on professional practice and healthcare outcomes (update).

PubMed

Reeves, Scott; Perrier, Laure; Goldman, Joanne; Freeth, Della; Zwarenstein, Merrick

2013-03-28

The delivery of effective, high-quality patient care is a complex activity. It demands health and social care professionals collaborate in an effective manner. Research continues to suggest that collaboration between these professionals can be problematic. Interprofessional education (IPE) offers a possible way to improve interprofessional collaboration and patient care. To assess the effectiveness of IPE interventions compared to separate, profession-specific education interventions; and to assess the effectiveness of IPE interventions compared to no education intervention. For this update we searched the Cochrane Effective Practice and Organisation of Care Group specialised register, MEDLINE and CINAHL, for the years 2006 to 2011. We also handsearched the Journal of Interprofessional Care (2006 to 2011), reference lists of all included studies, the proceedings of leading IPE conferences, and websites of IPE organisations. Randomised controlled trials (RCTs), controlled before and after (CBA) studies and interrupted time series (ITS) studies of IPE interventions that reported objectively measured or self reported (validated instrument) patient/client or healthcare process outcomes. At least two review authors independently assessed the eligibility of potentially relevant studies. For included studies, at least two review authors extracted data and assessed study quality. A meta-analysis of study outcomes was not possible due to heterogeneity in study designs and outcome measures. Consequently, the results are presented in a narrative format. This update located nine new studies, which were added to the six studies from our last update in 2008. This review now includes 15 studies (eight RCTs, five CBA and two ITS studies). All of these studies measured the effectiveness of IPE interventions compared to no educational intervention. Seven studies indicated that IPE produced positive outcomes in the following areas: diabetes care, emergency department culture and patient satisfaction; collaborative team behaviour and reduction of clinical error rates for emergency department teams; collaborative team behaviour in operating rooms; management of care delivered in cases of domestic violence; and mental health practitioner competencies related to the delivery of patient care. In addition, four of the studies reported mixed outcomes (positive and neutral) and four studies reported that the IPE interventions had no impact on either professional practice or patient care. This updated review reports on 15 studies that met the inclusion criteria (nine studies from this update and six studies from the 2008 update). Although these studies reported some positive outcomes, due to the small number of studies and the heterogeneity of interventions and outcome measures, it is not possible to draw generalisable inferences about the key elements of IPE and its effectiveness. To improve the quality of evidence relating to IPE and patient outcomes or healthcare process outcomes, the following three gaps will need to be filled: first, studies that assess the effectiveness of IPE interventions compared to separate, profession-specific interventions; second, RCT, CBA or ITS studies with qualitative strands examining processes relating to the IPE and practice changes; third, cost-benefit analyses.

Clinical, Ergonomic, and Economic Outcomes With Multichamber Bags Compared With (Hospital) Pharmacy Compounded Bags and Multibottle Systems: A Systematic Literature Review.

PubMed

Alfonso, Jorge Emilio; Berlana, David; Ukleja, Andrew; Boullata, Joseph

2017-09-01

Multichamber bags (MCBs) may offer potential clinical, ergonomic, and economic advantages compared with (hospital) pharmacy compounded bags (COBs) and multibottle systems (MBSs). A systematic literature review was performed to identify and assess the available evidence regarding advantages of MCBs compared with COBs and MBSs. Medline, Embase, the Cochrane Databases, and EconLit were searched for articles reporting clinical, ergonomic, and economic outcomes for MCBs compared with COBs or MBSs. The search was limited to studies conducted in hospitalized patients >2 years of age that were published in English between January 1990 and November 2014. The Population Intervention Comparison Outcomes Study Design (PICOS) framework was used for the analysis. From 1307 unique citations, 74 potentially relevant publications were identified; review of references identified 2 additional publications. Among the 76 publications, 18 published studies met the inclusion criteria. Most were retrospective in design. Ten studies reported clinical outcomes, including 1 prospective randomized trial and multiple retrospective analyses that reported a lower risk of bloodstream infection for MCBs compared with other delivery systems. Sixteen studies reported ergonomic and/or economic outcomes; most reported a potential cost benefit for MCBs, with consistent reports of reduced time and labor compared with other systems. The largest cost benefit was observed in studies evaluating total hospitalization costs. The systematic literature review identified evidence of potential clinical, ergonomic, and economic benefits for MCBs compared with COBs and MBSs; however, methodological factors limited evidence quality. More prospective studies are required to corroborate existing evidence.

Appraising the uptake and use of recommendations for a common outcome data set for clinical trials: a case study in fall injury prevention.

PubMed

Copsey, Bethan; Hopewell, Sally; Becker, Clemens; Cameron, Ian D; Lamb, Sarah E

2016-03-10

Many researchers and professional bodies are seeking consensus for core outcomes for clinical trials. The Prevention of Falls Network Europe (ProFaNE) developed a common outcome data set for fall injury prevention trials 10 years ago. This study assesses the impact of these recommendations. A systematic search (up to 16 January 2015) was performed using Web of Science, Scopus and PubMed for articles citing the ProFaNE recommendations. Randomised trials on fall prevention in older people were selected for further analysis. Data were extracted on study characteristics and adherence to the key domains recommended by the ProFaNE consensus: falls, fall injury, physical activity, psychological consequences and health-related quality of life. Details of non-recommended outcome measures used were also recorded. The ProFaNE recommendations were cited in a total of 464 published articles, of which 34 were randomised trials on fall prevention in older people. Only one study (3 %) reported on all core domains. Most of the trials reported on falls (n = 32/34, 94 %) as a core outcome measure. Most of the recommendations within the falls domain were well-followed. Around half of the trials reported on fall-related injury (n = 16/34, 47 %). However, none reported the number of radiologically confirmed peripheral fracture events, which is the recommended outcome measure for injury. The other key domains (quality of life, physical activity and psychological consequences) were less frequently reported on, with a lack of consistency in the outcome measures used. The ProFaNE recommendations had a limited effect on standardising the reporting of outcomes in randomised trials on fall injury prevention in older people during the search period. Authors of consensus guidelines should consider maximising buy-in by including a diversity of geographic areas and academic disciplines at the development stage and using a solid dissemination strategy.

The Instrumental Side of Corporal Punishment: Parents' Reported Practices and Outcome Expectancies.

ERIC Educational Resources Information Center

Holden, George W.; Miller, Pamela C.; Harris, Susan D.

1999-01-01

Reports on two studies that assessed the relationship between mothers' and fathers' disciplinary practices with three-year-olds and outcome expectancies. Mothers who used corporal punishment at least once a week believed that it was more likely to result in positive outcomes than mothers who never or occasionally spanked. No significant…

Core outcome sets for prevention and treatment of postpartum haemorrhage: an international Delphi consensus study.

PubMed

Meher, Shireen; Cuthbert, Anna; Kirkham, Jamie J; Williamson, Paula; Abalos, Edgardo; Aflaifel, Nasreen; Bhutta, Zulfiqar A; Bishop, Alina; Blum, Jennifer; Collins, Peter; Devane, Declan; Ducloy-Bouthors, Anne-Sophie; Fawole, Bukola; Gülmezoglu, A Metin; Gutteridge, Kathryn; Gyte, Gill; Homer, Caroline S E; Mallaiah, Shuba; Smith, Jeffrey M; Weeks, Andrew D; Alfirevic, Zarko

2018-06-19

To develop core outcome sets (COS) for studies evaluating interventions for (1) prevention and (2) treatment of PPH, and recommendations on how to report the COS. A two-round Delphi survey and face-to-face meeting. Health care professionals and women's representatives. Outcomes were identified from systematic reviews of PPH studies and stakeholder consultation. Participants scored each outcome in the Delphi on a Likert scale between 1 (not important) and 9 (critically important). Results were discussed at the face-to-face meeting to agree the final COS. Consensus at the meeting was defined as ≥ 70% of participants scoring the outcome as critically important (7-9). Lectures, discussion and voting were used to agree how to report COS outcomes. outcomes from systematic reviews and consultations. Both Delphi rounds were completed by 152/205 (74%) participants for prevention and 143/197 (73%) for treatment. For prevention of PPH, nine core outcomes were selected: blood loss, shock, maternal death, use of additional uterotonics, blood transfusion, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding and adverse effects. For treatment of PPH, 12 core outcomes were selected: blood loss, shock, coagulopathy, hysterectomy, organ dysfunction, maternal death, blood transfusion, use of additional haemostatic intervention, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding and adverse effects. Recommendations were developed on how to report these outcomes where possible. These COS will help standardise outcome reporting in PPH trials. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Survival, morbidity, growth and developmental delay for babies born preterm in low and middle income countries - a systematic review of outcomes measured.

PubMed

Gladstone, Melissa; Oliver, Clare; Van den Broek, Nynke

2015-01-01

Premature birth is the leading cause of neonatal death and second leading in children under 5. Information on outcomes of preterm babies surviving the early neonatal period is sparse although it is considered a major determinant of immediate and long-term morbidity. Systematic review of studies reporting outcomes for preterm babies in low and middle income settings was conducted using electronic databases, citation tracking, expert recommendations and "grey literature". Reviewers screened titles, abstracts and articles. Data was extracted using inclusion and exclusion criteria, study site and facilities, assessment methods and outcomes of mortality, morbidity, growth and development. The Child Health Epidemiology Reference Group criteria (CHERG) were used to assess quality. Of 197 eligible publications, few (10.7%) were high quality (CHERG). The majority (83.3%) report on the outcome of a sample of preterm babies at time of birth or admission. Only 16.0% studies report population-based data using standardised mortality definitions. In 50.5% of studies, gestational age assessment method was unclear. Only 15.8% followed-up infants for 2 years or more. Growth was reported using standardised definitions but recommended morbidity definitions were rarely used. The criteria for assessment of neurodevelopmental outcomes was variable with few standardised tools - Bayley II was used in approximately 33% of studies, few studies undertook sensory assessments. To determine the relative contribution of preterm birth to the burden of disease in children and to inform the planning of healthcare interventions to address this burden, a renewed understanding of the assessment and documentation of outcomes for babies born preterm is needed. More studies assessing outcomes for preterm babies who survive the immediate newborn period are needed. More consistent use of data is vital with clear and aligned definitions of health outcomes in newborn (preterm or term) and intervention packages aimed to save lives and improve health.

Survival, Morbidity, Growth and Developmental Delay for Babies Born Preterm in Low and Middle Income Countries – A Systematic Review of Outcomes Measured

PubMed Central

Gladstone, Melissa; Oliver, Clare; Van den Broek, Nynke

2015-01-01

Background Premature birth is the leading cause of neonatal death and second leading in children under 5. Information on outcomes of preterm babies surviving the early neonatal period is sparse although it is considered a major determinant of immediate and long-term morbidity. Methods Systematic review of studies reporting outcomes for preterm babies in low and middle income settings was conducted using electronic databases, citation tracking, expert recommendations and “grey literature”. Reviewers screened titles, abstracts and articles. Data was extracted using inclusion and exclusion criteria, study site and facilities, assessment methods and outcomes of mortality, morbidity, growth and development. The Child Health Epidemiology Reference Group criteria (CHERG) were used to assess quality. Findings Of 197 eligible publications, few (10.7%) were high quality (CHERG). The majority (83.3%) report on the outcome of a sample of preterm babies at time of birth or admission. Only 16.0% studies report population-based data using standardised mortality definitions. In 50.5% of studies, gestational age assessment method was unclear. Only 15.8% followed-up infants for 2 years or more. Growth was reported using standardised definitions but recommended morbidity definitions were rarely used. The criteria for assessment of neurodevelopmental outcomes was variable with few standardised tools - Bayley II was used in approximately 33% of studies, few studies undertook sensory assessments. Conclusions To determine the relative contribution of preterm birth to the burden of disease in children and to inform the planning of healthcare interventions to address this burden, a renewed understanding of the assessment and documentation of outcomes for babies born preterm is needed. More studies assessing outcomes for preterm babies who survive the immediate newborn period are needed. More consistent use of data is vital with clear and aligned definitions of health outcomes in newborn (preterm or term) and intervention packages aimed to save lives and improve health. PMID:25793703

Clinically Relevant Outcome Measures Following Limb Osseointegration; Systematic Review of the Literature.

PubMed

Al Muderis, Munjed M; Lu, William Y; Li, Jiao Jiao; Kaufman, Kenton; Orendurff, Michael; Highsmith, M Jason; Lunseth, Paul A; Kahle, Jason T

2018-02-01

The current standard of care for an amputee is a socket-based prostheses. An osseointegrated implant (OI) is an alternative for prosthetic attachment. Osseointegration addresses reported problems related to wearing a socket interface, such as skin issues, discomfort, diminished function, quality of life, prosthetic use, and abandonment. The purpose of this report is to systematically review current literature regarding OI to identify and categorize the reported clinically relevant outcome measures, rate the quality of available evidence, and synthesize the findings. A multidisciplinary team used PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methods. Search methodology was based on identifying clinically relevant articles. Three databases were searched: PubMed, CINAHL, and Web of Science. Clinical studies with aggregated data reporting at least 1 clinically relevant outcome measure were included. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criterion was used for critical appraisal and recommendations. This review identified 21 clinically relevant observational studies. Outcome measures were categorized into the following 9 categories: vibratory stimulation, complications, biomechanics, economics, patient-reported outcome measures, electromyography, x-ray, physical functional performance, and energy consumption. This systematic review consisted of Level III and IV observational studies. Homogeneous outcome measures with strong psychometric properties across prospective studies do not exist to date. Higher-level, prospective, randomized, long-term, clinically relevant trials are needed to prove efficacy of OI compared with socket prosthetic attachment. Osseointegration was at least equivalent to sockets in most studies. In some cases, it was superior. Osseointegration represents a promising alternative to socket prosthetic attachments for extremity amputees. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data

PubMed Central

Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F.; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich

2013-01-01

Background Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. Methods and Findings We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as “completely reported” or “incompletely reported.” For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically significant for all types of outcomes. The main limitation of our study is that our sample is not representative because only CSRs provided voluntarily by pharmaceutical companies upon request could be assessed. In addition, the sample covered only a limited number of therapeutic areas and was restricted to randomized controlled trials investigating drugs. Conclusions In contrast to CSRs, publicly available sources provide insufficient information on patient-relevant outcomes of clinical trials. CSRs should therefore be made publicly available. Please see later in the article for the Editors' Summary PMID:24115912

Nursing Education Interventions for Managing Acute Pain in Hospital Settings: A Systematic Review of Clinical Outcomes and Teaching Methods.

PubMed

Drake, Gareth; de C Williams, Amanda C

2017-02-01

The objective of this review was to examine the effects of nursing education interventions on clinical outcomes for acute pain management in hospital settings, relating interventions to health care behavior change theory. Three databases were searched for nursing education interventions from 2002 to 2015 in acute hospital settings with clinical outcomes reported. Methodological quality was rated as strong, moderate, or weak using the Effective Public Health Practice Project Quality Assessment Tool for quantitative studies. The 12 eligible studies used varied didactic and interactive teaching methods. Several studies had weaknesses attributable to selection biases, uncontrolled confounders, and lack of blinding of outcome assessors. No studies made reference to behavior change theory in their design. Eight of the 12 studies investigated nursing documentation of pain assessment as the main outcome, with the majority reporting positive effects of education interventions on nursing pain assessment. Of the remaining studies, two reported mixed findings on patient self-report of pain scores as the key measure, one reported improvements in patient satisfaction with pain management after a nursing intervention, and one study found an increase in nurses' delivery of a relaxation treatment following an intervention. Improvements in design and evaluation of nursing education interventions are suggested, drawing on behavior change theory and emphasizing the relational, contextual, and emotionally demanding nature of nursing pain management in hospital settings. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

Circles of Support and Accountability for Sex Offenders: A Systematic Review of Outcomes.

PubMed

Clarke, Martin; Brown, Susan; Völlm, Birgit

2017-08-01

We conducted a systematic review of studies reporting on the effectiveness of Circles of Support and Accountability (Circles). Circles use volunteers to provide support for sex offenders living in the community. We searched 10 databases up to the end of 2013 and identified 3 relevant outcome studies. An additional 12 papers or reports were identified by searching reference lists, Google, and contacting key authors and Circles providers to obtain unpublished data. These 15 studies comprised one randomized controlled trial, three retrospective cohorts with matched controls, and 11 case series. The majority reported measures of recidivism, particularly reconviction. The 4 studies with controls generally reported that participation in Circles was associated with lower recidivism although there were few statistically significant differences. Few studies examined changes in risk or psychosocial outcomes. A number of methodological issues are discussed. Longer term, prospective follow-up studies with control groups are required to address these issues.

Flexible working conditions and their effects on employee health and wellbeing.

PubMed

Joyce, Kerry; Pabayo, Roman; Critchley, Julia A; Bambra, Clare

2010-02-17

Flexible working conditions are increasingly popular in developed countries but the effects on employee health and wellbeing are largely unknown. To evaluate the effects (benefits and harms) of flexible working interventions on the physical, mental and general health and wellbeing of employees and their families. Our searches (July 2009) covered 12 databases including the Cochrane Public Health Group Specialised Register, CENTRAL; MEDLINE; EMBASE; CINAHL; PsycINFO; Social Science Citation Index; ASSIA; IBSS; Sociological Abstracts; and ABI/Inform. We also searched relevant websites, handsearched key journals, searched bibliographies and contacted study authors and key experts. Randomised controlled trials (RCT), interrupted time series and controlled before and after studies (CBA), which examined the effects of flexible working interventions on employee health and wellbeing. We excluded studies assessing outcomes for less than six months and extracted outcomes relating to physical, mental and general health/ill health measured using a validated instrument. We also extracted secondary outcomes (including sickness absence, health service usage, behavioural changes, accidents, work-life balance, quality of life, health and wellbeing of children, family members and co-workers) if reported alongside at least one primary outcome. Two experienced review authors conducted data extraction and quality appraisal. We undertook a narrative synthesis as there was substantial heterogeneity between studies. Ten studies fulfilled the inclusion criteria. Six CBA studies reported on interventions relating to temporal flexibility: self-scheduling of shift work (n = 4), flexitime (n = 1) and overtime (n = 1). The remaining four CBA studies evaluated a form of contractual flexibility: partial/gradual retirement (n = 2), involuntary part-time work (n = 1) and fixed-term contract (n = 1). The studies retrieved had a number of methodological limitations including short follow-up periods, risk of selection bias and reliance on largely self-reported outcome data. Four CBA studies on self-scheduling of shifts and one CBA study on gradual/partial retirement reported statistically significant improvements in either primary outcomes (including systolic blood pressure and heart rate; tiredness; mental health, sleep duration, sleep quality and alertness; self-rated health status) or secondary health outcomes (co-workers social support and sense of community) and no ill health effects were reported. Flexitime was shown not to have significant effects on self-reported physiological and psychological health outcomes. Similarly, when comparing individuals working overtime with those who did not the odds of ill health effects were not significantly higher in the intervention group at follow up. The effects of contractual flexibility on self-reported health (with the exception of gradual/partial retirement, which when controlled by employees improved health outcomes) were either equivocal or negative. No studies differentiated results by socio-economic status, although one study did compare findings by gender but found no differential effect on self-reported health outcomes. The findings of this review tentatively suggest that flexible working interventions that increase worker control and choice (such as self-scheduling or gradual/partial retirement) are likely to have a positive effect on health outcomes. In contrast, interventions that were motivated or dictated by organisational interests, such as fixed-term contract and involuntary part-time employment, found equivocal or negative health effects. Given the partial and methodologically limited evidence base these findings should be interpreted with caution. Moreover, there is a clear need for well-designed intervention studies to delineate the impact of flexible working conditions on health, wellbeing and health inequalities.

Do Natural Experiments of Changes in Neighborhood Built Environment Impact Physical Activity and Diet? A Systematic Review

PubMed Central

George, Emma S.; Feng, Xiaoqi; Merom, Dafna; Bennie, Andrew; Cook, Amelia; Dwyer, Genevieve; Pang, Bonnie; Astell-Burt, Thomas

2018-01-01

Physical activity and diet are major modifiable risk factors for chronic disease and have been shown to be associated with neighborhood built environment. Systematic review evidence from longitudinal studies on the impact of changing the built environment on physical activity and diet is currently lacking. A systematic review of natural experiments of neighborhood built environment was conducted. The aims of this systematic review were to summarize study characteristics, study quality, and impact of changes in neighborhood built environment on physical activity and diet outcomes among residents. Natural experiments of neighborhood built environment change, exploring longitudinal impacts on physical activity and/or diet in residents, were included. From five electronic databases, 2084 references were identified. A narrative synthesis was conducted, considering results in relation to study quality. Nineteen papers, reporting on 15 different exposures met inclusion criteria. Four studies included a comparison group and 11 were pre-post/longitudinal studies without a comparison group. Studies reported on the impact of redeveloping or introducing cycle and/or walking trails (n = 5), rail stops/lines (n = 4), supermarkets and farmers’ markets (n = 4) and park and green space (n = 2). Eight/15 studies reported at least one beneficial change in physical activity, diet or another associated health outcome. Due to limitations in study design and reporting, as well as the wide array of outcome measures reported, drawing conclusions to inform policy was challenging. Future research should consider a consistent approach to measure the same outcomes (e.g., using measurement methods that collect comparable physical activity and diet outcome data), to allow for pooled analyses. Additionally, including comparison groups wherever possible and ensuring high quality reporting is essential. PMID:29373567

Do Natural Experiments of Changes in Neighborhood Built Environment Impact Physical Activity and Diet? A Systematic Review.

PubMed

MacMillan, Freya; George, Emma S; Feng, Xiaoqi; Merom, Dafna; Bennie, Andrew; Cook, Amelia; Sanders, Taren; Dwyer, Genevieve; Pang, Bonnie; Guagliano, Justin M; Kolt, Gregory S; Astell-Burt, Thomas

2018-01-26

Physical activity and diet are major modifiable risk factors for chronic disease and have been shown to be associated with neighborhood built environment. Systematic review evidence from longitudinal studies on the impact of changing the built environment on physical activity and diet is currently lacking. A systematic review of natural experiments of neighborhood built environment was conducted. The aims of this systematic review were to summarize study characteristics, study quality, and impact of changes in neighborhood built environment on physical activity and diet outcomes among residents. Natural experiments of neighborhood built environment change, exploring longitudinal impacts on physical activity and/or diet in residents, were included. From five electronic databases, 2084 references were identified. A narrative synthesis was conducted, considering results in relation to study quality. Nineteen papers, reporting on 15 different exposures met inclusion criteria. Four studies included a comparison group and 11 were pre-post/longitudinal studies without a comparison group. Studies reported on the impact of redeveloping or introducing cycle and/or walking trails ( n = 5), rail stops/lines ( n = 4), supermarkets and farmers' markets ( n = 4) and park and green space ( n = 2). Eight/15 studies reported at least one beneficial change in physical activity, diet or another associated health outcome. Due to limitations in study design and reporting, as well as the wide array of outcome measures reported, drawing conclusions to inform policy was challenging. Future research should consider a consistent approach to measure the same outcomes (e.g., using measurement methods that collect comparable physical activity and diet outcome data), to allow for pooled analyses. Additionally, including comparison groups wherever possible and ensuring high quality reporting is essential.

Impact of reduction in working hours for doctors in training on postgraduate medical education and patients' outcomes: systematic review.

PubMed

Moonesinghe, S R; Lowery, J; Shahi, N; Millen, A; Beard, J D

2011-03-22

To determine whether a reduction in working hours of doctors in postgraduate medical training has had an effect on objective measures of medical education and clinical outcome. Systematic review. Medline, Embase, ISI Web of Science, Google Scholar, ERIC, and SIGLE were searched without language restriction for articles published between 1990 and December 2010. Reference lists and citations of selected articles. Studies that assessed the impact of a change in duty hours using any objective measure of outcome related to postgraduate medical training, patient safety, or clinical outcome. Any study design was eligible for inclusion. 72 studies were eligible for inclusion: 38 reporting training outcomes, 31 reporting outcomes in patients, and three reporting both. A reduction in working hours from greater than 80 hours a week (in accordance with US recommendations) does not seem to have adversely affected patient safety and has had limited effect on postgraduate training. Reports on the impact of European legislation limiting working hours to less than 56 or 48 a week are of poor quality and have conflicting results, meaning that firm conclusions cannot be made. Reducing working hours to less than 80 a week has not adversely affected outcomes in patient or postgraduate training in the US. The impact of reducing hours to less than 56 or 48 a week in the UK has not yet been sufficiently evaluated in high quality studies. Further work is required, particularly in the European Union, using large multicentre evaluations of the impact of duty hours' legislation on objective educational and clinical outcomes.

Adverse birth outcomes associated with Zika virus exposure during pregnancy in São José do Rio Preto, Brazil.

PubMed

Nogueira, M L; Nery Júnior, N R R; Estofolete, C F; Bernardes Terzian, A C; Guimarães, G F; Zini, N; Alves da Silva, R; Dutra Silva, G C; Junqueira Franco, L C; Rahal, P; Bittar, C; Carneiro, B; Vasconcelos, P F C; Freitas Henriques, D; Barbosa, D M U; Lopes Rombola, P; de Grande, L; Negri Reis, A F; Palomares, S A; Wakai Catelan, M; Cruz, L E A A; Necchi, S H; Mendonça, R C V; Penha Dos Santos, I N; Alavarse Caron, S B; Costa, F; Bozza, F A; Soares de Souza, A; Brandão de Mattos, C C; de Mattos, L C; Vasilakis, N; Oliani, A H; Vaz Oliani, D C M; Ko, A I

2018-06-01

We aimed to report the first 54 cases of pregnant women infected by Zika virus (ZIKV) and their virologic and clinical outcomes, as well as their newborns' outcomes, in 2016, after the emergence of ZIKV in dengue-endemic areas of São Paulo, Brazil. This descriptive study was performed from February to October 2016 on 54 quantitative real-time PCR ZIKV-positive pregnant women identified by the public health authority of São José do Rio Preto, São Paulo, Brazil. The women were followed and had clinical and epidemiologic data collected before and after birth. Adverse outcomes in newborns were analysed and reported. Urine or blood samples from newborns were collected to identify ZIKV infection by reverse transcription PCR (RT-PCR). A total of 216 acute Zika-suspected pregnant women were identified, and 54 had the diagnosis confirmed by RT-PCR. None of the 54 women miscarried. Among the 54 newborns, 15 exhibited adverse outcomes at birth. The highest number of ZIKV infections occurred during the second and third trimesters. No cases of microcephaly were reported, though a broad clinical spectrum of outcomes, including lenticulostriate vasculopathy, subependymal cysts, and auditory and ophthalmologic disorders, were identified. ZIKV RNA was detected in 18 of 51 newborns tested and in eight of 15 newborns with adverse outcomes. Although other studies have associated many newborn outcomes to ZIKV infection during pregnancy, these same adverse outcomes were rare or nonexistent in this study. The clinical presentation the newborns we studied was mild compared to other reports, suggesting that there is significant heterogeneity in congenital Zika infection. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Patient-Reported Outcomes of Periacetabular Osteotomy from the Prospective ANCHOR Cohort Study

PubMed Central

Clohisy, John C.; Ackerman, Jeffrey; Baca, Geneva; Baty, Jack; Beaulé, Paul E.; Kim, Young-Jo; Millis, Michael B.; Podeszwa, David A.; Schoenecker, Perry L.; Sierra, Rafael J.; Sink, Ernest L.; Sucato, Daniel J.; Trousdale, Robert T.; Zaltz, Ira

2017-01-01

Background: Current literature describing the periacetabular osteotomy (PAO) is mostly limited to retrospective case series. Larger, prospective cohort studies are needed to provide better clinical evidence regarding this procedure. The goals of the current study were to (1) report minimum 2-year patient-reported outcomes (pain, hip function, activity, overall health, and quality of life), (2) investigate preoperative clinical and disease characteristics as predictors of clinical outcomes, and (3) report the rate of early failures and reoperations in patients undergoing contemporary PAO surgery. Methods: A large, prospective, multicenter cohort of PAO procedures was established, and outcomes at a minimum of 2 years were analyzed. A total of 391 hips were included for analysis (79% of the patients were female, and the average patient age was 25.4 years). Patient-reported outcomes, conversion to total hip replacement, reoperations, and major complications were documented. Variables with a p value of ≤0.10 in the univariate linear regressions were included in the multivariate linear regression. The backward stepwise selection method was used to determine the final risk factors of clinical outcomes. Results: Clinical outcome analysis demonstrated major clinically important improvements in pain, function, quality of life, overall health, and activity level. Increasing age and a body mass index status of overweight or obese were predictive of improved results for certain outcome metrics. Male sex and mild acetabular dysplasia were predictive of lesser improvements in certain outcome measures. Three (0.8%) of the hips underwent early conversion to total hip arthroplasty, 12 (3%) required reoperation, and 26 (7%) experienced a major complication. Conclusions: This large, prospective cohort study demonstrated the clinical success of contemporary PAO surgery for the treatment of symptomatic acetabular dysplasia. Patient and disease characteristics demonstrated predictive value that should be considered in surgical decision-making. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. PMID:28060231

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.

Use of Objective Metrics in Dynamic Facial Reanimation: A Systematic Review.

PubMed

Revenaugh, Peter C; Smith, Ryan M; Plitt, Max A; Ishii, Lisa; Boahene, Kofi; Byrne, Patrick J

2018-06-21

Facial nerve deficits cause significant functional and social consequences for those affected. Existing techniques for dynamic restoration of facial nerve function are imperfect and result in a wide variety of outcomes. Currently, there is no standard objective instrument for facial movement as it relates to restorative techniques. To determine what objective instruments of midface movement are used in outcome measurements for patients treated with dynamic methods for facial paralysis. Database searches from January 1970 to June 2017 were performed in PubMed, Embase, Cochrane Library, Web of Science, and Scopus. Only English-language articles on studies performed in humans were considered. The search terms used were ("Surgical Flaps"[Mesh] OR "Nerve Transfer"[Mesh] OR "nerve graft" OR "nerve grafts") AND (face [mh] OR facial paralysis [mh]) AND (innervation [sh]) OR ("Face"[Mesh] OR facial paralysis [mh]) AND (reanimation [tiab]). Two independent reviewers evaluated the titles and abstracts of all articles and included those that reported objective outcomes of a surgical technique in at least 2 patients. The presence or absence of an objective instrument for evaluating outcomes of midface reanimation. Additional outcome measures were reproducibility of the test, reporting of symmetry, measurement of multiple variables, and test validity. Of 241 articles describing dynamic facial reanimation techniques, 49 (20.3%) reported objective outcome measures for 1898 patients. Of those articles reporting objective measures, there were 29 different instruments, only 3 of which reported all outcome measures. Although instruments are available to objectively measure facial movement after reanimation techniques, most studies do not report objective outcomes. Of objective facial reanimation instruments, few are reproducible and able to measure symmetry and multiple data points. To accurately compare objective outcomes in facial reanimation, a reproducible, objective, and universally applied instrument is needed.

Quality of reporting of randomized clinical trials in implant dentistry. A systematic review on critical aspects in design, outcome assessment and clinical relevance.

PubMed

Cairo, Francesco; Sanz, Ignacio; Matesanz, Paula; Nieri, Michele; Pagliaro, Umberto

2012-02-01

The aim of this systematic review (SR) was to assess the quality of reporting randomized clinical trials (RCTs) in the field of implant dentistry, its evolution over time and the possible relations between quality items and reported outcomes. RCTs in implant dentistry were retrieved through electronic and hand searches. Risk of bias in individual studies was assessed focusing on study design, outcome assessment and clinical relevance. Associations between quality items and year of publication of RCTs or reporting of statistically significant outcomes were tested. Among the 495 originally screened manuscripts published from 1989 to April 2011, 276 RCTs were assessed in this SR; 59% of them were published between 2006 and 2011. RCTs were mainly parallel (65%), with a single centre (83%) and a superiority design (88%). Trials in implant dentistry showed several methodological flaws: only 37% showed a random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, only 12% performed a correct sample size calculation, the examiner was blind solely in 42% of studies where blinding was feasible. In addition, only 21% of RCTs declared operator experience and 31% reported patient-related outcomes. Many quality items improved over time. Allocation concealment at high risk of bias (p = 0.0125), no information on drop-out (p = 0.0318) and lack of CONSORT adherence (p = 0.0333) were associated with statistically significant reported outcomes. The overall quality of reporting of RCTs in implant dentistry is poor and only partially improved in the last years. Caution is suggested when interpreting these RCTs since risk of bias was associated with higher chance of reporting of statistically significant results. © 2012 John Wiley & Sons A/S.

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

Clinical research in implant dentistry: evaluation of implant-supported restorations, aesthetic and patient-reported outcomes.

PubMed

Lang, Niklaus P; Zitzmann, Nicola U

2012-02-01

The articles discussed in working group 3 dealt with specific aspects of clinical research. In this context, the literature reporting on survival and complication rates of implant-supported or implant-tooth supported restorations in longitudinal studies of at least 5 years were discussed. The second aspect dealt with the evaluation of aesthetic outcomes in clinical studies and the related index systems available. Finally, the third aspect discussed dealt with patient-reported outcome measures (PROMs). A detailed appraisal of the available methodology was presented. © 2012 John Wiley & Sons A/S.

Improved knee biomechanics among patients reporting a good outcome in knee-related quality of life one year after total knee arthroplasty.

PubMed

Naili, Josefine E; Wretenberg, Per; Lindgren, Viktor; Iversen, Maura D; Hedström, Margareta; Broström, Eva W

2017-03-21

It is not well understood why one in five patients report poor outcomes following knee arthroplasty. This study evaluated changes in knee biomechanics, and perceived pain among patients reporting either a good or a poor outcome in knee-related quality of life after total knee arthroplasty. Twenty-eight patients (mean age 66 (SD 7) years) were included in this prospective study. Within one month of knee arthroplasty and one year after surgery, patients underwent three-dimensional (3D) gait analysis, completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), and rated perceived pain using a visual analogue scale. A "good outcome" was defined as a change greater than the minimally detectable change in the KOOS knee-related quality of life, and a "poor outcome" was defined as change below the minimally detectable change. Nineteen patients (68%) were classified as having a good outcome. Groups were analyzed separately and knee biomechanics were compared using a two-way repeated measures ANOVA. Differences in pain between groups were evaluated using Mann Whitney U test. Patients classified as having a good outcome improved significantly in most knee gait biomechanical outcomes including increased knee flexion-extension range, reduced peak varus angle, increased peak flexion moment, and reduced peak valgus moment. The good outcome group also displayed a significant increase in walking speed, a reduction (normalization) of stance phase duration (% of gait cycle) and increased passive knee extension. Whereas, the only change in knee biomechanics, one year after surgery, for patients classified as having a poor outcome was a significant reduction in peak varus angle. No differences in pain postoperatively were found between groups. Patients reporting a good outcome in knee-related quality of life improved in knee biomechanics during gait, while patients reporting a poor outcome, despite similar reduction in pain, remained unchanged in knee biomechanics one year after total knee arthroplasty. With regards to surgeon-controlled biomechanical factors, surgery may most successfully address frontal plane knee alignment. However, achieving a good outcome in patient-reported knee-related quality of life may be related to dynamic improvements in the sagittal plane.

Planning and reporting of quality-of-life outcomes in cancer trials

PubMed Central

Schandelmaier, S.; Conen, K.; von Elm, E.; You, J. J.; Blümle, A.; Tomonaga, Y.; Amstutz, A.; Briel, M.; Kasenda, B.

2015-01-01

Background Information about the impact of cancer treatments on patients' quality of life (QoL) is of paramount importance to patients and treating oncologists. Cancer trials that do not specify QoL as an outcome or fail to report collected QoL data, omit crucial information for decision making. To estimate the magnitude of these problems, we investigated how frequently QoL outcomes were specified in protocols of cancer trials and subsequently reported. Design Retrospective cohort study of RCT protocols approved by six research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We compared protocols to corresponding publications, which were identified through literature searches and investigator surveys. Results Of the 173 cancer trials, 90 (52%) specified QoL outcomes in their protocol, 2 (1%) as primary and 88 (51%) as secondary outcome. Of the 173 trials, 35 (20%) reported QoL outcomes in a corresponding publication (4 modified from the protocol), 18 (10%) were published but failed to report QoL outcomes in the primary or a secondary publication, and 37 (21%) were not published at all. Of the 83 (48%) trials that did not specify QoL outcomes in their protocol, none subsequently reported QoL outcomes. Failure to report pre-specified QoL outcomes was not associated with industry sponsorship (versus non-industry), sample size, and multicentre (versus single centre) status but possibly with trial discontinuation. Conclusions About half of cancer trials specified QoL outcomes in their protocols. However, only 20% reported any QoL data in associated publications. Highly relevant information for decision making is often unavailable to patients, oncologists, and health policymakers. PMID:26133966

Inequalities in multiple health outcomes by education, sex, and race in 93 US counties: Why we should measure them all

PubMed Central

2014-01-01

Introduction Regular reporting of health inequalities is essential to monitoring progress of efforts to reduce health inequalities. While reporting of population health became increasingly common, reporting of a subpopulation group breakdown of each indicator of the health of the population is rarely a standard practice. This study reports education-, sex-, and race-related inequalities in four health outcomes in each of the selected 93 counties in the United States in a systematic and comparable manner. Methods This study is a cross-sectional analysis of large, publicly available data, 2008, 2009, and 2010 Behavioral Risk Factor Surveillance System (BRFSS) Selected Metropolitan/Micropolitan Area Risk Trends (SMART) and 2008, 2009, and 2010 United States Birth Records from the National Vital Statistics System. The study population is American adults older than 25 years of age residing in the selected 93 counties, representing about 30% of the US population, roughly equally covering all geographic regions of the country. Main outcome measures are: (1) Attribute (group characteristic)-specific inequality: education-, sex-, or race-specific inequality in each of the four health outcomes (poor or fair health, poor physical health days, poor mental health days, and low birthweight) in each county; (2) Overall inequality: the average of these three attribute-specific inequalities for each health outcome in each county; and (3) Summary inequality in total morbidity: the weighted average of the overall inequalities across the four health outcomes in each county. Results The range of inequality across the counties differed considerably by health outcome; inequality in poor or fair health had the widest range and the highest median among inequalities in all health outcomes. In more than 70% of the counties, education-specific inequality was the largest in all health outcomes except for low birthweight. Conclusions It is feasible to extend population health reporting to include reporting of a subpopulation group breakdown of each indicator of the health of the population at a small jurisdictional level using publicly available data. No single group characteristic or health outcome represents the whole picture of health inequalities in a population. Examining multiple group characteristics and outcomes in a comparable manner is essential in reporting health inequalities. PMID:24927805

Patient-reported outcomes in randomised controlled trials of colorectal cancer: an analysis determining the availability of robust data to inform clinical decision-making

PubMed Central

Whale, Katie; Fish, Daniel; Fayers, Peter; Cafaro, Valentina; Pusic, Andrea; Blazeby, Jane M.; Efficace, Fabio

2016-01-01

Purpose Randomised controlled trials (RCTs) are the most robust study design measuring outcomes of colorectal cancer (CRC) treatments, but to influence clinical practice trial design and reporting of patient-reported outcomes (PROs) must be of high quality. Objectives of this study were as follows: to examine the quality of PRO reporting in RCTs of CRC treatment; to assess the availability of robust data to inform clinical decision-making; and to investigate whether quality of reporting improved over time. Methods A systematic review from January 2004–February 2012 identified RCTs of CRC treatment describing PROs. Relevant abstracts were screened and manuscripts obtained. Methodological quality was assessed using International Society for Quality of Life Research—patient-reported outcome reporting standards. Changes in reporting quality over time were established by comparison with previous data, and risk of bias was assessed with the Cochrane risk of bias tool. Results Sixty-six RCTs were identified, seven studies (10 %) reported survival benefit favouring the experimental treatment, 35 trials (53 %) identified differences in PROs between treatment groups, and the clinical significance of these differences was discussed in 19 studies (29 %). The most commonly reported treatment type was chemotherapy (n = 45; 68 %). Improvements over time in key methodological issues including the documentation of missing data and the discussion of the clinical significance of PROs were found. Thirteen trials (20 %) had high-quality reporting. Conclusions Whilst improvements in PRO quality reporting over time were found, several recent studies still fail to robustly inform clinical practice. Quality of PRO reporting must continue to improve to maximise the clinical impact of PRO findings. PMID:25910987

Modifying the Clinical Outcomes in Routine Evaluation Measure for Use with People Who Have a Learning Disability

ERIC Educational Resources Information Center

Marshall, Keith; Willoughby-Booth, Simon

2007-01-01

There are few reliable self-report measures suitable for people with a learning disability in reporting psychological distress. This study examines the modification of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), exploring its reliability, using two different presentation styles. One style included a sequencing task then…

Prevalence of Suicide Risk Factors and Suicide-Related Outcomes in the National Mental Health Study, Colombia

ERIC Educational Resources Information Center

Posada-Villa, Jose; Camacho, Juan Camilo; Valenzuela, Jose Ignacio; Arguello, Arturo; Cendales, Juan Gabriel; Fajardo, Roosevelt

2009-01-01

A community survey in 4,426 adults was undertaken as part of the World Mental Health Survey Initiative reporting the prevalence and risk factors for suicide-related outcomes in Colombia. Lifetime prevalence estimates of suicide ideation, plans, attempts, and risk factors for suicide-related outcomes were assessed. Retrospective reports of…

Outcomes Reported by Spanish-Speaking Families in Early Intervention

ERIC Educational Resources Information Center

Olmsted, Murrey G.; Bailey, Donald B., Jr.; Raspa, Melissa; Nelson, Robin E.; Robinson, Nyle D.; Simpson, Mary Ellen; Guillen, Chelsea

2010-01-01

In this study, the authors use data from two states to compare how families participating in early intervention who completed a Spanish version of the Family Outcomes Survey (FOS) (n = 291) compared with Hispanic (n = 486) and non-Hispanic (n = 2,363) families who completed the English version. In general, most families reported positive outcomes,…

A Multilevel Model to Examine Adolescent Outcomes in Outdoor Behavioral Healthcare: The Parent Perspective

ERIC Educational Resources Information Center

Combs, Katie Massey; Hoag, Matthew J.; Roberts, Sean D.; Javorski, Stephen

2016-01-01

Background: Outdoor Behavioral Healthcare (OBH) has arisen to fill a gap in mental health treatment. While research shows large positive changes in adolescent self-reports, little is known about predictors of change, longitudinal outcomes, and parent-reports of change. Objective This study sought to identify treatment outcomes up to 18 months…

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.

The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) framework: protocol to determine a core outcome set for efficacy and effectiveness trials of alcohol screening and brief intervention.

PubMed

Shorter, G W; Heather, N; Bray, Jeremy W; Giles, E L; Holloway, A; Barbosa, C; Berman, A H; O'Donnell, A J; Clarke, M; Stockdale, K J; Newbury-Birch, D

2017-12-22

The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporting guidance for its use in future trials of ABI in a range of settings. An international Special Interest Group was convened through INEBRIA (International Network on Brief Interventions for Alcohol and Other Drugs) to inform the development of a COS for trials of ABI. ORBITAL will incorporate a systematic review to map outcomes used in efficacy and effectiveness trials of ABI and their measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This will support a multi-round Delphi study to prioritise outcomes. Delphi panellists will be drawn from a range of settings and stakeholder groups, and the Delphi study will also be used to determine if a single COS is relevant for all settings. A consensus meeting with key stakeholder representation will determine the final COS and associated guidance for its use in trials of ABI. ORBITAL will develop a COS for alcohol screening and brief intervention trials, with outcomes stratified into domains and guidance on outcome measurement instruments. The standardisation of ABI outcomes and their measurement will support the ongoing development of ABI studies and a systematic synthesis of emerging research findings. We will track the extent to which the COS delivers on this promise through an exploration of the use of the guidance in the decade following COS publication.

A core outcome set for clinical trials in acute diarrhoea.

PubMed

Karas, Jacek; Ashkenazi, Shai; Guarino, Alfredo; Lo Vecchio, Andrea; Shamir, Raanan; Vandenplas, Yvan; Szajewska, Hania

2015-04-01

Core outcome sets are the baseline for what should be measured in clinical research and, thus, should serve as a guide for what should be collected and reported. The Consensus Group on Outcome Measures Made in Pediatric Enteral Nutrition Clinical Trials, established in 2012, agreed that consensus on a core set of outcomes with agreed-upon definitions that should be measured and reported in clinical trials was needed. To achieve this goal, six working groups (WGs) were setup, including WG on acute diarrhoea, whose main goal was to develop a core outcome set for trials in acute diarrhoea. The first step identified how published outcomes related to acute diarrhoea were reported. The second focused on the methodology for determining which outcomes to measure in clinical trials. The third employed a two-phase questionnaire study using the Delphi technique to define clinically important outcomes to clinicians and parents. For therapeutic studies, the five most important outcome measures were diarrhoea duration, degree of dehydration, need for hospitalisation (or duration of hospitalisation for inpatients), the proportion of patients recovered by 48 h and adverse effects. The prophylactic core outcome set included prevention of diarrhoea, prevention of dehydration, prevention of hospitalisation and adverse effects. The outcome sets for therapy and prevention can be recommended for use in future trials of patients with gastroenteritis. Their envisioned goal is to decrease study heterogeneity and to ease the comparability of studies. WG's next step is to determine how to measure the outcomes included in the core set. 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.

A Systematic Review of Associations between Amount of Meditation Practice and Outcomes in Interventions Using the Four Immeasurables Meditations

PubMed Central

Zeng, Xianglong; Chio, Floria H. N.; Oei, Tian P. S.; Leung, Freedom Y. K.; Liu, Xiangping

2017-01-01

Interventions using the “Four Immeasurables Meditations” (FIM) are effective for various outcomes; however, whether increased meditation practice in these interventions leads to better results has not been well investigated. This systematic review included 22 FIM interventions that reported associations between the amount of meditation practice and its outcomes. Despite the heterogeneity in intervention components and outcome variables, there were generally few significant associations between amount of meditation practice and its outcomes. Specifically, only five studies reported that more than half of the calculated results were significant. In comparison with correlations between total amount of practice and overall outcomes, the short-term influence of meditation practice was evaluated in fewer studies; however, it had a better association with outcomes. More studies are required that address the underlying mechanisms that elucidate how meditation practice leads to outcome changes in daily life. In this study, two promising mechanisms with initial evidence were discussed. This review also summarized common methodological issues including a lack of experimental manipulation and inaccurate measuring of meditation practice. PMID:28220101

A Systematic Review of Associations between Amount of Meditation Practice and Outcomes in Interventions Using the Four Immeasurables Meditations.

PubMed

Zeng, Xianglong; Chio, Floria H N; Oei, Tian P S; Leung, Freedom Y K; Liu, Xiangping

2017-01-01

Interventions using the "Four Immeasurables Meditations" (FIM) are effective for various outcomes; however, whether increased meditation practice in these interventions leads to better results has not been well investigated. This systematic review included 22 FIM interventions that reported associations between the amount of meditation practice and its outcomes. Despite the heterogeneity in intervention components and outcome variables, there were generally few significant associations between amount of meditation practice and its outcomes. Specifically, only five studies reported that more than half of the calculated results were significant. In comparison with correlations between total amount of practice and overall outcomes, the short-term influence of meditation practice was evaluated in fewer studies; however, it had a better association with outcomes. More studies are required that address the underlying mechanisms that elucidate how meditation practice leads to outcome changes in daily life. In this study, two promising mechanisms with initial evidence were discussed. This review also summarized common methodological issues including a lack of experimental manipulation and inaccurate measuring of meditation practice.

Using patient-reported outcomes in schizophrenia: the Scottish Schizophrenia Outcomes Study.

PubMed

Hunter, Robert; Cameron, Rosie; Norrie, John

2009-02-01

The primary aim of the Scottish Schizophrenia Outcomes Study (SSOS) was to assess the feasibility and utility of routinely collecting outcome data in everyday clinical settings. Data were collected over three years in the Scottish National Health Service (NHS). There were two secondary aims of SSOS: first, to compare data from patient-rated, objective, and clinician-rated outcomes, and second, to describe trends in outcome data and service use across Scotland over the three years of the study (2002-2005). This study used a naturalistic, longitudinal, observational cohort design. A representative sample of 1,015 persons with ICD-10 F20-F29 diagnoses (schizophrenia, schizotypal disorders, or delusional disorders) was assessed annually using the clinician-rated measure, the Health of the Nation Outcome Scale (HoNOS), and the patient-reported assessment, the Avon Mental Health Measure (Avon). Objective outcomes data and information on services and interventions were collected. Data were analyzed with regression modeling. Of the 1,015 persons recruited, 78% of the cohort (N=789) completed the study. Over the study period, significant decreases were seen in the number of hospitalizations, incidence of attempted suicide and self-harm, and civil detentions. Avon scores indicated significant improvement on all subscales (behavior, social, access, and mental health) and on the total score. However, HoNOS scores on the behavior and symptom subscales did not change, scores on the impairment subscale increased significantly (indicating increased levels of impairment), and scores on the social subscale decreased significantly (indicating improved social functioning). This study has demonstrated that it is feasible within the Scottish NHS to routinely collect meaningful outcomes data in schizophrenia. Patient-reported assessments were also successfully collected and used in care plans. This model shows that it is possible to incorporate patient-reported assessments into routine care for schizophrenia. Such assessments may provide useful data for clinicians and may improve treatment adherence. The pattern of outcomes and interventions confirms that despite the introduction of guidelines, new treatments, and new services, people with schizophrenia continue to have high levels of chronic disability.

The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument.

PubMed

Mokkink, Lidwine B; Prinsen, Cecilia A C; Bouter, Lex M; Vet, Henrica C W de; Terwee, Caroline B

2016-01-19

COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments.

The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument

PubMed Central

Mokkink, Lidwine B.; Prinsen, Cecilia A. C.; Bouter, Lex M.; de Vet, Henrica C. W.; Terwee, Caroline B.

2016-01-01

Background: COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. Method: In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. Conclusions: In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments. PMID:26786084

High statistical heterogeneity is more frequent in meta-analysis of continuous than binary outcomes.

PubMed

Alba, Ana C; Alexander, Paul E; Chang, Joanne; MacIsaac, John; DeFry, Samantha; Guyatt, Gordon H

2016-02-01

We compared the distribution of heterogeneity in meta-analyses of binary and continuous outcomes. We searched citations in MEDLINE and Cochrane databases for meta-analyses of randomized trials published in 2012 that reported a measure of heterogeneity of either binary or continuous outcomes. Two reviewers independently performed eligibility screening and data abstraction. We evaluated the distribution of I(2) in meta-analyses of binary and continuous outcomes and explored hypotheses explaining the difference in distributions. After full-text screening, we selected 671 meta-analyses evaluating 557 binary and 352 continuous outcomes. Heterogeneity as assessed by I(2) proved higher in continuous than in binary outcomes: the proportion of continuous and binary outcomes reporting an I(2) of 0% was 34% vs. 52%, respectively, and reporting an I(2) of 60-100% was 39% vs. 14%. In continuous but not binary outcomes, I(2) increased with larger number of studies included in a meta-analysis. Increased precision and sample size do not explain the larger I(2) found in meta-analyses of continuous outcomes with a larger number of studies. Meta-analyses evaluating continuous outcomes showed substantially higher I(2) than meta-analyses of binary outcomes. Results suggest differing standards for interpreting I(2) in continuous vs. binary outcomes may be appropriate. Copyright © 2016 Elsevier Inc. All rights reserved.

Developing a core outcome set for chronic rhinosinusitis: a systematic review of outcomes utilised in the current literature.

PubMed

Soni-Jaiswal, Archana; Lakhani, Raj; Hopkins, Claire

2017-07-11

A core outcome set (COS) is an agreed standardised collection of outcomes that should be measured and reported by all trials for a specific clinical area, in this case chronic rhinosinusitis. These are not restrictive and researchers may continue to explore other outcomes alongside these that they feel are relevant to their intervention. The aim of this systematic review was to identify the need for a COS for chronic rhinosinusitis. A sensitive search strategy was used to identify all published Cochrane systematic reviews and randomised control trials of intervention for adult patients with chronic rhinosinusitis. Two independent authors reviewed these to obtain a list of outcomes and outcome measures reported by each clinical trial. Sixty-nine randomised control trials and eight Cochrane systematic reviews were included in this study. They reported 68 individual outcomes and outcome measures, with an average of four to ten outcomes per clinical trial. These outcomes were mapped to 23 subcategories belonging to eight core categories. The key finding of this review was the heterogeneity of outcomes reported and measured by clinical trials of patients with chronic rhinosinusitis, precluding meaningful meta-analysis of data. This review supports the need for development of a COS, to be used in future trials on adult patients with chronic rhinosinusitis.

[Patient-reported and patient-weighted outcomes in ophthalmology].

PubMed

Scheibler, F; Finger, R P; Grosselfinger, R; Dintsios, C-M

2010-03-01

Considering patients' values and preferences in comparative effectiveness research (CER) is one of the main challenges in ophthalmology (value-based medicine). This article defines core terms in CER. The concept of patient-relevant (or patient-important) outcomes is distinguished from patient-reported outcomes (PRO) by means of examples in the field of ophthalmology. In order to be able to give a consistant recommendation if an intervention leads to conflicting results for different outcomes (trade-off), a ranking of outcomes will be necessary. Examples of studies in glaucoma patients are provided that demonstrate the possibilities of ranking of outcomes based on patient preferences.

Potential for erroneous interpretation of poisoning outcomes due to changes in National Poison Data System reporting.

PubMed

Anderson, Bruce; Ke, Xuehua; Klein-Schwartz, Wendy

2010-08-01

In 2006, the annual report of poison centers in the United States changed the method of reporting profiles for generic substance categories from all exposures to single-substance exposures only. The objective of this study is to describe the potential impact of this reporting change on longitudinal analysis of outcomes. Generic substance categories with data available for all years of the study were manually extracted from Table 22 of the National Poison Data System (NPDS) annual reports for 2002-2007. For each generic substance category, the following data were extracted for each of the 6 years: total number of substance mentions (2002-2005) or single-substance exposures (2006-2007), reason (unintentional or intentional), pediatric exposures (children age <6 years), and outcomes of major effect and death. Data were compared using descriptive analysis (Wilcoxon signed-rank test) and negative binomial regression. There were 65 generic substance categories (30 drug categories and 35 nondrug categories) that had data in all study years. For drug categories the average annual number of reported deaths by substance category decreased by 80.8%, from 2,229 in year 2002-2005 to 428 after the 2006 reporting change (p < 0.0001). The average annual number of reported major outcomes by substance category dropped by 76.0% (p < 0.0001). The impact on nondrug categories was similar: the annual average number of deaths and major effects by substance category decreased by about 50% from 394 and 4,639 per year during 2002-2005 to 198 deaths (p < 0.0001) and 2,357 major effects (p ≤ 0.0001) during 2006-2007. After controlling for potential covariates, multivariate regression showed that there were significant decreases in average rates of reported deaths (61.7 and 35.9%) and major effects (36.3 and 11.2%) for drug categories and nondrug categories, respectively (p < 0.01 for all). Overall rates of major outcomes and deaths reported to poison control centers from 2002 to 2007 have remained constant. The new method of describing demographic data in Table 22 results in outcomes that are different from those reported in previous NPDS annual reports. Comparing NPDS generic substance outcome data before and after the reporting change in 2006 will yield inaccurate results if the change in reporting methodology is not taken into account.

Interventions to modify sexual risk behaviours for preventing HIV in homeless youth.

PubMed

Naranbhai, Vivek; Abdool Karim, Quarraisha; Meyer-Weitz, Anna

2011-01-19

Homeless youth are at high risk for HIV infection as a consequence of risky sexual behaviour. Interventions for homeless youth are challenging. Assessment of the effectiveness of interventions to modify sexual risk behaviours for preventing HIV in homeless youth is needed. To evaluate and summarize the effectiveness of interventions for modifying sexual risk behaviours and preventing transmission of HIV among homeless youth. We searched electronic databases (CENTRAL, MEDLINE, EMBASE, AIDSearch, Gateway, PsycInfo, LILACS), reference lists of eligible articles, international health agency publication lists, and clinical trial registries. The search was updated January 2010. We contacted authors of published reports and other key role players. Randomised studies of interventions to modify sexual risk behaviour (biological, self-reporting of sexual-risk behaviour or health-seeking behaviour) in homeless youth (12-24 years). Data from eligible studies were extracted by two reviewers. We assessed risk of bias per the Cochrane Collaborations tool. None of the eligible studies reported any primary biological outcomes for this review. Reports of self-reporting sexual risk behaviour outcomes varied across studies precluding calculation of summary measures of effect; we present the outcomes descriptively for each study. We contacted authors for missing or ambiguous data. We identified three eligible studies after screening a total of 255 unique records. All three were performed in the United States of America and recruited substance-abusing male and female adolescents (total N=615) through homeless shelters into randomised controlled trials of independent and non-overlapping behavioural interventions. The three trials differed in theoretical background, delivery method, dosage (number of sessions,) content and outcome assessments. Overall, the variability in delivery and outcomes precluded estimation of summary of effect measures. We assessed the risk of bias to be high for each of the studies. Whilst some effect of the interventions on outcome measures were reported, heterogeneity and lack of robustness in these studies necessitate caution in interpreting the effectiveness of these interventions.  The body of evidence does not permit conclusions on the impact of interventions to modify sexual risk behaviour in homeless youth; more research is required. While the psychosocial and contextual factors that fuel sexual risk behaviours among homeless youth challenge stringent methodologies of RCT's, novel ways for program delivery and trial retention are in need of development. Future trials should comply with rigorous methodology in design, delivery, outcome measurement and reporting.

A systematic review of outcome and impact of Master’s in health and health care

PubMed Central

2013-01-01

Background The ‘human resources for health’ crisis has highlighted the need for more health (care) professionals and led to an increased interest in health professional education, including master’s degree programmes. The number of these programmes in low- and middle-income countries (LMIC) is increasing, but questions have been raised regarding their relevance, outcome and impact. We conducted a systematic review to evaluate the outcomes and impact of health-related master’s degree programmes. Methods We searched the databases Scopus, Pubmed, Embase, CINAHL, ERIC, Psychinfo and Cochrane (1999 - November 2011) and selected websites. All papers describing outcomes and impact of health-related Master programmes were included. Three reviewers, two for each article, extracted data independently. The articles were categorised by type of programme, country, defined outcomes and impact, study methods used and level of evidence, and classified according to outcomes: competencies used in practice, graduates’ career progression and impact on graduates’ workplaces and sector/society. Results Of the 33 articles included in the review, most originated from the US and the UK, and only one from a low-income country. The programmes studied were in public health (8), nursing (8), physiotherapy (5), family practice (4) and other topics (8). Outcomes were defined in less than one third of the articles, and impact was not defined at all. Outcomes and impact were measured by self-reported alumni surveys and qualitative methods. Most articles reported that competencies learned during the programme were applied in the workplace and alumni reported career progression or specific job changes. Some articles reported difficulties in using newly gained competencies in the workplace. There was limited evidence of impact on the workplace. Only two articles reported impact on the sector. Most studies described learning approaches, but very few described a mechanism to ensure outcome and impact of the programme. Conclusions Evidence suggests that graduates apply newly learned competencies in the field and that they progress in their career. There is a paucity of well-designed studies assessing the outcomes and impact of health-related master’s degree programmes in low- and middle-income countries. Studies of such programmes should consider the context and define outcomes and impact. PMID:23388181

Effect Sizes and Primary Outcomes in Large-Budget, Cardiovascular-Related Behavioral Randomized Controlled Trials Funded by NIH Since 1980

PubMed Central

Irvin, Veronica L.; Kaplan, Robert M.

2015-01-01

Purpose We reviewed large-budget, National Institutes of Health (NIH)-supported randomized controlled trials (RCTs) with behavioral interventions to assess (1) publication rates, (2) trial registration, (3) use of objective measures, (4) significant behavior and physiological change, and (5) effect sizes. Methods We identified large-budget grants (>$500,000/year) funded by NIH (National Heart Lung and Blood Institute (NHLBI) or National Institute of Diabetes & Digestive and Kidney Diseases (NIDDK)) for cardiovascular disease (dates January 1, 1980 to December 31, 2012). Among 106 grants that potentially met inclusion criteria, 20 studies were not published and 48 publications were excluded, leaving 38 publications for analysis. ClinicalTrials.gov abstracts were used to determine whether outcome measures had been pre-specified. Results Three fourths of trials were registered in ClinicalTrials.gov and all published pre-specified outcomes. Twenty-six trials reported a behavioral outcome with 81 % reporting significant improvements for the target behavior. Thirty-two trials reported a physiological outcome. All were objectively measured, and 81 % reported significant benefit. Seventeen trials reported morbidity outcomes, and seven reported a significant benefit. Nine trials assessed mortality, and all were null for this outcome. Conclusions Behavioral trials complied with trial registration standards. Most reported a physiological benefit, but few documented morbidity or mortality benefits. PMID:26507906

Methods of term labour induction for women with a previous caesarean section.

PubMed

West, Helen M; Jozwiak, Marta; Dodd, Jodie M

2017-06-09

Women with a prior caesarean delivery have an increased risk of uterine rupture and for women subsequently requiring induction of labour it is unclear which method is preferable to avoid adverse outcomes. This is an update of a review that was published in 2013. To assess the benefits and harms associated with different methods used to induce labour in women who have had a previous caesarean birth. We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2016) and reference lists of retrieved studies. Randomised controlled trials (RCTs) comparing any method of third trimester cervical ripening or labour induction, with placebo/no treatment or other methods in women with prior caesarean section requiring labour induction in a subsequent pregnancy. Two review authors independently assessed studies for inclusion and trial quality, extracted data, and checked them for accuracy. Eight studies (data from 707 women and babies) are included in this updated review. Meta-analysis was not possible because studies compared different methods of labour induction. All included studies had at least one design limitation (i.e. lack of blinding, sample attrition, other bias, or reporting bias). One study stopped prematurely due to safety concerns. Vaginal PGE2 versus intravenous oxytocin (one trial, 42 women): no clear differences for caesarean section (risk ratio (RR) 0.67, 95% confidence interval (CI) 0.22 to 2.03, evidence graded low), serious neonatal morbidity or perinatal death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low), serious maternal morbidity or death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low). Also no clear differences between groups for the reported secondary outcomes. The GRADE outcomes vaginal delivery not achieved within 24 hours, and uterine hyperstimulation with fetal heart rate changes were not reported. Vaginal misoprostol versus intravenous oxytocin (one trial, 38 women): this trial stopped early because one woman who received misoprostol had a uterine rupture (RR 3.67, 95% CI 0.16 to 84.66) and one had uterine dehiscence. No other outcomes (including GRADE outcomes) were reported. Foley catheter versus intravenous oxytocin (one trial, subgroup of 53 women): no clear difference between groups for vaginal delivery not achieved within 24 hours (RR 1.47, 95% CI 0.89 to 2.44, evidence graded low), uterine hyperstimulation with fetal heart rate changes (RR 3.11, 95% CI 0.13 to 73.09, evidence graded low), and caesarean section (RR 0.93, 95% CI 0.45 to 1.92, evidence graded low). There were also no clear differences between groups for the reported secondary outcomes. The following GRADE outcomes were not reported: serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Double-balloon catheter versus vaginal PGE2 (one trial, subgroup of 26 women): no clear difference in caesarean section (RR 0.97, 95% CI 0.41 to 2.32, evidence graded very low). Vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death were not reported. Oral mifepristone versus Foley catheter (one trial, 107 women): no primary/GRADE outcomes were reported. Fewer women induced with mifepristone required oxytocin augmentation (RR 0.54, 95% CI 0.38 to 0.76). There were slightly fewer cases of uterine rupture among women who received mifepristone, however this was not a clear difference between groups (RR 0.29, 95% CI 0.08 to 1.02). No other secondary outcomes were reported. Vaginal isosorbide mononitrate (IMN) versus Foley catheter (one trial, 80 women): fewer women induced with IMN achieved a vaginal delivery within 24 hours (RR 2.62, 95% CI 1.32 to 5.21, evidence graded low). There was no difference between groups in the number of women who had a caesarean section (RR 1.00, 95% CI 0.39 to 2.59, evidence graded very low). More women induced with IMN required oxytocin augmentation (RR 1.65, 95% CI 1.17 to 2.32). There were no clear differences in the other reported secondary outcomes. The following GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. 80 mL versus 30 mL Foley catheter (one trial, 154 women): no clear difference between groups for the primary outcomes: vaginal delivery not achieved within 24 hours (RR 1.05, 95% CI 0.91 to 1.20, evidence graded moderate) and caesarean section (RR 1.05, 95% CI 0.89 to 1.24, evidence graded moderate). However, more women induced using a 30 mL Foley catheter required oxytocin augmentation (RR 0.81, 95% CI 0.66 to 0.98). There were no clear differences between groups for other secondary outcomes reported. Several GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Vaginal PGE2 pessary versus vaginal PGE2 tablet (one trial, 200 women): no difference between groups for caesarean section (RR 1.09, 95% CI 0.74 to 1.60, evidence graded very low), or any of the reported secondary outcomes. Several GRADE outcomes were not reported: vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. RCT evidence on methods of induction of labour for women with a prior caesarean section is inadequate, and studies are underpowered to detect clinically relevant differences for many outcomes. Several studies reported few of our prespecified outcomes and reporting of infant outcomes was especially scarce. The GRADE level for quality of evidence was moderate to very low, due to imprecision and study design limitations.High-quality, adequately-powered RCTs would be the best approach to determine the optimal method for induction of labour in women with a prior caesarean birth. However, such trials are unlikely to be undertaken due to the very large numbers needed to investigate the risk of infrequent but serious adverse outcomes (e.g. uterine rupture). Observational studies (cohort studies), including different methods of cervical ripening, may be the best alternative. Studies could compare methods believed to provide effective induction of labour with low risk of serious harm, and report the outcomes listed in this review.

The incremental value of self-reported mental health measures in predicting functional outcomes of veterans.

PubMed

Eisen, Susan V; Bottonari, Kathryn A; Glickman, Mark E; Spiro, Avron; Schultz, Mark R; Herz, Lawrence; Rosenheck, Robert; Rofman, Ethan S

2011-04-01

Research on patient-centered care supports use of patient/consumer self-report measures in monitoring health outcomes. This study examined the incremental value of self-report mental health measures relative to a clinician-rated measure in predicting functional outcomes among mental health service recipients. Participants (n = 446) completed the Behavior and Symptom Identification Scale, the Brief Symptom Inventory, and the Veterans/Rand Short Form-36 at enrollment in the study (T1) and 3 months later (T2). Global Assessment of Functioning (GAF) ratings, mental health service utilization, and psychiatric diagnoses were obtained from administrative data files. Controlling for demographic and clinical variables, results indicated that improvement based on the self-report measures significantly predicted one or more functional outcomes (i.e., decreased likelihood of post-enrollment psychiatric hospitalization and increased likelihood of paid employment), above and beyond the predictive value of the GAF. Inclusion of self-report measures may be a useful addition to performance measurement efforts.

Effectiveness of teaching quality improvement to clinicians: a systematic review.

PubMed

Boonyasai, Romsai T; Windish, Donna M; Chakraborti, Chayan; Feldman, Leonard S; Rubin, Haya R; Bass, Eric B

2007-09-05

Accreditation requirements mandate teaching quality improvement (QI) concepts to medical trainees, yet little is known about the effectiveness of teaching QI. To perform a systematic review of the effectiveness of published QI curricula for clinicians and to determine whether teaching methods influence the effectiveness of such curricula. The electronic literature databases of MEDLINE, EMBASE, CINAHL, and ERIC were searched for English-language articles published between January 1, 1980, and April 30, 2007. Experts in the field of QI were queried about relevant studies. Two independent reviewers selected studies for inclusion if the curriculum taught QI principles to clinicians and the evaluation used a comparative study design. Information about the features of each curriculum, its use of 9 principles of adult learning, and the type of educational and clinical outcomes were extracted. The relationship between the outcomes and the number of educational principles used was assessed. Of 39 studies that met eligibility criteria, 31 described team-based projects; 37 combined didactic instruction with experiential learning. The median number of adult learning principles used was 7 (range, 2-8). Evaluations included 22 controlled trials (8 randomized and 14 nonrandomized) and 17 pre/post or time series studies. Fourteen studies described educational outcomes (attitudes, knowledge, or skills or behaviors) and 28 studies described clinical process or patient outcomes. Nine of the 10 studies that evaluated knowledge reported only positive effects but only 2 of these described a validated assessment tool. The 6 assessments of attitudes found mixed results. Four of the 6 studies on skill or behavior outcomes reported only positive effects. Eight of the 28 studies of clinical outcomes reported only beneficial effects. Controlled studies were more likely than other studies to report mixed or null effects. Only 4 studies evaluated both educational and clinical outcomes, providing limited evidence that educational outcomes influence the clinical effectiveness of the interventions. Most published QI curricula apply sound adult learning principles and demonstrate improvement in learners' knowledge or confidence to perform QI. Additional studies are needed to determine whether educational methods have meaningful clinical benefits.

Clinical research in implant dentistry: study design, reporting and outcome measurements: consensus report of Working Group 2 of the VIII European Workshop on Periodontology.

PubMed

Tonetti, Maurizio; Palmer, Richard

2012-02-01

The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes. Discussions were informed by three systematic reviews on quality of reporting of observational studies (case series, case-control and cohort) and experimental research (randomized clinical trials). An additional systematic review provided information on choice of outcomes and analytical methods. In addition, an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems. The Workshop attempted to clarify the characteristics and the value in dental implant research of different study designs. In most areas, measurable quality improvements over time were identified. The Workshop recognized important aspects that require continued attention by clinical researchers, funding agencies and peer reviewers to decrease potential bias. With regard to choice of outcomes, the limitations of currently used systems were recognized. Three broad outcome domains that need to be captured by future research were identified: (i) patient reported outcome measures, (ii) peri-implant tissue health and (iii) performance of implant supported restorations. Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses. The Workshop recommended that collaboration between clinicians and epidemiologists/clinical trials specialists should be encouraged. Aspects of design aimed at limitation of potential bias should receive attention by clinical researchers, funding agencies and journal editors. Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary standards. Research on outcome measure domains is an area of top priority and should urgently inform a proper process leading to a consensus on outcome measures in dental implant research. © 2012 John Wiley & Sons A/S.

Issues Relating to Selective Reporting When Including Non-Randomized Studies in Systematic Reviews on the Effects of Healthcare Interventions

ERIC Educational Resources Information Center

Norris, Susan L.; Moher, David; Reeves, Barnaby C.; Shea, Beverley; Loke, Yoon; Garner, Sarah; Anderson, Laurie; Tugwell, Peter; Wells, George

2013-01-01

Background: Selective outcome and analysis reporting (SOR and SAR) occur when only a subset of outcomes measured and analyzed in a study is fully reported, and are an important source of potential bias. Key methodological issues: We describe what is known about the prevalence and effects of SOR and SAR in both randomized controlled trials (RCTs)…

Teacher, parent, and peer reports of early aggression as screening measures for long-term maladaptive outcomes: who provides the most useful information?

PubMed

Clemans, Katherine H; Musci, Rashelle J; Leoutsakos, Jeannie-Marie S; Ialongo, Nicholas S

2014-04-01

This study compared the ability of teacher, parent, and peer reports of aggressive behavior in early childhood to accurately classify cases of maladaptive outcomes in late adolescence and early adulthood. Weighted kappa analyses determined optimal cut points and relative classification accuracy among teacher, parent, and peer reports of aggression assessed for 691 students (54% male; 84% African American and 13% White) in the fall of first grade. Outcomes included antisocial personality, substance use, incarceration history, risky sexual behavior, and failure to graduate from high school on time. Peer reports were the most accurate classifier of all outcomes in the full sample. For most outcomes, the addition of teacher or parent reports did not improve overall classification accuracy once peer reports were accounted for. Additional gender-specific and adjusted kappa analyses supported the superior classification utility of the peer report measure. The results suggest that peer reports provided the most useful classification information of the 3 aggression measures. Implications for targeted intervention efforts in which screening measures are used to identify at-risk children are discussed.

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

Parent- and child-reported parenting. Associations with child weight-related outcomes.

PubMed

Taylor, Amanda; Wilson, Carlene; Slater, Amy; Mohr, Philip

2011-12-01

The present study aimed to investigate associations of both parent-reported and child-perceived parenting styles and parent-reported parenting practices with child weight and weight-related behaviours. Participants were 175 children (56% female) aged between 7 and 11, and their primary caregivers (91% female), recruited through South Australian primary schools. Children completed measures of parenting style, attitude toward fruit, vegetables, and non-core food, and attraction to physical activity. Parents completed measures of parenting style and domain-specific parenting practices (feeding and activity-related practices) and reported on child dietary intake, physical activity, and sedentary behaviour. Objective height and weight measurements were taken from children, from which body mass index (BMI) was calculated. Child-reported parenting style and parent-reported parenting practices were uniquely associated with child weight-related outcomes, but styles and practices did not interact in their association with child outcomes. Child-reported parenting style was associated with child food and activity attitudes, whereas parent-reported parenting style was not associated with child outcomes. The findings of the present study generally support the recommendation of a parenting style high in demandingness and responsiveness for supporting healthy child weight-related behaviours, along with appropriate domain-specific practices. The child's perspective should be incorporated into research involving child outcomes wherever possible. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

What is the impact of professional learning on physical activity interventions among preschool children? A systematic review.

PubMed

Peden, M E; Okely, A D; Eady, M J; Jones, R A

2018-05-31

The purpose of this systematic review was to investigate professional learning models (length, mode, content) offered as part of objectively measured physical childcare-based interventions. A systematic review of eight electronic databases was conducted to June 2017. Only English, peer-reviewed studies that evaluated childcare-based physical activity interventions, incorporated professional learning and reported objectively measured physical activity were included. Study designs included randomized controlled trails, cluster randomized trials, experimental or pilot studies. The search identified 11 studies. Ten studies objectively measured physical activity using accelerometers; five studies used both accelerometer and direct observation tools and one study measured physical activity using direct observation only. Seven of these studies reported statistically significant intervention effects. Only six studies described all components of professional learning, but only two studies reported specific professional learning outcomes and physical activity outcomes. No patterns were identified between the length, mode and content of professional learning and children's physical activity outcomes in childcare settings. Educators play a critical role in modifying children's levels of physical activity in childcare settings. The findings of this review suggest that professional learning offered as part of a physical activity intervention that potentially impacts on children's physical activity outcomes remains under-reported. © 2018 World Obesity Federation.

Using the Patient Reported Outcomes Measurement Information System to Evaluate Psychosocial Functioning among Children with Craniofacial Anomalies.

PubMed

Shapiro, Danielle N; Waljee, Jennifer; Ranganathan, Kavitha; Buchman, Steven; Warschausky, Seth

2015-06-01

Children with craniofacial anomalies are at risk for social exclusion, bullying, and psychological symptoms, all of which are associated with poor developmental and health outcomes. The National Institutes of Health-developed Patient Reported Outcomes Measurement Information System instruments may be useful tools for monitoring psychosocial functioning in clinical settings and for integrating patient and parent perspectives. The current study included 74 children (50 percent male) with craniofacial anomalies recruited through a multidisciplinary clinic. The authors obtained child self-report and parent-proxy ratings of depression, anxiety, and peer relationship quality using National Institutes of Health Patient Reported Outcomes Measurement Information System instruments. The authors compared sample means to Patient Reported Outcomes Measurement Information System instruments norms and analyzed the reliability of parents' and children's reporting of psychosocial variables. All reliability statistics were satisfactory (α values ranging from 0.74 to 0.96) and sample standard deviations were similar to those obtained in a general population, suggesting that Patient Reported Outcomes Measurement Information System instruments are reliable among children with craniofacial anomalies. In general, children and parents did not report unusual levels of psychological distress; however, they did report poorer peer relationship quality relative to normed data, a trend that was particularly pronounced among boys. National Institutes of Health Patient Reported Outcomes Measurement Information System instruments are efficient and accurate tools for monitoring psychosocial adjustment among children with craniofacial anomalies. It may be especially important to monitor social functioning, particularly among boys.

Mother-Child Discrepancy in Perceived Family Functioning and Adolescent Developmental Outcomes in Families Experiencing Economic Disadvantage in Hong Kong.

PubMed

Leung, Janet T Y; Shek, Daniel T L; Li, Lin

2016-10-01

Though growing attention has been devoted to examining informant discrepancies of family attributes in social science research, studies that examine how interactions between mother-reported and adolescent-reported family functioning predict adolescent developmental outcomes in underprivileged families are severely lacking. The current study investigated the difference between mothers and adolescents in their reports of family functioning, as well as the relationships between mother-reported and adolescent-reported family functioning and adolescent developmental outcomes in a sample of 432 Chinese single-mother families (mean age of adolescents = 13.7 years, 51.2 % girls, mean age of mothers = 43.5 years, 69.9 % divorced) experiencing economic disadvantage in Hong Kong. Polynomial regression analyses were conducted to assess whether discrepancy in family functioning between mother reports and adolescent reports predicted resilience, beliefs in the future, cognitive competence, self-efficacy and self-determination of adolescents. The results indicated that adolescents reported family functioning more negatively than did their mothers. Polynomial regression analyses showed that the interaction term between mothers' reports and adolescents' reports of family functioning predicted adolescent developmental outcomes in Chinese single-mother families living in poverty. Basically, under poor adolescent-reported family functioning, adolescent development would be relatively better if their mothers reported more positive family functioning. In contrast, under good adolescent-reported family functioning, adolescents expressed better developmental outcomes when mothers reported lower levels of family functioning than those mothers who reported higher levels of family functioning. The findings provide insights on how congruency and discrepancy between informant reports of family functioning would influence adolescent development. Theoretical and practical implications of the findings are discussed.

Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

PubMed

Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B

2017-01-01

A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of ClinRO assessments used as end points in clinical trials. Applying good measurement practices to ClinRO assessment development and evaluation will lead to more efficient and accurate measurement of treatment effects. This is important beyond regulatory approval in that it provides evidence for the uptake of new interventions into clinical practice and provides justification to payers for reimbursement on the basis of the clearly demonstrated added value of the new intervention. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

ADATSA Treatment Outcomes: Employment and Cost Avoidance: An Eighteen Month Follow-Up Study of Indigent Persons Served by Washington State's Alcoholism and Drug Addiction Treatment and Support Act. Report No. 4-19.

ERIC Educational Resources Information Center

Longhi, Dario; And Others

This report provides a cost-benefit analysis of a program that provides publicly-funded treatment and support for persons who are addicted to alcohol or other drugs and who are judged to be indigent, unemployable, and incapacitated due to their addiction. The study focused on two client outcomes: (1) determine employment outcomes during an 18…

Clinical applications of cell-based approaches in alveolar bone augmentation: a systematic review.

PubMed

Shanbhag, Siddharth; Shanbhag, Vivek

2015-01-01

Cell-based approaches, utilizing adult mesenchymal stem cells (MSCs), are reported to overcome the limitations of conventional bone augmentation procedures. The study aims to systematically review the available evidence on the characteristics and clinical effectiveness of cell-based ridge augmentation, socket preservation, and sinus-floor augmentation, compared to current evidence-based methods in human adult patients. MEDLINE, EMBASE, and CENTRAL databases were searched for related literature. Both observational and experimental studies reporting outcomes of "tissue engineered" or "cell-based" augmentation in ≥5 adult patients alone, or in comparison with non-cell-based (conventional) augmentation methods, were eligible for inclusion. Primary outcome was histomorphometric analysis of new bone formation. Effectiveness of cell-based augmentation was evaluated based on outcomes of controlled studies. Twenty-seven eligible studies were identified. Of these, 15 included a control group (8 randomized controlled trials [RCTs]), and were judged to be at a moderate-to-high risk of bias. Most studies reported the combined use of cultured autologous MSCs with an osteoconductive bone substitute (BS) scaffold. Iliac bone marrow and mandibular periosteum were frequently reported sources of MSCs. In vitro culture of MSCs took between 12 days and 1.5 months. A range of autogenous, allogeneic, xenogeneic, and alloplastic scaffolds was identified. Bovine bone mineral scaffold was frequently reported with favorable outcomes, while polylactic-polyglycolic acid copolymer (PLGA) scaffold resulted in graft failure in three studies. The combination of MSCs and BS resulted in outcomes similar to autogenous bone (AB) and BS. Three RCTs and one controlled trial reported significantly greater bone formation in cell-based than conventionally grafted sites after 3 to 8 months. Based on limited controlled evidence at a moderate-to-high risk of bias, cell-based approaches are comparable, if not superior, to current evidence-based bone grafting methods, with a significant advantage of avoiding AB harvesting. Future clinical trials should additionally evaluate patient-based outcomes and the time-/cost-effectiveness of these approaches. © 2013 Wiley Periodicals, Inc.

Financial conflicts of interest and their association with outcome and quality of fibromyalgia drug therapy randomized controlled trials.

PubMed

Pang, Winnie K; Yeter, Karen C; Torralba, Karina D; Spencer, Horace J; Khan, Nasim A

2015-07-01

To evaluate the association of financial conflicts of interest (FCOI) with the characteristics, outcome and reported methodological quality of fibromyalgia drug therapy randomized controlled trials (FM-RCTs). A cross-sectional study of original, parallel-group, drug therapy FM-RCTs published between 1997 and 2011 from Medline and Cochrane Central Register of Controlled Trials was conducted. Two reviewers independently assessed each RCT for funding source, authors' FCOI(s), study characteristics, reporting of methodological measures important for internal validity and outcome (positive [statistically significant result favoring experimental drug for the primary outcome] or non-positive). Forty-seven RCTs were eligible with funding source as: 26 (55.3%) industry; eight (17%) non-profit source(s); five (10.6%) mixed; and eight (17%) unspecified. Industry-funded RCTs were more likely to be multicenter and enroll greater number of patients. Reporting of key methodological measures was suboptimal; however, industry and non-profit funded RCTs did not differ in their reporting. Thirty (63.8%) RCTs had ≥ one author who disclosed an FCOI (receipt of research grant [21, 44.7%], industry sponsor employee [20, 42.6%], receipt of consultancy fee/honorarium [16, 34%] and stock ownership [11, 23.4%]). Although industry funding and certain authors' FCOIs (employment and receipt of consultancy fee/honorarium) were univariately associated with positive outcome, such association was not observed after adjusting for study sample size. The majority of FM-RCTs were industry-sponsored, and had at least one author with an FCOI. Reporting of key methodological measures was suboptimal. After adjusting for study sample size, no association of industry funding or author's FCOI with study outcome was seen. © 2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

Sexual Outcomes and Satisfaction with Hysterectomy: Influence of Patient Education

PubMed Central

Bradford, Andrea; Meston, Cindy

2010-01-01

Introduction Many women experience improved sexual function after hysterectomy. However, a sizeable minority of women report worsened sexual function after the surgery, and concerns about the effect of surgery on sexual function are common among women planning to undergo hysterectomy. Aim The present study examined the role of education about the potential sexual consequences of hysterectomy in predicting self-reported outcomes and satisfaction with the procedure. Methods We conducted a cross-sectional survey of 204 women who had undergone simple hysterectomy in the preceding 3–12 months. Participants volunteered in response to a Web-based advertisement. Main Outcome Measures Participants indicated their current sexual function using the Female Sexual Function Index (FSFI), and reported positive and negative sexual outcomes experienced after hysterectomy using a checklist. Participants also completed questionnaire items regarding satisfaction with hysterectomy and education from their physicians about sexual risks and benefits prior to surgery. Results Current sexual function scores were related to self-reports of positive and negative sexual outcomes following hysterectomy and overall satisfaction with hysterectomy. Education from a physician about possible adverse sexual outcomes was largely unrelated to self-reports of having experienced those outcomes. However, education about possible negative sexual outcomes predicted overall satisfaction with hysterectomy when controlling for self-reports of positive and negative sexual outcomes. Conclusion Education about potential negative sexual outcomes after surgery may enhance satisfaction with hysterectomy, independent of whether negative sexual outcomes were experienced. Including a discussion of potential sexual changes after surgery may enhance the benefits of presurgical counseling prior to hysterectomy. PMID:17087803

Developing a Theoretical Framework to Illustrate Associations Among Patient Satisfaction, Body Image and Quality of Life for Women Undergoing Breast Reconstruction

PubMed Central

Fingeret, Michelle Cororve; Nipomnick, Summer; Crosby, Melissa A.; Reece, Gregory P.

2013-01-01

Within the field of breast reconstruction there is increasing focus on patient-reported outcomes related to satisfaction, body image, and quality of life. These outcomes are deemed highly relevant because the primary goal of breast reconstruction is to recreate the appearance of a breast (or breasts) that is satisfying to the patient. Prominent researchers have suggested the need to develop improved standards for outcome evaluation which can ultimately benefit patients as well as physicians. The purpose of this article is to summarize key findings in the area of patient-reported outcomes for breast reconstruction and introduce a theoretical framework for advancing research in this field. We conducted an extensive literature review of outcome studies for breast reconstruction focusing on patient-reported results. We developed a theoretical framework illustrating core patient-reported outcomes related to breast reconstruction and factors associated with these outcomes. Our theoretical model highlights domains and distinguishing features of patient satisfaction, body image, and quality of life outcomes for women undergoing breast reconstruction. This model further identifies a broad range of variables (e.g., historical/premorbid influences, disease and treatment-related factors) that have been found to influence patient-reported outcomes and need to be taken into consideration when designing future research in this area. Additional attention is given to examining the relationship between patient reported outcomes and outside evaluation of breast reconstruction. Our proposed theoretical framework suggests key opportunities to expand research in this area with the goal of optimizing body image adjustment, satisfaction, and psychosocial outcomes for the individual patient. PMID:23380309

A test of theory of planned behavior in Korea: participation in alcohol-related social gatherings.

PubMed

Park, Hee Sun; Lee, Dong Wook

2009-12-01

Two studies are reported using the theory of planned behavior (TPB) to predict and explain joining and not joining alcohol-related social gatherings among Korean undergraduates in various engineering majors. Specifically, considering that the attitudinal component of TPB is behavioral-outcome-based, the current study investigated whether the outcomes of engaging in a behavior and of not engaging in a behavior would similarly predict intentions to engage in a behavior and intentions to not engage in a behavior. The current study also examined whether intentions to engage and intentions to not engage would be significantly related to self-reported behavior a week later. Participants in Study 1 reported TPB components (attitudes toward behavior, subjective norms, perceived behavioral control, and behavioral intentions) concerning joining alcohol-related social gatherings. Participants in Study 2 reported TPB components concerning not joining alcohol-related social gatherings. Additionally, a week later, the participants in both studies reported their participation in alcohol-related social gatherings from the past week. Generally, the results showed that the TPB components were significantly associated with undergraduates' intentions to join and intentions to not join. Specifically, conversation-related attitudes and senior-junior relationship-related attitudes were significantly related to intentions to join, and only group-related attitudes were significantly related to intentions to not join. Intentions to join and intentions to not join were not significantly related to self-reported behavior of joining alcohol-related social gatherings a week later. The findings from the current research provide some evidence that joining or not joining alcohol-related social gatherings may not be mere behavioral opposites, predictable by the presence or absence of the same behavioral outcomes. These two aspects of the behavior may require assessment of different behavioral outcomes or different assessments of the same behavioral outcomes.

The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial.

PubMed

Schakel, Lemmy; Veldhuijzen, Dieuwke S; van Middendorp, Henriët; Prins, Corine; Joosten, Simone A; Ottenhoff, Tom H M; Visser, Leo G; Evers, Andrea W M

2017-05-26

Previous research has provided evidence for the link between psychological processes and psychophysiological health outcomes. Psychological interventions, such as face-to-face or online cognitive behavioral therapy (CBT) and serious games aimed at improving health, have shown promising results in promoting health outcomes. Few studies so far, however, have examined whether Internet-based CBT combined with serious gaming elements is effective in modulating health outcomes. Moreover, studies often did not incorporate psychophysiological or immunological challenges in order to gain insight into physiological responses to real-life challenges after psychological interventions. The overall aim of this study is to investigate the effects of a psychological intervention on self-reported and physiological health outcomes in response to immune and psychophysiological challenges. In a randomized controlled trial, 60 healthy men are randomly assigned to either an experimental condition, receiving guided Internet-based (e-health) CBT combined with health-related serious gaming elements for 6 weeks, or a control condition receiving no intervention. After the psychological intervention, self-reported vitality is measured, and participants are given an immunological challenge in the form of a Mycobacterium bovis Bacillus Calmette-Guérin (BCG) vaccination. One day after the vaccination, participants are asked to perform several psychophysiological tasks in order to explore the effects of the psychological intervention on participants' stress response following the immune challenge. To assess the delayed effects of vaccination on self-reported and physiological health outcomes, a follow-up visit is planned 4 weeks later. Total study duration is approximately 14 weeks. The primary outcome measure is self-reported vitality measured directly after the intervention. Secondary outcome measures include inflammatory and endocrine markers, as well as psychophysiological measures of heart rate and skin conductance in response to the psychophysiological tasks after the BCG vaccination. The innovative design features of this study - e.g., combining guided e-health CBT with health-related serious gaming elements and incorporating immunological and psychophysiological challenges - will provide valuable information on the effects of a psychological intervention on both self-reported and physiological health outcomes. This study will offer further insights into the mechanisms underlying the link between psychological factors and health outcomes and is anticipated to contribute to the optimization of health care strategies. Nederlands Trial Register, NTR5610 . Registered on 4 January 2016.

A systematic review of the effectiveness of interruptive medication prescribing alerts in hospital CPOE systems to change prescriber behavior and improve patient safety.

PubMed

Page, N; Baysari, M T; Westbrook, J I

2017-09-01

To assess the evidence of the effectiveness of different categories of interruptive medication prescribing alerts to change prescriber behavior and/or improve patient outcomes in hospital computerized provider order entry (CPOE) systems. PubMed, Embase, CINAHL and the Cochrane Library were searched for relevant articles published between January 2000 and February 2016. Studies were included if they compared the outcomes of automatic, interruptive medication prescribing alert/s to a control/comparison group to determine alert effectiveness. Twenty-three studies describing 32 alerts classified into 11 alert categories were identified. The most common alert categories studied were drug-condition interaction (n=6), drug-drug interaction alerts (n=6) and corollary order alerts (n=6). All 23 papers investigated the effect of the intervention alert on at least one outcome measure of prescriber behavior. Just over half of the studies (53%, n=17) reported a statistically significant beneficial effect from the intervention alert; 34% (n=11) reported no statistically significant effect, and 6% (n=2) reported a significant detrimental effect. Two studies also evaluated the effect of alerts on patient outcome measures; neither finding that patient outcomes significantly improved following alert implementation (6%, n=2). The greatest volume of evidence relates to three alert categories: drug-condition, drug-drug and corollary order alerts. Of these, drug-condition alerts had the greatest number of studies reporting positive effects (five out of six studies). Only two of six studies of drug-drug interaction and one of six of corollary alerts reported positive benefits. The current evidence-base does not show a clear indication that particular categories of alerts are more effective than others. While the majority of alert categories were shown to improve outcomes in some studies, there were also many cases where outcomes did not improve. This lack of evidence hinders decisions about the amount and type of decision support that should be integrated into CPOE systems to increase safety while reducing the risk of alert fatigue. Virtually no studies have sought to investigate the impact on changes to prescriber behavior and outcomes overall when alerts from multiple categories are incorporated within the same system. Copyright © 2017 Elsevier B.V. All rights reserved.

Mapping to Estimate Health-State Utility from Non-Preference-Based Outcome Measures: An ISPOR Good Practices for Outcomes Research Task Force Report.

PubMed

Wailoo, Allan J; Hernandez-Alava, Monica; Manca, Andrea; Mejia, Aurelio; Ray, Joshua; Crawford, Bruce; Botteman, Marc; Busschbach, Jan

2017-01-01

Economic evaluation conducted in terms of cost per quality-adjusted life-year (QALY) provides information that decision makers find useful in many parts of the world. Ideally, clinical studies designed to assess the effectiveness of health technologies would include outcome measures that are directly linked to health utility to calculate QALYs. Often this does not happen, and even when it does, clinical studies may be insufficient for a cost-utility assessment. Mapping can solve this problem. It uses an additional data set to estimate the relationship between outcomes measured in clinical studies and health utility. This bridges the evidence gap between available evidence on the effect of a health technology in one metric and the requirement for decision makers to express it in a different one (QALYs). In 2014, ISPOR established a Good Practices for Outcome Research Task Force for mapping studies. This task force report provides recommendations to analysts undertaking mapping studies, those that use the results in cost-utility analysis, and those that need to critically review such studies. The recommendations cover all areas of mapping practice: the selection of data sets for the mapping estimation, model selection and performance assessment, reporting standards, and the use of results including the appropriate reflection of variability and uncertainty. This report is unique because it takes an international perspective, is comprehensive in its coverage of the aspects of mapping practice, and reflects the current state of the art. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Specialist home-based nursing services for children with acute and chronic illnesses.

PubMed

Parab, Chitra S; Cooper, Carolyn; Woolfenden, Susan; Piper, Susan M

2013-06-15

Specialist paediatric home-based nursing services have been proposed as a cost-effective means of reducing distress resulting from hospital admissions, while enhancing primary care and reducing length of hospital stay. This review is an update of our original review, which was published in 2006. To evaluate specialist home-based nursing services for children with acute and chronic illnesses. We searched the following databases in February 2012: the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library 2012 Issue 2, Ovid MEDLINE, EMBASE, PsycINFO, CINAHL and Sociological Abstracts. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform. No language restrictions were applied. Randomised controlled trials (RCTs) of children from birth to age 18 years with acute or chronic illnesses allocated to specialist home-based nursing services compared with conventional health care. Outcomes included utilisation of health care, physical and mental health, satisfaction, adverse health outcomes and costs. Two review authors extracted data from the studies independently and resolved any discrepancies by recourse to a third author. Meta-analysis was not appropriate because of the clinical diversity of the studies and the lack of common outcome measures. We screened 4226 titles to yield seven RCTs with a total of 840 participants. Participants, interventions and outcomes were diverse. No significant differences were reported in health outcomes; two studies reported a reduction in the hospital stay with no difference in the hospital readmission rates. Three studies reported a reduction in parental anxiety and improvement in child behaviours was reported in three studies. Overall increased parental satisfaction was reported in three studies. Also, better parental coping and family functioning was reported in one study. By contrast, one study each reported no impact on parental burden of care or on functional status of children. Home care was reported as more costly for service providers with substantial cost savings for the family in two studies, while one study revealed no significant cost benefits for the family. Current research does not provide supporting evidence for a reduction in access to hospital services or a reduction in hospital readmission rate for children with acute and chronic illnesses using specialist home-based nursing services; however, the only summary finding across a few studies was that there is a significant decrease in length of hospitalisation. The preliminary results show no adverse impact on physical health outcomes and a number of papers reported improved satisfaction with home-based care. Further trials are required, measuring health, satisfaction, service utilisation and long-term costs.

Multivariate meta-analysis using individual participant data

PubMed Central

Riley, R. D.; Price, M. J.; Jackson, D.; Wardle, M.; Gueyffier, F.; Wang, J.; Staessen, J. A.; White, I. R.

2016-01-01

When combining results across related studies, a multivariate meta-analysis allows the joint synthesis of correlated effect estimates from multiple outcomes. Joint synthesis can improve efficiency over separate univariate syntheses, may reduce selective outcome reporting biases, and enables joint inferences across the outcomes. A common issue is that within-study correlations needed to fit the multivariate model are unknown from published reports. However, provision of individual participant data (IPD) allows them to be calculated directly. Here, we illustrate how to use IPD to estimate within-study correlations, using a joint linear regression for multiple continuous outcomes and bootstrapping methods for binary, survival and mixed outcomes. In a meta-analysis of 10 hypertension trials, we then show how these methods enable multivariate meta-analysis to address novel clinical questions about continuous, survival and binary outcomes; treatment–covariate interactions; adjusted risk/prognostic factor effects; longitudinal data; prognostic and multiparameter models; and multiple treatment comparisons. Both frequentist and Bayesian approaches are applied, with example software code provided to derive within-study correlations and to fit the models. PMID:26099484

Physical Activity and Benign Prostatic Hyperplasia-Related Outcomes and Nocturia

PubMed Central

WOLIN, KATHLEEN Y.; GRUBB, ROBERT L.; PAKPAHAN, RATNA; RAGARD, LAWRENCE; MABIE, JEROME; ANDRIOLE, GERALD L.; SUTCLIFFE, SIOBHAN

2015-01-01

ABSTRACT Introduction Benign prostatic hyperplasia (BPH) and its associated lower urinary tract symptoms (LUTS), including nocturia, are extremely common among middle- and older-age American men. Although studies on physical activity (PA) and prevalent BPH-related outcomes suggest that PA may protect against the development of this common condition, only a few studies have examined the relation between PA and incident BPH-related outcomes and LUTS with mixed findings. In addition, although nocturia is the most commonly reported and most bothersome LUTS in men with or without evidence of BPH, few studies have examined the association of PA and nocturia independent of BPH. The purpose of this analysis was to examine the association of PA with BPH-related outcomes and nocturia in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening trial. Methods We examined this association with both prevalent (n = 28,404) and incident (n = 4710) BPH-related outcomes (measured by self-report of physician diagnosis, BPH surgery, finasteride use, and clinical indicators) and nocturia. Poisson regression with robust variance was used to calculate prevalence ratios and relative risks. Results PA was weakly positively associated with several prevalent BPH-related outcomes and was strongly inversely associated with prevalent nocturia. In incident analyses, PA was only associated with nocturia. Men who were active ≥1 h·wk−1 were 13% less likely (95% confidence interval, 2%–22%) to report nocturia and 34% less likely (95% confidence interval, 15%–49%) to report severe nocturia as compared with men who reported no PA. The associations were similar for men with and without additional BPH-related outcomes, except for prevalent nocturia, where the association was stronger for men without other BPH-related outcomes. Conclusions Combined with other management strategies, PA may provide a strategy for the management of BPH-related outcomes, particularly nocturia. PMID:25010403

Texas Junior High School Study: Final Report of Process-Outcome Relationships; Manual for Low Inference Behavioral Coding System. Appendix C. R&D Report No. 4061.

ERIC Educational Resources Information Center

Brophy, Jere; And Others

This is the fourth in a series of four reports describing a study of 1,614 junior high school mathematics and English students and 69 of their teachers that was undertaken to discover the effects of different teaching behaviors on cognitive and affective student outcomes. This booklet is the working manual used for coder training and includes…

Do dietary supplements have beneficial health effects in industrialized nations: what is the evidence?

PubMed

Marik, Paul E; Flemmer, Mark

2012-03-01

Dietary supplements are regularly used by at least half of the American population, yet the health benefits of these agents are unclear. A systematic review to determine the benefits and risks of dietary supplements in Westernized societies. MEDLINE, Embase, Cochrane Register of Controlled Trials and citation review of relevant articles. Randomized, placebo-controlled clinical trials in non-pregnant Westernized adults that evaluated clinical outcomes of nutritional supplements. Data were abstracted on study design, study size, study setting, patient population, dietary intervention and clinical outcomes. The outcome of each study was classified as non-beneficial, beneficial or harmful according to whether the end-point(s) of interest reached statistical significance. Sixty-three studies met the criteria for our systematic review. No benefit was recorded in 45 studies, with 10 of these showing a trend towards harm and with two showing a trend towards benefit. Four studies reported harm with increased cancer deaths (n=2) and increased fractures (n=2). Two studies reported both a harmful as well as a beneficial outcome. A beneficial outcome was reported in 12 studies; 6 which studied vitamin D and three which investigated omega-3 fatty acids. While a benefit was reported in one study each which investigated Vitamin E, folic acid and Ginkgo biloba this benefit was not confirmed by larger and more adequately powered studies. With the possible exceptions of Vitamin D and omega-3 fatty acids there is no data to support the widespread use of dietary supplements in Westernized populations; indeed, many of these supplements may be harmful.

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.

Impact of a walking intervention on cardiorespiratory fitness, self-reported physical function, and pain in patients undergoing treatment for solid tumors.

PubMed

Griffith, Kathleen; Wenzel, Jennifer; Shang, JingJing; Thompson, Carol; Stewart, Kerry; Mock, Victoria

2009-10-15

Cancer treatment is associated with decline in measured and self-reported physical function and increased pain. In the current study, the authors evaluated the impact of a walking intervention on these outcomes during chemotherapy/radiation. Patients with breast, prostate, and other cancers (N=126) were randomized to a home-based walking intervention (exercise) or usual care (control). Exercise dose during the intervention was assessed using a 5-item Physical Activity Questionnaire. Outcome measures were cardiorespiratory fitness, expressed as peak oxygen uptake (VO2) measured during treadmill testing (n=85) or estimated by 12-minute walk (n=27), and self-reported physical function, role limitations, and pain derived from Medical Outcomes Study Short Form 36. Linear regression was used to evaluate pre-to-post intervention change outcomes between groups. The mean (standard deviation) age of the patients was 60.2 (10.6) years. Diagnoses included prostate (55.6%) and breast (32.5%) cancer. Treatment included external beam radiotherapy (52.3%) and chemotherapy (34.9%). Exercise patients reported worsening Medical Outcomes Study physical function role limitations by the end of cancer treatment (P=.037). Younger age was associated with improved Medical Outcomes Study physical function (P=.048). In all patients, increased exercise dose was associated with decreased Medical Outcomes Study pain (P=.046), regardless of diagnosis. The percent change of VO2 between prostate and nonprostate cancer patients when adjusted for baseline VO2 and Physical Activity Questionnaire values was 17.45% (P=.008), with better VO2 maintenance in the prostate group. Exercise during cancer treatment improves cardiorespiratory fitness and self-reported physical function in prostate cancer patients and in younger patients, regardless of diagnosis, and may attenuate loss of those capacities in patients undergoing chemotherapy. Exercise also reduces the pain experience. Copyright (c) 2009 American Cancer Society.

Differences in Functional Outcomes for Adult Patients with Prosthodontically-Treated and -Untreated Shortened Dental Arches: A Systematic Review

PubMed Central

Khan, Saadika; Musekiwa, Alfred; Chikte, Usuf M. E.; Omar, Ridwaan

2014-01-01

This review examined differences in functional outcomes and patient satisfaction when shortened dental arches are left untreated compared to their restoration to complete arch lengths with different prosthodontic interventions. Methods A protocol was developed according to the criteria for a systematic review. All relevant databases were searched to identify appropriate clinical trials regardless of language or publication status. Predetermined eligibility criteria were applied, trial quality assessed and data extracted for each study. Relevant outcomes assessed were: functioning ability, patient satisfaction and harmful effects on oral structures. Results Searches yielded 101 articles: 81 from electronic databases and 20 from reference lists of retrieved articles (PEARLing searches). Sixty-nine citations were assessed for eligibility after removing 32 duplicate records. After reading titles and abstracts, a total of 41 records were excluded and the full-texts of the remaining 28 records were read. Only 21 records were included for the SR because 7 records were excluded after reading the full-text reports. These 21 records report the outcomes of four randomized controlled trials (RCTs) and one non-randomized clinical trial (CT) which were pre-specified and used for this review. No on-going studies were found and no eligible studies were excluded for failure to report the reviewer’s pre-specified outcomes. Outcomes were reported in the retrieved 21 articles. A narrative explanation of the pre-specified outcomes is reported for the 3 comparison groups (which were based on the different interventions used for the individual clinical trials). The shortened dental arch as a treatment option is encouraging in terms of functioning, patient satisfaction and cost-effectiveness. By using only high quality studies it was expected that the results would be more reliable when making conclusions and recommendations, but some of the included studies had to be downgraded due to methodological errors. PMID:24992473

The quiet revolution: reporting of health outcomes in general medical journals.

PubMed

Seymour, J; Newell, D; Shiell, A

1997-01-01

This study reviews the extent of evaluation of health outcomes in three general medical journals over the past decade by examining papers published in the original research section of the New England Journal of Medicine (NEJM), The Lancet, and the Medical Journal of Australia (MJA) in 1982 and 1992. Evaluations were identified and classified according to the type of comparison group and the type of outcome measures employed. They were divided into three categories: those employing a comparison group; those employing a before-and-after study design (or own comparison group); and those with no comparison group. The categories of outcome measures were mortality, clinical or intermediate measures of health state, and final outcome measures (quality of life). Results show that the proportion of papers evaluating a health services intervention remained stable over the period. However, the MJA published considerably fewer evaluations than the other journals. In the NEJM and The Lancet, 75 per cent of evaluations incorporated comparison groups, in the MJA, less than 40 per cent. Overall, the proportion of papers reporting final outcome measures increased significantly between 1982 and 1992 (p = 0.04) but the change in each journal individually did not reach statistical significance. This study indicates that the reporting of health outcomes evaluations has remained constant but there has been some change in the use of comparison groups and final outcome measures over time.

Prospective and Retrospective Studies of Substance Abuse Treatment Outcomes: Methods and Results of Four Large-Scale Follow-Up Studies.

ERIC Educational Resources Information Center

Gerstein, Dean R.; Johnson, Robert A.

This report compares the research methods, provider and patient characteristics, and outcome results from four large-scale followup studies of drug treatment during the 1990s: (1) the California Drug and Alcohol Treatment Assessment (CALDATA); (2) Services Research Outcomes Study (SROS); (3) National Treatment Improvement Evaluation Study (NTIES);…

The need for randomization in animal trials: an overview of systematic reviews.

PubMed

Hirst, Jennifer A; Howick, Jeremy; Aronson, Jeffrey K; Roberts, Nia; Perera, Rafael; Koshiaris, Constantinos; Heneghan, Carl

2014-01-01

Randomization, allocation concealment, and blind outcome assessment have been shown to reduce bias in human studies. Authors from the Collaborative Approach to Meta Analysis and Review of Animal Data from Experimental Studies (CAMARADES) collaboration recently found that these features protect against bias in animal stroke studies. We extended the scope the work from CAMARADES to include investigations of treatments for any condition. We conducted an overview of systematic reviews. We searched Medline and Embase for systematic reviews of animal studies testing any intervention (against any control) and we included any disease area and outcome. We included reviews comparing randomized versus not randomized (but otherwise controlled), concealed versus unconcealed treatment allocation, or blinded versus unblinded outcome assessment. Thirty-one systematic reviews met our inclusion criteria: 20 investigated treatments for experimental stroke, 4 reviews investigated treatments for spinal cord diseases, while 1 review each investigated treatments for bone cancer, intracerebral hemorrhage, glioma, multiple sclerosis, Parkinson's disease, and treatments used in emergency medicine. In our sample 29% of studies reported randomization, 15% of studies reported allocation concealment, and 35% of studies reported blinded outcome assessment. We pooled the results in a meta-analysis, and in our primary analysis found that failure to randomize significantly increased effect sizes, whereas allocation concealment and blinding did not. In our secondary analyses we found that randomization, allocation concealment, and blinding reduced effect sizes, especially where outcomes were subjective. Our study demonstrates the need for randomization, allocation concealment, and blind outcome assessment in animal research across a wide range of outcomes and disease areas. Since human studies are often justified based on results from animal studies, our results suggest that unduly biased animal studies should not be allowed to constitute part of the rationale for human trials.

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.

Establishing Maximal Medical Improvement After Arthroscopic Rotator Cuff Repair.

PubMed

Zuke, William A; Leroux, Timothy S; Gregory, Bonnie P; Black, Austin; Forsythe, Brian; Romeo, Anthony A; Verma, Nikhil N

2018-03-01

As health care transitions from a pay-for-service to a pay-for-performance infrastructure, the value of orthopaedic care must be defined accurately. Significant efforts have been made in defining quality and cost in arthroplasty; however, there remains a lag in ambulatory orthopaedic care. Two-year follow-up has been a general requirement for reporting outcomes after rotator cuff repair. However, this time requirement has not been established scientifically and is of increasing importance in the era of value-based health care. Given that arthroscopic rotator cuff repair is a common ambulatory orthopaedic procedure, the purpose of this study was to establish a time frame for maximal medical improvement (the state when improvement has stabilized) after arthroscopic rotator cuff repair. Systematic review. A systematic review of the literature was conducted, identifying studies reporting sequential patient-reported outcomes up to a minimum of 2 years after arthroscopic rotator cuff repair. The primary clinical outcome was patient-reported outcomes at 3-month, 6-month, 1-year, and 2-year follow-up. Secondary clinical outcomes included range of motion, strength, retears, and complications. Clinically significant improvement was determined between various time intervals by use of the minimal clinically important difference. The review included 19 studies including 1370 patients who underwent rotator cuff repair. Clinically significant improvement in patient-reported outcomes was seen up to 1 year after rotator cuff repair, but no clinical significance was noted from 1 year to 2 years. The majority of improvement in strength and range of motion was seen up to 6 months, but no clinically meaningful improvement was seen thereafter. All reported complications and the majority of retears occurred within 6 months after rotator cuff repair. After rotator cuff repair, a clinically significant improvement in patient-reported outcomes, range of motion, and strength was seen up to 1 year after surgery, but not beyond this. This information is important not only to establish appropriate patient expectations but also to determine a time frame for outcome collection after surgery to better define value in orthopaedic care.

Validation of Patient-Reported Outcomes Measurement Information System Computerized Adaptive Tests Against the Foot and Ankle Outcome Score for 6 Common Foot and Ankle Pathologies.

PubMed

Koltsov, Jayme C B; Greenfield, Stephen T; Soukup, Dylan; Do, Huong T; Ellis, Scott J

2017-08-01

The field of foot and ankle surgery lacks a widely accepted gold-standard patient-reported outcome instrument. With the changing infrastructure of the medical profession, more efficient patient-reported outcome tools are needed to reduce respondent burden and increase participation while providing consistent and reliable measurement across multiple pathologies and disciplines. The primary purpose of the present study was to validate 3 Patient-Reported Outcomes Measurement Information System computer adaptive tests (CATs) most relevant to the foot and ankle discipline against the Foot and Ankle Outcome Score (FAOS) and the Short Form 12 general health status survey in patients with 6 common foot and ankle pathologies. Patients (n = 240) indicated for operative treatment for 1 of 6 common foot and ankle pathologies completed the CATs, FAOS, and Short Form 12 at their preoperative surgical visits, 1 week subsequently (before surgery), and at 6 months postoperatively. The psychometric properties of the instruments were assessed and compared. The Patient-Reported Outcomes Measurement Information System CATs each took less than 1 minute to complete, whereas the FAOS took 6.5 minutes, and the Short Form 12 took 3 minutes. CAT scores were more normally distributed and had fewer floor and ceiling effects than those on the FAOS, which reached as high as 24%. The CATs were more precise than the FAOS and had similar responsiveness and test-retest reliability. The physical function and mobility CATs correlated strongly with the activities subscale of the FAOS, and the pain interference CAT correlated strongly with the pain subscale of the FAOS. The CATs and FAOS were responsive to changes with operative treatment for 6 common foot and ankle pathologies. The CATs performed as well as or better than the FAOS in all aspects of psychometric validity. The Patient-Reported Outcomes Measurement Information System CATs show tremendous potential for improving the study of patient outcomes in foot and ankle research through improved precision and reduced respondent burden. Level II, prospective comparative study.

No common denominator: a review of outcome measures in IVF RCTs.

PubMed

Wilkinson, Jack; Roberts, Stephen A; Showell, Marian; Brison, Daniel R; Vail, Andy

2016-12-01

Which outcome measures are reported in RCTs for IVF? Many combinations of numerator and denominator are in use, and are often employed in a manner that compromises the validity of the study. The choice of numerator and denominator governs the meaning, relevance and statistical integrity of a study's results. RCTs only provide reliable evidence when outcomes are assessed in the cohort of randomised participants, rather than in the subgroup of patients who completed treatment. Review of outcome measures reported in 142 IVF RCTs published in 2013 or 2014. Trials were identified by searching the Cochrane Gynaecology and Fertility Specialised Register. English-language publications of RCTs reporting clinical or preclinical outcomes in peer-reviewed journals in the period 1 January 2013 to 31 December 2014 were eligible. Reported numerators and denominators were extracted. Where they were reported, we checked to see if live birth rates were calculated correctly using the entire randomised cohort or a later denominator. Over 800 combinations of numerator and denominator were identified (613 in no more than one study). No single outcome measure appeared in the majority of trials. Only 22 (43%) studies reporting live birth presented a calculation including all randomised participants or only excluding protocol violators. A variety of definitions were used for key clinical numerators: for example, a consensus regarding what should constitute an ongoing pregnancy does not appear to exist at present. Several of the included articles may have been secondary publications. Our categorisation scheme was essentially arbitrary, so the frequencies we present should be interpreted with this in mind. The analysis of live birth denominators was post hoc. There is massive diversity in numerator and denominator selection in IVF trials due to its multistage nature, and this causes methodological frailty in the evidence base. The twin spectres of outcome reporting bias and analysis of non-randomised comparisons do not appear to be widely recognised. Initiatives to standardise outcome reporting, such as requiring all effectiveness studies to report live birth or cumulative live birth, are welcome. However, there is a need to recognise that early outcomes of treatment, such as stimulation response or embryo quality, may be appropriate choices of primary outcome for early phase studies. J.W. is funded by a Doctoral Research Fellowship from the National Institute for Health Research. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health. J.W. also declares that publishing research is beneficial to his career. J.W. and A.V. are statistical editors, and M.S. is Information Specialist, for the Cochrane Gynaecology and Fertility Group, although the views expressed here are not necessarily those of the group. D.R.B. is funded by the NHS as Scientific Director of a clinical IVF service. The authors declare no other conflicts of interest. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.

Surgical Treatment of Rotator Cuff Tears After 65 Years of Age: A Systematic Review.

PubMed

Silva, Bruno Mota; Cartucho, António; Sarmento, Marco; Moura, Nuno

2017-04-28

The objective of this study was to analyze current evidence regarding surgical management of rotator cuff tears in patients of 65 years of age and above. Our hypothesis was that surgical repair of rotator cuff tears, in patients older than 65 years, conveys good outcome scores. We have not found a similar systematic review in current literature. Medline®, PubMed, Scopus, and the Cochrane Register of Controlled Trials were searched from January 1999 unto December 2015 for studies, regardless of language, including the words 'rotator cuff' and '65 years' or '70 years'. Inclusion criteria were studies (level I to IV) that reported clinical outcomes in patients older than 65 years, having undertaken surgical repair of a symptomatic rotator cuff tears. Arthroscopic, mini open and open techniques were included. Exclusion criteria were: studies with patients younger than 65 years, studies that did not use validated outcome evaluation scores as primary assessment tools and those with follow up under one year. This work followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses - PRISMA guidelines. Data abstracted included patient demographics, tear pattern, surgical procedures, clinical and repair results. Outcome scores were converted to percentages, allowing comparison of data between studies. After deep analysis, 14 studies met the inclusion criteria: 11 level IV studies, 1 level III study and 2 level II studies. Seven studies found statistically significant outcome improvements between pre and postoperative evaluations. All studies reported good or excellent surgical outcomes. Better results would probably be achieved if all studies had rigorous and homogeneous patient selection criteria, but the fact is, that even though this was not the case, the clinical scores remained favorable, and with statistically significant outcome improvement in all studies with prospectively collected data. Based on current literature, rotator cuff repair in patients older than 65 years imparts favorable improvement in clinical outcome scores and overall patient satisfaction.

Development of a core outcome set for medication review in older patients with multimorbidity and polypharmacy: a study protocol.

PubMed

Beuscart, Jean-Baptiste; Dalleur, Olivia; Boland, Benoit; Thevelin, Stefanie; Knol, Wilma; Cullinan, Shane; Schneider, Claudio; O'Mahony, Denis; Rodondi, Nicolas; Spinewine, Anne

2017-01-01

Medication review has been advocated to address the challenge of polypharmacy in older patients, yet there is no consensus on how best to evaluate its efficacy. Heterogeneity of outcomes reported in clinical trials can hinder the comparison of clinical trial findings in systematic reviews. Moreover, the outcomes that matter most to older patients might be under-reported or disregarded altogether. A core outcome set can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials in any particular field of research. As part of the European Commission-funded project, called OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid elderly, this paper describes the methods used to develop a core outcome set for clinical trials of medication review in older patients with multimorbidity. The study was designed in several steps. First, a systematic review established which outcomes were measured in published and ongoing clinical trials of medication review in older patients. Second, we undertook semistructured interviews with older patients and carers aimed at identifying additional relevant outcomes. Then, a multilanguage European Delphi survey adapted to older patients was designed. The international Delphi survey was conducted with older patients, health care professionals, researchers, and clinical experts in geriatric pharmacotherapy to validate outcomes to be included in the core outcome set. Consensus meetings were conducted to validate the results. We present the method for developing a core outcome set for medication review in older patients with multimorbidity. This study protocol could be used as a basis to develop core outcome sets in other fields of geriatric research.

Indications and Outcomes for Microfracture as an Adjunct to Hip Arthroscopy for Treatment of Chondral Defects in Patients With Femoroacetabular Impingement: A Systematic Review.

PubMed

MacDonald, Austin E; Bedi, Asheesh; Horner, Nolan S; de Sa, Darren; Simunovic, Nicole; Philippon, Marc J; Ayeni, Olufemi R

2016-01-01

To evaluate the indications, preoperative workup outcomes, and postoperative rehabilitation of patients with femoroacetabular impingement (FAI) receiving microfracture as an adjunct to hip arthroscopy for chondral defects. The electronic databases MEDLINE, EMBASE, and PubMed were searched and screened in duplicate for studies involving patients with FAI treated arthroscopically with microfracture of the hip for chondral defects either solely or as an adjunct to hip arthroscopy. Data regarding indications, investigations, outcomes, and postoperative rehabilitation were abstracted from eligible studies. The references of included studies were additionally searched, and descriptive statistics are provided. There were 12 studies included in this review, involving 267 patients. With the exception of a single, one-patient case report, 11 of the 12 studies reported positive outcomes after hip arthroscopy with microfracture. Only 0.7% of the total patients experienced a complication, and 1.1% required further surgery on the basis of outcomes evaluated at a mean follow-up of 29.5 (range, 4 to 60) months across the studies. Eight of 12 studies discussed the preoperative workup of these patients, with X-rays and magnetic resonance imaging being the most common preoperative imaging used. There was little reported on weight-bearing status during postoperative rehabilitation. The outcomes reported in the literature after hip arthroscopy with microfracture for chondral defects are, in general, positive, with a very low percentage of patients requiring further surgery or experiencing complications. The most common indication used in the literature for microfracture is a full-thickness, focal chondral defect (Outerbridge grade IV). The vast majority of literature recommends limited weight bearing after microfracture; however, there was significant variation among the specific rehabilitation protocols used. More research is needed to explore what indications and postoperative rehabilitation result in the best outcomes for patients. Level IV, systematic review of Level II, III, and IV studies. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Do we know how to design effective health coaching interventions: a systematic review of the state of the literature.

PubMed

Hill, Briony; Richardson, Ben; Skouteris, Helen

2015-01-01

To systematically review health coaching interventions regarding effectiveness of health coaching for specific outcomes, optimal intervention approaches, and identification of specific techniques associated with effectiveness. Articles were sourced from CINAHL, Global Health, PsycINFO, Academic Search Complete, Health Source, Psychology and Behavioral Sciences Collection, and Medline. Randomized controlled trials were included if the study (1) employed health coaching according to a predefined criterion; (2) clearly reported the use of health coaching; or (3) incorporated the use of coaching. Aims, participants, approach, behavior change techniques (BCTs), and findings pertaining to each study were summarized. BCTs were classified according to the CALO-RE taxonomy. Data were synthesized by cross-tabulation of BCTs with study outcomes. Fifteen of 16 eligible studies reported a positive intervention effect in at least one outcome. Nine studies (56%) did not define health coaching; the number of intervention sessions provided ranged from 2 to 48; and in three studies, one or more intervention details were unclear. It was hence difficult to synthesize the studies to adequately address our research questions. Health coaching is a promising strategy for health improvements; however, future research should ensure clarity in reporting intervention details, clearer definitions of health coaching/theoretical bases, consistency in reporting BCTs, and the inclusion of process variables as outcome measures.

Progress on core outcome sets for critical care research.

PubMed

Blackwood, Bronagh; Marshall, John; Rose, Louise

2015-10-01

Appropriate selection and definition of outcome measures are essential for clinical trials to be maximally informative. Core outcome sets (an agreed, standardized collection of outcomes measured and reported in all trials for a specific clinical area) were developed due to established inconsistencies in trial outcome selection. This review discusses the rationale for, and methods of, core outcome set development, as well as current initiatives in critical care. Recent systematic reviews of reported outcomes and measurement instruments relevant to the critically ill highlight inconsistencies in outcome selection, definition, and measurement, thus establishing the need for core outcome sets. Current critical care initiatives include development of core outcome sets for trials aimed at reducing mechanical ventilation duration; rehabilitation following critical illness; long-term outcomes in acute respiratory failure; and epidemic and pandemic studies of severe acute respiratory infection. Development and utilization of core outcome sets for studies relevant to the critically ill is in its infancy compared to other specialties. Notwithstanding, core outcome set development frameworks and guidelines are available, several sets are in various stages of development, and there is strong support from international investigator-led collaborations including the International Forum for Acute Care Trialists.

Review: Assessment of completeness of reporting in intervention studies using livestock: an example from pain mitigation interventions in neonatal piglets.

PubMed

O'Connor, A; Anthony, R; Bergamasco, L; Coetzee, J F; Dzikamunhenga, R S; Johnson, A K; Karriker, L A; Marchant-Forde, J N; Martineau, G P; Millman, S T; Pajor, E A; Rutherford, K; Sprague, M; Sutherland, M A; von Borell, E; Webb, S R

2016-04-01

Accurate and complete reporting of study methods, results and interpretation are essential components for any scientific process, allowing end-users to evaluate the internal and external validity of a study. When animals are used in research, excellence in reporting is expected as a matter of continued ethical acceptability of animal use in the sciences. Our primary objective was to assess completeness of reporting for a series of studies relevant to mitigation of pain in neonatal piglets undergoing routine management procedures. Our second objective was to illustrate how authors can report the items in the Reporting guidElines For randomized controLled trials for livEstoCk and food safety (REFLECT) statement using examples from the animal welfare science literature. A total of 52 studies from 40 articles were evaluated using a modified REFLECT statement. No single study reported all REFLECT checklist items. Seven studies reported specific objectives with testable hypotheses. Six studies identified primary or secondary outcomes. Randomization and blinding were considered to be partially reported in 21 and 18 studies, respectively. No studies reported the rationale for sample sizes. Several studies failed to report key design features such as units for measurement, means, standard deviations, standard errors for continuous outcomes or comparative characteristics for categorical outcomes expressed as either rates or proportions. In the discipline of animal welfare science, authors, reviewers and editors are encouraged to use available reporting guidelines to ensure that scientific methods and results are adequately described and free of misrepresentations and inaccuracies. Complete and accurate reporting increases the ability to apply the results of studies to the decision-making process and prevent wastage of financial and animal resources.

Evaluating test-retest reliability in patient-reported outcome measures for older people: A systematic review.

PubMed

Park, Myung Sook; Kang, Kyung Ja; Jang, Sun Joo; Lee, Joo Yun; Chang, Sun Ju

2018-03-01

This study aimed to evaluate the components of test-retest reliability including time interval, sample size, and statistical methods used in patient-reported outcome measures in older people and to provide suggestions on the methodology for calculating test-retest reliability for patient-reported outcomes in older people. This was a systematic literature review. MEDLINE, Embase, CINAHL, and PsycINFO were searched from January 1, 2000 to August 10, 2017 by an information specialist. This systematic review was guided by both the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist and the guideline for systematic review published by the National Evidence-based Healthcare Collaborating Agency in Korea. The methodological quality was assessed by the Consensus-based Standards for the selection of health Measurement Instruments checklist box B. Ninety-five out of 12,641 studies were selected for the analysis. The median time interval for test-retest reliability was 14days, and the ratio of sample size for test-retest reliability to the number of items in each measure ranged from 1:1 to 1:4. The most frequently used statistical methods for continuous scores was intraclass correlation coefficients (ICCs). Among the 63 studies that used ICCs, 21 studies presented models for ICC calculations and 30 studies reported 95% confidence intervals of the ICCs. Additional analyses using 17 studies that reported a strong ICC (>0.09) showed that the mean time interval was 12.88days and the mean ratio of the number of items to sample size was 1:5.37. When researchers plan to assess the test-retest reliability of patient-reported outcome measures for older people, they need to consider an adequate time interval of approximately 13days and the sample size of about 5 times the number of items. Particularly, statistical methods should not only be selected based on the types of scores of the patient-reported outcome measures, but should also be described clearly in the studies that report the results of test-retest reliability. Copyright © 2017 Elsevier Ltd. All rights reserved.

Meta-analysis of studies comparing oncologic outcomes of radical prostatectomy and brachytherapy for localized prostate cancer

PubMed Central

Cozzi, Gabriele; Musi, Gennaro; Bianchi, Roberto; Bottero, Danilo; Brescia, Antonio; Cioffi, Antonio; Cordima, Giovanni; Delor, Maurizio; Di Trapani, Ettore; Ferro, Matteo; Matei, Deliu Victor; Russo, Andrea; Mistretta, Francesco Alessandro; De Cobelli, Ottavio

2017-01-01

Background: The aim of this study was to compare oncologic outcomes of radical prostatectomy (RP) with brachytherapy (BT). Methods: A literature review was conducted according to the ‘Preferred reporting items for systematic reviews and meta-analyses’ (PRISMA) statement. We included studies reporting comparative oncologic outcomes of RP versus BT for localized prostate cancer (PCa). From each comparative study, we extracted the study design, the number and features of the included patients, and the oncologic outcomes expressed as all-cause mortality (ACM), PCa-specific mortality (PCSM) or, when the former were unavailable, as biochemical recurrence (BCR). All of the data retrieved from the selected studies were recorded in an electronic database. Cumulative analysis was conducted using the Review Manager version 5.3 software, designed for composing Cochrane Reviews (Cochrane Collaboration, Oxford, UK). Statistical heterogeneity was tested using the Chi-square test. Results: Our cumulative analysis did not show any significant difference in terms of BCR, ACM or PCSM rates between the RP and BT cohorts. Only three studies reported risk-stratified outcomes of intermediate- and high-risk patients, which are the most prone to treatment failure. Conclusions: our analysis suggested that RP and BT may have similar oncologic outcomes. However, the analysis included a limited number of studies, and most of them were retrospective, making it impossible to derive any definitive conclusion, especially for intermediate- and high-risk patients. In this scenario, appropriate urologic counseling remains of utmost importance. PMID:29662542

Meta-analysis of studies comparing oncologic outcomes of radical prostatectomy and brachytherapy for localized prostate cancer.

PubMed

Cozzi, Gabriele; Musi, Gennaro; Bianchi, Roberto; Bottero, Danilo; Brescia, Antonio; Cioffi, Antonio; Cordima, Giovanni; Delor, Maurizio; Di Trapani, Ettore; Ferro, Matteo; Matei, Deliu Victor; Russo, Andrea; Mistretta, Francesco Alessandro; De Cobelli, Ottavio

2017-11-01

The aim of this study was to compare oncologic outcomes of radical prostatectomy (RP) with brachytherapy (BT). A literature review was conducted according to the 'Preferred reporting items for systematic reviews and meta-analyses' (PRISMA) statement. We included studies reporting comparative oncologic outcomes of RP versus BT for localized prostate cancer (PCa). From each comparative study, we extracted the study design, the number and features of the included patients, and the oncologic outcomes expressed as all-cause mortality (ACM), PCa-specific mortality (PCSM) or, when the former were unavailable, as biochemical recurrence (BCR). All of the data retrieved from the selected studies were recorded in an electronic database. Cumulative analysis was conducted using the Review Manager version 5.3 software, designed for composing Cochrane Reviews (Cochrane Collaboration, Oxford, UK). Statistical heterogeneity was tested using the Chi-square test. Our cumulative analysis did not show any significant difference in terms of BCR, ACM or PCSM rates between the RP and BT cohorts. Only three studies reported risk-stratified outcomes of intermediate- and high-risk patients, which are the most prone to treatment failure. our analysis suggested that RP and BT may have similar oncologic outcomes. However, the analysis included a limited number of studies, and most of them were retrospective, making it impossible to derive any definitive conclusion, especially for intermediate- and high-risk patients. In this scenario, appropriate urologic counseling remains of utmost importance.

Impact of incidental/misdiagnosed intrahepatic cholangiocarcinoma and combined hepatocellular cholangiocarcinoma on the outcomes of liver transplantation: an institutional case series and literature review.

PubMed

Gupta, Rahul; Togashi, Junichi; Akamatsu, Nobuhisa; Sakamoto, Yoshihiro; Kokudo, Norihiro

2017-08-01

Intrahepatic cholangiocarcinoma (ICC) or combined hepatocellular cholangiocarcinoma (cHCC-CC) is considered to be contraindications for liver transplantation (LT); however, recent studies have shown that the outcomes of LT in small incidental ICC/cHCC-CC tumors are comparable to those in HCC. Studies reporting the survival outcome of patient(s) undergoing LT and found to have incidental or misdiagnosed ICC and/or cHCC-CC in liver explants were reviewed. Our institutional data were also included in the review analysis. In this review, 21 studies reporting 19865 cases of liver transplantation were included. The incidence of misdiagnosed/incidental ICC/cHCC-CC in liver explants was found to be 0.7% (136/19636). Hepatitis B and C virus infection was reported in 19 and 47% of the cases, respectively. The recurrence rate after LT was 42%. The most common site for recurrence was extrahepatic (73%). The disease free survival rate at 3 years was reported to range 33-86%. The 3-year overall survival rate was reported be 22-70%. The outcome of LT in patients with incidental/misdiagnosed ICC/cHCC-CC was found to be poorer than that of matched patients with HCC in five studies; however, the outcome becomes equivalent to those of HCC in cases of small (<2 cm), well-differentiated ICC/cHCC-CC tumors without vascular invasion.

Walking Gait Asymmetries Six Months Following Anterior Cruciate Ligament Reconstruction Predict Twelve-Month Patient-Reported Outcomes.

PubMed

Pietrosimone, Brian; Blackburn, J Troy; Padua, Darin A; Pfeiffer, Steven J; Davis, Hope C; Luc-Harkey, Brittney A; Harkey, Matthew S; Stanley, Laura E; Frank, Barnett S; Creighton, R Alexander; Kamath, Ganesh M; Spang, Jeffery T

2018-05-21

The study sought to determine the association between gait biomechanics (vertical ground reaction force [vGRF], vGRF loading rate [vGRF-LR]) collected six months following anterior cruciate ligament reconstruction (ACLR) with patient-reported outcomes at twelve months following ACLR. Walking gait mechanics and all subsections of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) were collected at six and twelve months following ACLR, respectively, in 25 individuals with a unilateral ACLR. Peak vGRF and peak instantaneous vGRF-LR were extracted from the first 50% of the stance phase. Limb symmetry indices (LSI) were used to normalize outcomes in the ACLR limb to that of the uninjured limb (ACLR /uninjured). Linear regression analyses were used to determine associations between biomechanical outcomes and KOOS while accounting for walking speed. Receiver operator characteristic curves were used to determine the accuracy of 6-month biomechanical outcomes for identifying individuals with acceptable patient-reported outcomes, using previously defined KOOS cut-off scores,12 months post-ACLR. Individuals with lower peak vGRF LSI 6 months post-ACLR demonstrated worse patient-reported outcomes (KOOS Pain, Activities of Daily life, Sport and Recreation, Quality of Life) at the 12-month exam. A peak vGRF LSI ≥0.99 6 months following ACLR associated with 13.33x higher odds of reporting acceptable patient-reported outcomes 12 months post-ACLR. Lesser peak vGRF LSI during walking at 6-months post-ACLR may be a critical indicator of worse future patient-reported outcomes. Achieving early symmetrical lower extremity loading and minimizing under-loading of the ACLR limb during walking may be a potential therapeutic target for improving patient-reported outcomes post-ACLR. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting.

PubMed

Zhang, Sheng; Liang, Fei; Li, Wenfeng

2017-11-01

The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. We identified phase III RCTs published between January 1, 2012, and June 30, 2015, in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, and The BMJ with available protocols. Consistency in primary outcomes between protocols and registries (articles) was evaluated. We identified 299 phase III RCTs with available protocols in this analysis. Out of them, 25 trials (8.4%) had some discrepancy for primary outcomes between publications and protocols. Types of discrepancies included protocol-defined primary outcome reported as nonprimary outcome in publication (11 trials, 3.7%), protocol-defined primary outcome omitted in publication (10 trials, 3.3%), new primary outcome introduced in publication (8 trials, 2.7%), protocol-defined nonprimary outcome reported as primary outcome in publication (4 trials, 1.3%), and different timing of assessment of primary outcome (4 trials, 1.3%). Out of trials with discrepancies in primary outcome, 15 trials (60.0%) had discrepancies that favored statistically significant results. Registration could be seen as a valid surrogate of protocol in 237 of 299 trials (79.3%) with regard to primary outcome. Despite unrestricted public access to protocols, selective outcome reporting persists in a small fraction of phase III RCTs. Only studies from four leading journals were included, which may cause selection bias and limit the generalizability of this finding. Copyright © 2017 Elsevier Inc. All rights reserved.

Perceptions of distress and positive consequences following exposure to a major disaster amongst a well-studied cohort.

PubMed

Fergusson, David M; Boden, Joseph M; Horwood, L John; Mulder, Roger T

2015-04-01

Research on the impact of natural disasters on health and well-being faces several methodological challenges, including: sampling issues; exposure assessment; and outcome measurement. The present study used a comprehensive measure of disaster exposure to assess relationships between exposure to the Canterbury (New Zealand) Earthquakes of 2010-2011 and both: (a) self-reported distress and (b) positive outcomes; and also investigated gender differences in reports. Data were gathered from the Christchurch Health and Development Study, a 35-year longitudinal study. The study examined data from 495 individuals exposed to the Canterbury Earthquakes for who complete data on exposure and reactions to the earthquakes at age 35 were available. Participants with higher levels of exposure to the earthquakes reported significantly (p<0.0001) higher levels of distress due to fear, death and injury, and disruption caused by the earthquakes. Higher levels of exposure to the earthquakes were also associated with significantly (p<0.0001) higher levels of reporting positive consequences following the earthquakes. Women reported significantly (p<0.0001) greater distress than men and significantly (p<0.001) greater positive consequences. Higher levels of exposure to disaster were associated with higher levels of distress, but also with higher levels of self-reported positive outcomes, with females reporting higher levels of both positive and negative outcomes. The findings highlight the need for comprehensive assessment of disaster exposure, to consider gender and other group differences in reactions to disaster exposure, and for studies of disasters to examine both positive and negative consequences. © The Royal Australian and New Zealand College of Psychiatrists 2014.

Mental health outcomes in HIV and childhood maltreatment: a systematic review

PubMed Central

2012-01-01

Background High rates of childhood maltreatment have been documented in HIV-positive men and women. In addition, mental disorders are highly prevalent in both HIV-infected individuals and victims of childhood maltreatment. However, there is a paucity of research investigating the mental health outcomes associated with childhood maltreatment in the context of HIV infection. The present systematic review assessed mental health outcomes in HIV-positive individuals who were victims of childhood maltreatment. Methods A systematic search of all retrospective, prospective, or clinical trial studies assessing mental health outcomes associated with HIV and childhood maltreatment. The following online databases were searched on 25–31 August 2010: PubMed, Social Science Citation Index, and the Cochrane Library (the Cochrane Central Register of Controlled Trials and the Cochrane Developmental, Psychosocial and Learning Problems, HIV/AIDS, and Depression, Anxiety and Neurosis registers). Results We identified 34 studies suitable for inclusion. A total of 14,935 participants were included in these studies. A variety of mixed mental health outcomes were reported. The most commonly reported psychiatric disorders among HIV-positive individuals with a history of childhood maltreatment included: substance abuse, major depressive disorder, and posttraumatic stress disorder. An association between childhood maltreatment and poor adherence to antiretroviral regimens was also reported in some studies. Conclusion A broad range of adult psychopathology has been reported in studies of HIV-infected individuals with a history of childhood maltreatment. However, a direct causal link cannot be well established. Longer term assessment will better delineate the nature, severity, and temporal relationship of childhood maltreatment to mental health outcomes. PMID:22742536

Methodological review: measured and reported congruence between preferred and actual place of death.

PubMed

Bell, C L; Somogyi-Zalud, E; Masaki, K H

2009-09-01

Congruence between preferred and actual place of death is an important palliative care outcome reported in the literature. We examined methods of measuring and reporting congruence to highlight variations impairing cross-study comparisons. Medline, PsychInfo, CINAHL, and Web of Science were systematically searched for clinical research studies examining patient preference and congruence as an outcome. Data were extracted into a matrix, including purpose, reported congruence, and method for eliciting preference. Studies were graded for quality. Using tables of preferred versus actual places of death, an overall congruence (total met preferences out of total preferences) and a kappa statistic of agreement were determined for each study. Twelve studies were identified. Percentage of congruence was reported using four different definitions. Ten studies provided a table or partial table of preferred versus actual deaths for each place. Three studies provided kappa statistics. No study achieved better than moderate agreement when analysed using kappa statistics. A study which elicited ideal preference reported the lowest agreement, while longitudinal studies reporting final preferred place of death yielded the highest agreement (moderate agreement). Two other studies of select populations also yielded moderate agreement. There is marked variation in methods of eliciting and reporting congruence, even among studies focused on congruence as an outcome. Cross-study comparison would be enhanced by the use of similar questions to elicit preference, tables of preferred versus actual places of death, and kappa statistics of agreement.

Treating Pain in Pregnancy with Acupuncture: Observational Study Results from a Free Clinic in New Zealand.

PubMed

Soliday, Elizabeth; Betts, Debra

2018-02-01

Clinic-based acupuncturists, midwives, and physiotherapists have reported using acupuncture to treat lumbopelvic pain in pregnancy, a common condition that may affect functioning and quality of life. To contribute to the emerging evidence on treatment outcomes, we collected patient-reported pain reduction data from women treated during pregnancy in a no-pay, hospital-based acupuncture service in New Zealand. Observational study of patient-reported symptom reduction.The main outcome measure was the MYMOP (Measure Your Medical Outcome Profile), a brief, validated self-report instrument. Open-ended questions on treatment experiences and adverse events were included. Of the 81 women on whom we had complete treatment data, the majority (N = 72, 89%) reported clinically meaningful symptom reduction. Patient-reported adverse events were infrequent and mild. Patient-reported and treatment-related lumbopelvic pain symptom reduction findings provide further evidence that acupuncture in pregnancy is safe and beneficial in a field setting. We discuss this study's unique contributions in providing guidance for clinicians who practice acupuncture in pregnancy, including midwives, physiotherapists, and physicians. Copyright © 2018. Published by Elsevier B.V.

Lies that feel honest: Dissociating between incentive and deviance processing when evaluating dishonesty.

PubMed

Lelieveld, Gert-Jan; Shalvi, Shaul; Crone, Eveline A

2016-05-01

This study investigated neural responses to evaluations of lies made by others. Participants learned about other individuals who were instructed to privately roll a die twice and report the outcome of the first roll to determine their pay (with higher rolls leading to higher pay). Participants evaluated three types of outcomes: honest reports, justifiable lies (reporting the second outcome instead of the first), or unjustifiable lies (reporting a different outcome than both die rolls). Evaluating lies relative to honest reports was associated with increased activation in the anterior cingulate cortex (ACC), insula and lateral prefrontal cortex. Moreover, justifiable lies were associated with even stronger activity in the dorsal ACC and dorsolateral prefrontal cortex compared to unjustifiable lies. These activities were more pronounced for justifiable lies where the deviance from the real outcome was larger. Together, these findings have implications for understanding how humans judge misconduct behavior of others. Copyright © 2016 Elsevier B.V. All rights reserved.

Do Health Care Delivery System Reforms Improve Value? The Jury Is Still Out.

PubMed

Korenstein, Deborah; Duan, Kevin; Diaz, Manuel J; Ahn, Rosa; Keyhani, Salomeh

2016-01-01

Widespread restructuring of health delivery systems is underway in the United States to reduce costs and improve the quality of health care. To describe studies evaluating the impact of system-level interventions (incentives and delivery structures) on the value of US health care, defined as the balance between quality and cost. We identified articles in PubMed (2003 to July 2014) using keywords identified through an iterative process, with reference and author tracking. We searched tables of contents of relevant journals from August 2014 through 11 August 2015 to update our sample. We included prospective or retrospective studies of system-level changes, with a control, reporting both quality and either cost or utilization of resources. Data about study design, study quality, and outcomes was extracted by one reviewer and checked by a second. Thirty reports of 28 interventions were included. Interventions included patient-centered medical home implementations (n=12), pay-for-performance programs (n=10), and mixed interventions (n=6); no other intervention types were identified. Most reports (n=19) described both cost and utilization outcomes. Quality, cost, and utilization outcomes varied widely; many improvements were small and process outcomes predominated. Improved value (improved quality with stable or lower cost/utilization or stable quality with lower cost/utilization) was seen in 23 reports; 1 showed decreased value, and 6 showed unchanged, unclear, or mixed results.Study limitations included variability among specific endpoints reported, inconsistent methodologies, and lack of full adjustment in some observational trials. Lack of standardized MeSH terms was also a challenge in the search. On balance, the literature suggests that health system reforms can improve value. However, this finding is tempered by the varying outcomes evaluated across studies with little documented improvement in outcome quality measures. Standardized measures of value would facilitate assessment of the impact of interventions across studies and better estimates of the broad impact of system change.

Effectiveness of Universal Self-regulation-Based Interventions in Children and Adolescents: A Systematic Review and Meta-analysis.

PubMed

Pandey, Anuja; Hale, Daniel; Das, Shikta; Goddings, Anne-Lise; Blakemore, Sarah-Jayne; Viner, Russell M

2018-06-01

Childhood and adolescence self-regulation (SR) is gaining importance as a target of intervention because of mounting evidence of its positive associations with health, social and educational outcomes. To conduct a systematic review and meta-analysis of rigorously evaluated interventions to improve self-regulation in children and adolescents. Keyword searches of the PsycINFO, PubMed, EMBASE, CINAHL Plus, ERIC, British Education Index, Child Development and Adolescent Studies, and CENTRAL were used to identify all studies published through July 2016. To be eligible for this review, studies had to report cluster randomized trials or randomized clinical trials, evaluate universal interventions designed to improve self-regulation in children and adolescents aged 0 to 19 years, include outcomes associated with self-regulation skills, and be published in a peer-reviewed journal with the full text available in English. A total of 14 369 published records were screened, of which 147 were identified for full-text review and 49 studies reporting 50 interventions were included in the final review. Results were summarized by narrative review and meta-analysis. Self-regulation outcomes in children and adolescents. This review identified 17 cluster randomized trials and 32 randomized clinical trials evaluating self-regulation interventions, which included a total of 23 098 participants ranging in age from 2 to 17 years (median age, 6.0 years). Consistent improvement in self-regulation was reported in 16 of 21 curriculum-based interventions (76%), 4 of the 8 mindfulness and yoga interventions (50%), 5 of 9 family-based programs (56%), 4 of 6 exercise-based programs (67%), and 4 of 6 social and personal skills interventions (67%), or a total of 33 of 50 interventions (66%). A meta-analysis evaluating associations of interventions with self-regulation task performance scores showed a positive effect of such interventions with pooled effect size of 0.42 (95% CI, 0.32-0.53). Only 24 studies reported data on distal outcomes (29 outcomes). Positive associations were reported in 11 of 13 studies (85%) on academic achievement, 4 of 5 studies on substance abuse (80%), and in all studies reporting on conduct disorders (n = 3), studies on social skills (n = 2), studies on depression (n = 2), studies on behavioral problems (n = 2), and study on school suspensions (n = 1). No effect was seen on 2 studies reporting on academic achievement, 1 study reporting on substance abuse, and 1 additional study reporting on psychological well-being. A wide range of interventions were successful in improving self-regulation in children and adolescents. There was improvement in distal academic, health, and behavioral outcomes in most intervention groups compared with controls.

Effect of glycemic control and type of diabetes treatment on unsuccessful TB treatment outcomes among people with TB-Diabetes: A systematic review

PubMed Central

Jeyashree, Kathiresan; Mahajan, Preetam; Shah, Amar N.; Kirubakaran, Richard; Rao, Raghuram; Kumar, Ajay M. V.

2017-01-01

Background Stringent glycemic control by using insulin as a replacement or in addition to oral hypoglycemic agents (OHAs) has been recommended for people with tuberculosis and diabetes mellitus (TB-DM). This systematic review (PROSPERO 2016:CRD42016039101) analyses whether this improves TB treatment outcomes. Objectives Among people with drug-susceptible TB and DM on anti-TB treatment, to determine the effect of i) glycemic control (stringent or less stringent) compared to poor glycemic control and ii) insulin (only or with OHAs) compared to ‘OHAs only’ on unsuccessful TB treatment outcome(s). We looked for unfavourable TB treatment outcomes at the end of intensive phase and/or end of TB treatment (minimum six months and maximum 12 months follow up). Secondary outcomes were development of MDR-TB during the course of treatment, recurrence after 6 months and/or after 1 year post successful treatment completion and development of adverse events related to glucose lowering treatment (including hypoglycemic episodes). Methods All interventional studies (with comparison arm) and cohort studies on people with TB-DM on anti-TB treatment reporting glycemic control, DM treatment details and TB treatment outcomes were eligible. We searched electronic databases (EMBASE, PubMed, Google Scholar) and grey literature between 1996 and April 2017. Screening, data extraction and risk of bias assessment were done independently by two investigators and recourse to a third investigator, for resolution of differences. Results After removal of duplicates from 2326 identified articles, 2054 underwent title and abstract screening. Following full text screening of 56 articles, nine cohort studies were included. Considering high methodological and clinical heterogeneity, we decided to report the results qualitatively and not perform a meta-analysis. Eight studies dealt with glycemic control, of which only two were free of the risk of bias (with confounder-adjusted measures of effect). An Indian study reported 30% fewer unsuccessful treatment outcomes (aOR (0.95 CI): 0.72 (0.64−0.81)) and 2.8 times higher odds of ‘no recurrence’ (aOR (0.95 CI): 2.83 (2.60−2.92)) among patients with optimal glycemic control at baseline. A Peruvian study reported faster culture conversion among those with glycemic control (aHR (0.95 CI): 2.2 (1.1,4)). Two poor quality studies reported the effect of insulin on TB treatment outcomes. Conclusion We identified few studies that were free of the risk of bias. There were limited data and inconsistent findings among available studies. We recommend robustly designed and analyzed studies including randomized controlled trials on the effect of glucose lowering treatment options on TB treatment outcomes. PMID:29059214

Effect of glycemic control and type of diabetes treatment on unsuccessful TB treatment outcomes among people with TB-Diabetes: A systematic review.

PubMed

Shewade, Hemant Deepak; Jeyashree, Kathiresan; Mahajan, Preetam; Shah, Amar N; Kirubakaran, Richard; Rao, Raghuram; Kumar, Ajay M V

2017-01-01

Stringent glycemic control by using insulin as a replacement or in addition to oral hypoglycemic agents (OHAs) has been recommended for people with tuberculosis and diabetes mellitus (TB-DM). This systematic review (PROSPERO 2016:CRD42016039101) analyses whether this improves TB treatment outcomes. Among people with drug-susceptible TB and DM on anti-TB treatment, to determine the effect of i) glycemic control (stringent or less stringent) compared to poor glycemic control and ii) insulin (only or with OHAs) compared to 'OHAs only' on unsuccessful TB treatment outcome(s). We looked for unfavourable TB treatment outcomes at the end of intensive phase and/or end of TB treatment (minimum six months and maximum 12 months follow up). Secondary outcomes were development of MDR-TB during the course of treatment, recurrence after 6 months and/or after 1 year post successful treatment completion and development of adverse events related to glucose lowering treatment (including hypoglycemic episodes). All interventional studies (with comparison arm) and cohort studies on people with TB-DM on anti-TB treatment reporting glycemic control, DM treatment details and TB treatment outcomes were eligible. We searched electronic databases (EMBASE, PubMed, Google Scholar) and grey literature between 1996 and April 2017. Screening, data extraction and risk of bias assessment were done independently by two investigators and recourse to a third investigator, for resolution of differences. After removal of duplicates from 2326 identified articles, 2054 underwent title and abstract screening. Following full text screening of 56 articles, nine cohort studies were included. Considering high methodological and clinical heterogeneity, we decided to report the results qualitatively and not perform a meta-analysis. Eight studies dealt with glycemic control, of which only two were free of the risk of bias (with confounder-adjusted measures of effect). An Indian study reported 30% fewer unsuccessful treatment outcomes (aOR (0.95 CI): 0.72 (0.64-0.81)) and 2.8 times higher odds of 'no recurrence' (aOR (0.95 CI): 2.83 (2.60-2.92)) among patients with optimal glycemic control at baseline. A Peruvian study reported faster culture conversion among those with glycemic control (aHR (0.95 CI): 2.2 (1.1,4)). Two poor quality studies reported the effect of insulin on TB treatment outcomes. We identified few studies that were free of the risk of bias. There were limited data and inconsistent findings among available studies. We recommend robustly designed and analyzed studies including randomized controlled trials on the effect of glucose lowering treatment options on TB treatment outcomes.

Teacher, parent, and peer reports of early aggression as screening measures for long-term maladaptive outcomes: Who provides the most useful information?

PubMed Central

Clemans, Katherine H.; Musci, Rashelle J.; Leoutsakos, Jeannie-Marie S.; Ialongo, Nicholas S.

2014-01-01

Objective This study compared the ability of teacher, parent, and peer reports of aggressive behavior in early childhood to accurately classify cases of maladaptive outcomes in late adolescence and early adulthood. Method Weighted kappa analyses determined optimal cut points and relative classification accuracy among teacher, parent, and peer reports of aggression assessed for 691 students (54% male; 84% African American, 13% White) in the fall of first grade. Outcomes included antisocial personality, substance use, incarceration history, risky sexual behavior, and failure to graduate from high school on time. Results Peer reports were the most accurate classifier of all outcomes in the full sample. For most outcomes, the addition of teacher or parent reports did not improve overall classification accuracy once peer reports were accounted for. Additional gender-specific and adjusted kappa analyses supported the superior classification utility of the peer report measure. Conclusion The results suggest that peer reports provided the most useful classification information of the three aggression measures. Implications for targeted intervention efforts which use screening measures to identify at-risk children are discussed. PMID:24512126

Impact of quality of research on patient outcomes in the Institute of Medicine 2013 report on dietary sodium.

PubMed

Lucko, Aaron; Doktorchik, Chelsea Ta; Campbell, Norm Rc

2018-02-01

The 2013 Institute of Medicine report entitled "Sodium Intake in Populations: Assessment of Evidence" found inconsistent evidence of health benefit with dietary sodium intake <2300 mg/d. Different studies reported benefit and harm of population dietary intake <2300 mg/d. The Institute of Medicine committee, however, did not assess whether the methodology used in each of the studies was appropriate to examine dietary sodium and health outcomes. This review investigates the association of methodological rigor and outcomes of studies in the Institute of Medicine report. For the 13 studies that met all methodological criteria, nine found a detrimental impact of high sodium consumption on health, one found a health benefit, and in three the effect was unclear (P = .068). For the 22 studies that failed to meet all criteria, 11 showed a detrimental impact, four a health benefit, and seven had unclear effects from increasing dietary sodium (P = .42). ©2018 Wiley Periodicals, Inc.

Are outcomes reported in surgical randomized trials patient-important? A systematic review and meta-analysis

PubMed Central

Adie, Sam; Harris, Ian A.; Naylor, Justine M.; Mittal, Rajat

2017-01-01

Background The dangers of using surrogate outcomes are well documented. They may have little or no association with their patient-important correlates, leading to the approval and use of interventions that lack efficacy. We sought to assess whether primary outcomes in surgical randomized controlled trials (RCTs) are more likely to be patient-important outcomes than surrogate or laboratory-based outcomes. Methods We reviewed RCTs assessing an operative intervention published in 2008 and 2009 and indexed in MEDLINE, EMBASE or the Cochrane Central Register of Controlled Trials. After a pilot of the selection criteria, 1 reviewer selected trials and another reviewer checked the selection. We extracted information on outcome characteristics (patient-important, surrogate, or laboratory-based outcome) and whether they were primary or secondary outcomes. We calculated odds ratios (OR) and pooled in random-effects meta-analysis to obtain an overall estimate of the association between patient importance and primary outcome specification. Results In 350 included RCTs, a total of 8258 outcomes were reported (median 18 per trial. The mean proportion (per trial) of patient-important outcomes was 60%, and 66% of trials specified a patient-important primary outcome. The most commonly reported patient-important primary outcomes were morbid events (41%), intervention outcomes (11%), function (11%) and pain (9%). Surrogate and laboratory-based primary outcomes were reported in 33% and 8% of trials, respectively. Patient-important outcomes were not associated with primary outcome status (OR 0.82, 95% confidence interval 0.63–1.1, I2 = 21%). Conclusion A substantial proportion of surgical RCTs specify primary outcomes that are not patient-important. Authors, journals and trial funders should insist that patient-important outcomes are the focus of study. PMID:28234219

[Outcome Quality in Medical Rehabilitation: Relationship Between "Patient-Reported Outcomes" (PROs) and Social Security Contributions].

PubMed

Nübling, R; Kaluscha, R; Krischak, G; Kriz, D; Martin, H; Müller, G; Renzland, J; Reuss-Borst, M; Schmidt, J; Kaiser, U; Toepler, E

2017-02-01

Aim of the Study The outcome quality of medical rehabilitation is evaluated often by "Patient Reported Outcomes" (PROs). It is examined to what extent these PROs are corresponding with "hard" or "objective" outcomes such as payments of contributions to social insurance. Methods The "rehabilitation QM outcome study" includes self-reports of patients as well as data from the Rehabilitation Statistics Database (RSD) of the German pension insurance Baden-Wurttemberg. The sample for the question posed includes N=2 947 insured who were treated in 2011 in 21 clinics of the "health quality network" and who were either employed or unemployed at the time of the rehabilitation application (e. g. the workforce or labour force group, response rate: 55%). The sample turned out widely representative for the population of the insured persons. Results PROs and payment of contributions to pension insurance clearly correspond. In the year after the rehabilitation improved vs. not improved rehabilitees differed clearly with regard to their payments of contributions. Conclusions The results support the validity of PROs. For a comprehensive depiction of the outcome quality of rehabilitation PROs and payments of contributions should be considered supplementary. © Georg Thieme Verlag KG Stuttgart · New York.

Shaped versus Round Implants in Breast Reconstruction: A Multi-Institutional Comparison of Surgical and Patient-Reported Outcomes.

PubMed

Khavanin, Nima; Clemens, Mark W; Pusic, Andrea L; Fine, Neil A; Hamill, Jennifer B; Kim, H Myra; Qi, Ji; Wilkins, Edwin G; Kim, John Y S

2017-05-01

Since the 2012 approval of shaped implants, their use in breast reconstruction has increased in the United States. However, large-scale comparisons of complications and patient-reported outcomes are lacking. The authors endeavored to compare surgical and patient-reported outcomes across implant types. The Mastectomy Reconstruction Outcomes Consortium database was queried for expander/implant reconstructions with at least 1-year postexchange follow-up (mean, 18.5 months). Outcomes of interest included postoperative complications, 1-year revisions, and patient-reported outcomes. Bivariate and mixed-effects regression analyses evaluated the effect of implant type on patient outcomes. Overall, 822 patients (73.5 percent) received round and 297 patients (26.5 percent) received shaped implants. Patients undergoing unilateral reconstructions with round implants underwent more contralateral symmetry procedures, including augmentations (round, 18.7 percent; shaped, 6.8 percent; p = 0.003) and reductions (round, 32.2 percent; shaped, 20.5 percent; p = 0.019). Shaped implants were associated with higher rates of infection (shaped, 6.1 percent; round, 2.3 percent; p = 0.002), that remained significant after multivariable adjustment. Other complication rates did not differ significantly between cohorts. Round and shaped implants experienced similar 2-year patient-reported outcome scores. This prospective, multicenter study is the largest evaluating outcomes of shaped versus round implants in breast reconstruction. Although recipients of round implants demonstrated lower infection rates compared with shaped implants, these patients were more likely to undergo contralateral symmetry procedures. Both implant types yielded comparable patient-reported outcome scores. With appropriate patient selection, both shaped and round implants can provide acceptable outcomes in breast reconstruction. Therapeutic, III.

Developing a theoretical framework to illustrate associations among patient satisfaction, body image and quality of life for women undergoing breast reconstruction.

PubMed

Fingeret, Michelle Cororve; Nipomnick, Summer W; Crosby, Melissa A; Reece, Gregory P

2013-10-01

Within the field of breast reconstruction there is increasing focus on patient-reported outcomes related to satisfaction, body image, and quality of life. These outcomes are deemed highly relevant because the primary goal of breast reconstruction is to recreate the appearance of a breast (or breasts) that is satisfying to the patient. Prominent researchers have suggested the need to develop improved standards for outcome evaluation which can ultimately benefit patients as well as physicians. The purpose of this article is to summarize key findings in the area of patient-reported outcomes for breast reconstruction and introduce a theoretical framework for advancing research in this field. We conducted an extensive literature review of outcome studies for breast reconstruction focusing on patient-reported results. We developed a theoretical framework illustrating core patient-reported outcomes related to breast reconstruction and factors associated with these outcomes. Our theoretical model highlights domains and distinguishing features of patient satisfaction, body image, and quality of life outcomes for women undergoing breast reconstruction. This model further identifies a broad range of variables (e.g., historical/premorbid influences, disease and treatment-related factors) that have been found to influence patient-reported outcomes and need to be taken into consideration when designing future research in this area. Additional attention is given to examining the relationship between patient reported outcomes and outside evaluation of breast reconstruction. Our proposed theoretical framework suggests key opportunities to expand research in this area with the goal of optimizing body image adjustment, satisfaction, and psychosocial outcomes for the individual patient. Copyright © 2013 Elsevier Ltd. All rights reserved.

Task-specific gross motor skills training for ambulant school-aged children with cerebral palsy: a systematic review.

PubMed

Toovey, Rachel; Bernie, Charmaine; Harvey, Adrienne R; McGinley, Jennifer L; Spittle, Alicia J

2017-01-01

The primary objective is to systematically evaluate the evidence for the effectiveness of task-specific training (TST) of gross motor skills for improving activity and/or participation outcomes in ambulant school-aged children with cerebral palsy (CP). The secondary objective is to identify motor learning strategies reported within TST and assess relationship to outcome. Systematic review. Relevant databases were searched for studies including: children with CP (mean age >4 years and >60% of the sample ambulant); TST targeting gross motor skills and activity (skill performance, gross motor function and functional skills) and/or participation-related outcomes. Quality of included studies was assessed using standardised tools for risk of bias, study design and quality of evidence across outcomes. Continuous data were summarised for each study using standardised mean difference (SMD) and 95% CIs. Thirteen studies met inclusion criteria: eight randomised controlled trials (RCTs), three comparative studies, one repeated-measures study and one single-subject design study. Risk of bias was moderate across studies. Components of TST varied and were often poorly reported. Within-group effects of TST were positive across all outcomes of interest in 11 studies. In RCTs, between-group effects were conflicting for skill performance and functional skills, positive for participation-related outcomes (one study: Life-HABITS performance SMD=1.19, 95% CI 0.3 to 2.07, p<0.001; Life-HABITS satisfaction SMD=1.29, 95% CI 0.40 to 2.18, p=0.001), while no difference or negative effects were found for gross motor function. The quality of evidence was low-to-moderate overall. Variability and poor reporting of motor learning strategies limited assessment of relationship to outcome. Limited evidence for TST for gross motor skills in ambulant children with CP exists for improving activity and participation-related outcomes and recommendations for use over other interventions are limited by poor study methodology and heterogeneous interventions. PROSPERO ID42016036727.

Task-specific gross motor skills training for ambulant school-aged children with cerebral palsy: a systematic review

PubMed Central

Bernie, Charmaine; Harvey, Adrienne R; McGinley, Jennifer L; Spittle, Alicia J

2017-01-01

Objectives The primary objective is to systematically evaluate the evidence for the effectiveness of task-specific training (TST) of gross motor skills for improving activity and/or participation outcomes in ambulant school-aged children with cerebral palsy (CP). The secondary objective is to identify motor learning strategies reported within TST and assess relationship to outcome. Design Systematic review. Method Relevant databases were searched for studies including: children with CP (mean age >4 years and >60% of the sample ambulant); TST targeting gross motor skills and activity (skill performance, gross motor function and functional skills) and/or participation-related outcomes. Quality of included studies was assessed using standardised tools for risk of bias, study design and quality of evidence across outcomes. Continuous data were summarised for each study using standardised mean difference (SMD) and 95% CIs. Results Thirteen studies met inclusion criteria: eight randomised controlled trials (RCTs), three comparative studies, one repeated-measures study and one single-subject design study. Risk of bias was moderate across studies. Components of TST varied and were often poorly reported. Within-group effects of TST were positive across all outcomes of interest in 11 studies. In RCTs, between-group effects were conflicting for skill performance and functional skills, positive for participation-related outcomes (one study: Life-HABITS performance SMD=1.19, 95% CI 0.3 to 2.07, p<0.001; Life-HABITS satisfaction SMD=1.29, 95% CI 0.40 to 2.18, p=0.001), while no difference or negative effects were found for gross motor function. The quality of evidence was low-to-moderate overall. Variability and poor reporting of motor learning strategies limited assessment of relationship to outcome. Conclusions Limited evidence for TST for gross motor skills in ambulant children with CP exists for improving activity and participation-related outcomes and recommendations for use over other interventions are limited by poor study methodology and heterogeneous interventions. Registration PROSPERO ID42016036727 PMID:29637118

The (cost-)effectiveness of preventive, integrated care for community-dwelling frail older people: A systematic review.

PubMed

Looman, Wilhelmina Mijntje; Huijsman, Robbert; Fabbricotti, Isabelle Natalina

2018-04-17

Integrated care is increasingly promoted as an effective and cost-effective way to organise care for community-dwelling frail older people with complex problems but the question remains whether high expectations are justified. Our study aims to systematically review the empirical evidence for the effectiveness and cost-effectiveness of preventive, integrated care for community-dwelling frail older people and close attention is paid to the elements and levels of integration of the interventions. We searched nine databases for eligible studies until May 2016 with a comparison group and reporting at least one outcome regarding effectiveness or cost-effectiveness. We identified 2,998 unique records and, after exclusions, selected 46 studies on 29 interventions. We assessed the quality of the included studies with the Effective Practice and Organization of Care risk-of-bias tool. The interventions were described following Rainbow Model of Integrated Care framework by Valentijn. Our systematic review reveals that the majority of the reported outcomes in the studies on preventive, integrated care show no effects. In terms of health outcomes, effectiveness is demonstrated most often for seldom-reported outcomes such as well-being. Outcomes regarding informal caregivers and professionals are rarely considered and negligible. Most promising are the care process outcomes that did improve for preventive, integrated care interventions as compared to usual care. Healthcare utilisation was the most reported outcome but we found mixed results. Evidence for cost-effectiveness is limited. High expectations should be tempered given this limited and fragmented evidence for the effectiveness and cost-effectiveness of preventive, integrated care for frail older people. Future research should focus on unravelling the heterogeneity of frailty and on exploring what outcomes among frail older people may realistically be expected. © 2018 The Authors. Health and Social Care in the Community Published by John Wiley & Sons Ltd.

The association between EMS workplace safety culture and safety outcomes.

PubMed

Weaver, Matthew D; Wang, Henry E; Fairbanks, Rollin J; Patterson, Daniel

2012-01-01

Prior studies have highlighted wide variation in emergency medical services (EMS) workplace safety culture across agencies. To determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, working conditions, stress recognition, and job satisfaction. A panel of medical directors, emergency medical technicians and paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Sixteen percent of all respondents reported experiencing an injury in the past three months, four of every 10 respondents reported an error or adverse event (AE), and 89% reported safety-compromising behaviors. Respondents reporting injury scored lower on five of the six domains of safety culture. Respondents reporting an error or AE scored lower for four of the six domains, while respondents reporting safety-compromising behavior had lower safety culture scores for five of the six domains. Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes.

The association between EMS workplace safety culture and safety outcomes

PubMed Central

Weaver, Matthew D.; Wang, Henry E.; Fairbanks, Rollin J.; Patterson, Daniel

2012-01-01

Objective Prior studies have highlighted wide variation in EMS workplace safety culture across agencies. We sought to determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. Methods We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, perceptions of working conditions, stress recognition, and job satisfaction. A panel of medical directors, paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Results Sixteen percent of all respondents reported experiencing an injury in the past 3 months, four of every 10 respondents reported an error or adverse event (AE), and 90% reported safety-compromising behaviors. Respondents reporting injury scored lower on 5 of the 6 domains of safety culture. Respondents reporting an error or AE scored lower for 4 of the 6 domains, while respondents reporting safety-compromising behavior had lower safety culture scores for 5 of 6 domains. Conclusions Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes. PMID:21950463

Validation of birth outcomes from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS): population-based analysis from the Massachusetts Outcome Study of Assisted Reproductive Technology (MOSART).

PubMed

Stern, Judy E; Gopal, Daksha; Liberman, Rebecca F; Anderka, Marlene; Kotelchuck, Milton; Luke, Barbara

2016-09-01

To assess the validity of outcome data reported to the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) compared with data from vital records and the birth defects registry in Massachusetts. Longitudinal cohort. Not applicable. A total of 342,035 live births and fetal deaths from Massachusetts mothers giving birth in the state from July 1, 2004, to December 31, 2008; 9,092 births and fetal deaths were from mothers who had conceived with the use of assisted reproductive technology (ART) and whose cycle data had been reported to the SART CORS. Not applicable. Percentage agreement between maternal race and ethnicity, delivery outcome (live birth or fetal death), plurality (singleton, twin, or triplet+), delivery date, and singleton birth weight reported in the SART CORS versus vital records; sensitivity and specificity for birth defects among singletons as reported in the SART CORS versus the Massachusetts Birth Defects Monitoring Program (BDMP). There was >95% agreement between the SART CORS and vital records for fields of maternal race/ethnicity, live birth/fetal death, and plurality; birth outcome date was within 1 day with 94.9% agreement and birth weight was within 100 g with 89.6% agreement. In contrast, sensitivity for report of any birth defect was 38.6%, with a range of 18.4%-50.0%, for specific birth defect categories. Although most SART CORS outcome fields are accurately reported, birth defect variables showed poor sensitivity compared with the gold standard data from the BDMP. We suggest that reporting of birth defects be discontinued. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Non-replication of the association between 5HTTLPR and response to psychological therapy for child anxiety disorders

PubMed Central

Lester, Kathryn J.; Roberts, Susanna; Keers, Robert; Coleman, Jonathan R. I.; Breen, Gerome; Wong, Chloe C. Y.; Xu, Xiaohui; Arendt, Kristian; Blatter-Meunier, Judith; Bögels, Susan; Cooper, Peter; Creswell, Cathy; Heiervang, Einar R.; Herren, Chantal; Hogendoorn, Sanne M.; Hudson, Jennifer L.; Krause, Karen; Lyneham, Heidi J.; McKinnon, Anna; Morris, Talia; Nauta, Maaike H.; Rapee, Ronald M.; Rey, Yasmin; Schneider, Silvia; Schneider, Sophie C.; Silverman, Wendy K.; Smith, Patrick; Thastum, Mikael; Thirlwall, Kerstin; Waite, Polly; Wergeland, Gro Janne; Eley, Thalia C.

2016-01-01

Background We previously reported an association between 5HTTLPR genotype and outcome following cognitive–behavioural therapy (CBT) in child anxiety (Cohort 1). Children homozygous for the low-expression short-allele showed more positive outcomes. Other similar studies have produced mixed results, with most reporting no association between genotype and CBT outcome. Aims To replicate the association between 5HTTLPR and CBT outcome in child anxiety from the Genes for Treatment study (GxT Cohort 2, n = 829). Method Logistic and linear mixed effects models were used to examine the relationship between 5HTTLPR and CBT outcomes. Mega-analyses using both cohorts were performed. Results There was no significant effect of 5HTTLPR on CBT outcomes in Cohort 2. Mega-analyses identified a significant association between 5HTTLPR and remission from all anxiety disorders at follow-up (odds ratio 0.45, P = 0.014), but not primary anxiety disorder outcomes. Conclusions The association between 5HTTLPR genotype and CBT outcome did not replicate. Short-allele homozygotes showed more positive treatment outcomes, but with small, non-significant effects. Future studies would benefit from utilising whole genome approaches and large, homogenous samples. PMID:26294368

Core Outcome Set–STAndards for Reporting: The COS-STAR Statement

PubMed Central

Kirkham, Jamie J.; Gorst, Sarah; Altman, Douglas G.; Blazeby, Jane M.; Clarke, Mike; Devane, Declan; Moher, David; Schmitt, Jochen; Tugwell, Peter; Tunis, Sean; Williamson, Paula R.

2016-01-01

Background Core outcome sets (COS) can enhance the relevance of research by ensuring that outcomes of importance to health service users and other people making choices about health care in a particular topic area are measured routinely. Over 200 COS to date have been developed, but the clarity of these reports is suboptimal. COS studies will not achieve their goal if reports of COS are not complete and transparent. Methods and Findings In recognition of these issues, an international group that included experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives developed the Core Outcome Set–STAndards for Reporting (COS-STAR) Statement as a reporting guideline for COS studies. The developmental process consisted of an initial reporting item generation stage and a two-round Delphi survey involving nearly 200 participants representing key stakeholder groups, followed by a consensus meeting. The COS-STAR Statement consists of a checklist of 18 items considered essential for transparent and complete reporting in all COS studies. The checklist items focus on the introduction, methods, results, and discussion section of a manuscript describing the development of a particular COS. A limitation of the COS-STAR Statement is that it was developed without representative views of low- and middle-income countries. COS have equal relevance to studies conducted in these areas, and, subsequently, this guideline may need to evolve over time to encompass any additional challenges from developing COS in these areas. Conclusions With many ongoing COS studies underway, the COS-STAR Statement should be a helpful resource to improve the reporting of COS studies for the benefit of all COS users. PMID:27755541

The household food insecurity gradient and potential reductions in adverse population mental health outcomes in Canadian adults.

PubMed

Jessiman-Perreault, Geneviève; McIntyre, Lynn

2017-12-01

Household food insecurity is related to poor mental health. This study examines whether the level of household food insecurity is associated with a gradient in the risk of reporting six adverse mental health outcomes. This study further quantifies the mental health impact if severe food insecurity, the extreme of the risk continuum, were eliminated in Canada. Using a pooled sample of the Canadian Community Health Survey (N = 302,683), we examined the relationship between level of food insecurity, in adults 18-64 years, and reporting six adverse mental health outcomes. We conducted a probit analysis adjusted for multi-variable models, to calculate the reduction in the odds of reporting mental health outcomes that might accrue from the elimination of severe food insecurity. Controlling for various demographic and socioeconomic covariates, a food insecurity gradient was found in six mental health outcomes. We calculated that a decrease between 8.1% and 16.0% in the reporting of these mental health outcomes would accrue if those who are currently severely food insecure became food secure, after controlling for covariates. Household food insecurity has a pervasive graded negative effect on a variety of mental health outcomes, in which significantly higher levels of food insecurity are associated with a higher risk of adverse mental health outcomes. Reduction of food insecurity, particularly at the severe level, is a public health concern and a modifiable structural determinant of health worthy of macro-level policy intervention.

Effects of Regular Classes in Outdoor Education Settings: A Systematic Review on Students’ Learning, Social and Health Dimensions

PubMed Central

Becker, Christoph; Lauterbach, Gabriele; Spengler, Sarah; Dettweiler, Ulrich; Mess, Filip

2017-01-01

Background: Participants in Outdoor Education Programmes (OEPs) presumably benefit from these programmes in terms of their social and personal development, academic achievement and physical activity (PA). The aim of this systematic review was to identify studies about regular compulsory school- and curriculum-based OEPs, to categorise and evaluate reported outcomes, to assess the methodological quality, and to discuss possible benefits for students. Methods: We searched online databases to identify English- and German-language peer-reviewed journal articles that reported any outcomes on a student level. Two independent reviewers screened studies identified for eligibility and assessed the methodological quality. Results: Thirteen studies were included for analysis. Most studies used a case-study design, the average number of participants was moderate (mean valued (M) = 62.17; standard deviation (SD) = 64.12), and the methodological quality was moderate on average for qualitative studies (M = 0.52; SD = 0.11), and low on average for quantitative studies (M = 0.18; SD = 0.42). Eight studies described outcomes in terms of social dimensions, seven studies in learning dimensions and four studies were subsumed under additional outcomes, i.e., PA and health. Eleven studies reported positive, one study positive as well as negative, and one study reported negative effects. PA and mental health as outcomes were underrepresented. Conclusion: Tendencies were detected that regular compulsory school- and curriculum-based OEPs can promote students in respect of social, academic, physical and psychological dimensions. Very little is known concerning students’ PA or mental health. We recommend conducting more quasi-experimental design and longitudinal studies with a greater number of participants, and a high methodological quality to further investigate these tendencies. PMID:28475167

Effects of Regular Classes in Outdoor Education Settings: A Systematic Review on Students' Learning, Social and Health Dimensions.

PubMed

Becker, Christoph; Lauterbach, Gabriele; Spengler, Sarah; Dettweiler, Ulrich; Mess, Filip

2017-05-05

Participants in Outdoor Education Programmes (OEPs) presumably benefit from these programmes in terms of their social and personal development, academic achievement and physical activity (PA). The aim of this systematic review was to identify studies about regular compulsory school- and curriculum-based OEPs, to categorise and evaluate reported outcomes, to assess the methodological quality, and to discuss possible benefits for students. We searched online databases to identify English- and German-language peer-reviewed journal articles that reported any outcomes on a student level. Two independent reviewers screened studies identified for eligibility and assessed the methodological quality. Thirteen studies were included for analysis. Most studies used a case-study design, the average number of participants was moderate (mean valued (M) = 62.17; standard deviation (SD) = 64.12), and the methodological quality was moderate on average for qualitative studies (M = 0.52; SD = 0.11), and low on average for quantitative studies (M = 0.18; SD = 0.42). Eight studies described outcomes in terms of social dimensions, seven studies in learning dimensions and four studies were subsumed under additional outcomes, i.e., PA and health. Eleven studies reported positive, one study positive as well as negative, and one study reported negative effects. PA and mental health as outcomes were underrepresented. Tendencies were detected that regular compulsory school- and curriculum-based OEPs can promote students in respect of social, academic, physical and psychological dimensions. Very little is known concerning students' PA or mental health. We recommend conducting more quasi-experimental design and longitudinal studies with a greater number of participants, and a high methodological quality to further investigate these tendencies.

A Systematic Review of Interventions on Patients' Social and Economic Needs.

PubMed

Gottlieb, Laura M; Wing, Holly; Adler, Nancy E

2017-11-01

Healthcare systems are experimenting increasingly with interventions to address patients' social and economic needs. This systematic review examines how often and how rigorously interventions bridging social and medical care have been evaluated. The review included literature from PubMed published between January 2000 and February 2017. Additional studies were identified by reference searches and consulting local experts. Included studies were based in the U.S.; addressed at least one social or economic determinant of health (e.g., housing, employment, food insecurity); and were integrated within the medical care delivery system. Data from included studies were abstracted in June 2015 (studies published January 2000-December 2014) and in March 2017 (studies published January 2015-February 2017). Screening of 4,995 articles identified 67 studies of 37 programs addressing social needs. Interventions targeted a broad range of social needs and populations. Forty studies involved non-experimental designs. There was wide heterogeneity in outcome measures selected. More studies reported findings associated with process (69%) or social or economic determinants of health (48%) outcomes than health (30%) or healthcare utilization or cost (27%) outcomes. Studies reporting health, utilization, or cost outcomes reported mixed results. Healthcare systems increasingly incorporate programs to address patients' social and economic needs in the context of care. But evaluations of these programs to date focus primarily on process and social outcomes and are often limited by poor study quality. Higher-quality studies that include common health and healthcare utilization outcomes would advance effectiveness research in this rapidly expanding field. Copyright © 2017 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Sunitinib Possible Sex-Divergent Therapeutic Outcomes.

PubMed

Segarra, Ignacio; Modamio, Pilar; Fernández, Cecilia; Mariño, Eduardo L

2016-10-01

Sunitinib is a tyrosine kinase inhibitor used for the treatment of renal cell carcinoma and metastatic brain tumors. Preclinical pharmacokinetic studies have shown higher sunitinib hepatic and brain exposure in female mice and higher sunitinib kidney concentrations in male mice. We explored whether sex-divergent tissue pharmacokinetics may anticipate sex-divergent therapeutic and toxicology responses in male and female patients. The review of the available scientific literature identified case reports, case series reports, clinical trials, and other studies associating sex with sunitinib outcomes. The results suggest male patients may respond better to renal cell carcinoma treatment and female patients may have better brain tumor treatment outcomes but a higher incidence of adverse events. Although more high-quality evidence is needed, these results, as anticipated by the preclinical data, may indicate possible sunitinib sex-divergent therapeutic outcomes in patients. In addition, we propose the systematic analysis of sex-based outcomes in clinical trial reports and their inclusion and review in the ethics committees and review boards to prevent, amongst others, patient burden in upcoming clinical trials.

Epidemiology of the reported severity of cottonmouth (Agkistrodon piscivorus) snakebite.

PubMed

Walter, Frank G; Stolz, Uwe; French, Robert N E; Chase, Peter B; McNally, Jude; Shirazi, Farshad

2014-03-01

The goal of this study was to analyze trends in the annual rates of reported medical outcomes of cottonmouth (Agkistrodon piscivorus) snakebites in the United States, published in the annual reports of the American Association of Poison Control Centers in the course of 29 years. This was a retrospective analysis of medical outcomes for cottonmouth snakebite victims who developed fatal, major, moderate, minor, or no effects. The annual rates for these medical outcomes were calculated by dividing the annual number of patients in each outcome category by the total annual number of people reported as being bitten by cottonmouths. Negative binomial regression was used to examine trends in annual rates. From 1985 through 2011, after controlling for the availability of CroFab, the annual incidence rate of cottonmouth snakebites causing no effect decreased significantly by 7.3%/year (incidence rate ratio [IRR] 0.927, 95% confidence interval [CI] 0.885-0.970), the incidence rate of minor outcomes did not change significantly (IRR 0.989, CI 0.974-1.006), the incidence rate of moderate outcomes increased significantly by 2.3%/year (IRR 1.023, CI 1.004-1.042), and the incidence rate of major outcomes did not change significantly (IRR 0.987, CI 0.935-1.041). One fatality was reported in 2011. Annual rates of cottonmouth snakebites producing no effects decreased significantly, those producing minor outcomes did not change significantly, those producing moderate outcomes increased significantly, and those producing major outcomes did not change significantly, from 1985 through 2011.

Complementary and alternative medicine for the treatment of bronchiolitis in infants: A systematic review.

PubMed

Kua, Kok Pim; Lee, Shaun Wen Huey

2017-01-01

Bronchiolitis is a common cause of hospitalization among infants. The limited effectiveness of conventional medication has prompted the use of complementary and alternative medicine (CAM) as alternative or adjunctive therapy for the management of bronchiolitis. To determine the effectiveness and safety of CAM for the treatment of bronchiolitis in infants aged less than 2 years. A systematic electronic search was performed in Medline, Embase, CINAHL, AMED, and Cochrane Central Register of Controlled Trials (CENTRAL) from their respective inception to June 30, 2016 for studies evaluating CAM as an intervention to treat bronchiolitis in infants (1 month to 2 years of age). The CAM could be any form of treatment defined by the National Center for Complementary and Integrative Health (NCCIH) and was utilized either as a single agent or adjunctive therapy. The predefined primary outcome was length of hospital stay. Secondary outcomes were time to resolution of bronchiolitis symptoms, adverse events, and all other clinical outcomes reported by the included studies. The review identified 11 studies (8 randomized controlled trials and 3 cohort studies) examining four herbal preparations and four supplements used either as adjunctive or alternative therapy for bronchiolitis in 904 infants. Most studies were of moderate quality. Among six studies reporting on length of stay, a significant benefit was found for Chinese herbal medicine compared to ribavirin in one cohort study (n = 66) and vitamin D compared to placebo in one randomized controlled trial (n = 89). Studies of Chinese herbal medicine (4 studies, n = 365), vitamin D (1 study, n = 89), N-acetylcysteine (1 study, n = 100), and magnesium (2 studies, n = 176) showed some benefits with respect to clinical severity scores, oxygen saturation, and other symptoms, although data were sparse for any single intervention and the outcomes assessed and reported varied across studies. Only five studies reported on adverse events; no serious adverse events were reported. Among 11 studies examining the effect of CAM on inpatients with bronchiolitis, six reported on the review's primary outcome of length of hospital stay. In general, findings did not show a significant benefit associated with the primary outcome. Preliminary evidence indicated that Chinese herbal medicine mixtures, vitamin D, N-acetylcysteine, and magnesium might be useful in managing the symptoms of bronchiolitis. However, the evidence was not sufficient or rigorous enough to formulate recommendations for the use of any CAM. Among studies that reported adverse events, no serious harms were noted.

Impact of user fees on maternal health service utilization and related health outcomes: a systematic review.

PubMed

Dzakpasu, Susie; Powell-Jackson, Timothy; Campbell, Oona M R

2014-03-01

To assess the evidence of the impact of user fees on maternal health service utilization and related health outcomes in low- and middle-income countries, as well as their impact on inequalities in these outcomes. Studies were identified by modifying a search strategy from a related systematic review. Primary studies of any design were included if they reported the effect of fee changes on maternal health service utilization, related health outcomes and inequalities in these outcomes. For each study, data were systematically extracted and a quality assessment conducted. Due to the heterogeneity of study methods, results were examined narratively. Twenty studies were included. Designs and analytic approaches comprised: two interrupted time series, eight repeated cross-sectional, nine before-and-after without comparison groups and one before-and-after in three groups. Overall, the quality of studies was poor. Few studies addressed potential sources of bias, such as secular trends over time, and even basic tests of statistical significance were often not reported. Consistency in the direction of effects provided some evidence of an increase in facility delivery in particular after fees were removed, as well as possible increases in the number of managed delivery complications. There was little evidence of the effect on health outcomes or inequality in accessing care and, where available, the direction of effect varied. Despite the global momentum to abolish user fees for maternal and child health services, robust evidence quantifying impact remains scant. Improved methods for evaluating and reporting on these interventions are recommended, including better descriptions of the interventions and context, looking at a range of outcome measures, and adopting robust analytical methods that allow for adjustment of underlying and seasonal trends, reporting immediate as well as longer-term (e.g. at 6 months and 1 year) effects and using comparison groups where possible.

Outcomes of Hip Arthroscopy in the Older Adult: A Systematic Review of the Literature.

PubMed

Griffin, Daniel W; Kinnard, Matthew J; Formby, Peter M; McCabe, Michael P; Anderson, Terrence D

2017-07-01

The indications for hip preservation surgery have expanded to include treatment of hip pathology in older adults. While several studies have examined the efficacy of hip arthroscopy in the setting of osteoarthritis, there has been no review of outcomes in older adults. To review the outcomes of hip arthroscopy in older adults and identify factors associated with treatment failures. Systematic review. PubMed, EMBASE, and the Cochrane Library were searched through March 2016 for studies reporting outcomes of primary hip arthroscopy in patients older than 40 years. Inclusion in the review was based on age, patient-reported outcome (PRO) measures, and duration of follow-up. Two authors screened the results and extracted data for use in this review. Standardized mean difference was calculated to estimate effect size for PRO scores within studies. Eight studies with 401 total patients undergoing hip arthroscopy for femoroacetabular impingement (FAI) or labral tears were included in this review. Seven of the 8 studies reported favorable PRO scores and significant postoperative improvement with moderate to large effect size. The included studies demonstrated a trend toward higher effect sizes with an increasing percentage of labral repair compared to isolated labral debridement. The complication rate was comparable to that of previous reports involving younger patients; however, the overall reoperation rate was 20.8%. Conversion to hip arthroplasty ranged from 0% to 30%, with an overall conversion rate of 18.5% at a mean time of 17.5 months following arthroscopy. The most common risk factors for conversion to arthroplasty were low preoperative PRO scores and advanced arthritis. Hip arthroscopy appears to be a safe and efficacious treatment for labral tears and FAI in older patients who do not have significant underlying degenerative changes. However, in this population, there is a significant proportion of patients who eventually require hip arthroplasty. Outcomes may be affected by type of treatment (ie, labral debridement vs repair). Additional high-quality studies are needed to understand how these factors affect outcomes.

Strategies to use tablet computers for collection of electronic patient-reported outcomes.

PubMed

Schick-Makaroff, Kara; Molzahn, Anita

2015-01-22

Mobile devices are increasingly being used for data collection in research. However, many researchers do not have experience in collecting data electronically. Hence, the purpose of this short report was to identify issues that emerged in a study that incorporated electronic capture of patient-reported outcomes in clinical settings, and strategies used to address the issues. The issues pertaining to electronic patient-reported outcome data collection were captured qualitatively during a study on use of electronic patient-reported outcomes in two home dialysis units. Fifty-six patients completed three surveys on tablet computers, including the Kidney Disease Quality of Life-36, the Edmonton Symptom Assessment Scale, and a satisfaction measure. Issues that arose throughout the research process were recorded during ethics reviews, implementation process, and data collection. Four core issues emerged including logistics of technology, security, institutional and financial support, and electronic design. Although use of mobile devices for data collection has many benefits, it also poses new challenges for researchers. Advance consideration of possible issues that emerge in the process, and strategies that can help address these issues, may prevent disruption and enhance validity of findings.

Lest we forget: comparing retrospective and prospective assessments of adverse childhood experiences in the prediction of adult health.

PubMed

Reuben, Aaron; Moffitt, Terrie E; Caspi, Avshalom; Belsky, Daniel W; Harrington, Honalee; Schroeder, Felix; Hogan, Sean; Ramrakha, Sandhya; Poulton, Richie; Danese, Andrea

2016-10-01

Adverse childhood experiences (ACEs; e.g. abuse, neglect, and parental loss) have been associated with increased risk for later-life disease and dysfunction using adults' retrospective self-reports of ACEs. Research should test whether associations between ACEs and health outcomes are the same for prospective and retrospective ACE measures. We estimated agreement between ACEs prospectively recorded throughout childhood (by Study staff at Study member ages 3, 5, 7, 9, 11, 13, and 15) and retrospectively recalled in adulthood (by Study members when they reached age 38), in the population-representative Dunedin cohort (N = 1,037). We related both retrospective and prospective ACE measures to physical, mental, cognitive, and social health at midlife measured through both objective (e.g. biomarkers and neuropsychological tests) and subjective (e.g. self-reported) means. Dunedin and U.S. Centers for Disease Control ACE distributions were similar. Retrospective and prospective measures of adversity showed moderate agreement (r = .47, p < .001; weighted Kappa = .31, 95% CI: .27-.35). Both associated with all midlife outcomes. As compared to prospective ACEs, retrospective ACEs showed stronger associations with life outcomes that were subjectively assessed, and weaker associations with life outcomes that were objectively assessed. Recalled ACEs and poor subjective outcomes were correlated regardless of whether prospectively recorded ACEs were evident. Individuals who recalled more ACEs than had been prospectively recorded were more neurotic than average, and individuals who recalled fewer ACEs than recorded were more agreeable. Prospective ACE records confirm associations between childhood adversity and negative life outcomes found previously using retrospective ACE reports. However, more agreeable and neurotic dispositions may, respectively, bias retrospective ACE measures toward underestimating the impact of adversity on objectively measured life outcomes and overestimating the impact of adversity on self-reported outcomes. Associations between personality factors and the propensity to recall adversity were extremely modest and warrant further investigation. Risk predictions based on retrospective ACE reports should utilize objective outcome measures. Where objective outcome measurements are difficult to obtain, correction factors may be warranted. © 2016 Association for Child and Adolescent Mental Health.

Lest we forget: Comparing retrospective and prospective assessments of adverse childhood experiences in the prediction of adult health

PubMed Central

Reuben, Aaron; Moffitt, Terrie E.; Caspi, Avshalom; Belsky, Daniel W.; Harrington, Honalee; Schroeder, Felix; Hogan, Sean; Ramrakha, Sandhya; Poulton, Richie; Danese, Andrea

2017-01-01

Background Adverse childhood experiences (ACEs; e.g., abuse, neglect, parental loss, etc.) have been associated with increased risk for later-life disease and dysfunction using adults’ retrospective self-reports of ACEs. Research should test whether associations between ACEs and health outcomes are the same for prospective and retrospective ACE measures. Methods We estimated agreement between ACEs prospectively-recorded throughout childhood (by Study staff at Study member ages 3, 5, 7, 9, 11, 13, and 15) and retrospectively-recalled in adulthood (by Study members when they reached age 38), in the population-representative Dunedin cohort (N=1,037). We related both retrospective and prospective ACE measures to physical, mental, cognitive, and social health at midlife measured through both objective (e.g., biomarkers and neuropsychological tests) and subjective (e.g., self-reported) means. Results Dunedin and CDC ACE distributions were similar. Retrospective and prospective measures of adversity showed moderate agreement (r=.47, p<.001; weighted Kappa = .31, 95% CI: .27–.35). Both associated with all midlife outcomes. As compared to prospective ACEs, retrospective ACEs showed stronger associations with life outcomes that were subjectively assessed, and weaker associations with life outcomes that were objectively assessed. Recalled ACEs and poor subjective outcomes were correlated regardless of whether prospectively-recorded ACEs were evident. Individuals who recalled more ACEs than had been prospectively recorded were more neurotic than average, and individuals who recalled fewer ACEs than recorded were more agreeable. Conclusions Prospective ACE records confirm associations between childhood adversity and negative life outcomes found previously using retrospective ACE reports. However, more agreeable and neurotic dispositions may respectively bias retrospective ACE measures toward underestimating the impact of adversity on objectively-measured life outcomes and overestimating the impact of adversity on self-reported outcomes. Associations between personality factors and the propensity to recall adversity were extremely modest and warrant further investigation. Risk predictions based on retrospective ACE reports should utilize objective outcome measures. Where objective outcome measurements are difficult to obtain, correction factors may be warranted. PMID:27647050

Outcomes assessment in men undergoing open retropubic radical prostatectomy, laparoscopic radical prostatectomy, and robotic-assisted radical prostatectomy.

PubMed

Kowalczyk, Keith J; Yu, Hua-Yin; Ulmer, William; Williams, Stephen B; Hu, Jim C

2012-02-01

To review the various methods of outcomes assessment used for effectiveness studies comparing retropubic radical prostatectomy (RRP), laparoscopic radical prostatectomy (LRP), and robotic-assisted laparoscopic prostatectomy (RALP). A review of the peer reviewed literature was performed for reported series of RRP, LRP, and RALP using Pubmed and MEDLINE with emphasis on comparing perioperative, functional, and oncologic outcomes. Common methods used for outcomes assessment were categorized and compared, highlighting the pros and cons of each approach. The majority of the literature comparing RRP, LRP, and RALP comes in the form of observational data or administrative data from secondary datasets. While randomized controlled trials are ideal for outcomes assessment, only one such study was identified and was limited. Non-randomized observational studies contribute to the majority of data, however are limited due to retrospective study design, lack of consistent endpoints, and limited application to the general community. Administrative data provide accurate assessment of operative outcomes in both academic and community settings, however has limited ability to convey accurate functional outcomes. Non-randomized observational studies and secondary data are useful resources for assessment of outcomes; however, limitations exist for both. Neither is without flaws, and conclusions drawn from either should be viewed with caution. Until standardized prospective comparative analyses of RRP, LRP, and RALP are established, comparative outcomes data will remain imperfect. Urologic researchers must strive to provide the best available outcomes data through accurate prospective data collection and consistent outcomes reporting.

The Arts and Achievement in At-Risk Youth: Findings from Four Longitudinal Studies. Research Report #55

ERIC Educational Resources Information Center

Catterall, James S.

2012-01-01

This report examines the academic and civic behavior outcomes of teenagers and young adults who have engaged deeply with the arts in or out of school. In several small-group studies, children and teenagers who participated in arts education programs have shown more positive academic and social outcomes in comparison to students who did not…

Interventions to modify sexual risk behaviours for preventing HIV in homeless youth

PubMed Central

Naranbhai, Vivek; Karim, Quarraisha Abdool; Meyer-Weitz, Anna

2013-01-01

Background Homeless youth are at high risk for HIV infection as a consequence of risky sexual behavior. Interventions in homeless youth are challenging. Assessment of the effectiveness of interventions to modify sexual risk behaviours for preventing HIV in homeless youth is needed. Objectives To evaluate and summarize the effectiveness of interventions for modifying sexual risk behaviours and preventing transmission of HIV among homeless youth. Search methods We searched electronic databases (CENTRAL, Medline, EMBASE, AIDSearch, Gateway, PsycInfo, LILACS), reference lists of eligible articles, international health agency publication lists, and clinical trial registries. The search was updated January 2010. We contacted authors of published reports and other key role players. Selection criteria Randomized studies of interventions to modify sexual risk behavior (biological, self-report sexual-risk behavior or health seeking behavior) in homeless youth (12–24 years). Data collection and analysis Data from eligible studies were extracted by two reviewers. We assessed risk of bias per the Cochrane Collaborations tool. None of the eligible studies reported any primary biological outcomes for this review and the reporting of self-report sexual risk behavior outcomes was highly variable across studies precluding calculation of summary measures of effect; we present the outcomes descriptively for each study. We contacted authors for missing or ambiguous data. Results We identified three eligible studies after screening a total of 255 unique records. All three were performed in the United States of America and recruited substance-abusing male and female adolescents (total N=615) through homeless shelters into randomised controlled trials of independent and non-overlapping behavioural interventions. The three trials differed in theoretical background, delivery method, dosage (number of sessions,) content and outcome assessments. Overall, the variability in delivery and outcomes precluded estimation of summary of effect measures. We assessed the risk of bias to be high for each of the studies. Whilst some effect of the interventions on outcome measures were reported, heterogeneity and lack of robustness in these studies necessitate caution in interpreting the effectiveness of these interventions. Authors’ conclusions The body of evidence does not permit conclusions on the impact of interventions to modify sexual risk behaviour in homeless youth. More research is required. While the psychosocial and contextual factors that fuel sexual risk behaviours among homeless youth challenge stringent methodologies of RCT’s, novel ways for program delivery and trial retention are in need of development. Future trials should endeavour to comply with rigorous methodology in design, delivery, outcome measurement and reporting. PMID:21249691

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

Clinical and economic impact of non-adherence to antidepressants in major depressive disorder: A systematic review.

PubMed

Ho, Siew Ching; Chong, Huey Yi; Chaiyakunapruk, Nathorn; Tangiisuran, Balamurugan; Jacob, Sabrina Anne

2016-03-15

Medication non-adherence is one of the major challenges in treating patients with depression. This systematic review aims to determine the clinical and economic outcomes of non-adherence in depression. A systematic search was performed across the following databases: PubMed, EMBASE, DARE, CINAHL, PsycINFO, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews; from database inception to March 31, 2015. Studies must report on the association between adherence and outcomes, and English full texts needed to be available. The quality of each study was assessed using the Newcastle-Ottawa scale. A total of 11 articles were included, with eight reporting on clinical outcomes, two reporting on economic outcomes, and one reporting on both. The majority of studies were retrospective cohort studies. The mean quality of all included studies was 7, with a range from 3 to 9. Results clearly indicate that patients who were non-adherent were more likely to experience increased risks of relapse and/or recurrence, emergency department visits, and hospitalization rates; increased severity of depression, and a decrease in response and remission rates. The worsening of clinical outcomes in patients who were non-adherent subsequently translated to an increase in healthcare utilization and charges. No standardized adherence measurement tools were used, and few studies looked at the economic impact of non-adherence in depression. There is a strong association between non-adherence to antidepressants and a worsening of patients' clinical and economic outcomes. Cost-effective interventions should be directed to this group of patients to improve medication adherence. Copyright © 2015 Elsevier B.V. All rights reserved.

Comparison of outcomes and other variables between conference abstracts and subsequent peer-reviewed papers involving pre-harvest or abattoir-level interventions against foodborne pathogens.

PubMed

Snedeker, Kate G; Campbell, Mollie; Totton, Sarah C; Guthrie, Alessia; Sargeant, Jan M

2010-11-01

Accuracy in the reporting of studies in conference abstracts is important because the majority of studies in such abstracts are never further detailed in peer-reviewed publications, and data from such abstracts may be used in systematic reviews. Previous research on interventional studies in human biomedicine indicates that there is no guarantee of consistency between a conference abstract and paper in the reporting of results and other key variables. However, no research has been done to determine if this lack of reporting consistency in abstracts and papers extends to interventional studies in pre-harvest/harvest-level food safety. The goal of this study was to compare outcome results and other key variables between conference abstracts and subsequent peer-reviewed publications describing studies of pre-harvest and abattoir-level interventions against foodborne pathogens, and to determine whether the agreement in the results or key variables was associated with the time to full publication. A systematic search identified 59 conference abstracts with matching peer-reviewed papers (matches), and data on variables including outcome measures and results, pathogens, species, interventions, overall efficacy of intervention, sample size and housing were extracted from both the conference abstracts and the papers. The matching of variables between abstracts and papers was described, and logistic regression used to test for associations between variable matching and time to publication. Sample size was only provided for both abstract and paper in 24 matches; the same sample size was reported in 20 of these matches. Most other variables were reported in the majority of abstracts/papers, and with the exception of outcomes and intervention effect, the reporting of variables was relatively consistent. There was no significant difference in the numbers of authors, with the first author the same in 78.3% of matches. Of 231 outcome measures reported in both abstracts and papers, nearly one third (77% or 32.2%) had different results, with 32 changing direction of effect. More than a quarter of matches involved at least one significant change in outcome result. The overall conclusion on the efficacy of the intervention changed in 10.7% of matches. There was a significant association between increased time to publication and differences in the number of authors, and having fewer outcome measures in the abstract reported in the paper. These results suggest that data from conference abstracts should be considered with caution. Copyright © 2010 Elsevier B.V. All rights reserved.

The Consistency and Reporting of Quality-of-Life Outcomes in Trials of Immunosuppressive Agents in Kidney Transplantation: A Systematic Review and Meta-analysis.

PubMed

Howell, Martin; Wong, Germaine; Turner, Robin M; Tan, Ho Teck; Tong, Allison; Craig, Jonathan C; Howard, Kirsten

2016-05-01

Shared decision making regarding immunosuppression in kidney transplantation requires an understanding of effects on quality of life (QoL). Our aim was to review the frequency and reliability of QoL measures reported in randomized controlled trials of maintenance immunosuppression following kidney transplantation. Systematic literature review. Kidney transplant recipients enrolled in randomized trials of maintenance immunosuppression. Systematic search of the Cochrane Kidney and Transplant register, CENTRAL, MEDLINE, EMBASE, PsycINFO, and CINAHL databases to January 2014 identifying maintenance immunosuppression trials. An EQUATOR Network-endorsed checklist was used to assess QoL reporting and effect sizes estimated. Maintenance immunosuppression (comparative studies, dose adjustment, and agent withdrawal). Any quantitative patient-reported measure of physical, emotional, or social well-being. Of 2,272 reports, 41 (2%; involving 4,549 participants from 23 trials) included QoL outcomes using 22 instruments (8 generic, 2 disease specific, and 12 symptom specific). Reporting was incomplete for the majority with 1 (4%) addressing all 11 items of the checklist, 4 (17%) addressing clinical significance, and 15 (65%) reporting outcomes selectively. Almost all (n = 96 [95%]) effect size estimates for 101 QoL outcomes (18 trials; 3,919 participants) favored the interventions, with 37 (37%) statistically significant. In comparison, 30 (73%) clinical outcomes favored the intervention and 13 (31%) were significant. QoL outcomes are commonly secondary outcomes and may not be indexed or found using text word searches. Effect sizes were estimated from different QoL measures, populations, and interventions. The small number of trials limits the ability to identify statistically significant associations between effect size and study-/patient-related factors. QoL is infrequently reported in immunosuppression trials in kidney transplantation, appears subject to major biases, and thus may be unreliable for decision making. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Using ClinicalTrials.gov to supplement information in ophthalmology conference abstracts about trial outcomes: a comparison study.

PubMed

Scherer, Roberta W; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

2015-01-01

Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching "new" outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conference abstracts may be a valuable source of information about results for outcomes of unpublished RCTs that have been registered in ClinicalTrials.gov. Complementary additional descriptive information may be present for outcomes reported in both sources. However, ARVO abstract authors also present outcomes not reported in ClinicalTrials.gov and these may represent analyses not originally planned.

Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force

PubMed Central

Powers, John H.; Patrick, Donald L.; Walton, Marc K.; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B.

2017-01-01

A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients’ health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient’s health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of ClinRO assessments used as end points in clinical trials. Applying good measurement practices to ClinRO assessment development and evaluation will lead to more efficient and accurate measurement of treatment effects. This is important beyond regulatory approval in that it provides evidence for the uptake of new interventions into clinical practice and provides justification to payers for reimbursement on the basis of the clearly demonstrated added value of the new intervention. PMID:28212963

Leadership development programs for physicians: a systematic review.

PubMed

Frich, Jan C; Brewster, Amanda L; Cherlin, Emily J; Bradley, Elizabeth H

2015-05-01

Physician leadership development programs typically aim to strengthen physicians' leadership competencies and improve organizational performance. We conducted a systematic review of medical literature on physician leadership development programs in order to characterize the setting, educational content, teaching methods, and learning outcomes achieved. Articles were identified through a search in Ovid MEDLINE from 1950 through November 2013. We included articles that described programs designed to expose physicians to leadership concepts, outlined teaching methods, and reported evaluation outcomes. A thematic analysis was conducted using a structured data entry form with categories for setting/target group, educational content, format, type of evaluation and outcomes. We identified 45 studies that met eligibility criteria, of which 35 reported on programs exclusively targeting physicians. The majority of programs focused on skills training and technical and conceptual knowledge, while fewer programs focused on personal growth and awareness. Half of the studies used pre/post intervention designs, and four studies used a comparison group. Positive outcomes were reported in all studies, although the majority of studies relied on learner satisfaction scores and self-assessed knowledge or behavioral change. Only six studies documented favorable organizational outcomes, such as improvement in quality indicators for disease management. The leadership programs examined in these studies were characterized by the use of multiple learning methods, including lectures, seminars, group work, and action learning projects in multidisciplinary teams. Physician leadership development programs are associated with increased self-assessed knowledge and expertise; however, few studies have examined outcomes at a system level. Our synthesis of the literature suggests important gaps, including a lack of programs that integrate non-physician and physician professionals, limited use of more interactive learning and feedback to develop greater self-awareness, and an overly narrow focus on individual-level rather than system-level outcomes.

What is the Impact of Body Mass Index on Cardiovascular and Musculoskeletal Health?

PubMed

Chughtai, Morad; Khlopas, Anton; Newman, Jared M; Curtis, Gannon L; Sodhi, Nipun; Ramkumar, Prem N; Khan, Rafay; Shaffiy, Shervin; Nadhim, Ali; Bhave, Anil; Mont, Michael A

2017-07-25

Obesity has become a major public health concern over the past several decades and has been shown to be associated with type 2 diabetes, cardiovascular diseases, dyslipidemia, hypertension, osteoarthritis (OA), and certain types of cancer. The impact of excess weight on cardiovascular and musculoskeletal health is not well-summarized in the literature, and there are some contradictory reports. Therefore, the purpose of this study was to assess the impact of body mass index (BMI) on: 1) cardiovascular outcomes; 2) osteoarthritis risk and progression; and 3) total knee arthroplasty outcomes (TKA). Three literature searches were performed to identify clinical studies that assessed how BMI affects cardiovascular and musculoskeletal health. We included reports published within last five years. A total of 138 studies on cardiovascular health and 140 studies on musculoskeletal health were identified. After reviewing the abstracts and related citations from the references, there were 29 studies included in the present study. The effect of varying levels of BMI have demonstrated a relationship to cardiovascular disease, osteoarthritis, and TKA outcomes. The evidence suggests that as BMI increases, the chance of developing cardiovascular disease, OA, and negative TKA outcomes also increases. Furthermore, there appears to be a negative effect with being underweight on outcomes as well, suggesting that being at "normal" weight may optimize outcomes. However, there are several reports which make these findings more complicated. Several beneficial factors associated with higher BMI include increased muscle mass and strength, which can potentially be beneficial through better cardiorespiratory fitness or hormonal effects. Additionally, several studies suggest that improving fitness is more important than intentional weight loss for cardiovascular health and osteoarthritis. Therefore, future studies are warranted to assess the combination of BMI and activity to assess the optimal balance and how they affect cardiovascular and musculoskeletal outcomes.

Functional and cognitive impairment, social environment, frailty and adverse health outcomes in older patients with head and neck cancer, a systematic review.

PubMed

van Deudekom, Floor J; Schimberg, Anouk S; Kallenberg, Marije H; Slingerland, Marije; van der Velden, Lily-Ann; Mooijaart, Simon P

2017-01-01

Older head and neck cancer patients are at increased risk for adverse health outcomes, but little is known about which geriatric assessment associates with poor outcome. The aim is to study the association of functional or cognitive impairment, social environment and frailty with adverse health outcomes in patients with head and neck cancer. Four libraries were searched for studies reporting on an association of functional or cognitive impairment, social environment and frailty with adverse outcomes in head and neck cancer patients. Of 4158 identified citations, 31 articles were included. The mean age was ⩾60years in twelve studies (39%). Geriatric conditions were prevalent: between 40 and 50% of the included participants were functional impaired, around 50% had depressive symptoms, and around 40% did not have a partner. Functional impairment was assessed in 18 studies, two studies reported on a cognitive test, eight studies examined mood and social status was depicted by 14 studies. None of the included studies addressed frailty or objectively measured physical capacity such as hand grip strength, gait speed or balance tests. In 64% of the reported associations, a decline in functional or cognitive impairment, mood or social environment was associated with adverse outcomes. Functional and cognitive impairment, depressive symptoms and social isolation are highly prevalent in head and neck cancer patients and associate with high risk of adverse health outcomes. In the future, these measurements may guide decision-making and customize treatments, but more research is needed to further improve and firmly establish clinical usability. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Ethnic discrimination and health: the relationship between experienced ethnic discrimination and multiple health domains in Norway's rural Sami population

PubMed Central

Hansen, Ketil Lenert

2015-01-01

Objective Self-reported ethnic discrimination has been associated with a range of health outcomes. This study builds on previous efforts to investigate the prevalence of self-reported ethnic discrimination in the indigenous (Sami) population, and how such discrimination may be associated with key health indicators. Study design The study relies on data from the 2003/2004 (n=4,389) population-based study of adults (aged 36–79 years) in 24 rural municipalities of Central and North Norway (the SAMINOR study). Self-reported ethnic discrimination was measured using the question: “Have you ever experienced discrimination due to your ethnic background?” Health indicators included questions regarding cardiovascular disease, diabetes, chronic muscle pain, metabolic syndrome and obesity. Logistic regression was applied to examine the relationship between self-reported ethnic discrimination and health outcomes. Results The study finds that for Sami people living in minority areas, self-reported ethnic discrimination is associated with all the negative health indicators included in the study. Conclusion We conclude that ethnic discrimination affects a wide range of health outcomes. Our findings highlight the importance of ensuring freedom from discrimination for the Sami people of Norway. PMID:25683064

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.

Agreement between Self-Report and Archival Public Service Utilization Data among Chronically Homeless Individuals with Severe Alcohol Problems

ERIC Educational Resources Information Center

Clifasefi, Seema L.; Collins, Susan E.; Tanzer, Kenneth; Burlingham, Bonnie; Hoang, Sara E.; Larimer, Mary E.

2011-01-01

Public service utilization data are often used as key outcomes in studies on homelessness. Although self-report data on these outcomes are accessible and cost-effective, various factors may affect retrospective recall in homeless populations. It is therefore necessary to establish validity of self-report to ensure the integrity of studies…

Predicting Reports of a Personal Event. Technical Report No. 387.

ERIC Educational Resources Information Center

Tenney, Yvette J.

Focusing on how people select topics to mention when reporting on a personal event, a study investigated the hypotheses that people would be more likely to mention topics (1) of high prior concern than topics of low concern and (2) with an unusually good or bad outcome than topics with an ordinary outcome. Subjects, 12 couples expecting babies,…

Systematic review of universal school-based resilience interventions targeting adolescent tobacco, alcohol or illicit drug use: review protocol

PubMed Central

Hodder, Rebecca Kate; Freund, Megan; Wolfenden, Luke; Bowman, Jenny; Gillham, Karen; Dray, Julia; Wiggers, John

2014-01-01

Introduction Tobacco, alcohol and illicit drug use contribute significantly to global rates of morbidity and mortality. Despite evidence suggesting interventions designed to increase adolescent resilience may represent a means of reducing adolescent substance use, and schools providing a key opportunity to implement such interventions, existing systematic reviews assessing the effectiveness of school-based interventions targeting adolescent substance use have not examined this potential. Methods and analysis The aim of the systematic review is to determine whether universal interventions focused on enhancing the resilience of adolescents are effective in reducing adolescent substance use. Eligible studies will: include participants 5–18 years of age; report tobacco use, alcohol consumption or illicit drug use as outcomes; and implement a school-based intervention designed to promote internal (eg, self-esteem) and external (eg, school connectedness) resilience factors. Eligible study designs include randomised controlled trials, cluster randomised controlled trials, staggered enrolment trials, stepped wedged trials, quasi-randomised trials, quasi-experimental trials, time series/interrupted time-series trials, preference trials, regression discontinuity trials and natural experiment studies with a parallel control group. A search strategy including criteria for participants, study design, outcome, setting and intervention will be implemented in various electronic databases and information sources. Two reviewers will independently screen studies to assess eligibility, as well as extract data from, and assess risk of bias of included studies. A third reviewer will resolve any discrepancies. Attempts will be made to quantify trial effects by meta-analysis. Binary outcomes will be pooled and effect size reported using ORs. For continuous data, effect size of trials will be reported using a mean difference where trial outcomes report the same outcome using a consistent measure, or standardised mean difference where trials report a comparable measure. Otherwise, trial outcomes will be described narratively. Dissemination Review findings will be disseminated via peer-reviewed journals and conferences. PMID:24861548

Dental implant outcomes may vary in patients with a history of periodontal disease.

PubMed

Stanford, Clark

2010-03-01

This systematic review used a set of defined inclusion criteria and identified 4448 publications. These were sorted and 10 were identified with sufficient strength to be considered in the systematic review. The authors used a series of inclusion criteria to sort though the identified systematic reviews on this topic. Criterion included the following: use of longitudinal studies (up to March 2006) or case series in which all subjects were included, studies addressing only partially edentulous subjects in which a variety of implant systems were used, and reviews that classified and ranked quality of the studies (eg, > 6-month recall, > 10 subjects). All studies were located through a search of MEDLINE and EMBASE. The primary prognostic factor in this study was to identify dental implant outcomes (survival or success as defined by the respective studies) and reports of peri-implantitis in subjects with a previous history of periodontitis. The authors focused on 3 outcome measures: implant survival, implant success, and peri-implantitis. The authors' inclusion criteria were generally all inclusive and did not limit studies based on definitions of these 3 outcomes. The authors state that "overall, the non-periodontitis patients demonstrated better outcomes than treated periodontitis patients," yet they admit that there is a "medium to high level of bias" with a lack of consistent outcome variables. They correctly state that owing to the heterogeneity of study designs (p. 459), they were not able to provide a meta-analysis. Unfortunately, the strength of the associations claimed are difficult to assess because there were no reports of odds ratios or confidence intervals. They also report significant inconsistencies between studies for the key outcome variables. For instance, only 3 of the 9 studies reviewed reported any form of peri-implant bone loss associated with inflammation (peri-implantitis). Bone loss was statistically observed in only 1 study, with a nonsignificant trend of greater bone loss in the subjects who had a history of periodontitis in the other studies reviewed. The authors suggest there is "some evidence" that patients treated for periodontitis may experience more implant loss and complications around implants than patients without periodontitis.

Relationship between hospital financial performance and publicly reported outcomes.

PubMed

Nguyen, Oanh Kieu; Halm, Ethan A; Makam, Anil N

2016-07-01

Hospitals that have robust financial performance may have improved publicly reported outcomes. To assess the relationship between hospital financial performance and publicly reported outcomes of care, and to assess whether improved outcome metrics affect subsequent hospital financial performance. Observational cohort study. Hospital financial data from the Office of Statewide Health Planning and Development in California in 2008 and 2012 were linked to data from the Centers for Medicare and Medicaid Services Hospital Compare website. Hospital financial performance was measured by net revenue by operations, operating margin, and total margin. Outcomes were 30-day risk-standardized mortality and readmission rates for acute myocardial infarction (AMI), congestive heart failure (CHF), and pneumonia (PNA). Among 279 hospitals, there was no consistent relationship between measures of financial performance in 2008 and publicly reported outcomes from 2008 to 2011 for AMI and PNA. However, improved hospital financial performance (by any of the 3 measures) was associated with a modest increase in CHF mortality rates (ie, 0.26% increase in CHF mortality rate for every 10% increase in operating margin [95% confidence interval: 0.07%-0.45%]). Conversely, there were no significant associations between outcomes from 2008 to 2011 and subsequent financial performance in 2012 (P > 0.05 for all). Robust financial performance is not associated with improved publicly reported outcomes for AMI, CHF, and PNA. Financial incentives in addition to public reporting, such as readmissions penalties, may help motivate hospitals with robust financial performance to further improve publicly reported outcomes. Reassuringly, improved mortality and readmission rates do not necessarily lead to loss of revenue. Journal of Hospital Medicine 2016;11:481-488. © 2016 Society of Hospital Medicine. © 2016 Society of Hospital Medicine.

Outcomes for youth residential treatment programs using administrative data from the child welfare system: a risk-adjustment application.

PubMed

McMillen, J Curtis; Lee, Bethany R; Jonson-Reid, Melissa

2008-05-01

This study assessed whether administrative data from the public child welfare system could be used to develop risk-adjusted performance reports for residential mental health programs for adolescents. Regression methods were used with 3,759 residential treatment spells for 2,784 children and youth to determine which outcomes could be adequately risk adjusted for case mix. Expected outcomes were created for each residential program given its case mix; then, expected and achieved outcomes were compared. For most programs, achieved results did not differ significantly from expected results for individual outcomes. Overall, outcomes achieved were not impressive. Only one quarter of spells resulted in a youth being maintained in a single less restrictive setting in the year following discharge. Methodological implications of this study suggest further refinements are needed for child welfare administrative data in order to develop risk-adjusted report cards of program performance.

Homework Adherence and Cognitive Behaviour Treatment Outcome for Children and Adolescents with Anxiety Disorders.

PubMed

Arendt, Kristian; Thastum, Mikael; Hougaard, Esben

2016-03-01

Homework assignments are considered an essential component for a successful outcome of cognitive behavioural therapy for youths with anxiety disorders. However, only two studies have examined the association between homework adherence and outcome of cognitive behavioural therapy for youths with anxiety disorders. The study examined the association between homework adherence and treatment outcome following a generic group cognitive behaviour treatment program (Cool Kids) for anxiety disordered youths and their parents. The treatment program was completed by 98 children and adolescents (ages 7-16). Homework adherence was measured as time spent doing homework assignments between each session, reported by youths as well as parents. Outcome criteria consisted of youth-reported anxiety symptoms and clinician rated severity of primary anxiety diagnosis at posttreatment and 3-month follow-up. Results did not support an association between homework adherence and treatment outcome when controlling for pretreatment severity. The study found no convincing evidence that homework adherence predicted outcome of cognitive behavioural therapy for youths with anxiety disorders. Reasons for divergent findings on homework adherence in cognitive behavioural therapy for youths compared to adults are discussed.

Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

PubMed

Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

2016-01-28

Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov had their results published at least 30 months after study completion. The registration of these observational studies allowed searching other sources (results posted at ClinicalTrials.gov and sponsor website) and obtaining results for half of unpublished studies and 93% of the total target number of participants.

Outcome of Vaginoplasty in Male-to-Female Transgenders: A Systematic Review of Surgical Techniques.

PubMed

Horbach, Sophie E R; Bouman, Mark-Bram; Smit, Jan Maerten; Özer, Müjde; Buncamper, Marlon E; Mullender, Margriet G

2015-06-01

Gender reassignment surgery is the keystone of the treatment of transgender patients. For male-to-female transgenders, this involves the creation of a neovagina. Many surgical methods for vaginoplasty have been opted. The penile skin inversion technique is the method of choice for most gender surgeons. However, the optimal surgical technique for vaginoplasty in transgender women has not yet been identified, as outcomes of the different techniques have never been compared. With this systematic review, we aim to give a detailed overview of the published outcomes of all currently available techniques for vaginoplasty in male-to-female transgenders. A PubMed and EMBASE search for relevant publications (1995-present), which provided data on the outcome of techniques for vaginoplasty in male-to-female transgender patients. Main outcome measures are complications, neovaginal depth and width, sexual function, patient satisfaction, and improvement in quality of life (QoL). Twenty-six studies satisfied the inclusion criteria. The majority of these studies were retrospective case series of low to intermediate quality. Outcome of the penile skin inversion technique was reported in 1,461 patients, bowel vaginoplasty in 102 patients. Neovaginal stenosis was the most frequent complication in both techniques. Sexual function and patient satisfaction were overall acceptable, but many different outcome measures were used. QoL was only reported in one study. Comparison between techniques was difficult due to the lack of standardization. The penile skin inversion technique is the most researched surgical procedure. Outcome of bowel vaginoplasty has been reported less frequently but does not seem to be inferior. The available literature is heterogeneous in patient groups, surgical procedure, outcome measurement tools, and follow-up. Standardized protocols and prospective study designs are mandatory for correct interpretation and comparability of data. © 2015 International Society for Sexual Medicine.

Is patient responsibility for managing musculoskeletal disorders related to self-reported better outcome of physiotherapy treatment?

PubMed

Larsson, Maria E H; Kreuter, Margareta; Nordholm, Lena

2010-07-01

Musculoskeletal disorders are prevalent and a major burden on individuals and society. Information on relationships of patient involvement and responsibility to outcome is limited. This study aimed to explore relationships between self-reported outcome of physiotherapy treatment and attitudes toward responsibility for musculoskeletal disorders. A cross-sectional postal survey design was used. Patients (n=615) from an outpatient physiotherapy clinic, who had finished their physiotherapy treatment within the last 6 months were sent a questionnaire that included the Attitudes regarding Responsibility for Musculoskeletal disorders instrument (ARM), self-reported outcome of treatment and sociodemographic data. A total of 279 (45%) completed forms were returned. Multiple logistic regression analysis was used. The patients' scores on the four dimensions of ARM ("responsibility self active," "responsibility out of my hands," "responsibility employer," and "responsibility medical professionals"), controlled for age, sex, education, and physical activity as well as for number of treatments, main treatment, and physiotherapist, were associated with the patients' self-reported treatment outcome. Patients who attributed responsibility more to themselves were more likely (OR 2.37 and over) to report considerable improvement as the outcome of physiotherapy treatment. Because this study was conducted at only one physiotherapy outpatient clinic and had a cross-sectional design, the results should be replicated in other settings. Because patients' attitudes regarding responsibility for musculoskeletal disorders can possibly affect the outcome of physiotherapy treatment, it might be useful to decide whether to systematically try to influence the person's attitude toward responsibility for the management of the disorder or to match treatment to attitude.

Student Outcomes Survey: Self-Reported Graduate Model Review. Technical Paper

ERIC Educational Resources Information Center

Sanders, Ben

2018-01-01

The National Student Outcomes Survey (SOS) collects information about students who completed their vocational education and training (VET) in the previous calendar year. The gathered information on the surveyed VET students includes their reasons for training, employment outcomes, satisfaction with training, and further study outcomes. The survey…

Measurement properties of patient-reported outcome measures (PROMS) in Patellofemoral Pain Syndrome: a systematic review.

PubMed

Green, Andrew; Liles, Clive; Rushton, Alison; Kyte, Derek G

2014-12-01

This systematic review investigated the measurement properties of disease-specific patient-reported outcome measures used in Patellofemoral Pain Syndrome. Two independent reviewers conducted a systematic search of key databases (MEDLINE, EMBASE, AMED, CINHAL+ and the Cochrane Library from inception to August 2013) to identify relevant studies. A third reviewer mediated in the event of disagreement. Methodological quality was evaluated using the validated COSMIN (Consensus-based Standards for the Selection of Health Measurement Instruments) tool. Data synthesis across studies determined the level of evidence for each patient-reported outcome measure. The search strategy returned 2177 citations. Following the eligibility review phase, seven studies, evaluating twelve different patient-reported outcome measures, met inclusion criteria. A 'moderate' level of evidence supported the structural validity of several measures: the Flandry Questionnaire, Anterior Knee Pain Scale, Functional Index Questionnaire, Eng and Pierrynowski Questionnaire and Visual Analogue Scales for 'usual' and 'worst' pain. In addition, there was a 'Limited' level of evidence supporting the test-retest reliability and validity (cross-cultural, hypothesis testing) of the Persian version of the Anterior Knee Pain Scale. Other measurement properties were evaluated with poor methodological quality, and many properties were not evaluated in any of the included papers. Current disease-specific outcome measures for Patellofemoral Pain Syndrome require further investigation. Future studies should evaluate all important measurement properties, utilising an appropriate framework such as COSMIN to guide study design, to facilitate optimal methodological quality. Copyright © 2014 Elsevier Ltd. All rights reserved.

How are we assessing near-peer teaching in undergraduate health professional education? A systematic review.

PubMed

Irvine, Susan; Williams, Brett; McKenna, Lisa

2017-03-01

Near Peer teaching (NPT) is reported as an effective pedagogical approach to student learning and performance. Studies in medicine, nursing and health sciences have relied mainly on self-reports to describe its benefits, focusing on psychomotor and cognitive aspects of learning. Despite increasing research reports on peer teaching internationally, little is known about the various domains of learning used in assessment of performance and objective learning outcomes of NPT. To determine the domains of learning and assessment outcomes used in NPT in undergraduate health professional education. Quantitative systematic review was conducted in accord with the PRISMA protocol and the Joanna Briggs Institute processes. A wide literature search was conducted for the period 1990-November 2015 of fourteen databases. Grey literature was undertaken from all key research articles. Studies meeting the inclusion criteria were eligible for consideration, including measured learning outcomes of near-peer teaching in undergraduate education in nursing, medicine and health sciences. Set limitations included publications after 1990 (2015 inclusive), English language and objective learning outcomes. A quality appraisal process involving two independent reviewers was used to analyse the data. Of 212 selected articles, 26 were included in the review. Terminology was confusing and found to be a barrier to the review process. Although some studies demonstrated effective learning outcomes resulting from near-peer teaching, others were inconclusive. Studies focused on cognitive and psychomotor abilities of learners with none assessing metacognition, affective behaviours or learning outcomes from quality of understanding. The studies reviewed focused on cognitive and psychomotor abilities of learners. Even though evidence clearly indicates that metacognition and affective behaviours have direct influence on learning and performance, indicating more research around this topic is warranted. Methodological quality of the studies and lack of theoretical frameworks underpinned by educational psychology may have contributed to inconsistencies in learning outcomes reported. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

Systematic review of adverse outcomes of external cephalic version and persisting breech presentation at term.

PubMed

Nassar, Natasha; Roberts, Christine L; Barratt, Alexandra; Bell, Jane C; Olive, Emily C; Peat, Brian

2006-03-01

The aim of this study was to determine the frequency of adverse maternal and fetal outcomes of both external cephalic version (ECV) and persisting breech presentation at term. We conducted a systematic review of the literature using Medline, Embase and All Evidence Based Medicine (EBM) Reviews databases. Data were extracted from studies that compared women who had an ECV from 36 weeks' gestation with a similar control group of women enrolled at the same gestational age, eligible for, but who did not have an ECV. Eleven studies with a total of 2503 women were included. Adverse outcomes related to ECV were rarely reported and in most studies there was no evidence that relevant outcomes were ascertained among similar women who did not have an ECV. There was no increased risk of antepartum fetal death associated with ECV, but numbers were small. There were no reported cases of uterine rupture, placental abruption, prelabour rupture of membranes or cord prolapse, but these outcomes were not examined among controls. Onset of labour within 24 h and nuchal cord was non-significantly higher among women who had an ECV compared with those with a persisting breech. Despite limited reporting and small numbers, the results of our review suggest that adverse maternal and fetal outcomes of both ECV and persisting breech presentation are rare. Only with improved reporting and collection of safety data on ECV and persisting breech presentation can we provide high-quality information to assist informed decision making by pregnant women with a breech presentation at term.

Characteristics and temporal trends in patient registries: focus on the life sciences industry, 1981–2012

PubMed Central

Travers, Karin; Sallum, Rachel H; Burns, Meghan D; Barr, Charles E; Beattie, Mary S; Pashos, Chris L; Luce, Bryan R

2015-01-01

Purpose Patient registries are used to monitor safety, examine real-world effectiveness, and may potentially contribute to comparative effectiveness research. To our knowledge, life sciences industry (LSI)-sponsored registries have not been systematically categorized. This study represents a first step toward understanding such registries over time. Methods Studies described as registries were identified in the ClinicalTrials.gov database. Characteristics from these registry records were abstracted and analyzed. Results Of 1202 registries identified, approximately 47% reported LSI sponsorship. These 562 LSI registries varied in focus: medical devices (n = 193, 34%), specific drugs (n = 173, 31%), procedures (n = 29, 5%), or particular diseases (n = 139, 25%). Thirty-three registries (<6%) evaluated pregnancy outcomes. The most common therapeutic area was cardiovascular (n = 234, 42%); others included endocrinology, immunology, oncology, musculoskeletal disorders, and neurology. The two most often measured outcomes were clinical effectiveness and safety, each of which appeared in 363/562 (65%) of LSI registries. Other outcomes included real-world clinical practice patterns (n = 122, 22%), patient-reported outcomes (n = 106, 19%), disease epidemiology/natural history (n = 69, 12%), and economic outcomes (n = 30, 5%). The number of LSI registries and their geographic diversity has increased over time. Conclusions The LSI registries represent a substantial proportion of all patient registries documented in ClinicalTrials.gov. These prospective studies are growing in number and encompass diverse therapeutic areas and geographic regions. Most registries measure multiple outcomes and capture real-world data that may be unavailable through other study designs. This classification of LSI registries documents their use for studying heterogeneity of diseases, examining treatment patterns, measuring patient-reported outcomes, examining economic outcomes, and performing comparative effectiveness research. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:25079108

Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials.

PubMed

Perlmutter, A S; Tran, V-T; Dechartres, A; Ravaud, P

2017-04-01

Protocols are often unavailable to peer-reviewers and readers. To detect outcome reporting bias (ORB), readers usually have to resort to publicly available descriptions of study design such as public clinical trial registries. We compared primary outcomes in protocols, ClinicalTrials.gov and publications of oncology trials and evaluated the use of ClinicalTrials.gov as compared with protocols in detecting discrepancies between planned and published outcomes. We searched for phase III oncology trials registered in ClinicalTrials.gov and published in the Journal of Clinical Oncology and New England Journal of Medicine between January 2014 and June 2015. We extracted primary outcomes reported in the protocol, ClinicalTrials.gov and the publication. First, we assessed the quality of primary outcome descriptions by using a published framework. Second, we evaluated modifications of primary outcomes between each source. Finally, we evaluated the agreement, specificity and sensitivity of detecting modifications between planned and published outcomes by using protocols or ClinicalTrials.gov. We included 65 trials, with 81 primary outcomes common among the 3 sources. The proportion of primary outcomes reporting all items from the framework was 73%, 22%, and 75% for protocols, ClinicalTrials.gov and publications, respectively. Eight (12%) trials presented a discrepancy between primary outcomes reported in the protocol and in the publication. Twelve (18.5%) trials presented a discrepancy between primary outcomes registered at ClinicalTrials.gov and in publications. We found a moderate agreement in detecting discrepant reporting of outcomes by using protocols or ClinicalTrials.gov [κ = 0.53, 95% confidence interval (0.25-0.81)]. Using ClinicalTrials.gov to detect discrepant reporting of outcomes showed high specificity (89.5%) but lacked sensitivity (75%) as compared with use of protocols. In oncology trials, primary outcome descriptions in ClinicalTrials.gov are often of low quality and may not reflect what is in the protocol, thus limiting the detection of modifications between planned and published outcomes. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Evidence of Deeper Learning Outcomes. Findings from the Study of Deeper Learning Opportunities and Outcomes: Report 3

ERIC Educational Resources Information Center

Zeiser, Kristina L.; Taylor, James; Rickles, Jordan; Garet, Michael S.; Segeritz, Michael

2014-01-01

The "Study of Deeper Learning: Opportunities and Outcomes"--funded by the William and Flora Hewlett Foundation--aimed to determine whether students attending high schools with a mature and at least moderately well implemented approach to promoting deeper learning actually experienced greater deeper learning opportunities and outcomes…

Effects of aquatic exercise on physical function and fitness among people with spinal cord injury: A systematic review.

PubMed

Li, Chunxiao; Khoo, Selina; Adnan, Athirah

2017-03-01

The aim of this review is to synthesize the evidence on the effects of aquatic exercise interventions on physical function and fitness among people with spinal cord injury. Six major databases were searched from inception till June 2015: MEDLINE, CINAHL, EMBASE, PsychInfo, SPORTDiscus, and Cochrane Center Register of Controlled Trials. Two reviewers independently rated methodological quality using the modified Downs and Black Scale and extracted and synthesized key findings (i.e., participant characteristics, study design, physical function and fitness outcomes, and adverse events). Eight of 276 studies met the inclusion criteria, of which none showed high research quality. Four studies assessed physical function outcomes and 4 studies evaluated aerobic fitness as outcome measures. Significant improvements on these 2 outcomes were generally found. Other physical or fitness outcomes including body composition, muscular strength, and balance were rarely reported. There is weak evidence supporting aquatic exercise training to improve physical function and aerobic fitness among adults with spinal cord injury. Suggestions for future research include reporting details of exercise interventions, evaluating other physical or fitness outcomes, and improving methodological quality.

Multivariate meta-analysis using individual participant data.

PubMed

Riley, R D; Price, M J; Jackson, D; Wardle, M; Gueyffier, F; Wang, J; Staessen, J A; White, I R

2015-06-01

When combining results across related studies, a multivariate meta-analysis allows the joint synthesis of correlated effect estimates from multiple outcomes. Joint synthesis can improve efficiency over separate univariate syntheses, may reduce selective outcome reporting biases, and enables joint inferences across the outcomes. A common issue is that within-study correlations needed to fit the multivariate model are unknown from published reports. However, provision of individual participant data (IPD) allows them to be calculated directly. Here, we illustrate how to use IPD to estimate within-study correlations, using a joint linear regression for multiple continuous outcomes and bootstrapping methods for binary, survival and mixed outcomes. In a meta-analysis of 10 hypertension trials, we then show how these methods enable multivariate meta-analysis to address novel clinical questions about continuous, survival and binary outcomes; treatment-covariate interactions; adjusted risk/prognostic factor effects; longitudinal data; prognostic and multiparameter models; and multiple treatment comparisons. Both frequentist and Bayesian approaches are applied, with example software code provided to derive within-study correlations and to fit the models. © 2014 The Authors. Research Synthesis Methods published by John Wiley & Sons, Ltd.

Systematic review of mental health and well-being outcomes following community-based obesity prevention interventions among adolescents.

PubMed

Hoare, Erin; Fuller-Tyszkiewicz, Matthew; Skouteris, Helen; Millar, Lynne; Nichols, Melanie; Allender, Steven

2015-01-05

This paper aimed to systematically evaluate the mental health and well-being outcomes observed in previous community-based obesity prevention interventions in adolescent populations. 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. 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 outcomes were measures of mental health and well-being, including diagnostic and symptomatic measures. Secondary outcomes included adiposity or weight-related measures. 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. 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. 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.

The use of computer adaptive tests in outcome assessments following upper limb trauma.

PubMed

Jayakumar, P; Overbeek, C; Vranceanu, A-M; Williams, M; Lamb, S; Ring, D; Gwilym, S

2018-06-01

Aims Outcome measures quantifying aspects of health in a precise, efficient, and user-friendly manner are in demand. Computer adaptive tests (CATs) may overcome the limitations of established fixed scales and be more adept at measuring outcomes in trauma. The primary objective of this review was to gain a comprehensive understanding of the psychometric properties of CATs compared with fixed-length scales in the assessment of outcome in patients who have suffered trauma of the upper limb. Study designs, outcome measures and methodological quality are defined, along with trends in investigation. Materials and Methods A search of multiple electronic databases was undertaken on 1 January 2017 with terms related to "CATs", "orthopaedics", "trauma", and "anatomical regions". Studies involving adults suffering trauma to the upper limb, and undergoing any intervention, were eligible. Those involving the measurement of outcome with any CATs were included. Identification, screening, and eligibility were undertaken, followed by the extraction of data and quality assessment using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. The review is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria and reg istered (PROSPERO: CRD42016053886). Results A total of 31 studies reported trauma conditions alone, or in combination with non-traumatic conditions using CATs. Most were cross-sectional with varying level of evidence, number of patients, type of study, range of conditions and methodological quality. CATs correlated well with fixed scales and had minimal or no floor-ceiling effects. They required significantly fewer questions and/or less time for completion. Patient-Reported Outcomes Measurement Information System (PROMIS) CATs were the most frequently used, and the use of CATs is increasing. Conclusion Early studies show valid and reliable outcome measurement with CATs performing as well as, if not better than, established fixed scales. Superior properties such as floor-ceiling effects and ease of use support their use in the assessment of outcome after trauma. As CATs are being increasingly used in patient outcomes research, further psychometric evaluation, especially involving longitudinal studies and groups of patients with specific injuries are required to inform clinical practice using these contemporary measures. Cite this article: Bone Joint J 2018;100-B:693-702.

Unremarked or Unperformed? Systematic Review on Reporting of Validation Efforts of Health Economic Decision Models in Seasonal Influenza and Early Breast Cancer.

PubMed

de Boer, Pieter T; Frederix, Geert W J; Feenstra, Talitha L; Vemer, Pepijn

2016-09-01

Transparent reporting of validation efforts of health economic models give stakeholders better insight into the credibility of model outcomes. In this study we reviewed recently published studies on seasonal influenza and early breast cancer in order to gain insight into the reporting of model validation efforts in the overall health economic literature. A literature search was performed in Pubmed and Embase to retrieve health economic modelling studies published between 2008 and 2014. Reporting on model validation was evaluated by checking for the word validation, and by using AdViSHE (Assessment of the Validation Status of Health Economic decision models), a tool containing a structured list of relevant items for validation. Additionally, we contacted corresponding authors to ask whether more validation efforts were performed other than those reported in the manuscripts. A total of 53 studies on seasonal influenza and 41 studies on early breast cancer were included in our review. The word validation was used in 16 studies (30 %) on seasonal influenza and 23 studies (56 %) on early breast cancer; however, in a minority of studies, this referred to a model validation technique. Fifty-seven percent of seasonal influenza studies and 71 % of early breast cancer studies reported one or more validation techniques. Cross-validation of study outcomes was found most often. A limited number of studies reported on model validation efforts, although good examples were identified. Author comments indicated that more validation techniques were performed than those reported in the manuscripts. Although validation is deemed important by many researchers, this is not reflected in the reporting habits of health economic modelling studies. Systematic reporting of validation efforts would be desirable to further enhance decision makers' confidence in health economic models and their outcomes.

Therapist-Reported Features of Exposure Tasks That Predict Differential Treatment Outcomes for Youth With Anxiety.

PubMed

Peris, Tara S; Caporino, Nicole E; O'Rourke, Sarah; Kendall, Philip C; Walkup, John T; Albano, Anne Marie; Bergman, R Lindsey; McCracken, James T; Birmaher, Boris; Ginsburg, Golda S; Sakolsky, Dara; Piacentini, John; Compton, Scott N

2017-12-01

Exposure tasks are recognized widely as a key component of cognitive-behavioral therapy (CBT) for child and adolescent anxiety. However, little research has examined specific exposure characteristics that predict outcomes for youth with anxiety and that may guide its application in therapy. This study draws on a sample of 279 children and adolescents (48.4% male; 79.6% white) with a principal anxiety disorder who received 14 sessions of CBT, either alone or in combination with medication, through the Child/adolescent Anxiety Multimodal treatment Study (CAMS). The present study examines therapist-reported quantity, difficulty level, compliance, and mastery of exposure tasks as they related to CBT response (i.e., Clinical Global Impressions-Improvement ratings). Secondary treatment outcomes included reduction in anxiety symptom severity on the Pediatric Anxiety Rating Scale, global impairment measured via the Children's Global Assessment Scale, and parent-report of anxiety-specific functional impairment on the Child Anxiety Impairment Scale. Regression analyses indicated a dose-response relationship between therapist-reported quantity of exposure and independent evaluations of treatment outcome, with more time devoted to exposure linked to better outcomes. Similarly, greater time spent on more difficult (rather than mild or moderate) exposure tasks predicted better outcomes, as did therapist ratings of child compliance and mastery. The present findings highlight the importance of challenging children and adolescents with difficult exposure tasks and of collaborating to ensure compliance and mastery. Copyright © 2017 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Worse self-reported outcomes but no limitations in performance-based measures in patients with long-standing hip and groin pain compared with healthy controls.

PubMed

Wörner, Tobias; Sigurðsson, Haraldur B; Pålsson, Anders; Kostogiannis, Ioannis; Ageberg, Eva

2017-01-01

This study aimed to evaluate patient-reported outcomes as well as lower extremity and trunk muscle function in patients with long-standing hip and groin pain, in comparison with matched, healthy controls. It was hypothesized that patients with long-standing hip and groin pain would report more deficiency on the Copenhagen Hip and Groin Outcome Score (HAGOS) and have worse outcomes on performance-based measures than healthy controls. Nineteen patients with long-standing hip and groin pain and 19 healthy, activity level-, age-, gender-, and weight-matched controls were assessed with the HAGOS for self-reported outcomes, and a parallel squat (w/kg), single-leg triple jump (cm), single-leg rise (n), barbell roll-out (% of height), and plank test (s) for performance-based measures. Independent sample t test was performed to assess between-group differences. The paired t test was used to analyse between-limb differences in unilateral performance tasks. The patients had worse scores than the controls in all HAGOS subscales (p ≤ 0.001), while no statistically significant differences were observed for any performance measure between groups or between symptomatic and non-symptomatic limbs. Despite significant self-reported functional limitations on the HAGOS, there were no significant differences between groups in performance-based strength or power measures. The results of this study highlight the need to identify performance-based measures, sensitive to functional deficiencies in patients with long-standing hip and groin pain in order to complement the clinical picture obtained by patient-reported outcomes such as the HAGOS. III.

Reporting individual surgeon outcomes does not lead to risk aversion in abdominal aortic aneurysm surgery.

PubMed

Saratzis, A; Thatcher, A; Bath, M F; Sidloff, D A; Bown, M J; Shakespeare, J; Sayers, R D; Imray, C

2017-02-01

INTRODUCTION Reporting surgeons' outcomes has recently been introduced in the UK. This has the potential to result in surgeons becoming risk averse. The aim of this study was to investigate whether reporting outcomes for abdominal aortic aneurysm (AAA) surgery impacts on the number and risk profile (level of fitness) of patients offered elective treatment. METHODS Publically available National Vascular Registry data were used to compare the number of AAAs treated in those centres across the UK that reported outcomes for the periods 2008-2012, 2009-2013 and 2010-2014. Furthermore, the number and characteristics of patients referred for consideration of elective AAA repair at a single tertiary unit were analysed yearly between 2010 and 2014. Clinic, casualty and theatre event codes were searched to obtain all AAAs treated. The results of cardiopulmonary exercise testing (CPET) were assessed. RESULTS For the 85 centres that reported outcomes in all three five-year periods, the median number of AAAs treated per unit increased between the periods 2008-2012 and 2010-2014 from 192 to 214 per year (p=0.006). In the single centre cohort study, the proportion of patients offered elective AAA repair increased from 74% in 2009-2010 to 81% in 2013-2014, with a maximum of 84% in 2012-2013. The age, aneurysm size and CPET results (anaerobic threshold levels) for those eventually offered elective treatment did not differ significantly between 2010 and 2014. CONCLUSIONS The results do not support the assumption that reporting individual surgeon outcomes is associated with a risk averse strategy regarding patient selection in aneurysm surgery at present.

Ethnic discrimination and health: the relationship between experienced ethnic discrimination and multiple health domains in Norway's rural Sami population.

PubMed

Hansen, Ketil Lenert

2015-01-01

Self-reported ethnic discrimination has been associated with a range of health outcomes. This study builds on previous efforts to investigate the prevalence of self-reported ethnic discrimination in the indigenous (Sami) population, and how such discrimination may be associated with key health indicators. The study relies on data from the 2003/2004 (n=4,389) population-based study of adults (aged 36-79 years) in 24 rural municipalities of Central and North Norway (the SAMINOR study). Self-reported ethnic discrimination was measured using the question: "Have you ever experienced discrimination due to your ethnic background?" Health indicators included questions regarding cardiovascular disease, diabetes, chronic muscle pain, metabolic syndrome and obesity. Logistic regression was applied to examine the relationship between self-reported ethnic discrimination and health outcomes. The study finds that for Sami people living in minority areas, self-reported ethnic discrimination is associated with all the negative health indicators included in the study. We conclude that ethnic discrimination affects a wide range of health outcomes. Our findings highlight the importance of ensuring freedom from discrimination for the Sami people of Norway.

Patient-centered and visual quality outcomes of premium cataract surgery: a systematic review.

PubMed

Wang, Sophia Y; Stem, Maxwell S; Oren, Gale; Shtein, Roni; Lichter, Paul R

2017-06-26

Over 8 million cataract surgeries are performed in the United States and the European Union annually, with many patients choosing to pay out of pocket for premium options including premium intraocular lens implants (IOLs) or laser-assisted cataract surgery (LACS). This report provides a systematic review evaluating patient-centered and visual quality outcomes comparing standard monofocal IOLs to premium cataract surgery options. PubMed and EMBASE were searched for publications published between January 1, 1980, and September 18, 2016, on multifocal, accommodative, and toric IOLs, monovision, and LACS, which reported on 1) dysphotopsias, 2) contrast sensitivity, 3) spectacle independence, 4) vision-related quality of life or patient satisfaction, and 5) IOL exchange. Multifocal lenses achieved higher rates of spectacle independence compared to monofocal lenses but also had higher reported frequency of dysphotopsia and worse contrast sensitivity, especially with low light or glare. Accommodative lenses were not associated with reduced contrast sensitivity or more dysphotopsia but had only modest improvements in spectacle independence compared to monofocal lenses. Studies of monovision did not target a sufficiently myopic outcome in the near-vision eye to achieve the full potential for spectacle independence. Patients reported high levels of overall satisfaction regardless of implanted IOL. No studies correlated patient-reported outcomes with patient expectations. Studies are needed to thoroughly compare patient-reported outcomes with concomitant patient expectations. In light of the substantial patient costs for premium options, patients and their surgeons will benefit from a better understanding of which surgical options best meet patients' expectations and how those expectations can be impacted by premium versus monofocal-including monovision-options.

Trust in the health care professional and health outcome: A meta-analysis.

PubMed

Birkhäuer, Johanna; Gaab, Jens; Kossowsky, Joe; Hasler, Sebastian; Krummenacher, Peter; Werner, Christoph; Gerger, Heike

2017-01-01

To examine whether patients' trust in the health care professional is associated with health outcomes. We searched 4 major electronic databases for studies that reported quantitative data on the association between trust in the health care professional and health outcome. We screened the full-texts of 400 publications and included 47 studies in our meta-analysis. We conducted random effects meta-analyses and meta-regressions and calculated correlation coefficients with corresponding 95% confidence intervals. Two interdependent researchers assessed the quality of the included studies using the Strengthening the Reporting of Observational Studies in Epidemiology guidelines. Overall, we found a small to moderate correlation between trust and health outcomes (r = 0.24, 95% CI: 0.19-0.29). Subgroup analyses revealed a moderate correlation between trust and self-rated subjective health outcomes (r = 0.30, 0.24-0.35). Correlations between trust and objective (r = -0.02, -0.08-0.03) as well as observer-rated outcomes (r = 0.10, -0.16-0.36) were non-significant. Exploratory analyses showed a large correlation between trust and patient satisfaction and somewhat smaller correlations with health behaviours, quality of life and symptom severity. Heterogeneity was small to moderate across the analyses. From a clinical perspective, patients reported more beneficial health behaviours, less symptoms and higher quality of life and to be more satisfied with treatment when they had higher trust in their health care professional. There was evidence for upward bias in the summarized results. Prospective studies are required to deepen our understanding of the complex interplay between trust and health outcomes.

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

Patient-Reported Allergies Predict Worse Outcomes After Hip and Knee Arthroplasty: Results From a Prospective Cohort Study.

PubMed

Otero, Jesse E; Graves, Christopher M; Gao, Yubo; Olson, Tyler S; Dickinson, Christopher C; Chalus, Rhonda J; Vittetoe, David A; Goetz, Devon D; Callaghan, John J

2016-12-01

Retrospective analyses have demonstrated correlation between patient-reported allergies and negative outcomes after total joint arthroplasty. We sought to validate these observations in a prospective cohort. One hundred forty-four patients undergoing total hip arthroplasty and 302 patients undergoing total knee arthroplasty were prospectively enrolled. Preoperatively, patients listed their allergies and completed the Medical Outcomes Study Short Form 36 (SF-36) and the Charlson Comorbidity Index (CCI) Questionnaire. At a mean of 17 months (range 12-25 months) postoperatively, SF-36, CCI, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were obtained by telephone survey. Regression analysis was used to determine the strength of correlation between patient age, comorbidity burden, and number of allergies and outcome measurements. In 446 patients, 273 reported at least 1 allergy. The number of allergies reported ranged from 0 to 33. Penicillin or its derivative was the most frequently reported allergy followed by sulfa, environmental allergen, and narcotic pain medication. Patients reporting at least 1 allergy had a significantly lower postoperative SF-36 Physical Component Score compared to those reporting no allergies (51.3 vs 49.4, P = .01). The SF-36 postoperative Mental Component Score was no different between groups. Multivariate regression analysis showed that age and patient reported allergies, but not comorbidities, were independently associated with worse postoperative SF-36 Physical Component Summary (PCS) and WOMAC score. Patients with allergies experienced the same improvement in SF-36 PCS as those without an allergy. Comorbidities did not correlate with patient-reported function postoperatively. Patients who report allergies have lower postoperative outcome scores but may experience the same increment in improvement after total joint arthroplasty. Copyright © 2016 Elsevier Inc. All rights reserved.

Definitions of cardiovascular insufficiency and relation to outcomes in critically ill newborn infants

PubMed Central

Fernandez, Erika; Watterberg, Kristi L.; Faix, Roger G.; Yoder, Bradley A.; Walsh, Michele C.; Lacy, Conra Backstrom; Osborne, Karen A.; Das, Abhik; Kendrick, Douglas E.; Stoll, Barbara J.; Poindexter, Brenda B.; Laptook, Abbot R.; Kennedy, Kathleen A.; Schibler, Kurt; Bell, Edward F.; Van Meurs, Krisa P.; Frantz, Ivan D.; Goldberg, Ronald N.; Shankaran, Seetha; Carlo, Waldemar A.; Ehrenkranz, Richard A.; Sanchez, Pablo J.; Higgins, Rosemary D.

2015-01-01

Background We previously reported on the overall incidence, management and outcomes in infants with cardiovascular insufficiency (CVI). However, there are limited data on the relationship of the specific different definitions of CVI to short term outcomes in term and late preterm newborn infants. Objective To evaluate how 4 definitions of CVI relate to short term outcomes and death. Study Design The previously reported study was a multicenter, prospective cohort study of 647 infants ≥ 34 weeks gestation admitted to a Neonatal Research Network (NRN) newborn intensive care unit (NICU) and mechanically ventilated (MV) during their first 72 hours. The relationship of five short term outcomes at discharge and 4 different definitions of CVI were further analyzed. Results All 4 definitions were associated with greater number of days on MV & days on O2. The definition using a threshold blood pressure (BP) measurement alone was not associated with days to full feeding, days in the NICU or death. The definition based on treatment of CVI was associated with all outcomes including death. Conclusions The definition using a threshold BP alone was not consistently associated with adverse short term outcomes. Using only a threshold BP to determine therapy may not improve outcomes. PMID:25825962

Personality disorder and alcohol treatment outcome: systematic review and meta-analysis.

PubMed

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

2017-07-01

Background Personality disorders commonly coexist with alcohol use disorders (AUDs), but there is conflicting evidence on their association with treatment outcomes. Aims To determine the size and direction of the association between personality disorder and the outcome of treatment for AUD. Method We conducted a systematic review and meta-analysis of randomised trials and longitudinal studies. Results Personality disorders were associated with more alcohol-related impairment at baseline and less retention in treatment. However, during follow-up people with a personality disorder showed a similar amount of improvement in alcohol outcomes to that of people without such disorder. Synthesis of evidence was hampered by variable outcome reporting and a low quality of evidence overall. Conclusions Current evidence suggests the pessimism about treatment outcomes for this group of patients may be unfounded. However, there is an urgent need for more consistent and better quality reporting of outcomes in future studies in this area. © The Royal College of Psychiatrists 2017.

A Systematic Review of the Outcomes of Posterolateral Corner Knee Injuries, Part 1: Surgical Treatment of Acute Injuries.

PubMed

Geeslin, Andrew G; Moulton, Samuel G; LaPrade, Robert F

2016-05-01

There is a paucity of outcome data to guide the surgical treatment of acute grade III posterolateral corner (PLC) knee injuries. To systematically review the literature to compare clinical outcomes of the treatment for acute grade III PLC injuries. Systematic review; Level of evidence, 4. A systematic review of the literature including Cochrane, PubMed, Medline, and Embase was performed. The following search terms were used: posterolateral corner knee, posterolateral knee, posterolateral instability, multiligament knee, and knee dislocation. Inclusion criteria were outcome studies of surgically treated acute PLC injuries with a minimum 2-year follow-up, subjective outcomes, objective outcomes including varus stability, and subgroup data on PLC injuries. Two investigators independently reviewed all abstracts. Accepted definitions of varus stability on examination or stress radiographs and the need for revision surgery were used to categorically define success and failure. Eight studies with a total of 134 patients were included. The mean patient age was reported in 7 studies (range, 21-31.5 years). The mean time to surgery was reported in 5 studies (range, 15-24.3 days); surgery was performed within 3 weeks in the other 3 studies. Four studies reported International Knee Documentation Committee scores (range, 78.1-91.3); 5 studies reported Lysholm scores (range, 87.5-90.3). Only 3 studies obtained bilateral varus stress radiographs. Based on an objective evaluation with varus stress examinations or radiographs, there was an overall success rate of 81% and failure rate of 19%. In 2 studies, the fibular collateral ligament and popliteus tendon were repaired and staged cruciate reconstruction performed in most patients; there were 17 failures of 45 patients (38%). In the remainder of the studies, patients were treated with local tissue transfer, hybrid repair for amenable structures or reconstruction for midsubstance tears, or reconstruction of all torn structures; the failure rate was 9%. The repair of acute grade III PLC injuries and staged treatment of combined cruciate injuries were associated with a substantially higher postoperative PLC failure rate. Further research is required to identify the reconstruction technique that provides optimal subjective and objective outcomes. © 2015 The Author(s).

The effect of zirconia or titanium as abutment material on soft peri-implant tissues: a systematic review and meta-analysis.

PubMed

Linkevicius, Tomas; Vaitelis, Julius

2015-09-01

The objective of this review was to analyze research with regard to the effect of zirconia or titanium as abutment material on soft peri-implant tissues. Clinical studies were selected via electronic and hand searches in English language journals until December 1, 2014. Only randomized clinical trials (RCTs) and prospective controlled clinical trials (CCTs) showing direct comparison between zirconia (Zr) and titanium (Ti) abutments in the same patient were considered. The outcome measures were (1) soft tissue color, (2) soft tissue recession, (3) peri-implant probing, (4) bleeding on probing, (5) esthetic indexes, (6) patient-reported outcome, (7) marginal bone level, and (8) biological complications. Nine relevant studies (11 papers) were identified: 4 RCTs and 5 CCTs. Due to heterogeneity in the study design, statistical methods, and reported results, a meta-analysis of the data was feasible only for soft tissue color. The outcome was found to be significantly superior for Zr abutments. For the other outcome measures, a qualitative analysis of the selected articles was performed. The studies did not show any statistically significant differences between Zr and Ti abutments on soft tissue recession, probing depths, bleeding on probing, marginal bone level, and patient-reported outcome. One study reported significantly higher pink esthetic score (PES) scores at Zr implants with Zr abutments, compared to metal implants and Ti abutments. Overall, the research does not support any obvious advantage of Ti or Zr abutments over each other. However, there is a significant tendency in Zr abutments evoking better color response of peri-implant mucosa and superior esthetic outcome measured by PES score. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

State of the science in ovarian cancer quality of life research: a systematic review.

PubMed

Hess, Lisa M; Stehman, Frederick B

2012-09-01

Health-related quality of life (HRQOL) has become an increasingly important focus of outcomes in cancer care with the movement toward more patient-oriented research. Quality-of-life outcomes are important in ovarian cancer, which has not yet benefitted from improved survival outcomes as have other diseases. This study was designed to systematically assess and summarize HRQOL in ovarian cancer. A systematic search strategy was initiated to identify published literature measuring HRQOL of women with a diagnosis of ovarian cancer (OC). Data were synthesized to evaluate HRQOL and patient-reported outcome data at various time points: before, during, and after chemotherapy. Data were pooled and summary statistics compared across published studies. Comparisons of means were conducted using analysis of variance. There were 170 publications meeting all eligibility criteria, representing 139 unique studies of patients with ovarian cancer, where QOL data were collected. Within this literature, more than 90 different patient-reported outcome (PRO) instruments were administered. The most common HRQOL instruments included the European Organisation for Research and Treatment of Cancer QLQ-C30 and the Functional Assessment of Cancer Therapy. Few studies alone demonstrated significant differences in QOL between the experimental and comparison arm or throughout the treatment period. Pooled data, however, show that baseline QOL may significantly improve, particularly after completion of chemotherapy treatment. Despite the increase in assessment and reporting of QOL in ovarian cancer research studies during the past 15 years, there remains little consistency in the types and format of data collected. There is a need to enhance the standardized collection and reporting of HRQOL data from research involving women with ovarian cancer so that research can build on the cumulative knowledge base to improve outcomes in this patient population.

Good research practices for comparative effectiveness research: approaches to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary data sources: the International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report--Part II.

PubMed

Cox, Emily; Martin, Bradley C; Van Staa, Tjeerd; Garbe, Edeltraut; Siebert, Uwe; Johnson, Michael L

2009-01-01

The goal of comparative effectiveness analysis is to examine the relationship between two variables, treatment, or exposure and effectiveness or outcome. Unlike data obtained through randomized controlled trials, researchers face greater challenges with causal inference with observational studies. Recognizing these challenges, a task force was formed to develop a guidance document on methodological approaches to addresses these biases. The task force was commissioned and a Chair was selected by the International Society for Pharmacoeconomics and Outcomes Research Board of Directors in October 2007. This report, the second of three reported in this issue of the Journal, discusses the inherent biases when using secondary data sources for comparative effectiveness analysis and provides methodological recommendations to help mitigate these biases. The task force report provides recommendations and tools for researchers to mitigate threats to validity from bias and confounding in measurement of exposure and outcome. Recommendations on design of study included: the need for data analysis plan with causal diagrams; detailed attention to classification bias in definition of exposure and clinical outcome; careful and appropriate use of restriction; extreme care to identify and control for confounding factors, including time-dependent confounding. Design of nonrandomized studies of comparative effectiveness face several daunting issues, including measurement of exposure and outcome challenged by misclassification and confounding. Use of causal diagrams and restriction are two techniques that can improve the theoretical basis for analyzing treatment effects in study populations of more homogeneity, with reduced loss of generalizability.

Parental Educational Expectations and Their Impact on Student Outcomes. Project LONGSTEP Memorandum Report.

ERIC Educational Resources Information Center

Chalupsky, Albert B.; Coles, Gary J.

This report summarizes the results of an exploratory study of the relationship between parents' educational expectations for their children, the children's perceptions of these expectations, and student outcomes. Of particular interest were the congruence between parental expectations and the children's perceptions of these expectations and the…

A Sense of Achievement: Outcomes of Adult Learning.

ERIC Educational Resources Information Center

Foster, Pablo; Howard, Ursula; Reisenberger, Anna

1997-01-01

This report, which is an outgrowth of the Further Education Development Agency's (FEDA's) Learning Outcomes study, explores ways of identifying, recording, and valuing adult learners' goals and achievements in learning opportunities that are not designed to lead to qualifications. The following topics are discussed in the report's six chapters:…

Child Peer Sexual Abuse: Preliminary Data on Outcomes and Disclosure Experiences

ERIC Educational Resources Information Center

Sperry, Debbie M.; Gilbert, Brenda O.

2005-01-01

Objective: This study compared experiences of children sexually abused by peers to those of children abused by adolescents/adults. Variables examined included perceived negativity of the abuse, self-reported outcomes, overall psychological functioning, and disclosure. Method: An archival data set containing retrospective reports of childhood…

Educational Inequality and the Latino Population of the United States

ERIC Educational Resources Information Center

Rivera-Batiz, Francisco L.

2008-01-01

This research report examines the comparative educational condition of Latinos in the United States. The report discusses the dramatic shortfalls that plague the educational outcomes of Latinos relative to other racial and ethnic groups. The outcomes studied include educational attainment, school and university enrollment, basic cognitive skills,…

Rater methodology for stroboscopy: a systematic review.

PubMed

Bonilha, Heather Shaw; Focht, Kendrea L; Martin-Harris, Bonnie

2015-01-01

Laryngeal endoscopy with stroboscopy (LES) remains the clinical gold standard for assessing vocal fold function. LES is used to evaluate the efficacy of voice treatments in research studies and clinical practice. LES as a voice treatment outcome tool is only as good as the clinician interpreting the recordings. Research using LES as a treatment outcome measure should be evaluated based on rater methodology and reliability. The purpose of this literature review was to evaluate the rater-related methodology from studies that use stroboscopic findings as voice treatment outcome measures. Systematic literature review. Computerized journal databases were searched for relevant articles using terms: stroboscopy and treatment. Eligible articles were categorized and evaluated for the use of rater-related methodology, reporting of number of raters, types of raters, blinding, and rater reliability. Of the 738 articles reviewed, 80 articles met inclusion criteria. More than one-third of the studies included in the review did not report the number of raters who participated in the study. Eleven studies reported results of rater reliability analysis with only two studies reporting good inter- and intrarater reliability. The comparability and use of results from treatment studies that use LES are limited by a lack of rigor in rater methodology and variable, mostly poor, inter- and intrarater reliability. To improve our ability to evaluate and use the findings from voice treatment studies that use LES features as outcome measures, greater consistency of reporting rater methodology characteristics across studies and improved rater reliability is needed. Copyright © 2015 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Do large-scale hospital- and system-wide interventions improve patient outcomes: a systematic review.

PubMed

Clay-Williams, Robyn; Nosrati, Hadis; Cunningham, Frances C; Hillman, Kenneth; Braithwaite, Jeffrey

2014-09-03

While health care services are beginning to implement system-wide patient safety interventions, evidence on the efficacy of these interventions is sparse. We know that uptake can be variable, but we do not know the factors that affect uptake or how the interventions establish change and, in particular, whether they influence patient outcomes. We conducted a systematic review to identify how organisational and cultural factors mediate or are mediated by hospital-wide interventions, and to assess the effects of those factors on patient outcomes. A systematic review was conducted and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Database searches were conducted using MEDLINE from 1946, CINAHL from 1991, EMBASE from 1947, Web of Science from 1934, PsycINFO from 1967, and Global Health from 1910 to September 2012. The Lancet, JAMA, BMJ, BMJ Quality and Safety, The New England Journal of Medicine and Implementation Science were also hand searched for relevant studies published over the last 5 years. Eligible studies were required to focus on organisational determinants of hospital- and system-wide interventions, and to provide patient outcome data before and after implementation of the intervention. Empirical, peer-reviewed studies reporting randomised and non-randomised controlled trials, observational, and controlled before and after studies were included in the review. Six studies met the inclusion criteria. Improved outcomes were observed for studies where outcomes were measured at least two years after the intervention. Associations between organisational factors, intervention success and patient outcomes were undetermined: organisational culture and patient outcomes were rarely measured together, and measures for culture and outcome were not standardised. Common findings show the difficulty of introducing large-scale interventions, and that effective leadership and clinical champions, adequate financial and educational resources, and dedicated promotional activities appear to be common factors in successful system-wide change.The protocol has been registered in the international prospective register of systematic reviews, PROSPERO (Registration No. CRD42103003050).

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.

The Patient Reported Outcomes, Burdens and Experiences (PROBE) Project: development and evaluation of a questionnaire assessing patient reported outcomes in people with haemophilia.

PubMed

Skinner, M W; Chai-Adisaksopha, C; Curtis, R; Frick, N; Nichol, M; Noone, D; O'Mahony, B; Page, D; Stonebraker, J S; Iorio, A

2018-01-01

The interest of health care agencies, private payers and policy makers for patient-reported outcomes (PRO) is continuously increasing. There is a substantial need to improve capacity to collect and interpret relevant PRO data to support implementation of patient-centered research and optimal care in haemophilia. The Patient Reported Outcomes, Burdens and Experiences (PROBE) Project aims to develop a patient-led research network, to develop a standardized questionnaire to gather patient-reported outcomes and to perform a feasibility study of implementing the PROBE questionnaire. A pilot questionnaire was developed using focus group methodology. Content and face validity were assessed by a pool of persons living with haemophilia (PWH) and content experts through interactive workshops. The PROBE questionnaire was translated with the forward-backward approach. PROBE recruited national haemophilia patient non-governmental organizations (NGOs) to administer the questionnaire to people with and without haemophilia. PROBE measured the time to complete the questionnaire and gathered feedback on its content and clarity; staff time and cost required to implement the questionnaire were also collected. The PROBE questionnaire is comprised of four major sections (demographic data, general health problems, haemophilia-related health problems and health-related quality of life using EQ-5D-5L and EQ-VAS). Seventeen NGOs participated in the pilot study of the PROBE Project, recruiting 656 participants. Of these, 71% completed the questionnaire within 15 min, and all participants completed within 30 min. The median total staff and volunteer time required for the NGOs to carry out the study within their country was 9 h (range 2 to 40 h). NGO costs ranged from $22.00 to $543.00 USD per country, with printing and postage being the most commonly reported expenditures. The PROBE questionnaire assesses patient-important reported outcomes in PWH and control participants, with a demonstrated short completion time. PROBE proved the feasibility to engage diverse patient communities in the structured generation of real-world outcome research at all stages. Trial registration: NCT02439710.

Outcome of shunting in idiopathic normal-pressure hydrocephalus and the value of outcome assessment in shunted patients.

PubMed

Klinge, Petra; Marmarou, Anthony; Bergsneider, Marvin; Relkin, Norman; Black, Peter McL

2005-09-01

To develop guidelines for assessing shunt outcome in patients with idiopathic normal-pressure hydrocephalus (INPH). To date, the literature available on this topic has been marked by disparate definitions of clinical improvement, varying postoperative follow-up protocols and periods, and substantial differences in the postoperative management. Because specific criteria for defining clinical improvement are seldom reported, conclusions drawn about shunt outcome may be subjective. A MEDLINE search back to 1966 was undertaken using the query NPH, normal-pressure hydrocephalus, shunting, shunt treatment, shunt response, outcome, and clinical outcome. The criteria for selection were studies that included INPH from 1966 to the present in which the outcome of INPH was reported in patient groups of 20 or more. To date, there is no standard for outcome assessment of shunt treatment in INPH. The variable improvement rates reported are not only because of different criteria for selection of patients but also because of different postoperative assessment procedures and follow-up intervals. Studies that have established fixed protocols for follow-up have shown that short- and long-term periods after shunting are determined by many factors. Whereas short-term results were more likely to be influenced by shunt-associated risks, long-term results were independent of factors inherent to the shunt procedure and shunt complications, i.e., death and morbidity related to concomitant cerebrovascular and vascular diseases. Studies have shown that beyond 1 year after surgery, these factors definitely influence the clinical effect of shunting, making the 1-year postshunt period a potential determinant of the shunt outcome. Guidelines for outcome assessment were developed on the basis of the available evidence and consensus of expert opinion.

'Miracle cure' or 'liquid handcuffs': reporting on naltrexone and methadone in the Australian print media.

PubMed

Matthew-Simmons, Francis; Ritter, Alison

2014-09-01

The news media is an important source of information regarding new developments in medicine and public health interventions. Previous research has indicated that in many cases, reporting on new treatments can be inaccurate or sensationalist. This paper presents analysis of Australian print media reporting on two treatment options for heroin dependence (naltrexone and methadone). The aim of this study was to quantitatively compare the volume and content of Australian print media reporting on these two treatments, one of which had a long history of use in Australia, and the other which was comparatively newer. The study constituted a quantitative content analysis of a sample of 859 Australian newspaper articles, published over a 10-year period (1997-2007). Each article paragraph was coded for positive outcomes/benefits of treatment, as well as negative outcomes associated with treatment. The analysis revealed that during this period, the Australian print media was significantly more likely to report the potential positive outcomes of naltrexone treatment, compared with the negative outcomes. In contrast, reporting on methadone focused more on the negative outcomes and side effects. The relative frequency by which the benefits of naltrexone were mentioned in this sample of news content is somewhat at odds with the extant efficacy and effectiveness research evidence. The findings suggest that reporting on these treatments in the Australian print media has not been balanced. This type of reporting has potential implications for public attitudes, as well as policy decisions. © 2014 Australasian Professional Society on Alcohol and other Drugs.

Impact of statin adherence on cardiovascular disease and mortality outcomes: a systematic review

PubMed Central

De Vera, Mary A; Bhole, Vidula; Burns, Lindsay C; Lacaille, Diane

2014-01-01

Aims While suboptimal adherence to statin medication has been quantified in real-world patient settings, a better understanding of its impact is needed, particularly with respect to distinct problems of medication taking. Our aim was to synthesize current evidence on the impacts of statin adherence, discontinuation and persistence on cardiovascular disease and mortality outcomes. Methods We conducted a systematic review of peer-reviewed studies using a mapped search of Medline, Embase and International Pharmaceutical Abstracts databases. Observational studies that met the following criteria were included: defined patient population; statin adherence exposure; defined study outcome [i.e. cardiovascular disease (CVD), mortality]; and reporting of statin-specific results. Results Overall, 28 studies were included, with 19 studies evaluating outcomes associated with statin adherence, six with statin discontinuation and three with statin persistence. Among adherence studies, the proportion of days covered was the most widely used measure, with the majority of studies reporting increased risk of CVD (statistically significant risk estimates ranging from 1.22 to 5.26) and mortality (statistically significant risk estimates ranging from 1.25 to 2.54) among non-adherent individuals. There was greater methodological variability in discontinuation and persistence studies. However, findings of increased CVD (statistically significant risk estimates ranging from 1.22 to 1.67) and mortality (statistically significant risk estimates ranging from 1.79 to 5.00) among nonpersistent individuals were also consistently reported. Conclusions Observational studies consistently report an increased risk of adverse outcomes associated with poor statin adherence. These findings have important implications for patients and physicians and emphasize the importance of monitoring and encouraging adherence to statin therapy. PMID:25364801

ClinicalTrials.gov registration can supplement information in abstracts for systematic reviews: a comparison study.

PubMed

Scherer, Roberta W; Huynh, Lynn; Ervin, Ann-Margret; Taylor, Jakeisha; Dickersin, Kay

2013-06-18

The inclusion of randomized controlled trials (RCTs) reported in conference abstracts in systematic reviews is controversial, partly because study design information and risk of bias is often not fully reported in the abstract. The Association for Research in Vision and Ophthalmology (ARVO) requires trial registration of abstracts submitted for their annual conference as of 2007. Our goal was to assess the feasibility of obtaining study design information critical to systematic reviews, but not typically included in conference abstracts, from the trial registration record. We reviewed all conference abstracts presented at the ARVO meetings from 2007 through 2009, and identified 496 RCTs; 154 had a single matching registration record in ClinicalTrials.gov. Two individuals independently extracted information from the abstract and the ClinicalTrials.gov record, including study design, sample size, inclusion criteria, masking, interventions, outcomes, funder, and investigator name and contact information. Discrepancies were resolved by consensus. We assessed the frequencies of reporting variables appearing in the abstract and the trial register and assessed agreement of information reported in both sources. We found a substantial amount of study design information in the ClinicalTrials.gov record that was unavailable in the corresponding conference abstract, including eligibility criteria associated with gender (83%; 128/154); masking or blinding of study participants (53%, 82/154), persons administering treatment (30%, 46/154), and persons measuring the outcomes (40%, 61/154)); and number of study centers (58%; 90/154). Only 34% (52/154) of abstracts explicitly described a primary outcome, but a primary outcome was included in the "Primary Outcome" field in the ClinicalTrials.gov record for 82% (126/154) of studies. One or more study interventions were reported in each abstract, but agreed exactly with those reported in ClinicalTrials.gov only slightly more than half the time (88/154, 56%). We found no contact information for study investigators in the abstract, but this information was available in less than one quarter of ClinicalTrial.gov records (17%; 26/154). RCT design information not reported in conference abstracts is often available in the corresponding ClinicalTrials.gov registration record. Sometimes there is conflicting information reported in the two sources and further contact with the trial investigators may still be required.

Later school start times for supporting the education, health, and well-being of high school students.

PubMed

Marx, Robert; Tanner-Smith, Emily E; Davison, Colleen M; Ufholz, Lee-Anne; Freeman, John; Shankar, Ravi; Newton, Lisa; Brown, Robert S; Parpia, Alyssa S; Cozma, Ioana; Hendrikx, Shawn

2017-07-03

A number of school systems worldwide have proposed and implemented later school start times as a means of avoiding the potentially negative impacts that early morning schedules can have on adolescent students. Even mild sleep deprivation has been associated with significant health and educational concerns: increased risk for accidents and injuries, impaired learning, aggression, memory loss, poor self-esteem, and changes in metabolism. Although researchers have begun to explore the effects of delayed school start time, no one has conducted a rigorous review of evidence to determine whether later school start times support adolescent health, education, and well-being. We aimed to assess the effects of a later school start time for supporting health, education, and well-being in high school students.Secondary objectives were to explore possible differential effects of later school start times in student subgroups and in different types of schools; to identify implementation practices, contextual factors, and delivery modes associated with positive and negative effects of later start times; and to assess the effects of later school start times on the broader community (high school faculty and staff, neighborhood, and families). We conducted the main search for this review on 28 October 2014 and updated it on 8 February 2016. We searched CENTRAL as well as 17 key electronic databases (including MEDLINE, Embase, ERIC, PsycINFO, and Sociological Abstracts), current editions of relevant journals and organizational websites, trial registries, and Google Scholar. We included any randomized controlled trials, controlled before-and-after studies, and interrupted time series studies with sufficient data points that pertained to students aged 13 to 19 years and that compared different school start times. Studies that reported either primary outcomes of interest (academic outcomes, amount or quality of sleep, mental health indicators, attendance, or alertness) or secondary outcomes (health behaviors, health and safety indicators, social outcomes, family outcomes, school outcomes, or community outcomes) were eligible. At least two review authors independently determined inclusion and exclusion decisions through screening titles, abstracts, and full-text reports. Two review authors independently extracted data for all eligible studies. We presented findings through a narrative synthesis across all studies. When two or more study samples provided sufficient information to permit effect size calculations, we conducted random-effects meta-analyses to synthesize effects across studies. Our search located 17 eligible records reporting on 11 unique studies with 297,994 participants; the studies examined academic outcomes, amount and quality of sleep, mental health indicators, attendance, and student alertness. Overall, the quality of the body of evidence was very low, as we rated most studies as being at high or unclear risk of bias with respect to allocation, attrition, absence of randomization, and the collection of baseline data. Therefore, we cannot be confident about the effects of later school start times.Preliminary evidence from the included studies indicated a potential association between later school start times and academic and psychosocial outcomes, but quality and comparability of these data were low and often precluded quantitative synthesis. Four studies examined the association between later school start times and academic outcomes, reporting mixed results. Six studies examined effects on total amount of sleep and reported significant, positive relationships between later school start times and amount of sleep. One study provided information concerning mental health outcomes, reporting an association between decreased depressive symptoms and later school start times. There were mixed results for the association between later school start times and absenteeism. Three studies reported mixed results concerning the association between later school start times and student alertness. There was limited indication of potential adverse effects on logistics, as the qualitative portions of one study reported less interaction between parents and children, and another reported staffing and scheduling difficulties. Because of the insufficient evidence, we cannot draw firm conclusions concerning adverse effects at this time.It is important to note the limitations of this evidence, especially as randomized controlled trials and high-quality primary studies are difficult to conduct; school systems are often unwilling or unable to allow researchers the necessary control over scheduling and data collection. Moreover, this evidence does not speak to the process of implementing later school starts, as the included studies focused on reporting the effects rather than exploring the process. This systematic review on later school start times suggests several potential benefits for this intervention and points to the need for higher quality primary studies. However, as a result of the limited evidence base, we could not determine the effects of later school start times with any confidence.

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.

Racial and ethnic variations in one-year clinical and patient-reported outcomes following breast reconstruction.

PubMed

Berlin, Nicholas L; Momoh, Adeyiza O; Qi, Ji; Hamill, Jennifer B; Kim, Hyungjin M; Pusic, Andrea L; Wilkins, Edwin G

2017-08-01

Existing studies evaluating racial and ethnic disparities focus on describing differences in procedure type and the proportion of women who undergo reconstruction following mastectomy. This study seeks to examine racial and ethnic variations in clinical and patient-reported outcomes (PROs) following breast reconstruction. The Mastectomy Reconstruction Outcomes Consortium is an 11 center, prospective cohort study collecting clinical and PROs following autologous and implant-based breast reconstruction. Mixed-effects regression models, weighted to adjust for non-response, were performed to evaluate outcomes at one-year postoperatively. The cohort included 2703 women who underwent breast reconstruction. In multivariable models, Hispanic or Latina patients were less likely to experience any complications and major complications. Black or African-American women reported greater improvements in psychosocial and sexual well-being. Despite differences in pertinent clinical and socioeconomic variables, racial and ethnic minorities experienced equivalent or better outcomes. These findings provide reassurance in the context of numerous racial and ethnic health disparities and build upon our understanding of the delivery of surgical care to women with or at risk for developing breast cancer. Copyright © 2017 Elsevier Inc. All rights reserved.

Deciding what type of evidence and outcomes to include in guidelines: article 5 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

PubMed

Wilt, Timothy J; Guyatt, Gordon; Kunz, Regina; Macnee, William; Puhan, Milo A; Viegi, Giovanni; Woodhead, Mark; Akl, Elie A; Schünemann, Holger J

2012-12-01

Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the fifth of a series of 14 articles that were prepared by an international panel to advise guideline developers in respiratory and other diseases on approaches for guideline development. This article focuses on what type of evidence and outcomes to include in guidelines. In this review we addressed the following topics and questions. (1) What methods should be used to select important outcomes? (2) What types of outcomes should be considered? (3) What sources of evidence should be considered? (4) How should the importance of outcomes be ranked? (5) How to deal with surrogate outcomes. (6) What issues related to outcomes should be considered in the evidence review? (7) What quality of evidence should be used? (8) How to interpret the effect on outcomes. (9) How to incorporate outcomes related to harm. We based our responses on a PubMed literature review, prior reviews, relevant methodological research, and workshop discussions. Guideline panels should use transparent and systematic methods to select both the evidence and important outcomes, with input from groups that represent a wide range of expertise and constituencies. Outcomes should address both benefits and downsides, with consideration of the definitions, severity, and time course of the outcomes. Guideline panels should use a transparent approach to rank outcome importance recognizing that stakeholder and patient values and preferences may vary. Intermediate and surrogate outcomes are frequently reported, but their correlation with patient important outcomes may be low. A guideline panel should determine a priori the magnitude of effect judged clinically significant, factors that may influence outcome reporting, and whether different ways of measuring the outcomes permit the outcomes to be combined. Comprehensive identification of the evidence includes the use of multiple data sources. While randomized controlled trials (RCTs) provide the highest quality evidence, reviewers of evidence also need to consider nonrandomized studies such as case series, registries, and case-control studies if randomized trials are not available. This is particularly true for harms. The outcomes reported from RCTs may not always directly apply to clinical practice settings (i.e., they may not be generalizable).

Temporal analyses of coral snakebite severity published in the American Association of Poison Control Centers' Annual Reports from 1983 through 2007.

PubMed

Walter, Frank G; Stolz, Uwe; Shirazi, Farshad; McNally, Jude

2010-01-01

The only U.S. Food and Drug Administration-approved coral snake antivenom was officially discontinued in 2007, causing ever-diminishing supplies. This study describes the severity of U.S. coral snakebites during the last 25 years to determine trends in annual rates of these bites' medical outcomes. This study retrospectively analyzed all human coral snakebites voluntarily reported by the public and/or health care professionals to poison centers that were subsequently published in the Annual Reports of the American Association of Poison Control Centers (AAPCC) from 1983 through 2007. Annual rates of medical outcomes from coral snakebites were calculated by dividing the annual number of people bitten by coral snakes who developed fatal, major, moderate, minor, or no effect outcomes by the total annual number of people bitten by coral snakes. Negative binomial regression was used to examine trends in annual rates. From 1983 through 2007, the incidence rate of coral snakebites producing no effects significantly decreased by 4.7% per year [incidence rate ratio (IRR) = 0.953; 95% confidence interval (CI) = 0.920-0.987]. From 1985 through 2007, the incidence rates of minor and major outcomes did not significantly change; however, moderate outcomes significantly increased by 3.4% per year (IRR = 1.034; 95% CI = 1.004-1.064). No fatalities were reported from 1983 through 2007. Annual rates of coral snakebites producing no effects significantly decreased and those producing moderate outcomes significantly increased in our analyses of data from the last 25 years of published AAPCC Annual Reports. This study has important limitations that must be considered when interpreting these conclusions.

A systematic review of oral herpetic viral infections in cancer patients: commonly used outcome measures and interventions.

PubMed

Elad, Sharon; Ranna, Vinisha; Ariyawardana, Anura; Correa, Maria Elvira Pizzigatti; Tilly, Vanessa; Nair, Raj G; Rouleau, Tanya; Logan, Richard M; Pinto, Andres; Charette, Veronica; Saunders, Debbie P; Jensen, Siri Beier

2017-02-01

To review the literature for outcome measures for oral viral infections in cancer patients. A secondary aim was to update the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) clinical practice guidelines for the management of oral viral infections in cancer patients. Databases were searched for articles published in the English language, 1981-2013. Studies that met the eligibility criteria were reviewed systematically. The data about the outcome measures were classified according to the aim of the study: prevention, treatment, or non-interventional. The results of interventional studies were compared to the 2010 MASCC/ISOO publication. Multiple clinical and laboratory tests were used to measure oral viral infections, with great variability between studies. Most of the studies were about Herpes Simplex Virus (HSV). The outcome measure that was most commonly used was the presence of HSV infection diagnosed based on a combination of suggestive clinical presentation with a positive laboratory result. HSV culture was the most commonly reported laboratory outcome measure. Acyclovir and valacyclovir were consistently reported to be efficacious in the management of oral herpetic infections. No new data on the quality of life and economic aspects was found. Considering the variability in outcome measures reported to assess oral herpetic infections the researcher should select carefully the appropriate measures based on the objective of the study. Acyclovir and valacyclovir are effective in the management of oral herpetic infections in patients receiving treatment for cancer. Studies on newer anti-viral drugs may be useful to address the issue of anti-viral resistance.

Does the Finnish intervention prevent obstetric anal sphincter injuries? A systematic review of the literature

PubMed Central

Poulsen, Mette Østergaard; Madsen, Mia Lund; Skriver-Møller, Anne-Cathrine; Overgaard, Charlotte

2015-01-01

Objectives A rise in obstetric anal sphincter injuries (OASIS) has been observed and a preventive approach, originating in Finland, has been introduced in several European hospitals. The aim of this paper was to systematically evaluate the evidence behind the ‘Finnish intervention’. Design A systematic review of the literature conducted according to the Preferred Reporting for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Outcome measures The primary outcome was OASIS. Secondary outcomes were (perinatal): Apgar scores, pH and standard base excess in the umbilical cord, and (maternal): episiotomy, intact perineum, first and second-degree perineal lacerations, duration of second stage, birth position and women's perceptions/birth experiences. Methods Multiple databases (Cochrane, Embase, Pubmed and SveMed) were systematically searched for studies published up to December 2014. Both randomised controlled trials and observational studies were eligible for inclusion. Studies were excluded if a full-text article was not available. Studies were evaluated by use of international reporting guidelines (eg, STROBE). Results Overall, 1042 articles were screened and 65 retrieved for full-text evaluation. Seven studies, all observational and with a level of evidence at 2c or lower, were included and consistently reported a significant reduction in OASIS. All evaluated episiotomy and found a significant increase. Three studies evaluated perinatal outcomes and reported conflicting results. No study reported on other perineal outcomes, duration of the second stage, birth positions or women's perceptions. Conclusions A reduction in OASIS has been contributed to the Finnish intervention in seven observational studies, all with a low level of evidence. Knowledge about the potential perinatal and maternal side effects and women's perceptions of the intervention is extremely limited and the biological mechanisms underlying the Finnish intervention are not well documented. Studies with a high level of evidence are needed to assess the effects of the intervention before implementation in clinical settings can be recommended. PMID:26369797

Do MRI Findings Change Over a Period of Up to 1 Year in Patients With Low Back Pain and/or Sciatica?: A Systematic Review.

PubMed

Panagopoulos, John; Hush, Julia; Steffens, Daniel; Hancock, Mark J

2017-04-01

Systematic review OBJECTIVE.: The aim of the study was to investigate whether magnetic resonance imaging (MRI) findings change over a relatively short period of time (<1 yr) in people with low back pain (LBP) or sciatica. We also investigated whether there was an association between any change in MRI findings and change in clinical outcomes. MRI offers the potential to identify possible pathoanatomic sources of LBP and/or sciatica; however, the clinical importance of MRI findings remains unclear. Little is known about whether lumbar MRI findings change over the short term and if so whether these changes are associated with changes in clinical outcomes. Medline, EMBASE, and CINAHL databases were searched. Included were cohort studies that performed repeat MRI scans within 12 months in patients with LBP and/or sciatica. Data on study characteristics and change in MRI findings were extracted from included studies. Any data describing associations between change in MRI findings and change in clinical outcomes were also extracted. A total of 12 studies met the inclusion criteria and were included in the review. Pooling was not possible due to heterogeneity of studies and findings. Seven studies reported on changes in disc herniation and reported 15% to 93% of herniations reduced or disappeared in size. Two studies reported on changes in nerve root compression and reported 17% to 91% reduced or disappeared. Only one study reported on the association between change in MRI findings and change in clinical outcomes within 1 year, and found no association. This review found moderate evidence that the natural course of herniations and nerve root compression is favorable over a 1-year period in people with sciatica or LBP. There is a lack of evidence on whether other MRI findings change, and whether changes in MRI findings are associated with changes in clinical outcomes. 1.

The common characteristics and outcomes of multidisciplinary collaboration in primary health care: a systematic literature review

PubMed Central

Schepman, Sanneke; Hansen, Johan; de Putter, Iris D.; Batenburg, Ronald S.; de Bakker, Dinny H.

2015-01-01

Introduction Research on collaboration in primary care focuses on specific diseases or types of collaboration. We investigate the effects of such collaboration by bringing together the results of scientific studies. Theory and methods We conducted a systematic literature review of PubMed, CINAHL, Cochrane and EMBASE. The review was restricted to publications that test outcomes of multidisciplinary collaboration in primary care in high-income countries. A conceptual model is used to structure the analysis. Results Fifty-one studies comply with the selection criteria about collaboration in primary care. Approximately half of the 139 outcomes in these studies is non-significant. Studies among older patients, in particular, report non-significant outcomes (p < .05). By contrast, a higher proportion of significant results were found in studies that report on clinical outcomes. Conclusions and discussion This review shows a large diversity in the types of collaboration in primary care; and also thus a large proportion of outcomes do not seem to be positively affected by collaboration. Both the characteristics of the structure of the collaboration and the collaboration processes themselves affect the outcomes. More research is necessary to understand the mechanism behind the success of collaboration, especially on the exact nature of collaboration and the context in which collaboration takes place. PMID:26150765

A systematic review of maternal antidepressant use in pregnancy and short- and long-term offspring's outcomes.

PubMed

Prady, Stephanie L; Hanlon, Inna; Fraser, Lorna K; Mikocka-Walus, Antonina

2018-04-01

The relative safety of antidepressants during pregnancy has received substantial attention, but most syntheses fail to account for mental illness effects. We aimed to evaluate the literature comparing low birth weight (LBW) and neurodevelopmental and neurobehavioural outcomes for children whose mothers took antidepressants in pregnancy compared to those whose mothers had common mental disorders, or symptoms, but who did not take antidepressants during pregnancy. A systematic review was conducted searching PubMed, MEDLINE, PsycINFO and Embase in January 2015. A modified version of the Newcastle Ottawa Scale was used to assess study quality. Eleven cohort studies were included: four reporting a LBW outcome (all with higher risk of bias) and seven reporting a neurodevelopmental outcome (five with higher risk of bias). We found only limited evidence of gestational age-adjusted LBW in exposed children in two studies which had a higher risk of bias and did not control for depressive symptom severity. Only five (7.5%) neurodevelopmental outcomes and one (12.5%) neurobehavioural outcome showed evidence of a statistically significant effect, three out of four were from studies with a higher risk of bias. There is little robust evidence indicating a detrimental effect of antidepressant use during pregnancy on LBW and neurodevelopmental and neurobehavioural outcomes. More rigorous study designs are needed.

Favourable rotational alignment outcomes in PSI knee arthroplasty: A Level 1 systematic review and meta-analysis.

PubMed

Mannan, A; Smith, T O

2016-03-01

Implant malposition in total knee arthroplasty (TKA) often results in unsatisfactory outcomes. Rotational malalignment leads to impaired patellar tracking, stability and joint biomechanics. Patient-specific instrumentation aims to improve three-dimensional implant positioning while reducing overall costs of instrumentation. A PRISMA compliant search of all relevant literature between 2000 and 2014 was performed. The primary outcome of interest was deviation from a neutral femoral and tibial axial alignment of patient-specific instrumentation (PSI) vs conventional instrumentation. Femoral rotation was measured with reference to the transepicondylar axis. Tibial rotation was reported with reference to the anterior tibial tuberosity and a "best fit" with the anterior tibial cortex. Six randomised studies met the inclusion criteria reporting on a total of 444 knees. Computed tomography (CT) based PSI systems were used exclusively in three studies, and two further studies in association with magnetic resonance imaging (MRI). MRI was used exclusively in one study. Mean femoral rotation in the conventional group was: -1.7 to 1.6° (vs -1.7 to 1° in the PSI group). Meta-analysis demonstrated a significant treatment effect favouring PSI with increased accuracy in "three-degree outliers" with femoral rotation: Z=2.07, P=0.04. A single study reported tibial rotational outcomes with no significant difference demonstrated in conventional instrumentation vs PSI. This Level 1 meta-analysis demonstrates favourable femoral rotational alignment outcomes in PSI knee arthroplasty. Only limited data is available for tibial rotational outcomes. Further studies with standardised "gold-standard" measurement criteria are required to clarify tibial rotational outcomes in PSI TKA. 1. Copyright © 2015 Elsevier B.V. All rights reserved.

Childhood self-control and adult outcomes: results from a 30-year longitudinal study.

PubMed

Fergusson, David M; Boden, Joseph M; Horwood, L John

2013-07-01

A study by Moffitt et al. reported pervasive associations between childhood self-control and adult outcomes. The current study attempts to replicate the findings reported by Moffitt et al., adjusting these results for the confounding influence of childhood conduct problems. Data were gathered from the Christchurch Health and Development Study, a longitudinal birth cohort studied to age 30 years. Self-control during ages 6 to 12 years was measured analogously to that in Moffitt et al., using parent-, teacher-, and self-report methods. Outcome measures to age 30 included criminal offending, substance use, education/employment, sexual behavior, and mental health. Associations between self-control and outcomes were adjusted for possible confounding by gender, socioeconomic status (SES), IQ, and childhood conduct problems (ages 6-10). In confirmation of the findings of Moffitt et al., all outcomes except major depression were significantly (p < .05) associated with childhood self-control. Adjustment for gender, SES, and IQ reduced to some extent the magnitude of the associations. However, adjustment for childhood conduct disorder further reduced the magnitude of many of these associations, with only 4 of the 14 outcomes remaining statistically significantly (p < .05) associated with self-control. After adjustment for gender, SES, IQ, and conduct problems, those individuals who scored higher in self-control had lower odds of violent offending and welfare dependence, were more likely to have obtained a university degree, and had higher income levels. The findings from this study suggest that observed linkages between a measure of childhood self-control and outcomes in adulthood were largely explained by the correlated effects of childhood conduct problems, SES, IQ, and gender. Copyright © 2013 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Trust in the health care professional and health outcome: A meta-analysis

PubMed Central

Gaab, Jens; Kossowsky, Joe; Hasler, Sebastian; Krummenacher, Peter; Werner, Christoph; Gerger, Heike

2017-01-01

Objective To examine whether patients’ trust in the health care professional is associated with health outcomes. Study selection We searched 4 major electronic databases for studies that reported quantitative data on the association between trust in the health care professional and health outcome. We screened the full-texts of 400 publications and included 47 studies in our meta-analysis. Data extraction and data synthesis We conducted random effects meta-analyses and meta-regressions and calculated correlation coefficients with corresponding 95% confidence intervals. Two interdependent researchers assessed the quality of the included studies using the Strengthening the Reporting of Observational Studies in Epidemiology guidelines. Results Overall, we found a small to moderate correlation between trust and health outcomes (r = 0.24, 95% CI: 0.19–0.29). Subgroup analyses revealed a moderate correlation between trust and self-rated subjective health outcomes (r = 0.30, 0.24–0.35). Correlations between trust and objective (r = -0.02, -0.08–0.03) as well as observer-rated outcomes (r = 0.10, -0.16–0.36) were non-significant. Exploratory analyses showed a large correlation between trust and patient satisfaction and somewhat smaller correlations with health behaviours, quality of life and symptom severity. Heterogeneity was small to moderate across the analyses. Conclusions From a clinical perspective, patients reported more beneficial health behaviours, less symptoms and higher quality of life and to be more satisfied with treatment when they had higher trust in their health care professional. There was evidence for upward bias in the summarized results. Prospective studies are required to deepen our understanding of the complex interplay between trust and health outcomes. PMID:28170443

Adult asthma disease management: an analysis of studies, approaches, outcomes, and methods.

PubMed

Maciejewski, Matthew L; Chen, Shih-Yin; Au, David H

2009-07-01

Disease management has been implemented for patients with asthma in various ways. We describe the approaches to and components of adult asthma disease-management interventions, examine the outcomes evaluated, and assess the quality of published studies. We searched the MEDLINE, EMBASE, CINAHL, PsychInfo, and Cochrane databases for studies published in 1986 through 2008, on adult asthma management. With the studies that met our inclusion criteria, we examined the clinical, process, medication, economic, and patient-reported outcomes reported, and the study designs, provider collaboration during the studies, and statistical methods. Twenty-nine articles describing 27 studies satisfied our inclusion criteria. There was great variation in the content, extent of collaboration between physician and non-physician providers responsible for intervention delivery, and outcomes examined across the 27 studies. Because of limitations in the design of 22 of the 27 studies, the differences in outcomes assessed, and the lack of rigorous statistical adjustment, we could not draw definitive conclusions about the effectiveness or cost-effectiveness of the asthma disease-management programs or which approach was most effective. Few well-designed studies with rigorous evaluations have been conducted to evaluate disease-management interventions for adults with asthma. Current evidence is insufficient to recommend any particular intervention.

The sooner, the better: exercise outcome proximity and intrinsic motivation.

PubMed

Evans, M Blair; Cooke, Lisa M; Murray, Robyn A; Wilson, Anne E

2014-11-01

Despite evidence that outcomes are highly valued when they are expected sooner rather than further into the future (Ainslie, 1975), limited research effort has been devoted to understanding the role of exercise outcome proximity. The purpose of this study was to examine how temporal proximity to positive outcomes influences exercisers' intrinsic motivation. We expected that focusing people on temporally proximal exercise outcomes would increase intrinsic motivation, especially among low-frequency exercisers. This online experimental study was completed by 135 community exercisers (Mage  = 31.11, SD = 10.29; 62% female) who reported an average of 4.86 exercise bouts per week (SD = 2.12). Participants were randomly assigned to a condition that primed temporally proximal positive exercise outcomes (i.e. experienced during or directly following an exercise bout) or temporally distal outcomes (i.e. experienced after days, months, or years of regular exercise). Participants then reported perceptions of behavioral regulation in exercise. As expected, the proximal exercise outcome condition elicited increased intrinsic regulation among those participants who exercised less frequently (i.e. 1 SD below the mean). This study reveals the importance of considering proximity as an important dimension of exercise outcomes-particularly when promoting intrinsic motivation among relatively infrequent exercisers. © 2014 The International Association of Applied Psychology.

Quality Measurements in Radiology: A Systematic Review of the Literature and Survey of Radiology Benefit Management Groups.

PubMed

Narayan, Anand; Cinelli, Christina; Carrino, John A; Nagy, Paul; Coresh, Josef; Riese, Victoria G; Durand, Daniel J

2015-11-01

As the US health care system transitions toward value-based reimbursement, there is an increasing need for metrics to quantify health care quality. Within radiology, many quality metrics are in use, and still more have been proposed, but there have been limited attempts to systematically inventory these measures and classify them using a standard framework. The purpose of this study was to develop an exhaustive inventory of public and private sector imaging quality metrics classified according to the classic Donabedian framework (structure, process, and outcome). A systematic review was performed in which eligibility criteria included published articles (from 2000 onward) from multiple databases. Studies were double-read, with discrepancies resolved by consensus. For the radiology benefit management group (RBM) survey, the six known companies nationally were surveyed. Outcome measures were organized on the basis of standard categories (structure, process, and outcome) and reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search strategy yielded 1,816 citations; review yielded 110 reports (29 included for final analysis). Three of six RBMs (50%) responded to the survey; the websites of the other RBMs were searched for additional metrics. Seventy-five unique metrics were reported: 35 structure (46%), 20 outcome (27%), and 20 process (27%) metrics. For RBMs, 35 metrics were reported: 27 structure (77%), 4 process (11%), and 4 outcome (11%) metrics. The most commonly cited structure, process, and outcome metrics included ACR accreditation (37%), ACR Appropriateness Criteria (85%), and peer review (95%), respectively. Imaging quality metrics are more likely to be structural (46%) than process (27%) or outcome (27%) based (P < .05). As national value-based reimbursement programs increasingly emphasize outcome-based metrics, radiologists must keep pace by developing the data infrastructure required to collect outcome-based quality metrics. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

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.

Temperament as a Predictor of Symptomotology and Adaptive Functioning in Adolescents with High-Functioning Autism

PubMed Central

Schwartz, Caley B.; Henderson, Heather A.; Inge, Anne P.; Zahka, Nicole E.; Coman, Drew C.; Kojkowski, Nicole M.; Hileman, Camilla M.; Mundy, Peter C.

2009-01-01

Variation in temperament is characteristic of all people but is rarely studied as a predictor of individual differences among individuals with autism. Relative to a matched comparison sample, adolescents with High-Functioning Autism (HFA) reported lower levels of Surgency and higher levels of Negative Affect. Variability in temperament predicted symptomotology, social skills, and social-emotional outcomes differently for individuals with HFA than for the comparison sample. This study is unique in that temperament was measured by self-report, while all outcome measures were reported by parents. The broader implications of this study suggest that by identifying individual variability in constructs, such as temperament, that may influence adaptive functioning, interventions may be developed to target these constructs and increase the likelihood that individuals with HFA will achieve more adaptive life outcomes. PMID:19165586

Effects of aquatic exercise on physical function and fitness among people with spinal cord injury

PubMed Central

Li, Chunxiao; Khoo, Selina; Adnan, Athirah

2017-01-01

Abstract Objective: The aim of this review is to synthesize the evidence on the effects of aquatic exercise interventions on physical function and fitness among people with spinal cord injury. Data source: Six major databases were searched from inception till June 2015: MEDLINE, CINAHL, EMBASE, PsychInfo, SPORTDiscus, and Cochrane Center Register of Controlled Trials. Study appraisal and synthesis methods: Two reviewers independently rated methodological quality using the modified Downs and Black Scale and extracted and synthesized key findings (i.e., participant characteristics, study design, physical function and fitness outcomes, and adverse events). Results: Eight of 276 studies met the inclusion criteria, of which none showed high research quality. Four studies assessed physical function outcomes and 4 studies evaluated aerobic fitness as outcome measures. Significant improvements on these 2 outcomes were generally found. Other physical or fitness outcomes including body composition, muscular strength, and balance were rarely reported. Conclusions and implications of key findings: There is weak evidence supporting aquatic exercise training to improve physical function and aerobic fitness among adults with spinal cord injury. Suggestions for future research include reporting details of exercise interventions, evaluating other physical or fitness outcomes, and improving methodological quality. PMID:28296754

Psychosocial factors associated with outcomes of sports injury rehabilitation in competitive athletes: a mixed studies systematic review.

PubMed

Forsdyke, Dale; Smith, Andy; Jones, Michelle; Gledhill, Adam

2016-05-01

The prime focus of research on sports injury has been on physical factors. This is despite our understanding that when an athlete sustains an injury it has psychosocial as well as physical impacts. Psychosocial factors have been suggested as prognostic influences on the outcomes of rehabilitation. The aim of this work was to address the question: are psychosocial factors associated with sports injury rehabilitation outcomes in competitive athletes? Mixed studies systematic review (PROSPERO reg.CRD42014008667). Electronic database and bibliographic searching was undertaken from the earliest entry until 1 June 2015. Studies that included injured competitive athletes, psychosocial factors and a sports injury rehabilitation outcome were reviewed by the authors. A quality appraisal of the studies was undertaken to establish the risk of reporting bias. 25 studies were evaluated that included 942 injured competitive athletes were appraised and synthesised. Twenty studies had not been included in previous reviews. The mean methodological quality of the studies was 59% (moderate risk of reporting bias). Convergent thematic analysis uncovered three core themes across the studies: (1) emotion associated with rehabilitation outcomes; (2) cognitions associated with rehabilitation outcomes; and (3) behaviours associated with rehabilitation outcomes. Injury and performance-related fears, anxiety and confidence were associated with rehabilitation outcomes. There is gender-related, age-related and injury-related bias in the reviewed literature. Psychosocial factors were associated with a range of sports injury rehabilitation outcomes. Practitioners need to recognise that an injured athlete's thoughts, feelings and actions may influence the outcome of rehabilitation. 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/

Can we predict the outcome for people with patellofemoral pain? A systematic review on prognostic factors and treatment effect modifiers.

PubMed

Matthews, M; Rathleff, M S; Claus, A; McPoil, T; Nee, R; Crossley, K; Vicenzino, B

2017-12-01

Patellofemoral pain (PFP) is a multifactorial and often persistent knee condition. One strategy to enhance patient outcomes is using clinically assessable patient characteristics to predict the outcome and match a specific treatment to an individual. A systematic review was conducted to determine which baseline patient characteristics were (1) associated with patient outcome (prognosis); or (2) modified patient outcome from a specific treatment (treatment effect modifiers). 6 electronic databases were searched (July 2016) for studies evaluating the association between those with PFP, their characteristics and outcome. All studies were appraised using the Epidemiological Appraisal Instrument. Studies that aimed to identify treatment effect modifiers underwent a checklist for methodological quality. The 24 included studies evaluated 180 participant characteristics. 12 studies investigated prognosis, and 12 studies investigated potential treatment effect modifiers. Important methodological limitations were identified. Some prognostic studies used a retrospective design. Studies aiming to identify treatment effect modifiers often analysed too many variables for the limiting sample size and typically failed to use a control or comparator treatment group. 16 factors were reported to be associated with a poor outcome, with longer duration of symptoms the most reported (>4 months). Preliminary evidence suggests increased midfoot mobility may predict those who have a successful outcome to foot orthoses. Current evidence can identify those with increased risk of a poor outcome, but methodological limitations make it difficult to predict the outcome after one specific treatment compared with another. Adequately designed randomised trials are needed to identify treatment effect modifiers. 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/.

Measuring Family Outcomes Early Intervention: Findings from a Large-Scale Assessment

ERIC Educational Resources Information Center

Raspa, Melissa; Bailey, Donald B., Jr.; Olmsted, Murrey G.; Nelson, Robin; Robinson, Nyle; Simpson, Mary Ellen; Guillen, Chelsea; Houts, Renate

2010-01-01

This article reports data from a large-scale assessment using the Family Outcomes Survey with families participating in early intervention. The study was designed to determine how families describe themselves with regard to outcomes achieved, the extent to which outcomes are interrelated, and the extent to which child, family, and program factors…

Systematic Review of Interventions to Reduce Urinary Tract Infection in Nursing Home Residents

PubMed Central

Meddings, Jennifer; Saint, Sanjay; Krein, Sarah L.; Gaies, Elissa; Reichert, Heidi; Hickner, Andrew; McNamara, Sara; Mann, Jason D.; Mody, Lona

2017-01-01

BACKGROUND Urinary tract infections (UTIs) in nursing homes are common, costly, and morbid. PURPOSE Systematic literature review of strategies to reduce UTIs in nursing home residents DATA SOURCES Ovid MEDLINE, Cochrane Library, CINAHL, Web of Science and Embase through June 22, 2015. STUDY SELECTION Interventional studies with a comparison group reporting at least one outcome for: catheter-associated UTI (CAUTI), UTIs not identified as catheter-associated, bacteriuria, or urinary catheter use. DATA EXTRACTION Two authors abstracted study design, participant and intervention details, outcomes, and quality measures. DATA SYNTHESIS Of 5,794 records retrieved, 20 records describing 19 interventions were included: 8 randomized controlled trials, 10 pre-post non-randomized interventions, and 1 non-randomized intervention with concurrent controls. Quality (range 8-25, median 15) and outcome definitions varied greatly. Thirteen studies employed strategies to reduce catheter use or improve catheter care; nine studies employed general infection prevention strategies (e.g., improving hand hygiene, surveillance, contact precautions, reducing antibiotics). The nineteen studies reported 12 UTI outcomes, 9 CAUTI outcomes, 4 bacteriuria outcomes, and 5 catheter use outcomes. Five studies showed CAUTI reduction (1 significantly); nine studies showed UTI reduction (none significantly); 2 studies showed bacteriuria reduction (none significantly). Four studies showed reduced catheter use (1 significantly). LIMITATIONS Studies were often underpowered to assess statistical significance; none were pooled given variety of interventions and outcomes. CONCLUSIONS Several practices, often implemented in bundles, appear to reduce UTI or CAUTI in nursing home residents such as improving hand hygiene, reducing and improving catheter use, managing incontinence without catheters, and enhanced barrier precautions. PMID:28459908

Effectiveness of the facility-based maternal near-miss case reviews in improving maternal and newborn quality of care in low-income and middle-income countries: a systematic review

PubMed Central

Lazzerini, Marzia; Richardson, Sonia; Ciardelli, Valentina; Erenbourg, Anna

2018-01-01

Objectives The maternal near-miss case review (NMCR) has been promoted by WHO as an approach to improve quality of care (QoC) at facility level. This systematic review synthesises evidence on the effectiveness of the NMCR on QoC and maternal and perinatal health outcomes in low-income and middle-income countries (LMICs). Methods Studies were searched for in six electronic databases (MEDLINE, Index Medicus, Web of Science, the Cochrane library, Embase, LILACS), with no language restrictions. Two authors independently screened papers and selected them for inclusion and independently extracted data. Maternal mortality was the primary outcome. Secondary outcomes included any outcome informing on any of the six dimensions of QoC: efficacy, safety, efficiency, equity, accessibility and timely care, acceptability and patient-centred care. Results Out of 24 822 papers retrieved, 17 studies from 11 countries were included. Maternal mortality measured before and after the implementation of the NMCR cycle significantly decreased (OR 0.77, 95% CI 0.61 to 0.98, eight studies, 55 573 043 women; I2=39%). A statistically significant reduction in the incidence of uterine rupture, postpartum haemorrhage and maternal sepsis was observed in three out of six studies. Ten studies reporting on maternal care process all showed some significant improvement when measured against predefined standards. All studies reported that the NMCR resulted in some amelioration of the facility structure (physical structure, staffing, equipment, training, organisation of care). Newborn outcomes were overall poorly reported; four studies showed no significant difference in perinatal mortality. Patient satisfaction and equity were also poorly reported. Conclusions Policy makers may consider implementing the maternal NMCR cycle approach among strategies aiming at improving QoC and reducing maternal mortality and morbidity in LMIC. Future studies should better document the effectiveness of the NMCR cycle particularly on outcomes reflecting patient-centred care and cost-effectiveness. PMID:29674368

Preventing and controlling foodborne disease in commercial and institutional food service settings: a systematic review of published intervention studies.

PubMed

Viator, Catherine; Blitstein, Jonathan; Brophy, Jenna E; Fraser, Angela

2015-02-01

This study reviews the current literature on behavioral and environmental food safety interventions conducted in commercial and institutional food service settings. A systematic search of the published literature yielded 268 candidate articles, from which a set of 23 articles reporting intervention outcomes was retained for evaluation. A categorization of measured outcomes is reported; studies addressed multiple outcomes ranging from knowledge, attitudes, and behavior of personal hygiene and food safety to management practices and disease rates and outbreaks. This study also investigates the quality of reported research methods used to evaluate the effectiveness of the interventions, using a nine-point quality index adapted by the authors. The observed scores suggest that there are opportunities to improve the design and reporting of research in the field of foodborne disease prevention as it applies to food safety interventions that target the food service industry. The aim is to aid researchers in this area to design higher quality studies and to produce clearer and more useful reports of their research. In turn, this can help to create a more complete evidence base that can be used to continually improve interventions in this domain.

Young drivers' responses to anti-speeding advertisements: Comparison of self-report and objective measures of persuasive processing and outcomes.

PubMed

Kaye, Sherrie-Anne; Lewis, Ioni; Algie, Jennifer; White, Melanie J

2016-05-18

Self-report measures are typically used to assess the effectiveness of road safety advertisements. However, psychophysiological measures of persuasive processing (i.e., skin conductance response [SCR]) and objective driving measures of persuasive outcomes (i.e., in-vehicle Global Positioning System [GPS] devices) may provide further insights into the effectiveness of these advertisements. This study aimed to explore the persuasive processing and outcomes of 2 anti-speeding advertisements by incorporating both self-report and objective measures of speeding behavior. In addition, this study aimed to compare the findings derived from these different measurement approaches. Young drivers (N = 20, M age = 21.01 years) viewed either a positive or negative emotion-based anti-speeding television advertisement. While viewing the advertisement, SCR activity was measured to assess ad-evoked arousal responses. The RoadScout GPS device was then installed in participants' vehicles for 1 week to measure on-road speed-related driving behavior. Self-report measures assessed persuasive processing (emotional and arousal responses) and actual driving behavior. There was general correspondence between the self-report measures of arousal and the SCR and between the self-report measure of actual driving behavior and the objective driving data (as assessed via the GPS devices). This study provides insights into how psychophysiological and GPS devices could be used as objective measures in conjunction with self-report measures to further understand the persuasive processes and outcomes of emotion-based anti-speeding advertisements.

Clinical Outcomes After the Nonoperative Management of Lateral Patellar Dislocations: A Systematic Review

PubMed Central

Moiz, Munim; Smith, Nick; Smith, Toby O.; Chawla, Amit; Thompson, Peter; Metcalfe, Andrew

2018-01-01

Background: The first-line treatment for patellar dislocations is often nonoperative and consists of physical therapy and immobilization techniques, with various adjuncts employed. However, the outcomes of nonoperative therapy are poorly described, and there is a lack of quality evidence to define the optimal intervention. Purpose: To perform a comprehensive review of the literature and assess the quality of studies presenting patient outcomes from nonoperative interventions for patellar dislocations. Study Design: Systematic review; Level of evidence, 4. Methods: The MEDLINE, AMED, Embase, CINAHL, Cochrane Library, PEDro, and SPORTDiscus electronic databases were searched through July 2017 by 3 independent reviewers. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Study quality was assessed using the CONSORT (Consolidated Standards for Reporting Trials) criteria for randomized controlled trials and the Newcastle-Ottawa Scale for cohort studies and case series. Results: A total of 25 studies met our inclusion criteria, including 12 randomized controlled trials, 7 cohort studies, and 6 case series, consisting of 1066 patients. Studies were grouped according to 4 broad categories of nonoperative interventions based on immobilization, weightbearing status, quadriceps exercise type, and alternative therapies. The most commonly used outcome measure was the Kujala score, and the pooled redislocation rate was 31%. Conclusion: This systematic review found that patient-reported outcomes consistently improved after all methods of treatment but did not return to normal. Redislocation rates were high and close to the redislocation rates reported in natural history studies. There is a lack of quality evidence to advocate the use of any particular nonoperative technique for the treatment of patellar dislocations. PMID:29942814

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

Do Multiple Concussions Lead to Cumulative Cognitive Deficits? A Literature Review.

PubMed

Yumul, Joy Noelle; McKinlay, Audrey

2016-11-01

A concussion is an important health concern for children and adolescents, particularly in the context of sporting injuries. Some research suggests a cumulative effect from multiple concussions (also referred to as mild traumatic brain injury), which creates a dilemma when considering how to manage children and young persons who may experience multiple concussive events within a sporting season. However, there is very little research regarding the outcomes of multiple concussions and their optimal management. The purpose of this review is to evaluate the evidence regarding the cognitive outcomes of multiple concussions. After assessing the eligibility of the articles from the literature search, 7 studies were identified and included in the review. In most of the available literature, the cognitive outcomes related to multiple concussions are measured during the same developmental age as when the injuries happened. Moreover, most studies that investigated multiple concussions are focused on sports-related injuries, and only some are conducted in children and adolescents in the general population. The current evidence is inconclusive; whereas some studies reported adverse outcomes, others reported null findings. The studies that reported adverse or cumulative effects based their findings on worse cognitive outcomes, more subjective symptoms, and prolonged recovery postinjury. II. Copyright © 2016 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Television viewing associated with adverse dietary outcomes in children ages 2-6.

PubMed

Ford, C; Ward, D; White, M

2012-12-01

The aim of this paper was to systematically review the evidence for the association between television viewing and diet in children ages 2-6. Data sources included PubMed, PsycINFO, EMBASE, ERIC, SportDISCUS, Sociological Abstracts, Web of Science and hand searches of reference lists of relevant articles. Twelve studies were reviewed in which the relationship between television viewing and diet was assessed in children between the ages of 2 and 6. All but one study reported significant relationship between television viewing time and adverse dietary outcomes. Parent-reported television viewing time was used to assay child television viewing in all included studies. Food frequency survey was the most frequent method of dietary assessment, and parent served as proxies for children in all studies. Lower fruit and/or vegetable intake was the most frequently reported dietary outcome, followed by increased energy intake with increased television viewing. The majority of studies reported adverse dietary outcomes with as little as 1 h of daily television exposure. While these results are consistent with recommendations from child health advocates to limit television viewing in young children, they also suggest that further efforts to limit television viewing in young children may be needed to aid in obesity prevention. © 2012 The Authors. obesity reviews © 2012 International Association for the Study of Obesity.

Asthma Outcomes: Healthcare Utilization and Costs

PubMed Central

Akinbami, Lara J.; Sullivan, Sean D.; Campbell, Jonathan D.; Grundmeier, Robert W.; Hartert, Tina V.; Lee, Todd A.; Smith, Robert A.

2014-01-01

Background Measures of healthcare utilization and indirect impact of asthma morbidity are used to assess clinical interventions and estimate cost. Objective National Institutes of Health (NIH) institutes and other federal agencies convened an expert group to propose standardized measurement, collection, analysis, and reporting of healthcare utilization and cost outcomes in future asthma studies. Methods We used comprehensive literature reviews and expert opinion to compile a list of asthma healthcare utilization outcomes that we classified as core (required in future studies), supplemental (used according to study aims and standardized) and emerging (requiring validation and standardization). We also have identified methodology to assign cost to these outcomes. This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011. Results We identified 3 ways to promote comparability across clinical trials for measures of healthcare utilization, resource use, and cost: (1) specify the study perspective (patient, clinician, payer, society), (2) standardize the measurement period (ideally, 12 months), and (3) use standard units to measure healthcare utilization and other asthma-related events. Conclusions Large clinical trials and observational studies should collect and report detailed information on healthcare utilization, intervention resources, and indirect impact of asthma, so that costs can be calculated and cost-effectiveness analyses can be conducted across several studies. Additional research is needed to develop standard, validated survey instruments for collection of provider-reported and participant-reported data regarding asthma-related health care. PMID:22386509

Sex Differences in Device Therapy for Heart Failure: Utilization, Outcomes, and Adverse Events

PubMed Central

Herz, Naomi D.; Engeda, Joseph; Zusterzeel, Robbert; Sanders, William E.; O'Callaghan, Kathryn M.; Strauss, David G.; Jacobs, Samantha B.; Selzman, Kimberly A.; Piña, Ileana L.

2015-01-01

Abstract Background: Multiple studies of heart failure patients demonstrated significant improvement in exercise capacity, quality of life, cardiac left ventricular function, and survival from cardiac resynchronization therapy (CRT), but the underenrollment of women in these studies is notable. Etiological and pathophysiological differences may result in different outcomes in response to this treatment by sex. The observed disproportionate representation of women suggests that many women with heart failure either do not meet current clinical criteria to receive CRT in trials or are not properly recruited and maintained in these studies. Methods: We performed a systematic literature review through May 2014 of clinical trials and registries of CRT use that stratified outcomes by sex or reported percent women included. One-hundred eighty-three studies contained sex-specific information. Results: Ninety percent of the studies evaluated included ≤35% women. Fifty-six articles included effectiveness data that reported response with regard to specific outcome parameters. When compared with men, women exhibited more dramatic improvement in specific parameters. In the studies reporting hazard ratios for hospitalization or death, women generally had greater benefit from CRT. Conclusions: Our review confirms women are markedly underrepresented in CRT trials, and when a CRT device is implanted, women have a therapeutic response that is equivalent to or better than in men, while there is no difference in adverse events reported by sex. PMID:25793483

Supplementation with multiple micronutrients for breastfeeding women for improving outcomes for the mother and baby.

PubMed

Abe, Sarah K; Balogun, Olukunmi O; Ota, Erika; Takahashi, Kenzo; Mori, Rintaro

2016-02-18

Globally, more than two billion people are estimated to be deficient in key vitamins and minerals, particularly iodine, iron and zinc. The majority of these people live in low-income settings and are typically deficient in more than one micronutrient. However, micronutrient deficiency among breastfeeding mothers and their infants also remains an issue in high-income settings, specifically among women who avoid meat and/or milk, women who may lack sufficient supplies of vitamin B12 and vitamin D, and/or women who are iron-deficient. Young children, pregnant and lactating women are particularly vulnerable to micronutrient deficiencies. They not only have a relatively greater need for vitamins and minerals because of their physiological state, but are also more susceptible to the harmful consequences of deficiencies. Multiple-micronutrient supplementation might be an option to solve these problems. The objective of this review was to evaluate the effects of multiple-micronutrient supplementation in breastfeeding mothers on maternal and infant outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2015) and reference lists of retrieved studies. Randomised controlled trials of multiple-micronutrient supplementation of three or more micronutrients versus placebo, no supplementation or supplementation with two or fewer micronutrients, irrespective of dosage of micronutrients, in breastfeeding mothers. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We found no studies that compared multiple-micronutrient supplementation (with three or more micronutrients) versus supplementation with two or fewer micronutrients.Two small studies (involving a total of 52 women) were included. One study compared multiple micronutrients with placebo and the other study compared multiple micronutrients with a group who received no supplementation. The studies were carried out in Brazil (36 adolescent mothers) and the USA (16 women) and included women with a low socioeconomic status. A lack of information in the study reports meant that risk of bias could not be adequately assessed (unclear risk of bias for many domains). There were no quantitative data for any of this review's outcomes so meta-analysis was not possible.Neither of the studies reported on the primary outcomes of interest in this review: maternal morbidity (febrile illness, respiratory tract infection, diarrhoea), adverse effects of micronutrients within three days of receiving the supplement, infant mortality (defined as a child dying before completing the first year of age).One study reported qualitatively on maternal anaemia (a secondary outcome of this review) - the study found that multiple-micronutrient supplementation was effective for recuperating from anaemia but there were no data for inclusion in our analyses. Maternal satisfaction was not reported in the included studies. Similarly, none of this review's infant secondary outcomes were reported in the included studies: clinical micronutrient deficiency; morbidity episodes (febrile illness, respiratory tract infection, diarrhoea, other), adverse effects of micronutrients within three days of receiving the supplement. We found no evidence to quantitatively assess the effectiveness of multiple-micronutrient supplementation in improving health outcomes in mother and baby. The results of this review are limited by the small numbers of studies available, small sample sizes and the studies not reporting on the outcomes of interest in this review. There is no evidence to evaluate potential adverse effects of multiple-micronutrient supplements, particularly excess dosages.There is a need for high-quality studies to assess the effectiveness and safety of multiple-micronutrient supplementation for breastfeeding women for improving outcomes for the mother and her baby. Further research should focus on whether multiple-micronutrient supplementation during lactation compared with none, a placebo or supplementation with fewer than two micronutrients is beneficial to maternal and infant health outcomes. Future studies should collect data on outcomes beyond micronutrient concentrations, for example: maternal and infant morbidity, adverse effects, maternal satisfaction, the risks of excess supplementation, and potential adverse interactions between the micronutrients and the other outcomes. This would help to bridge the gap between research on intermediary outcomes and health outcomes in order to develop sound policy in this field. Future studies could more precisely assess a variety of multiple-micronutrient combinations and different dosages and look at how these affect maternal and infant health outcomes. Larger studies with longer follow-up would improve the quality of studies and provide stronger evidence. In most of the included studies, bias could not be adequately assessed due to lack of information, therefore attention should be given to adequate methods of randomisation and allocation concealment, adequate methods of blinding of the participants, providers and the outcome assessors to improve the methodological quality of studies in this field.

Comparison of victims' reports and court records of intimate partner violence perpetrators' criminal case outcomes.

PubMed

Bell, Margret E; Larsen, Sadie E; Goodman, Lisa A; Dutton, Mary Ann

2013-09-01

Intimate partner violence (IPV) victims often report feeling confused and uninformed about court proceedings, including even about the final disposition of the case against their partner. This is problematic because victims' decisions in responding to subsequent abuse may be significantly influenced by their beliefs about the outcomes of prior court experiences. Also, researchers often rely on victim report of court case outcomes; discrepancies between women's reports and official records may account for some of the conflicting findings in the empirical literature. In the current study, we compared the reports of case outcome given by 81 women recruited immediately after the final hearing of an IPV-related criminal case against their perpetrator with court records of case outcome. Findings revealed a fair level of agreement between women's reports and court files that was significantly different from the level of agreement expected by chance, but far from perfect. Level of agreement increased substantially when cases involving suspended sentences were removed. In reviewing these findings, we discuss the extent to which results can or cannot be interpreted as reflecting the accuracy of women's knowledge and review their implications for IPV researchers and court systems.

Clinician characteristics, communication, and patient outcome in oncology: a systematic review.

PubMed

De Vries, A M M; de Roten, Y; Meystre, C; Passchier, J; Despland, J-N; Stiefel, F

2014-04-01

The aim of this study was to review the literature on clinician characteristics influencing patient-clinician communication or patient outcome in oncology. Studies investigating the association of clinician characteristics with quality of communication and with outcome for adult cancer patients were systematically searched in MEDLINE, PSYINFO, PUBMED, EMBASE, CINHAL, Web of Science and The Cochrane Library up to November 2012. We used the preferred reporting items for systematic reviews and meta-analyses statement to guide our review. Articles were extracted independently by two of the authors using predefined criteria. Twenty seven articles met the inclusion criteria. Clinician characteristics included a variety of sociodemographic, relational, and personal characteristics. A positive impact on quality of communication and/or patient outcome was reported for communication skills training, an external locus of control, empathy, a socioemotional approach, shared decision-making style, higher anxiety, and defensiveness. A negative impact was reported for increased level of fatigue and burnout and expression of worry. Professional experience of clinicians was not related to communication and/or to patient outcome, and divergent results were reported for clinician gender, age, stress, posture, and confidence or self-efficacy. Various clinician characteristics have different effects on quality of communication and/or patient outcome. Research is needed to investigate the pathways leading to effective communication between clinicians and patients. Copyright © 2013 John Wiley & Sons, Ltd.

Effects of web-based interventions on cancer patients' symptoms: review of randomized trials.

PubMed

Fridriksdottir, N; Gunnarsdottir, S; Zoëga, S; Ingadottir, B; Hafsteinsdottir, E J G

2018-02-01

Symptom management is of high priority in cancer care. Information and communication technology allows interventions to be provided through the internet to enhance the delivery of care. This study aimed to review the effects of web-based interventions on cancer patients' symptoms. MEDLINE, PSychINFO, PubMed, CINAHL, and Cochrane databases were systematically searched. Included were randomized controlled trials (RCTs), pilot RCTs, or quasi-experimental (QE) studies focusing on web-based interventions in adult cancer patients with at least one outcome primary or secondary, in terms of symptoms, treatment side effects, or distress. Data were analyzed study by study. Twenty studies were identified. All web interventions included information, 16 included self-management support, 14 included self-monitoring, 13 included feedback/tailored information, 12 used communication with health-care professionals, and eight used communication with other patients. Overall, 13 studies reported positive symptom outcomes. Psychological distress was reported in eight studies with positive intervention effects in three. Symptoms of anxiety/depression were reported in ten studies with positive intervention effects in five. Somatic symptom severity was reported in ten studies with intervention effects found in six, and symptom distress was reported in six studies with intervention effects found in all. This review shows the promising potential of web-based interventions for cancer symptom management, although it was limited by considerable heterogeneity in the interventions tested and targeted outcomes. The multidimensional nature of symptoms was partly addressed; only one study was guided by a comprehensive theoretical model of cancer symptom management. It can only be speculated which web elements are important for effective symptom outcomes. Further testing is needed for web-based cancer symptom management.

Systematic Review of Interventions to Reduce Urinary Tract Infection in Nursing Home Residents.

PubMed

Meddings, Jennifer; Saint, Sanjay; Krein, Sarah L; Gaies, Elissa; Reichert, Heidi; Hickner, Andrew; McNamara, Sara; Mann, Jason D; Mody, Lona

2017-05-01

Urinary tract infections (UTIs) in nursing homes are common, costly, and morbid. Systematic literature review of strategies to reduce UTIs in nursing home residents. Ovid MEDLINE, Cochrane Library, CINAHL, Web of Science and Embase through June 22, 2015. Interventional studies with a comparison group reporting at least 1 outcome for: catheter-associated UTI (CAUTI), UTIs not identified as catheter-associated, bacteriuria, or urinary catheter use. Two authors abstracted study design, participant and intervention details, outcomes, and quality measures. Of 5794 records retrieved, 20 records describing 19 interventions were included: 8 randomized controlled trials, 10 pre-post nonrandomized interventions, and 1 nonrandomized intervention with concurrent controls. Quality (range, 8-25; median, 15) and outcome definitions varied greatly. Thirteen studies employed strategies to reduce catheter use or improve catheter care; 9 studies employed general infection prevention strategies (eg, improving hand hygiene, surveillance, contact precautions, reducing antibiotics). The 19 studies reported 12 UTI outcomes, 9 CAUTI outcomes, 4 bacteriuria outcomes, and 5 catheter use outcomes. Five studies showed CAUTI reduction (1 significantly); 9 studies showed UTI reduction (none significantly); 2 studies showed bacteriuria reduction (none significantly). Four studies showed reduced catheter use (1 significantly). Studies were often underpowered to assess statistical significance; none were pooled given variety of interventions and outcomes. Several practices, often implemented in bundles, such as improving hand hygiene, reducing and improving catheter use, managing incontinence without catheters, and enhanced barrier precautions, appear to reduce UTI or CAUTI in nursing home residents. Journal of Hospital Medicine 2017;12:356-368. © 2017 Society of Hospital Medicine

Long-term prognosis after acute kidney injury (AKI): what is the role of baseline kidney function and recovery? A systematic review.

PubMed

Sawhney, Simon; Mitchell, Mhairi; Marks, Angharad; Fluck, Nick; Black, Corrinda

2015-01-06

To summarise the evidence from studies of acute kidney injury (AKI) with regard to the effect of pre-AKI renal function and post-AKI renal function recovery on long-term mortality and renal outcomes, and to assess whether these factors should be taken into account in future prognostic studies. A systematic review of observational studies listed in Medline and EMBASE from 1990 to October 2012. All AKI studies in adults with data on baseline kidney function to identify AKI; with outcomes either stratified by pre-AKI and/or post-AKI kidney function, or described by the timing of the outcomes. Long-term mortality and worsening chronic kidney disease (CKD). Of 7385 citations, few studies met inclusion criteria, reported baseline kidney function and stratified by pre-AKI or post-AKI function. For mortality outcomes, three studies compared patients by pre-AKI renal function and six by post-AKI function. For CKD outcomes, two studies compared patients by pre-AKI function and two by post-AKI function. The presence of CKD pre-AKI (compared with AKI alone) was associated with doubling of mortality and a fourfold to fivefold increase in CKD outcomes. Non-recovery of kidney function was associated with greater mortality and CKD outcomes in some studies, but findings were inconsistent varying with study design. Two studies also reported that risk of poor outcome reduced over time post-AKI. Meta-analysis was precluded by variations in definitions for AKI, CKD and recovery. The long-term prognosis after AKI varies depending on cause and clinical setting, but it may also, in part, be explained by underlying pre-AKI and post-AKI renal function rather than the AKI episode itself. While carefully considered in clinical practice, few studies address these factors and with inconsistent study design. Future AKI studies should report pre-AKI and post-AKI function consistently as additional factors that may modify AKI prognosis. 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.

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review

PubMed Central

van den Ende, Cornelia H. M.; Houterman, Anne E. J.; Heemskerk, Charlotte P. M.; van Dulmen, Sandra; van den Bemt, Bart J. F.

2017-01-01

Objective This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. Methods A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Results Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Conclusion Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF. PMID:28991903

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review.

PubMed

van Heuckelum, Milou; van den Ende, Cornelia H M; Houterman, Anne E J; Heemskerk, Charlotte P M; van Dulmen, Sandra; van den Bemt, Bart J F

2017-01-01

This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF.

The selection of core International Classification of Functioning, Disability, and Health (ICF) categories for patient-reported outcome measurement in spine trauma patients-results of an international consensus process.

PubMed

Sadiqi, Said; Lehr, A Mechteld; Post, Marcel W; Jacobs, Wilco C H; Aarabi, Bizhan; Chapman, Jens R; Dunn, Robert N; Dvorak, Marcel F; Fehlings, Michael G; Rajasekaran, S; Vialle, Luiz R; Vaccaro, Alexander R; Oner, F Cumhur

2016-08-01

There is no outcome instrument specifically designed and validated for spine trauma patients without complete paralysis, which makes it difficult to compare outcomes of different treatments of the spinal column injury within and between studies. The paper aimed to report on the evidence-based consensus process that resulted in the selection of core International Classification of Functioning, Disability, and Health (ICF) categories, as well as the response scale for use in a universal patient-reported outcome measure for patients with traumatic spinal column injury. The study used a formal decision-making and consensus process. The sample includes patients with a primary diagnosis of traumatic spinal column injury, excluding completely paralyzed and polytrauma patients. The wide array of function and health status of patients with traumatic spinal column injury was explored through the identification of all potentially meaningful ICF categories. A formal decision-making and consensus process integrated evidence from four preparatory studies. Three studies aimed to identify relevant ICF categories from three different perspectives. The research perspective was covered by a systematic literature review identifying outcome measures focusing on the functioning and health of spine trauma patients. The expert perspective was explored through an international web-based survey among spine surgeons from the five AOSpine International world regions. The patient perspective was investigated in an international empirical study. A fourth study investigated various response scales for their potential use in the future universal outcome instrument. This work was supported by AOSpine. AOSpine is a clinical division of the AO Foundation, an independent medically guided non-profit organization. The AOSpine Knowledge Forums are pathology-focused working groups acting on behalf of AOSpine in their domain of scientific expertise. Combining the results of the preparatory studies, the list of ICF categories presented at the consensus conference included 159 different ICF categories. Based on voting and discussion, 11 experts from 6 countries selected a total of 25 ICF categories as core categories for patient-reported outcome measurement in adult traumatic spinal column injury patients (9 body functions, 14 activities and participation, and 2 environmental factors). The experts also agreed to use the Numeric Rating Scale 0-100 as response scale in the future universal outcome instrument. A formal consensus process integrating evidence and expert opinion led to a set of 25 core ICF categories for patient-reported outcome measurement in adult traumatic spinal column injury patients, as well as the response scale for use in the future universal disease-specific outcome instrument. The adopted core ICF categories could also serve as a benchmark for assessing the content validity of existing and future outcome instruments used in this specific patient population. Copyright © 2016 Elsevier Inc. All rights reserved.

The Effects of Pay-for-Performance Programs on Health, Health Care Use, and Processes of Care: A Systematic Review.

PubMed

Mendelson, Aaron; Kondo, Karli; Damberg, Cheryl; Low, Allison; Motúapuaka, Makalapua; Freeman, Michele; O'Neil, Maya; Relevo, Rose; Kansagara, Devan

2017-03-07

The benefits of pay-for-performance (P4P) programs are uncertain. To update and expand a prior review examining the effects of P4P programs targeted at the physician, group, managerial, or institutional level on process-of-care and patient outcomes in ambulatory and inpatient settings. PubMed from June 2007 to October 2016; MEDLINE, PsycINFO, CINAHL, Business Economics and Theory, Business Source Elite, Scopus, Faculty of 1000, and Gartner Research from June 2007 to February 2016. Trials and observational studies in ambulatory and inpatient settings reporting process-of-care, health, or utilization outcomes. Two investigators extracted data, assessed study quality, and graded the strength of the evidence. Among 69 studies, 58 were in ambulatory settings, 52 reported process-of-care outcomes, and 38 reported patient outcomes. Low-strength evidence suggested that P4P programs in ambulatory settings may improve process-of-care outcomes over the short term (2 to 3 years), whereas data on longer-term effects were limited. Many of the positive studies were conducted in the United Kingdom, where incentives were larger than in the United States. The largest improvements were seen in areas where baseline performance was poor. There was no consistent effect of P4P on intermediate health outcomes (low-strength evidence) and insufficient evidence to characterize any effect on patient health outcomes. In the hospital setting, there was low-strength evidence that P4P had little or no effect on patient health outcomes and a positive effect on reducing hospital readmissions. Few methodologically rigorous studies; heterogeneous population and program characteristics and incentive targets. Pay-for-performance programs may be associated with improved processes of care in ambulatory settings, but consistently positive associations with improved health outcomes have not been demonstrated in any setting. U.S. Department of Veterans Affairs.

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

Student Reports of Peer Threats of Violence: Prevalence and Outcomes

ERIC Educational Resources Information Center

Nekvasil, Erin K.; Cornell, Dewey G.

2012-01-01

Authorities in education and law enforcement have recommended that schools use a threat-assessment approach to prevent violence, but there is relatively little research on characteristics and outcomes of threats among students. The current study examined student reports of threat experiences in a sample of 3,756 high school students. Approximately…

Student Self-Reported Learning Outcomes of Field Trips: The Pedagogical Impact

ERIC Educational Resources Information Center

Alon, Nirit Lavie; Tal, Tali

2015-01-01

In this study, we used the classification and regression trees (CART) method to draw relationships between student self-reported learning outcomes in 26 field trips to natural environments and various characteristics of the field trip that include variables associated with preparation and pedagogy. We wished to examine the extent to which the…

Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials.

PubMed

Efficace, Fabio; Fayers, Peter; Pusic, Andrea; Cemal, Yeliz; Yanagawa, Jane; Jacobs, Marc; la Sala, Andrea; Cafaro, Valentina; Whale, Katie; Rees, Jonathan; Blazeby, Jane

2015-09-15

The main objectives of this study were to identify the number of randomized controlled trials (RCTs) including a patient-reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. RCTs with a PRO endpoint that had been performed across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated on the basis of previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing the risk of bias of RCTs. Analyses were also conducted by the type of PRO endpoint (primary vs secondary) and by the cancer disease site. A total of 56,696 potentially eligible records were scrutinized, and 557 RCTs with a PRO evaluation, enrolling 254,677 patients overall, were identified. PROs were most frequently used in RCTs of breast (n = 123), lung (n = 85), and colorectal cancer (n = 66). Overall, PROs were secondary endpoints in 421 RCTs (76%). Four of 6 evaluated CONSORT PRO items were documented in less than 50% of the RCTs. The level of reporting was higher in RCTs with a PRO as a primary endpoint. The presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PROs as primary endpoints (β = .19, P = .001) and RCTs with PROs as secondary endpoints (β = .30, P < .001). Implementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute to revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting. © 2015 American Cancer Society.

Comparison of reporting phase III randomized controlled trials of antibiotic treatment for common bacterial infections in ClinicalTrials.gov and matched publications.

PubMed

Shepshelovich, D; Yelin, D; Gafter-Gvili, A; Goldman, S; Avni, T; Yahav, D

2018-02-15

Discrepancies between ClinicalTrials.gov entries and matching publications were previously described in general medicine. We aimed to evaluate the consistency of reporting in trials addressing systemic antibiotic therapy. We searched ClinicalTrials.gov for completed phase III trials comparing antibiotic regimens until May 2017. Matched publications were identified in PubMed. Two independent reviewers extracted data and identified inconsistencies. Reporting was assessed among studies started before and after 1 July 2005, when the International Committee of Medical Journal Editors (ICMJE) required mandatory registration as a prerequisite for considering a trial for publication. Matching publications were identified for 75 (70%) of 107 ClinicalTrials.gov entries. Median time from study completion to publication was 26 months (interquartile range 19-42). Primary outcome definition was inconsistent between ClinicalTrials.gov and publications in seven trials (7/72, 10%) and reporting of the primary outcome timeframe was inconsistent in 14 (14/71, 20%). Secondary outcomes definitions were inconsistent in 36 trials (36/66, 55%). Reporting of inclusion criteria and study timeline were inconsistent in 17% (13/65) and 3% (2/65), respectively. Trials started after July 2005 were significantly less likely to have reporting inconsistencies and were published in higher impact factor journals. We found a lower inconsistency rate of outcome reporting compared with other medical disciplines. Reporting completeness and consistency were significantly better after July 2005. The ICMJE requirement for mandatory registration was associated with significant improvement in reporting quality in infectious diseases trials. Prolonged time lag to publication and missing data from unpublished trials should raise a discussion on current reporting and publishing procedures. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Rasch-family models are more valuable than score-based approaches for analysing longitudinal patient-reported outcomes with missing data.

PubMed

de Bock, Élodie; Hardouin, Jean-Benoit; Blanchin, Myriam; Le Neel, Tanguy; Kubis, Gildas; Bonnaud-Antignac, Angélique; Dantan, Étienne; Sébille, Véronique

2016-10-01

The objective was to compare classical test theory and Rasch-family models derived from item response theory for the analysis of longitudinal patient-reported outcomes data with possibly informative intermittent missing items. A simulation study was performed in order to assess and compare the performance of classical test theory and Rasch model in terms of bias, control of the type I error and power of the test of time effect. The type I error was controlled for classical test theory and Rasch model whether data were complete or some items were missing. Both methods were unbiased and displayed similar power with complete data. When items were missing, Rasch model remained unbiased and displayed higher power than classical test theory. Rasch model performed better than the classical test theory approach regarding the analysis of longitudinal patient-reported outcomes with possibly informative intermittent missing items mainly for power. This study highlights the interest of Rasch-based models in clinical research and epidemiology for the analysis of incomplete patient-reported outcomes data. © The Author(s) 2013.

Ethnic differences in family member diabetes involvement and psychological outcomes: results from the second Diabetes Attitudes, Wishes and Needs (DAWN2) study in the USA.

PubMed

Peyrot, Mark; Egede, Leonard E; Funnell, Martha M; Hsu, William C; Ruggiero, Laurie; Siminerio, Linda M; Stuckey, Heather L

2015-01-01

To assess differences among USA ethnic groups in psychological status of adult family members (FMs) and their involvement with the diabetes of another adult. Data are from the FM survey of the USA DAWN2 study, including 105 White non-Hispanics, 47 African Americans, 46 Hispanic Americans and 40 Chinese Americans. All FMs lived with and cared for an adult with diabetes. Analysis of covariance controlled for respondent and patient characteristics to assess ethnic group differences (P < 0.05). Multiple regression analyses identified significant (P < 0.05) independent correlates of psychological outcomes. FM psychological outcomes measured include well-being, quality of life (QoL), impact of diabetes on life domains, diabetes distress, and burden. NCT01507116. White non-Hispanics reported less diabetes burden and distress, more negative life impact, and lower well-being than FMs from ethnic minority groups. African Americans reported the highest well-being and lowest negative life impact, Chinese Americans reported the most diabetes burden, Hispanic Americans reported the highest distress. There were no ethnic group differences in QoL. Ethnic minority FMs reported having more involvement with diabetes, greater support success, and more access to a diabetes support network than White non-Hispanics. Higher FM diabetes involvement was associated with negative psychological outcomes, while diabetes education, support success and diabetes support network size were associated with better psychological outcomes. Potential limitations are the sample sizes and representativeness. Minority ethnic FMs experienced both advantages and disadvantages in psychological outcomes relative to each other and to White non-Hispanics. Ethnic minority FMs had more involvement in diabetes care, support success and support from others, with the first associated with worse and the latter two with better psychological outcomes. Additional studies are needed with larger samples and broader representation of ethnic groups to better understand these associations and identify areas for intervention.

Validation study of an electronic method of condensed outcomes tools reporting in orthopaedics.

PubMed

Farr, Jack; Verma, Nikhil; Cole, Brian J

2013-12-01

Patient-reported outcomes (PRO) instruments are a vital source of data for evaluating the efficacy of medical treatments. Historically, outcomes instruments have been designed, validated, and implemented as paper-based questionnaires. The collection of paper-based outcomes information may result in patients becoming fatigued as they respond to redundant questions. This problem is exacerbated when multiple PRO measures are provided to a single patient. In addition, the management and analysis of data collected in paper format involves labor-intensive processes to score and render the data analyzable. Computer-based outcomes systems have the potential to mitigate these problems by reformatting multiple outcomes tools into a single, user-friendly tool.The study aimed to determine whether the electronic outcomes system presented produces results comparable with the test-retest correlations reported for the corresponding orthopedic paper-based outcomes instruments.The study is designed as a crossover study based on consecutive orthopaedic patients arriving at one of two designated orthopedic knee clinics.Patients were assigned to complete either a paper or a computer-administered questionnaire based on a similar set of questions (Knee injury and Osteoarthritis Outcome Score, International Knee Documentation Committee form, 36-Item Short Form survey, version 1, Lysholm Knee Scoring Scale). Each patient completed the same surveys using the other instrument, so that all patients had completed both paper and electronic versions. Correlations between the results from the two modes were studied and compared with test-retest data from the original validation studies.The original validation studies established test-retest reliability by computing correlation coefficients for two administrations of the paper instrument. Those correlation coefficients were all in the range of 0.7 to 0.9, which was deemed satisfactory. The present study computed correlation coefficients between the paper and electronic modes of administration. These correlation coefficients demonstrated similar results with an overall value of 0.86.On the basis of the correlation coefficients, the electronic application of commonly used knee outcome scores compare variably to the traditional paper variants with a high rate of test-retest correlation. This equivalence supports the use of the condensed electronic outcomes system and validates comparison of scores between electronic and paper modes. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Knowledge translation and implementation in spinal cord injury: a systematic review.

PubMed

Noonan, V K; Wolfe, D L; Thorogood, N P; Park, S E; Hsieh, J T; Eng, J J

2014-08-01

To conduct a systematic review examining the effectiveness of knowledge translation (KT) interventions in changing clinical practice and patient outcomes. MEDLINE/PubMed, CINAHL, EMBASE and PsycINFO were searched for studies published from January 1980 to July 2012 that reported and evaluated an implemented KT intervention in spinal cord injury (SCI) care. We reviewed and summarized results from studies that documented the implemented KT intervention, its impact on changing clinician behavior and patient outcomes as well as the facilitators and barriers encountered during the implementation. A total of 13 articles featuring 10 studies were selected and abstracted from 4650 identified articles. KT interventions included developing and implementing patient care protocols, providing clinician education and incorporating outcome measures into clinical practice. The methods (or drivers) to facilitate the implementation included organizing training sessions for clinical staff, introducing computerized reminders and involving organizational leaders. The methodological quality of studies was mostly poor. Only 3 out of 10 studies evaluated the success of the implementation using statistical analyses, and all 3 reported significant behavior change. Out of the 10 studies, 6 evaluated the effect of the implementation on patient outcomes using statistical analyses, with 4 reporting significant improvements. The commonly cited facilitators and barriers were communication and resources, respectively. The field of KT in SCI is in its infancy with only a few relevant publications. However, there is some evidence that KT interventions may change clinician behavior and improve patient outcomes. Future studies should ensure rigorous study methods are used to evaluate KT interventions.

Preoperative Delayed Gadolinium-Enhanced Magnetic Resonance Imaging of Cartilage (dGEMRIC) for Patients Undergoing Hip Arthroscopy: Indices Are Predictive of Magnitude of Improvement in Two-Year Patient-Reported Outcomes.

PubMed

Chandrasekaran, Sivashankar; Vemula, S Pavan; Lindner, Dror; Lodhia, Parth; Suarez-Ahedo, Carlos; Domb, Benjamin G

2015-08-19

Delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) has been used in the detection of chondropathy. Our study aimed to determine whether dGEMRIC indices are predictive of two-year patient-reported outcomes and pain scores following hip arthroscopy. Between August 2008 and April 2012, sixty-five patients (seventy-four hips) underwent primary hip arthroscopy with preoperative dGEMRIC and a minimum of two years of follow-up. Exclusion criteria were previous hip surgery, slipped capital femoral epiphysis, inflammatory arthropathy, Legg-Calvé-Perthes disease, and arthritis of >1 Tönnis grade. Patients were classified in two groups on the basis of a dGEMRIC cutoff of 323 msec, which was one standard deviation (SD) below the study cohort mean dGEMRIC index of 426 msec. Patient-reported outcome tools used included the modified Harris hip score (mHHS), the Nonarthritic Hip Score (NAHS), the Hip Outcome Score Activities of Daily Living (HOS-ADL), and the Hip Outcome Score Sport-Specific Subscale (HOS-SSS) as well as a visual analog scale (VAS) for pain and a patient satisfaction score. There were sixty-four hips that met the inclusion criteria; fifty-two (81.3%) had a minimum of two years of follow-up. Twelve of the sixty-four hips had a dGEMRIC index of <323 msec (Group 1), and fifty-two hips had a dGEMRIC index of ≥323 msec (Group 2). There was no significant difference between the groups with respect to age, sex, and body mass index. There was no significant difference between the groups in mean preoperative patient-reported outcome scores and the VAS for pain. At the two-year follow-up, Group 1 had significant improvement in the mHHS, whereas Group 2 demonstrated significant improvement in all patient-reported outcome scores and the VAS. The improvement in all patient-reported outcome scores was significantly larger for Group 2 compared with Group 1. There was no significant difference in patient satisfaction between groups and no significant correlation between dGEMRIC indices and the patient-reported outcome measures. Patients with a dGEMRIC index of ≥323 msec (less than one SD below the cohort mean) demonstrated significantly greater improvement in patient-reported outcome scores and the VAS for pain after hip arthroscopy. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

A Systematic Review of Outcomes after Arthroscopic Débridement for Triangular Fibrocartilage Complex Tear.

PubMed

Saito, Taichi; Malay, Sunitha; Chung, Kevin C

2017-11-01

Evidence regarding the effectiveness of arthroscopic débridement for a triangular fibrocartilage complex tear is uncertain. The purpose of this study was to conduct a systematic review of outcomes to evaluate the effectiveness of débridement for triangular fibrocartilage complex tears. The authors searched all available literature in the PubMed, Embase, and MEDLINE (Ovid) databases for articles reporting on triangular fibrocartilage complex tear débridement. Data collection included arc of motion, grip strength, patient-reported outcomes, and complications. A total of 1723 unique studies were identified, of which 18 studies met the authors' criteria. The mean before and after arc of wrist extension/flexion motion values were 120 and 146 degrees (six studies). The mean before and after grip strength values were 65 percent and 91 percent of the contralateral side (10 studies). Disabilities of the Arm, Shoulder, and Hand scores (six studies) and pain visual analogue scale scores (seven studies) improved from 39 to 18, and from 7 to 3, respectively. The mean pain visual analogue scale score after débridement was 1.9 in the ulnar-positive group and 2.4 in the ulnar-neutral and ulnar-negative groups. Eighty-seven percent of patients returned to their original work. Patients reported reduced pain and improved functional and patient-reported outcomes after débridement of triangular fibrocartilage complex tears. Most patients after débridement returned to previous work, with few complications. Although some of these cases may require secondary procedures, simple débridement can be performed with suitable satisfactory outcomes for cases with any type of ulnar variance.

Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study.

PubMed

Steffen, Armin; Sommer, J Ulrich; Hofauer, Benedikt; Maurer, Joachim T; Hasselbacher, Katrin; Heiser, Clemens

2018-02-01

Upper airway stimulation (UAS) of the hypoglossal nerve has been implemented in the routine clinical practice for patients with moderate-to-severe obstructive sleep apnea (OSA) who could not adhere to continuous positive airway pressure. This study reports objective and patient-reported outcome after 12 months of implantation. Multicenter prospective single-arm study. Consecutive patients who received the UAS system (Inspire Medical Systems, Inc., Minneapolis, Minnesota, Maple Grove, MN, U.S.A.) were enrolled in three German centers. Key study exclusion criteria included body mass index > 35 kg/m 2 , apnea-hypopnea index (AHI) < 15 or > 65, or complete concentric collapse at the soft palate during sedated endoscopy. Data collection at 6- and 12-month visit include home sleep test and patient-reported outcome measures. Among the total of 60 participants, the median AHI reduced from 28.6 to 9.5 from baseline to 12 months. Patient-reported outcome measured in Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire both improved significantly from baseline to 12 months. The average usage time was 39.1 ± 14.9 hours per week among all participants based on recordings by the implanted device. One patient requested a removal of the device for cosmetic and other personal reasons and was completed without sequelae. This study supported that UAS is a safe and effective treatment option for patients with OSA in routine clinical practice. 4. Laryngoscope, 128:509-515, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Cervical arthroplasty: a critical review of the literature.

PubMed

Alvin, Matthew D; Abbott, E Emily; Lubelski, Daniel; Kuhns, Benjamin; Nowacki, Amy S; Steinmetz, Michael P; Benzel, Edward C; Mroz, Thomas E

2014-09-01

Cervical disc arthroplasty (CDA) is a motion-preserving procedure that is an alternative to fusion. Proponents of arthroplasty assert that it will maintain cervical motion and prevent or reduce adjacent segment degeneration. Accordingly, CDA, compared with fusion, would have the potential to improve clinical outcomes. Published studies have varying conclusions on whether CDA reduces complications and/or improves outcomes. As many of these previous studies have been funded by CDA manufacturers, we wanted to ascertain whether there was a greater likelihood for these studies to report positive results. To critically assess the available literature on cervical arthroplasty with a focus on the time of publication and conflict of interest (COI). Review of the literature. All clinical articles about CDA published in English through August 1, 2013 were identified on Medline. Any article that presented CDA clinical results was included. Study design, sample size, type of disc, length of follow-up, use of statistical analysis, quality-of-life (QOL) outcome scores, COI, and complications were recorded. A meta-analysis was conducted stratifying studies by COI and publication date to identify differences in complication rates reported. Seventy-four studies were included that investigated 8 types of disc prosthesis and 22 met the criteria for a randomized controlled trial (RCT). All Level Ib RCTs reported superior quality-of-life outcomes for CDA versus anterior cervical discectomy and fusion (ACDF) at 24 months. Fifty of the 74 articles (68%) had a disclosure section, including all Level Ib RCTs, which had significant COIs related to the respective studies. Those studies without a COI reported mean weighted average adjacent segment disease rates of 6.3% with CDA and 6.2% with ACDF. In contrast, the reverse was reported by studies with a COI, for which the averages were 2.5% with CDA and 6.3% with ACDF. Those studies with a COI (n=31) had an overall weighted average heterotopic ossification rate of 22%, whereas those studies with no COI (n=43) had a rate of 46%. Associated COIs did not influence QOL outcomes. Conflicts of interest were more likely to be present in studies published after 2008, and those with a COI reported greater adjacent segment disease rates for ACDF than CDA. In addition, heterotopic ossification rates were much lower in studies with COI versus those without COI. Thus, COIs did not affect QOL outcomes but were associated with lower complication rates. Copyright © 2014 Elsevier Inc. All rights reserved.

Influence of interpersonal traits on patient outcomes in the treatment of chronic rhinosinusitis.

PubMed

Levy, Joshua M; Mace, Jess C; Smith, Timothy L; Soler, Zachary M

2017-04-01

Patient-reported outcome measures (PROMs) measure health states in chronic rhinosinusitis (CRS) and have become the dominant metrics of treatment outcomes. Interpersonal traits (IPTs) are patient-specific factors that include personality type, perceived social support, and trust in physicians. The association of IPTs on treatment outcomes among patients with CRS has not been described previously, and IPTs may represent major clinical factors influencing treatment outcomes. Adult patients electing medical or surgical treatment for recalcitrant CRS were prospectively enrolled into a multi-institutional, observational outcomes study. Validated measures of IPTs, including the Big Five Inventory-10 Short Version (BFI-10), Multidimensional Scale of Perceived Social Support (MSPSS), and the Trust in Physician Scale (TPS), were completed and compared with PROMs, which included the 22-item SinoNasal Outcome Test (SNOT-22), the Medical Outcomes Study Short Form-6D (SF-6D), and the Patient Health Questionnaire-2 (PHQ-2). Three hundred fifty-four participants were included and followed for an average (± standard deviation) of 16.3 (±4.8) months. Significant within-subject improvement in mean PROM scores was reported (all p <0.001). No association was detected between PROM score improvement and baseline BFI-10 or MSPSS scores (p > 0.050). Significant, but weak, absolute correlations were reported between baseline TPS scores and improvement in SNOT-22, SF-6D, and PHQ-2 total scores (p < 0.050; r ≤ 0.138). Personality type and perceived social support do not associate with improvement after treatment for CRS. However, increased trust in physicians is weakly associated with greater posttreatment improvement. Further study is needed to examine the relationship between physician trust, patient satisfaction, and treatment outcomes among patients with CRS. © 2016 ARS-AAOA, LLC.

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.

Closing the quality gap: revisiting the state of the science (vol. 5: public reporting as a quality improvement strategy).

PubMed

Totten, Annette M; Wagner, Jesse; Tiwari, Arpita; O'Haire, Christen; Griffin, Jessica; Walker, Miranda

2012-07-01

The goal of this review was to evaluate the effectiveness of public reporting of health care quality information as a quality improvement strategy. We sought to determine if public reporting results in improvements in health care delivery and patient outcomes. We also considered whether public reporting affects the behavior of patients or of health care providers. Finally we assessed whether the characteristics of the public reports and the context affect the impact of public reports. Articles available between 1980 and 2011 were identified through searches of the following bibliographical databases: MEDLINE®, Embase, EconLit, PsychINFO, Business Source Premier, CINAHL, PAIS, Cochrane Database of Systematic Reviews, EPOC Register of Studies, DARE, NHS EED, HEED, NYAM Grey Literature Report database, and other sources (experts, reference lists, and gray literature). We screened citations based on inclusion and exclusion criteria developed based on our definition of public reporting. We initially did not exclude any studies based on study design. Of the 11,809 citations identified through title and abstract triage, we screened and reviewed 1,632 articles. A total of 97 quantitative and 101 qualitative studies were included, abstracted, entered into tables, and evaluated. The heterogeneity of outcomes as well as methods prohibited formal quantitative synthesis. Systematic reviews were used to identify studies, but their conclusions were not incorporated into this review. For most of the outcomes, the strength of the evidence available to assess the impact of public reporting was moderate. This was due in part to the methodological challenges researchers face in designing and conducting research on the impact of population-level interventions. Public reporting is associated with improvement in health care performance measures such as those included in Nursing Home Compare. Almost all identified studies found no evidence or only weak evidence that public reporting affects the selection of health care providers by patients or their representatives. Studies of health care providers' response to public reports suggest they engage in activities to improve quality when performance data are made public. Characteristics of public reports and the context, which are likely to be important when considering the diffusion of quality improvement activities, were rarely studied or even described. The heterogeneity of the outcomes and the moderate strength of evidence for most outcomes make it difficult to draw definitive conclusions. However, some observations were supported by existing research. Public reporting is more likely to be associated with changes in health care provider behaviors than with selection of health services providers by patients or families. Quality measures that are publicly reported improve over time. Although the potential for harms is frequently cited by commentators and critics of public reporting, the amount of research on harms is limited and most studies do not confirm the potential harm.

Self-efficacy as a predictor of patient-reported outcomes in adults with congenital heart disease.

PubMed

Thomet, Corina; Moons, Philip; Schwerzmann, Markus; Apers, Silke; Luyckx, Koen; Oechslin, Erwin N; Kovacs, Adrienne H

2018-04-01

Self-efficacy is a known predictor of patient-reported outcomes in individuals with acquired diseases. With an overall objective of better understanding patient-reported outcomes in adults with congenital heart disease, this study aimed to: (i) assess self-efficacy in adults with congenital heart disease, (ii) explore potential demographic and medical correlates of self-efficacy and (iii) determine whether self-efficacy explains additional variance in patient-reported outcomes above and beyond known predictors. As part of a large cross-sectional international multi-site study (APPROACH-IS), we enrolled 454 adults (median age 32 years, range: 18-81) with congenital heart disease in two tertiary care centres in Canada and Switzerland. Self-efficacy was measured using the General Self-Efficacy (GSE) scale, which produces a total score ranging from 10 to 40. Variance in the following patient-reported outcomes was assessed: perceived health status, psychological functioning, health behaviours and quality of life. Hierarchical multivariable linear regression analysis was performed. Patients' mean GSE score was 30.1 ± 3.3 (range: 10-40). Lower GSE was associated with female sex ( p = 0.025), not having a job ( p = 0.001) and poorer functional class ( p = 0.048). GSE positively predicted health status and quality of life, and negatively predicted symptoms of anxiety and depression, with an additional explained variance up to 13.6%. No associations between self-efficacy and health behaviours were found. GSE adds considerably to our understanding of patient-reported outcomes in adults with congenital heart disease. Given that self-efficacy is a modifiable psychosocial factor, it may be an important focus for interventions targeting congenital heart disease patients' well-being.

Effectiveness of web-based tailored smoking cessation advice reports (iQuit): a randomized trial.

PubMed

Mason, Dan; Gilbert, Hazel; Sutton, Stephen

2012-12-01

To determine whether web-based tailored cessation advice, based on social cognitive theory and the perspectives on change model, was more effective in aiding a quit attempt than broadly similar web-based advice that was not tailored. Participants were allocated randomly to one of two groups, to receive either a cessation advice report and progress report that were tailored to individual-level characteristics or a cessation advice report that presented standardized (non-tailored) content. Tailoring was based on smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations. Participant enrolment and baseline assessments were conducted remotely online via the study website, with the advice reports presented by the same website. Participants (n = 1758) were visitors to the QUIT website who were based in the United Kingdom, aged 18 years or over and who smoked cigarettes or hand-rolled tobacco. Follow-up assessments were made at 6 months by telephone interview. The primary outcome measure was self-reported 3 months prolonged abstinence, and secondary outcomes were 1 month prolonged abstinence, 7-day and 24-hour point prevalence abstinence. The intervention group did not differ from the control group on the primary outcome (9.1% versus 9.3%; odds ratio = 1.02 95% confidence interval 0.73-1.42) or on any of the secondary outcomes. Intervention participants gave more positive evaluations of the materials than control participants. A web-based intervention that tailored content according to smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations, was not more effective than web-based materials presenting broadly similar non-tailored information. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

Using ClinicalTrials.gov to Supplement Information in Ophthalmology Conference Abstracts about Trial Outcomes: A Comparison Study

PubMed Central

Scherer, Roberta W.; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

2015-01-01

Background Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. Methods We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. Results We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching “new” outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conclusion Conference abstracts may be a valuable source of information about results for outcomes of unpublished RCTs that have been registered in ClinicalTrials.gov. Complementary additional descriptive information may be present for outcomes reported in both sources. However, ARVO abstract authors also present outcomes not reported in ClinicalTrials.gov and these may represent analyses not originally planned. PMID:26107924

Environmental Volunteering and Health Outcomes over a 20-Year Period

PubMed Central

Pillemer, Karl; Fuller-Rowell, Thomas E.; Reid, M. C.; Wells, Nancy M.

2010-01-01

Purpose: This study tested the hypothesis that volunteering in environmental organizations in midlife is associated with greater physical activity and improved mental and physical health over a 20-year period.  Design and Methods: The study used data from two waves (1974 and 1994) of the Alameda County Study, a longitudinal study of health and mortality that has followed a cohort of 6,928 adults since 1965. Using logistic and multiple regression models, we examined the prospective association between environmental and other volunteerism and three outcomes (physical activity, self-reported health, and depression), with 1974 volunteerism predicting 1994 outcomes, controlling for a number of relevant covariates.  Results: Midlife environmental volunteering was significantly associated with physical activity, self-reported health, and depressive symptoms.  Implications: This population-based study offers the first epidemiological evidence for a significant positive relationship between environmental volunteering and health and well-being outcomes. Further research, including intervention studies, is needed to confirm and shed additional light on these initial findings. PMID:20172902

Outcomes of Surgical Treatment for Anterior Tibial Stress Fractures in Athletes: A Systematic Review.

PubMed

Chaudhry, Zaira S; Raikin, Steven M; Harwood, Marc I; Bishop, Meghan E; Ciccotti, Michael G; Hammoud, Sommer

2017-12-01

Although most anterior tibial stress fractures heal with nonoperative treatment, some may require surgical management. To our knowledge, no systematic review has been conducted regarding surgical treatment strategies for the management of chronic anterior tibial stress fractures from which general conclusions can be drawn regarding optimal treatment in high-performance athletes. This systematic review was conducted to evaluate the surgical outcomes of anterior tibial stress fractures in high-performance athletes. Systematic review; Level of evidence, 4. In February 2017, a systematic review of the PubMed, MEDLINE, Cochrane, SPORTDiscus, and CINAHL databases was performed to identify studies that reported surgical outcomes for anterior tibial stress fractures. Articles meeting the inclusion criteria were screened, and reported outcome measures were documented. A total of 12 studies, published between 1984 and 2015, reporting outcomes for the surgical treatment of anterior tibial stress fractures were included in this review. All studies were retrospective case series. Collectively, surgical outcomes for 115 patients (74 males; 41 females) with 123 fractures were evaluated in this review. The overall mean follow-up was 23.3 months. The most common surgical treatment method reported in the literature was compression plating (n = 52) followed by drilling (n = 33). Symptom resolution was achieved in 108 of 123 surgically treated fractures (87.8%). There were 32 reports of complications, resulting in an overall complication rate of 27.8%. Subsequent tibial fractures were reported in 8 patients (7.0%). Moreover, a total of 17 patients (14.8%) underwent a subsequent procedure after their initial surgery. Following surgical treatment for anterior tibial stress fracture, 94.7% of patients were able to return to sports. The available literature indicates that surgical treatment of anterior tibial stress fractures is associated with a high rate of symptom resolution and return to play in athletes, although the high complication rate and potential need for subsequent procedures are important considerations for surgeons and patients.

Patient-reported Outcomes in Practice: Clinicians' Perspectives From an Inpatient Psychiatric Setting.

PubMed

Burr, Sean K; Fowler, James C; Allen, Jon G; Wiltgen, Anika; Madan, Alok

2017-09-01

The use of patient-reported outcomes (PROs) has become increasingly common. They have been used to assess quality of care and to support policy decisions, but the evidence concerning their utility to improve patient outcomes is inconsistent. A better understanding of clinicians' experience with PROs has the potential to improve their effectiveness. This exploratory, quantitative, and qualitative study investigated the perspectives of clinicians (N=70) from multiple disciplines (psychiatrists, psychologists, social workers, and psychiatric nurses) on the utility of PROs in an inpatient psychiatric setting. During scheduled, monthly, discipline-specific administrative meetings, clinicians in attendance completed a 1-time, 5-item survey. The highest rated item related to the frequency of reviewing outcomes reports; this item was rated higher than all other items (mean±SD, 4.5±1.5), which 37.5% of the participants in the overall sample stated they "always" did. The lowest rated item related to the frequency of conveying the results of the outcomes reports to patients (3.3±1.9), which 20% of participants reported "always" doing; this item was rated lower than all other items (P<0.03). Qualitative analyses were based on 30 comments from 22 clinicians, which resulted in the emergence of 6 themes. The 2 themes that received the highest number of comments related to: (1) the sensitivity and specificity of measures across the PROs platform and (2) the value of the reports in directly influencing treatment decisions. Clinicians' relatively favorable perspective of PROs in practice in this study may be related to the assessment-oriented culture at the study institution. Nonetheless, many barriers to the routine use of PROs exist. Addressing clinician concerns has the potential to improve utilization of this facet of good clinical care.

Small incision lenticule extraction (SMILE) in the correction of myopic astigmatism: outcomes and limitations - an update.

PubMed

Alió Del Barrio, Jorge L; Vargas, Verónica; Al-Shymali, Olena; Alió, Jorge L

2017-01-01

Small Incision Lenticule Extraction (SMILE) is a flap-free intrastromal technique for the correction of myopia and myopic astigmatism. To date, this technique lacks automated centration and cyclotorsion control, so several concerns have been raised regarding its capability to correct moderate or high levels of astigmatism. The objective of this paper is to review the reported SMILE outcomes for the correction of myopic astigmatism associated with a cylinder over 0.75 D, and its comparison with the outcomes reported with the excimer laser-based corneal refractive surgery techniques. A total of five studies clearly reporting SMILE astigmatic outcomes were identified. SMILE shows acceptable outcomes for the correction of myopic astigmatism, although a general agreement exists about the superiority of the excimer laser-based techniques for low to moderate levels of astigmatism. Manual correction of the static cyclotorsion should be adopted for any SMILE astigmatic correction over 0.75 D.

A comparison of consumer-directed and agency-directed personal assistance services programmes.

PubMed

Hagglund, Kristofer; Clark, Mary; Farmer, Janet; Sherman, Ashley

2004-05-06

To compare a consumer-directed personal assistance services (PAS) programme with an agency-directed PAS programme. A convenience sample was used for this cross-sectional study with one data collection point. Outcomes were compared for consumer-directed and agency-directed PAS. Hierarchical regressions were also used to determine the predictors of outcomes across PAS programmes. In-home interviews were conducted by a trained data collector from April 2000 to December 2001. Participants in the consumer-directed programme reported more choices over PAS and satisfaction with PAS. Self-reported outcomes were primarily predicted by the following variables: service arrangement, type of provider, importance of directing PAS, health status, number of personal assistants used in past 12 months, sufficient PAS hours received, and social support. Consumer-directed PAS enhances outcomes for many persons with disabilities. Self-reported outcomes are affected by many factors that could be addressed in PAS programme development.

Somatic outcome among patients hospitalised for anorexia nervosa in adolescence: disorders reported and links with global outcome.

PubMed

Roux, Hélène; Blanchet, Corinne; Stheneur, Chantal; Chapelon, Emeline; Godart, Nathalie

2013-06-01

(1) To describe the frequency of somatic pathologies and depression among former anorexia nervosa (AN) patients; (2) to study links with subjects' clinical history and global outcomes. 97 women hospitalised for AN during adolescence, 9.00 ± 1.92 years previously, were interviewed using structured questionnaires concerning somatic and psychiatric disorders that they had experienced. Iron deficiency, migraine, cystitis, upper digestive system disorders, fractures, osteoporosis, and dental problems were reported with a frequency >20 %. Depression was reported by 2/3 of the sample. Osteoporosis was 14 times more frequent in case of vitamin D deficiency. Fractures were three times more frequent in presence of osteoporosis and less frequent when the overall outcome was better. Among women who had AN in adolescence, somatic comorbidities are frequent in adulthood. They are linked to the severity and the duration of AN, and to the overall outcome of the subject.

Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report.

PubMed

Benjamin, Katy; Vernon, Margaret K; Patrick, Donald L; Perfetto, Eleanor; Nestler-Parr, Sandra; Burke, Laurie

Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing instruments developed for a similar condition or that contain symptoms of importance to the RD patient population, or using a generic instrument validated for the context of use. This report provides state-of-the-art solutions to patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments challenges in clinical trials of patients with RDs. These recommended solutions are both pragmatic and creative and posed with clear recognition of the global regulatory context used in RD clinical development programs. Copyright © 2017. Published by Elsevier Inc.

Meniscus Repair in Children and Adolescents: A Systematic Review of Treatment Approaches, Meniscal Healing, and Outcomes.

PubMed

Ferrari, Márcio Balbinotti; Murphy, Colin P; Gomes, João Luiz Ellera

2018-05-23

Although the consequences of traumatic meniscus tears and the importance of meniscal repair are well-established in adults, the same cannot be said for the young population. Better evidence regarding the outcomes following traumatic meniscal tears in children would improve our understanding of this increasing pathology and help define important factors in deciding the best treatment option. A systematic review was performed according to the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines using the Cochrane Database of Systematic Review, Cochrane Central Register of Controlled Trials, MEDLINE Ovid, and MEDLINE PubMed databases. Inclusion criteria were as follows: studies reporting the outcomes of meniscal repair in patients 18 years old or younger, with a minimum mean follow-up of 12 months, Portuguese, Spanish, or English languages, and human studies including 10 or more patients. Our search identified 2,534 individual titles. After application of the inclusion and exclusion criteria, 8 studies were included, evaluating 287 patients with repaired meniscal tears. All eight studies were classified as level of evidence IV. The mean methodological index for nonrandomized studies score was 8.6 ± 1.4. Meniscal repair included all meniscal zones and tear patterns. Anterior cruciate ligament tear was the most common associated injury. The all-inside and inside-out techniques were predominantly reported. The majority of the patients reported good to excellent outcomes and had clinical signals of meniscal healing; meniscectomies following meniscal repair were performed in just 44 cases. In conclusion, meniscal tears in pediatrics are not uncommon. Repairs of this injury were associated with good to excellent outcomes in most patients, regardless of the injury pattern, zone, or technique. Reported complications were minimal; however, higher quality studies are needed to confirm the findings of this systematic review. This is a systematic review study with Level IV. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Orthodontic trial outcomes: Plentiful, inconsistent, and in need of uniformity? A scoping review.

PubMed

Tsichlaki, Aliki; O'Brien, Kevin; Johal, Ama; Fleming, Padhraig S

2018-06-01

The selection of appropriate outcomes that matter to both patients and operators is increasingly appreciated, with core outcome sets in clinical trials gaining in popularity. The first step in core outcome set development is the generation of a list of possible important outcomes based on a scoping literature review. Moreover, outcome heterogeneity is known to detract from the findings of systematic reviews and meta-analyses. The aim of this study was to identify the range of outcome domains and specific outcome measures in contemporary orthodontic research. Multiple electronic databases were searched from December 31, 2012, to December 31, 2016, to identify clinical trials of orthodontic interventions, with no language restrictions. Abstracts, eligible full texts, and reference lists were screened, and all reported primary and nonprimary outcomes and methods of measurement were recorded. The search identified 1267 abstracts, of which 189 full-text articles were retrieved, and 164 studies were included in the analysis. A total of 54 outcomes were identified and categorized into 14 outcome domains. The most frequently measured outcomes were patient-reported pain, periodontal health, tooth angulation/inclination changes, and treatment duration, followed by rate of tooth movement and skeletal changes. Outcomes that followed the overall course of treatment were assessed in only 14 studies. Patient perspectives are increasingly being accounted for in orthodontic trials; however, there is little consistency in outcome selection among them. The identified list of outcomes will be used to inform a ranking exercise with service users and providers to establish an agreed core outcome set for future orthodontic clinical trials. Copyright © 2018 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Physical outcome measures for conductive and mixed hearing loss treatment: A systematic review.

PubMed

Johansson, M L; Tysome, J R; Hill-Feltham, P; Hodgetts, W E; Ostevik, A; McKinnon, B J; Monksfield, P; Sockalingam, R; Wright, T

2018-05-07

The number of potential options for rehabilitation of patients with conductive or mixed hearing loss is continually expanding. To be able to inform patients and other stakeholders there is a need to identify and develop patient-centred outcomes for treatment of hearing loss. To identify outcome measures in the physical core area used when reporting the outcome after treatment of conductive and mixed hearing loss in adult patients. Systematic review. Systematic review of literature related to reported physical outcome measures after treatment of mixed or conductive hearing loss without restrictions regarding type of intervention, treatment or device. Any measure reporting the physical outcome after treatment or intervention of mixed or conductive hearing loss was sought and categorised. The physical outcomes measures that had been extracted were then grouped into domains. The literature search resulted in the identification of 1,434 studies, of which 153 were selected for inclusion in the review. The majority (57%) of papers reported results from middle ear surgery, with the remainder reporting results from either bone conduction hearing devices or middle ear implants. Outcomes related to complications were categorised into 17 domains, whereas outcomes related to treatment success was categorised in 22 domains. The importance of these domains to patients and other stakeholders needs to be further explored in order to establish which of these domains are most relevant to interventions for conductive or mixed hearing loss. This will allow us to then assess which outcomes measures are most suitable for inclusion in the core set This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Hydration and Hot Yoga: Encouragement, Behaviors, and Outcomes.

PubMed

Mace Firebaugh, Casey J; Eggleston, Brandon

2017-01-01

Currently, the literature on hot yoga is lacking, and there is still much to understand regarding the safety of these practices. However, one point of safety often emphasized is hydration during the practice of hot yoga. The aim of this study was to examine hydration encouragement by hot yoga instructors and hydration behaviors and related outcomes by hot yoga participants. A cross-sectional study ( n = 700) collected self-report data on demographics, types and frequency of yoga practiced, hydration behaviors, and self-report measures of adverse outcomes experienced by participants during hot yoga. Associations between hydration encouragement, protective behaviors, and adverse outcomes were analyzed through Chi-square tests. Every protective hydration behavior was significantly associated with instructor encouragement ( P < 0.05). Hydration before or during hot yoga participation was associated with a lower occurrence of dehydration symptoms ( P < 0.05). Hot yoga instructors hold a key role in encouraging hydration and student safety outcomes.

Aquatic-Aerobic Exercise as a Means of Stress Reduction during Pregnancy

PubMed Central

Parker, Kara Mallory; Smith, Sheila A.

2003-01-01

The goals of this research were to explore the current literature regarding associations between psychological stress and adverse fetal outcome, associations between aerobic exercise and psychological stress reduction, and associations between aerobic exercise and fetal outcome. The published studies that were located provide evidence of the following: 1) Stress reactivity increases physiologically during pregnancy, 2) pregnant women may experience additional stressors that are usually not experienced in a nonpregnant state, 3) psychological stress in pregnancy is associated with adverse fetal outcome, 4) exercise can be a method of stress reduction, 5) exercise in pregnancy is not associated with adverse fetal outcome, and 6) exercise in pregnancy may provide benefit to the fetus. Data were analyzed from an original study and associations were reported between psychological stress-management activities and participation in aquatic aerobic exercise classes. No reports were available investigating an exercise-induced reduction in psychological stress with fetal outcome. PMID:17273326

Comparison of methodological quality of positive versus negative comparative studies published in Indian medical journals: a systematic review.

PubMed

Charan, Jaykaran; Chaudhari, Mayur; Jackson, Ryan; Mhaskar, Rahul; Reljic, Tea; Kumar, Ambuj

2015-06-24

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. 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. 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. 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. 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.

The use of information and communications technologies in the delivery of interprofessional education: A review of evaluation outcome levels.

PubMed

Curran, Vernon; Reid, Adam; Reis, Pamela; Doucet, Shelley; Price, Sheri; Alcock, Lindsay; Fitzgerald, Shari

2015-01-01

Interprofessional education (IPE) in health and human services educational and clinical settings has proliferated internationally. The use of information and communication technologies (ICTs) in the facilitation of interprofessional learning is also growing, yet reviews of the effectiveness of ICTs in the delivery of pre- and/or post-licensure IPE have been limited. The current study's purpose was to review the evaluation outcomes of IPE initiatives delivered using ICTs. Relevant electronic databases and journals from 1996 to 2013 were searched. Studies which evaluated the effectiveness of an IPE intervention using ICTs were included and analyzed using the Barr et al. modified Kirkpatrick educational outcomes typology. Fifty-five studies were identified and a majority reported evaluation findings at the level 1 (reaction/satisfaction). Analysis revealed that learners react favorably to the use of ICTs in the delivery of IPE, and ICT-mediated IPE can lead to positive attitudinal and knowledge change. A majority of the studies reported positive evaluation outcomes at the learner satisfaction level, with the use of web-based learning modalities. The limited number of studies at other levels of the outcomes typology and deficiencies in study designs indicate the need for more rigorous evaluation of outcomes in ICT-mediated IPE.

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…

Methodological Challenges in Studies Comparing Prehospital Advanced Life Support with Basic Life Support.

PubMed

Li, Timmy; Jones, Courtney M C; Shah, Manish N; Cushman, Jeremy T; Jusko, Todd A

2017-08-01

Determining the most appropriate level of care for patients in the prehospital setting during medical emergencies is essential. A large body of literature suggests that, compared with Basic Life Support (BLS) care, Advanced Life Support (ALS) care is not associated with increased patient survival or decreased mortality. The purpose of this special report is to synthesize the literature to identify common study design and analytic challenges in research studies that examine the effect of ALS, compared to BLS, on patient outcomes. The challenges discussed in this report include: (1) choice of outcome measure; (2) logistic regression modeling of common outcomes; (3) baseline differences between study groups (confounding); (4) inappropriate statistical adjustment; and (5) inclusion of patients who are no longer at risk for the outcome. These challenges may affect the results of studies, and thus, conclusions of studies regarding the effect of level of prehospital care on patient outcomes should require cautious interpretation. Specific alternatives for avoiding these challenges are presented. Li T , Jones CMC , Shah MN , Cushman JT , Jusko TA . Methodological challenges in studies comparing prehospital Advanced Life Support with Basic Life Support. Prehosp Disaster Med. 2017;32(4):444-450.

Patient-Provider Communication and Health Outcomes Among Individuals With Atherosclerotic Cardiovascular Disease in the United States: Medical Expenditure Panel Survey 2010 to 2013.

PubMed

Okunrintemi, Victor; Spatz, Erica S; Di Capua, Paul; Salami, Joseph A; Valero-Elizondo, Javier; Warraich, Haider; Virani, Salim S; Blaha, Michael J; Blankstein, Ron; Butt, Adeel A; Borden, William B; Dharmarajan, Kumar; Ting, Henry; Krumholz, Harlan M; Nasir, Khurram

2017-04-01

Consumer-reported patient-provider communication (PPC) assessed by Consumer Assessment of Health Plans Survey in ambulatory settings is incorporated as a complementary value metric for patient-centered care of chronic conditions in pay-for-performance programs. In this study, we examine the relationship of PPC with select indicators of patient-centered care in a nationally representative US adult population with established atherosclerotic cardiovascular disease. The study population consisted of a nationally representative sample of 6810 individuals (aged ≥18 years), representing 18.3 million adults with established atherosclerotic cardiovascular disease (self-reported or International Classification of Diseases, Ninth Edition diagnosis) reporting a usual source of care in the 2010 to 2013 pooled Medical Expenditure Panel Survey cohort. Participants responded to questions from Consumer Assessment of Health Plans Survey that assessed PPC, and we developed a weighted PPC composite score using their responses, categorized as 1 (poor), 2 (average), and 3 (optimal). Outcomes of interest were (1) patient-reported outcomes: 12-item Short Form physical/mental health status, (2) quality of care measures: statin and ASA use, (3) healthcare resource utilization: emergency room visits and hospital stays, and (4) total annual and out-of-pocket healthcare expenditures. Atherosclerotic cardiovascular disease patients reporting poor versus optimal were over 2-fold more likely to report poor outcomes; 52% and 26% more likely to report that they are not on statin and aspirin, respectively, had a significantly greater utilization of health resources (odds ratio≥2 emergency room visit, 1.41 [95% confidence interval, 1.09-1.81]; odds ratio≥2 hospitalization, 1.36 [95% confidence interval, 1.04-1.79]), as well as an estimated $1243 ($127-$2359) higher annual healthcare expenditure. This study reveals a strong relationship between PPC and patient-reported outcomes, utilization of evidence-based therapies, healthcare resource utilization, and expenditures among those with established atherosclerotic cardiovascular disease. © 2017 American Heart Association, Inc.

Hazelden's model of treatment and its outcome.

PubMed

Stinchfield, R; Owen, P

1998-01-01

Although the Minnesota Model of treatment for alcohol and drug addiction is a common treatment approach, there are few published reports of its effectiveness. This study describes the Minnesota Model treatment approach as practiced at Hazelden, a private residential alcohol and drug abuse treatment center located in Center City, Minnesota (a founding program of the Minnesota Model) and presents recent outcome results from this program. This study includes 1,083 male and female clients admitted to Hazelden for treatment of a psychoactive substance-use disorder between 1989 and 1991. The outcome study is a one group pretest/posttest design. Data collection occurred at admission to treatment and at 1-month, 6-month, and 12-month posttreatment. At 1-year follow-up, 53% reported that they remained abstinent during the year following treatment and an additional 35% had reduced their alcohol and drug use. These results are similar to those reported by other private treatment programs. The Minnesota Model has consistently yielded satisfactory outcome results, and future research needs to focus on the therapeutic process of this common treatment approach.

Navigation-assisted versus conventional total knee replacement: no difference in patient-reported outcome measures (PROMs) at 1 and 2 years.

PubMed

Singisetti, Kiran; Muthumayandi, Karthikeyan; Abual-Rub, Zaid; Weir, David

2015-11-01

Navigation technique for total knee replacement has been shown to improve accuracy of prosthesis alignment in several studies. The purpose was to compare the patient-reported outcome measures in primary total knee replacement (TKR) using navigation versus conventional surgical technique at 1- and 2-year follow-up. A retrospective review of prospectively collected patient-reported outcome data for 351 consecutively performed primary TKR was included in the study. The study group (N = 113) included patients who had Triathlon TKR using articular surface mounted (ASM Stryker) navigation technique and control group (N = 238) included patients who had Triathlon TKR using conventional jig. In addition to the WOMAC (Western Ontario and McMaster University Osteoarthritis Index) and SF-36 (Medical Outcomes Trust Short Form-36), a short self-report questionnaire evaluating the level of satisfaction, quality of life and whether patients would undergo knee replacement again. WOMAC: no significant difference between the groups was noted in mean WOMAC pain, function and stiffness scores at 1- and 2-year follow-up. SF-36: no significant difference between the groups was seen except in the physical function component of score at 1 year (p = 0.019). Navigation group mean 56.78 (CI 51.06-62.5) versus conventional group mean 48.34 (44.68-52.01) but this difference was not observed at 2-year follow-up. The overall patient-reported outcome scores improved after total knee replacement but appear to be comparable in both groups at 1- and 2-year follow-up.

Development of a Lifespan-Based Novel Composite Person-Reported Outcome Measure Using Data from the CINRG Duchenne Natural History Study

DTIC Science & Technology

2017-10-01

drug approval. 2. KEYWORDS: Provide a brief list of keywords (limit to 20 words). Duchenne muscular dystrophy Person-reported outcomes Health ...related quality of life Functional health assessment UC Davis / CINRG Duchenne Natural History Study 5 3. ACCOMPLISHMENTS: The PI is reminded...content, we will conduct focus group discussions with an expert advisory group of DMD clinical research professionals, health care providers, parent

Association between funding source, methodological quality and research outcomes in randomized controlled trials of synbiotics, probiotics and prebiotics added to infant formula: A Systematic Review

PubMed Central

2013-01-01

Background There is little or no information available on the impact of funding by the food industry on trial outcomes and methodological quality of synbiotics, probiotics and prebiotics research in infants. The objective of this study was to compare the methodological quality, outcomes of food industry sponsored trials versus non industry sponsored trials, with regards to supplementation of synbiotics, probiotics and prebiotics in infant formula. Methods A comprehensive search was conducted to identify published and unpublished randomized clinical trials (RCTs). Cochrane methodology was used to assess the risk of bias of included RCTs in the following domains: 1) sequence generation; 2) allocation concealment; 3) blinding; 4) incomplete outcome data; 5) selective outcome reporting; and 6) other bias. Clinical outcomes and authors’ conclusions were reported in frequencies and percentages. The association between source of funding, risk of bias, clinical outcomes and conclusions were assessed using Pearson’s Chi-square test and the Fisher’s exact test. A p-value < 0.05 was statistically significant. Results Sixty seven completed and 3 on-going RCTs were included. Forty (59.7%) were funded by food industry, 11 (16.4%) by non-industry entities and 16 (23.9%) did not specify source of funding. Several risk of bias domains, especially sequence generation, allocation concealment and blinding, were not adequately reported. There was no significant association between the source of funding and sequence generation, allocation concealment, blinding and selective reporting, majority of reported clinical outcomes or authors’ conclusions. On the other hand, source of funding was significantly associated with the domains of incomplete outcome data, free of other bias domains as well as reported antibiotic use and conclusions on weight gain. Conclusion In RCTs on infants fed infant formula containing probiotics, prebiotics or synbiotics, the source of funding did not influence the majority of outcomes in favour of the sponsors’ products. More non-industry funded research is needed to further assess the impact of funding on methodological quality, reported clinical outcomes and authors’ conclusions. PMID:24219082

Mechanisms and effects of public reporting of surgeon outcomes: A systematic review of the literature.

PubMed

Behrendt, Katja; Groene, Oliver

2016-10-01

Public reporting of surgeon outcomes has become a key strategy in the English NHS to ensure accountability and improve the quality of care. Much of the evidence that supported the design of the strategy originates from the USA. This report aims to assess how the evidence on public reporting could be harnessed for cross-country translation of this health system strategy; in particular, to gauge the expected results of the UK surgeon outcome initiative and to propose criteria that elucidate that prerequisites and factors that are needed to public reporting effective. A systematic search of academic databases was followed by snowballing from the reference lists. Only peer-reviewed articles and primary studies were included. 25 studies from the USA (n=22) and the UK (n=3) were included. Suggestive evidence of a negative effect on access to surgery was found for high-risk patients and non-whites; one survey indicated presence of gaming. There was anecdotal evidence of quality improvement measures adopted by low-rated hospitals in New York. Most studies reported only on the effectiveness of public reporting, rather than addressing how effects accrue. This limits cross-country transferability of policy lessons. Based on our analysis, we propose factors impacting on the transferability of the evidence underlying the public reporting of surgeon outcomes, which may inform the adoption of this strategy in other health systems. There is some evidence that public reporting can be an incentive for low performing surgeons to improve quality. Negative incentive on patient selection as suggested in the USA have not yet been observed in the UK. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Nursing Practice Environment and Outcomes for Oncology Nursing

PubMed Central

Shang, Jingjing; Friese, Christopher R.; Wu, Evan; Aiken, Linda H.

2012-01-01

Background It is commonly assumed that oncology nurses experience high job-related burnout and high turnover because their work involves inherent stressors such as caring for patients with serious and often life-threatening illness. Objectives The objectives of this study were to examine the differences in outcomes such as job dissatisfaction and burnout between oncology nurses and medical-surgical nurses, and to identify factors that affect oncology nurse outcomes. Methods A secondary analysis of nurse survey data collected in 2006 including 4047 nurses from 282 hospitals in 3 states was performed; t test and χ2 test compared differences between oncology nurses and medical-surgical nurses in nurse outcomes and their assessments of nurse practice environment, as measured by the Practice Environment Scale of the Nursing Work Index. Logistic regression models estimated the effect of nurse practice environment on 4 nurse-reported outcomes: burnout, job dissatisfaction, intention to leave the current position, and perceived quality of care. Results Oncology nurses reported favorable practice environments and better outcomes than did medical-surgical nurses. All 4 subscales of the Practice Environment Scale of the Nursing Work Index studied were significantly associated with outcomes. Specifically, nurses who reported favorable nursing foundations for quality of care (eg, active in-service or preceptorship programs) were less likely to report burnout and leave their current position. Conclusions Better practice environments, including nurse foundations for quality care, can help to achieve optimal nurse outcomes. Implications for Practice Improving hospital practice environments holds significant potential to improve nurse well-being, retention, and quality of care. Specifically, hospitals should consider preceptor programs and continuing education and increase nurses’ participation in hospital decision making. PMID:22751101

Permanent catheters for recurrent ascites-a critical and systematic review of study methodology.

PubMed

Christensen, Lars; Wildgaard, Lorna; Wildgaard, Kim

2016-06-01

Management of refractory ascites traditionally includes medical treatment with diuretics or intermittent paracentesis. Patients with recurrent ascites may benefit from the use of permanent intra-abdominal catheters with more frequent drainage without hospitalization. The objective was to systematically asses the methodology of factors and endpoints reported in studies investigating permanent catheters for recurrent ascites treatment. Using a systematic search strategy, we critically assessed the methodology when treating refractory ascites using a permanent catheter. Studies critically assessed included both retro- and prospective studies. A total of 715 unique articles were found via PubMed, The Cochrane Library and Embase. Twenty-nine studies (tunnelled catheter = 12, peritoneal ports = 6 and peritoneovenous shunts = 11) with three distinct types of permanent catheters fulfilled the inclusion criteria. Only three studies reported technical success less than 100 %. Data on complications and treatment were not available in all papers; peritonitis (48 %), cellulitis (41 %), prophylactic antibiotics (48 %) and complications to catheter insertion were difficult to distinguish from advanced co-morbidity of patients. Thirteen studies (45 %) reported some type of evaluating patient experience or functional outcome, but only three studies used validated reproducible scales when assessing outcomes. Fifteen of the 29 studies included 30 patients or less. Knowledge is limited because complications and outcomes are poorly defined. The expected increase in catheter treatment of refractory ascites necessitates comparative studies, using validated patient-related outcomes, and the reporting of unambiguous complications. A proposal of variables to include in future studies is presented.

Identifying thresholds for relationships between impacts of rationing of nursing care and nurse- and patient-reported outcomes in Swiss hospitals: a correlational study.

PubMed

Schubert, Maria; Clarke, Sean P; Glass, Tracy R; Schaffert-Witvliet, Bianca; De Geest, Sabina

2009-07-01

In the Rationing of Nursing Care in Switzerland Study, implicit rationing of care was the only factor consistently significantly associated with all six studied patient outcomes. These results highlight the importance of rationing as a new system factor regarding patient safety and quality of care. Since at least some rationing of care appears inevitable, it is important to identify the thresholds of its influences in order to minimize its negative effects on patient outcomes. To describe the levels of implicit rationing of nursing care in a sample of Swiss acute care hospitals and to identify clinically meaningful thresholds of rationing. Descriptive cross-sectional multi-center study. Five Swiss-German and three Swiss-French acute care hospitals. 1338 nurses and 779 patients. Implicit rationing of nursing care was measured using the newly developed Basel Extent of Rationing of Nursing Care (BERNCA) instrument. Other variables were measured using survey items from the International Hospital Outcomes Study battery. Data were summarized using appropriate descriptive measures, and logistic regression models were used to define a clinically meaningful rationing threshold level. For the studied patient outcomes, identified rationing threshold levels varied from 0.5 (i.e., between 0 ('never') and 1 ('rarely') to 2 ('sometimes')). Three of the identified patient outcomes (nosocomial infections, pressure ulcers, and patient satisfaction) were particularly sensitive to rationing, showing negative consequences anywhere it was consistently reported (i.e., average BERNCA scores of 0.5 or above). In other cases, increases in negative outcomes were first observed from the level of 1 (average ratings of rarely). Rationing scores generated using the BERNCA instrument provide a clinically meaningful method for tracking the correlates of low resources or difficulties in resource allocation on patient outcomes. Thresholds identified here provide parameters for administrators to respond to whenever rationing reports exceed the determined level of '0.5' or '1'. Since even very low levels of rationing had negative consequences on three of the six studied outcomes, it is advisable to treat consistent evidence of any rationing as a significant threat to patient safety and quality of care.

"Family Matters": A Systematic Review of the Evidence For Family Psychoeducation For Major Depressive Disorder.

PubMed

Brady, Pamela; Kangas, Maria; McGill, Katherine

2017-04-01

The first aim of this systematic review was to evaluate the evidence for family psychoeducation (FPE) interventions for major depressive disorder (MDD). A second aim was to compare the efficacy of different modes of delivering face-to-face FPE interventions. Ten studies (based on nine distinct samples) were identified comprising four single-family studies, four multifamily studies, one single versus multifamily comparative study, and one peer-led, mixed-diagnosis study. Seven studies measured patient functioning and six reported positive outcomes. Six studies measured carer's well-being and four reported positive outcomes. Results provide preliminary evidence that FPE leads to improved outcomes for patient functioning and family-carer's well-being for persons with depression. The implications for future development and delivery of FPE interventions for MDD are discussed. © 2016 American Association for Marriage and Family Therapy.

What matters to patients? A systematic review of preferences for medication-associated outcomes in mental disorders

PubMed Central

Eiring, Øystein; Landmark, Brynjar Fowels; Aas, Endre; Salkeld, Glenn; Nylenna, Magne

2015-01-01

Objective To investigate patients’ preferences for outcomes associated with psychoactive medications. Setting/design Systematic review of stated preference studies. No settings restrictions were applied. Participants/eligibility criteria We included studies containing quantitative data regarding the relative value adults with mental disorders place on treatment outcomes. Studies with high risk of bias were excluded. Primary and secondary outcome measures We restricted the scope of our review to preferences for outcomes, including the consequences from, attributes of, and health states associated with particular medications or medication classes, and process outcomes. Results After reviewing 11 215 citations, 16 studies were included in the systematic review. These studies reported the stated preferences from patients with schizophrenia (n=9), depression (n=4), bipolar disorder (n=2) and attention deficit hyperactive disorder (n=1). The median sample size was 81. Side effects and symptom outcomes outnumbered functioning and process outcomes. Severe disease and hospitalisation were reported to be least desirable. Patients with schizophrenia tended to value disease states as higher and side effects as lower, compared to other stakeholder groups. In depression, the ability to cope with activities was found to be more important than a depressed mood, per se. Patient preferences could not consistently be predicted from demographic or disease variables. Only a limited number of potentially important outcomes had been investigated. Benefits to patients were not part of the purpose in 9 of the 16 studies, and in 10 studies patients were not involved when the outcomes to present were selected. Conclusions Insufficient evidence exists on the relative value patients with mental disorders place on medication-associated outcomes. To increase patient-centredness in decisions involving psychoactive drugs, further research—with outcomes elicited from patients, and for a larger number of conditions—should be undertaken. Trial registration number PROSPERO CRD42013005685. PMID:25854979

Bone-Patellar Tendon-Bone Versus Soft-Tissue Allograft for Anterior Cruciate Ligament Reconstruction: A Systematic Review.

PubMed

Joyce, Christopher D; Randall, Kyle L; Mariscalco, Michael W; Magnussen, Robert A; Flanigan, David C

2016-02-01

To describe the outcomes of bone-patellar tendon-bone (BPTB) and soft-tissue allografts in anterior cruciate ligament (ACL) reconstruction with respect to graft failure risk, physical examination findings, instrumented laxity, and patient-reported outcomes. A search of the PubMed, Scopus, CINAHL (Cumulative Index to Nursing and Allied Health Literature) Complete, Cochrane Collaboration, and SPORTDiscus databases was performed. English-language studies with outcome data on primary ACL reconstruction with nonirradiated BPTB and soft-tissue allografts were identified. Outcome data included failure risk, physical examination findings, instrumented laxity measurements, and patient-reported outcome scores. Seventeen studies met the inclusion criteria. Of these studies, 11 reported on BPTB allografts exclusively, 5 reported on soft-tissue allografts exclusively, and 1 compared both types. The comparative study showed no difference in failure risk, Lachman grade, pivot-shift grade, instrumented laxity, or overall International Knee Documentation Committee score between the 2 allograft types. Data from all studies yielded a failure risk of 10.3% (95% confidence interval [CI], 4.5% to 18.1%) in the soft-tissue group and 15.2% (95% CI, 11.3% to 19.6%) in the BPTB group. The risk of a Lachman grade greater than 5 mm was 6.4% (95% CI, 1.7% to 13.7%) in the soft-tissue group and 8.6% (95% CI, 6.3% to 11.2%) in the BPTB group. The risk of a grade 2 or 3 pivot shift was 1.4% (95% CI, 0.3% to 3.3%) in the soft-tissue group and 4.1% (95% CI, 1.9% to 7.2%) in the BPTB group. One comparative study showed no difference in results after ACL reconstruction with nonirradiated BPTB and soft-tissue allografts. Inclusion of case series in the analysis showed qualitatively similar outcomes with the 2 graft types. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Adherence to antiretroviral therapy and treatment outcomes among conflict-affected and forcibly displaced populations: a systematic review

PubMed Central

2012-01-01

Background Optimal adherence to highly active antiretroviral therapy (HAART) is required to promote viral suppression and to prevent disease progression and mortality. Forcibly displaced and conflict-affected populations may face challenges succeeding on HAART. We performed a systematic review of the literature on adherence to HAART and treatment outcomes in these groups, including refugees and internally-displaced persons (IDPs), assessed the quality of the evidence and suggest a future research program. Methods Medline, Embase, and Global Health databases for 1995–2011 were searched using the Ovid platform. A backward citation review of subsequent work that had cited the Ovid results was performed using the Web of Science database. ReliefWeb and Médecins Sans Frontières (MSF) websites were searched for additional grey literature. Results and conclusion We screened 297 records and identified 17 reports covering 15 quantitative and two qualitative studies from 13 countries. Three-quarters (11/15) of the quantitative studies were retrospective studies based on chart review; five studies included <100 clients. Adherence or treatment outcomes were reported in resettled refugees, conflict-affected persons, internally-displaced persons (IDPs), and combinations of refugees, IDPs and other foreign-born persons. The reviewed reports showed promise for conflict-affected and forcibly-displaced populations; the range of optimal adherence prevalence reported was 87–99.5%. Treatment outcomes, measured using virological, immunological and mortality estimates, were good in relation to non-affected groups. Given the diversity of settings where forcibly-displaced and conflict-affected persons access ART, further studies on adherence and treatment outcomes are needed to support scale-up and provide evidence-based justifications for inclusion of these vulnerable groups in national treatment plans. Future studies and program evaluations should focus on systematic monitoring of adherence and treatment interruptions by using facility-based pharmacy records, understanding threats to optimal adherence and timely linkage to care throughout the displacement cycle, and testing interventions designed to support adherence and treatment outcomes in these settings. PMID:23110782

What outcomes are associated with developing and implementing co-produced interventions in acute healthcare settings? A rapid evidence synthesis

PubMed Central

Clarke, David; Jones, Fiona; Harris, Ruth; Robert, Glenn

2017-01-01

Background Co-production is defined as the voluntary or involuntary involvement of users in the design, management, delivery and/or evaluation of services. Interest in co-production as an intervention for improving healthcare quality is increasing. In the acute healthcare context, co-production is promoted as harnessing the knowledge of patients, carers and staff to make changes about which they care most. However, little is known regarding the impact of co-production on patient, staff or organisational outcomes in these settings. Aims To identify and appraise reported outcomes of co-production as an intervention to improve quality of services in acute healthcare settings. Design Rapid evidence synthesis. Data sources Medline, Cinahl, Web of Science, Embase, HMIC, Cochrane Database of Systematic Reviews, SCIE, Proquest Dissertation and Theses, EThOS, OpenGrey; CoDesign; The Design Journal; Design Issues. Study selection Studies reporting patient, staff or organisational outcomes associated with using co-production in an acute healthcare setting. Findings 712 titles and abstracts were screened; 24 papers underwent full-text review, and 11 papers were included in the evidence synthesis. One study was a feasibility randomised controlled trial, three were process evaluations and seven used descriptive qualitative approaches. Reported outcomes related to (a) the value of patient and staff involvement in co-production processes; (b) the generation of ideas for changes to processes, practices and clinical environments; and (c) tangible service changes and impacts on patient experiences. Only one study included cost analysis; none reported an economic evaluation. No studies assessed the sustainability of any changes made. Conclusions Despite increasing interest in and advocacy for co-production, there is a lack of rigorous evaluation in acute healthcare settings. Future studies should evaluate clinical and service outcomes as well as the cost-effectiveness of co-production relative to other forms of quality improvement. Potentially broader impacts on the values and behaviours of participants should also be considered. PMID:28701409

Using MicroCT to Assess Periodontal Regeneration Outcomes-Comparison of Image-Based and Histologic Results: A Case Report.

PubMed

Rebaudi, Alberto; Trisi, Paolo; Pagni, Giorgio; Wang, Hom-Lay

The purpose of this study was to compare microcomputed tomography (microCT) and histologic analysis outcomes of a periodontal regeneration of a human defect treated with a polylactic- and polyglycolic-acid copolymer. At 11 months following the grafting procedure, the root with the surrounding periodontal tissues was removed and analyzed using microCT and histologic techniques. The results suggest that microCT three-dimensional analysis may be used in synergy with two-dimensional histologic sections to provide additional information for studying the regeneration outcomes normally reported by histologic biopsies in humans. Additional data is needed to validate these findings.

A systematic review of studies examining the relationship between reported racism and health and wellbeing for children and young people.

PubMed

Priest, Naomi; Paradies, Yin; Trenerry, Brigid; Truong, Mandy; Karlsen, Saffron; Kelly, Yvonne

2013-10-01

Racial discrimination is increasingly recognised as a determinant of racial and ethnic health inequalities, with growing evidence of strong associations between racial discrimination and adult health outcomes. There is a growing body of literature that considers the effects of racial discrimination on child and youth health. The aim of this paper is to provide a systematic review of studies that examine relationships between reported racial discrimination and child and youth health. We describe the characteristics of 121 studies identified by a comprehensive search strategy, including definitions and measurements of racial discrimination and the nature of reported associations. Most studies were published in the last seven years, used cross-sectional designs and were conducted in the United States with young people aged 12-18 years. African American, Latino/a, and Asian populations were most frequently included in these studies. Of the 461 associations examined in these studies, mental health outcomes (e.g. depression, anxiety) were most commonly reported, with statistically significant associations with racial discrimination found in 76% of outcomes examined. Statistically significant associations were also found for over 50% of associations between racial discrimination and positive mental health (e.g. self esteem, resilience), behaviour problems, wellbeing, and pregnancy/birth outcomes. The field is currently limited by a lack of longitudinal studies, limited psychometrically validated exposure instruments and poor conceptualisation and definition of racial discrimination. There is also a need to investigate the complex and varying pathways by which reported racial discrimination affect child and youth health. Ensuring study quality in this field will allow future research to reveal the complex role that racial discrimination plays as a determinant of child and youth health. Copyright © 2012 Elsevier Ltd. All rights reserved.

American BRCA Outcomes and Utilization of Testing (ABOUT) study: a pragmatic research model that incorporates personalized medicine/patient-centered outcomes in a real world setting.

PubMed

Armstrong, Joanne; Toscano, Michele; Kotchko, Nancy; Friedman, Sue; Schwartz, Marc D; Virgo, Katherine S; Lynch, Kristian; Andrews, James E; Aguado Loi, Claudia X; Bauer, Joseph E; Casares, Carolina; Teten, Rachel Threet; Kondoff, Matthew R; Molina, Ashley D; Abdollahian, Mehrnaz; Brand, Lana; Walker, Gregory S; Sutphen, Rebecca

2015-02-01

Research to date regarding identification and management of hereditary breast and ovarian cancer syndrome (HBOC) in the U.S. has been confined primarily to academic center-based studies with limited patient engagement. To begin to understand and address the current gaps and disparities in delivery of services for the appropriate identification and optimal risk management of individuals with HBOC, we designed and have initiated the American BRCA Outcomes and Utilization of Testing (ABOUT) Study. ABOUT relies on a collaborative patient advocacy, academic and industry partnership to recruit and engage U.S. individuals who are at increased risk for HBOC and investigate their experiences, decisions and outcomes. It utilizes an extensive research infrastructure, including an interactive web-based data system and electronic interfaces for secure online participation and automated data exchange. We describe the novel recruitment approach that was designed for collaboration with a national commercial health plan partner to identify all individuals for whom a healthcare provider orders a BRCA test and mail to each individual an invitation to participate and study packet. The study packet contains detailed information about the study, a baseline questionnaire and informed consent for participation in the study, for release of relevant medical and health plan records and for ongoing research engagement. This approach employs patient-reported, laboratory-reported and health plan-reported outcomes and facilitates longitudinal engagement. We believe that the type of innovative methodology and collaborative framework we have developed for ABOUT is an ideal foundation for a patient-powered research network. This approach can make substantial contributions to identifying current and best practices in HBOC, leading to improved strategies for clinical care and optimal health outcomes among individuals with high inherited risk for cancer.

Cardiovascular Disease Outcomes Among the NASA Astronaut Corps

NASA Technical Reports Server (NTRS)

Charvat, Jacqueline M.; Lee, Stuart M. C.; Wear, Mary L.; Stenger, Michael B.; Van Baalen, Mary

2018-01-01

BACKGROUND: Acute effects of spaceflight on the cardiovascular system have been studied extensively, but the combined chronic effects of spaceflight and aging are not well understood. Preparation for and participation in spaceflight activities are associated with changes in the cardiovascular system such as decreased carotid artery distensibility and decreased ventricular mass which may lead to an increased risk of cardiovascular disease. Additionally, astronauts who travel into space multiple times or for longer durations may be at an increased risk across their lifespan. To that end, the purpose of this study was to determine the incidence of common cardiovascular disease (CVD) outcomes among the NASA astronaut corps during their active career and through retirement. METHODS: Cardiovascular disease outcomes were defined as reports of any of the following: myocardial infarction (MI), revascularization procedures (coronary artery bypass graft surgery [CABG] or percutaneous coronary intervention [PCI]), hypertension, stroke or transient ischemic attack [TIA], heart failure, or total CVD (as defined by the AHA - combined outcome of MI, Angina Pectoris, heart failure, stroke, and hypertension). Each outcome was identified individually from review of NASA's Electronic Medical Record (EMR), EKG reports, and death certificates using ICD-9 codes as well as string searches of physician notes of astronaut exams that occurred between 1959 and 2016. RESULTS: Of 338 NASA astronauts selected as of 2016, 9 reported an MI, 12 reported a revascularization procedure, (7 PCI and 5 CABG), 4 reported Angina (without MI), 5 reported heart failure, 9 reported stroke/TIA, and 96 reported hypertension. Total CVD was reported in 105 astronauts. No astronaut who had an MI or revascularization procedure flew a spaceflight mission following the event. All MI, revascularization, and stroke events occurred in male astronauts. When reviewing astronaut ECG reports, abnormal ECG reports were found in only 8% of records (n=430) and mainly among retired astronauts (82%), with marked sinus bradycardia being the reason for the abnormal classification.

Does Pharmacogenomic Testing Improve Clinical Outcomes for Major Depressive Disorder? A Systematic Review of Clinical Trials and Cost-Effectiveness Studies.

PubMed

Rosenblat, Joshua D; Lee, Yena; McIntyre, Roger S

2017-06-01

Pharmacogenomic testing has become scalable and available to the general public. Pharmacogenomics has shown promise for predicting antidepressant response and tolerability in the treatment of major depressive disorder (MDD). In theory, pharmacogenomics can improve clinical outcomes by guiding antidepressant selection and dosing. The current systematic review examines the extant literature to determine the impact of pharmacogenomic testing on clinical outcomes in MDD and assesses its cost-effectiveness. The MEDLINE/PubMed and Google Scholar databases were systematically searched for relevant articles published prior to October 2015. Search terms included various combinations of the following: major depressive disorder (MDD), depression, mental illness, mood disorder, antidepressant, response, remission, outcome, pharmacogenetic, pharmacogenomics, pharmacodynamics, pharmacokinetic, genetic testing, genome wide association study (GWAS), CYP450, personalized medicine, cost-effectiveness, and pharmacoeconomics. Of the 66 records identified from the initial search, relevant clinical studies, written in English, assessing the cost-effectiveness and/or efficacy of pharmacogenomic testing for MDD were included. Each publication was critically examined for relevant data. Two nonrandomized, open-label, 8-week, prospective studies reported overall greater improvement in depressive symptom severity in the group of MDD subjects receiving psychiatric care guided by results of combinatorial pharmacogenomic testing (GeneSight) when compared to the unguided group. One industry-sponsored, randomized, double-blind, 10-week prospective study reported a trend for improved outcomes for the GeneSight-guided group; however, the trend did not reach statistical significance. Another industry-sponsored, randomized, double-blind, 12-week prospective study reported a 2.5-fold increase in remission rates in the CNSDose-guided group (P < .0001). One naturalistic, unblinded, industry-sponsored study showed clinical improvement when pharmacogenomics testing guided prescribing; however, this study lacked a control group. A single cost-effectiveness study concluded that single gene testing was not cost-effective. Conversely, a separate study reported that combinatorial pharmacogenomic testing is cost-effective. A limited number of studies have shown promise for the clinical utility of pharmacogenomic testing; however, cost-effectiveness of pharmacogenomics, as well as demonstration of improved health outcomes, is not yet supported with replicated evidence. © Copyright 2017 Physicians Postgraduate Press, Inc.

Los Angeles County Juvenile Justice Crime Prevention Act: Fiscal Year 2005-2006. Report Summary

ERIC Educational Resources Information Center

Turner, Susan; Fain, Terry; Sehgal, Amber

2007-01-01

This document summarizes a study relating to California counties receiving state funds for Juvenile Justice Crime Prevention Act (JJCPA) programs. These counties are required to report six outcome measures to the California State Legislature on an annual basis to measure the success of the program. These outcome measures are (1) successful…

Voice-Related Patient-Reported Outcome Measures: A Systematic Review of Instrument Development and Validation

ERIC Educational Resources Information Center

Francis, David O.; Daniero, James J.; Hovis, Kristen L.; Sathe, Nila; Jacobson, Barbara; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.

2017-01-01

Purpose: The purpose of this study was to perform a comprehensive systematic review of the literature on voice-related patient-reported outcome (PRO) measures in adults and to evaluate each instrument for the presence of important measurement properties. Method: MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, and the Health…

Summary of Outcome Data for Youth Alcohol and Other Drug Abuse Programs.

ERIC Educational Resources Information Center

Buck, Connie

The purpose of this report is to summarize steps taken in evaluating outcomes for the prevention of youth alcohol and other drug abuse (AODA) for selected AODA prevention programs and projects as reported to Wisconsin's Department of Health and Family Services by grantees. A study by Wisconsin's Legislative Audit Bureau evaluated 6 projects, which…

The Investigation and Outcome of Reported Cases of Elder Abuse: The Forsyth County Aging Study.

ERIC Educational Resources Information Center

Shiferaw, Beletshachew; And Others

1994-01-01

Summarized outcome of all investigations of elder abuse conducted in Forsyth County, North Carolina, during three-year period ending December 1991. Of 123 cases investigated, 23 were confirmed as elder abuse. Found no statistically significant differences in age, sex, race, living arrangements, mental status, mobility, or source of report between…

Multivariate Meta-Analysis Using Individual Participant Data

ERIC Educational Resources Information Center

Riley, R. D.; Price, M. J.; Jackson, D.; Wardle, M.; Gueyffier, F.; Wang, J.; Staessen, J. A.; White, I. R.

2015-01-01

When combining results across related studies, a multivariate meta-analysis allows the joint synthesis of correlated effect estimates from multiple outcomes. Joint synthesis can improve efficiency over separate univariate syntheses, may reduce selective outcome reporting biases, and enables joint inferences across the outcomes. A common issue is…

Use of and confidence in administering outcome measures among clinical prosthetists: Results from a national survey and mixed-methods training program.

PubMed

Gaunaurd, Ignacio; Spaulding, Susan E; Amtmann, Dagmar; Salem, Rana; Gailey, Robert; Morgan, Sara J; Hafner, Brian J

2015-08-01

Outcome measures can be used in prosthetic practices to evaluate interventions, inform decision making, monitor progress, document outcomes, and justify services. Strategies to enhance prosthetists' ability to use outcome measures are needed to facilitate their adoption in routine practice. To assess prosthetists' use of outcome measures and evaluate the effects of training on their confidence in administering performance-based measures. Cross-sectional and single-group pretest-posttest survey. Seventy-nine certified prosthetists (mean of 16.0 years of clinical experience) were surveyed about their experiences with 20 standardized outcome measures. Prosthetists were formally trained by the investigators to administer the Timed Up and Go and Amputee Mobility Predictor. Prosthetists' confidence in administering the Timed Up and Go and Amputee Mobility Predictor was measured before and after training. The majority of prosthetists (62%) were classified as non-routine outcome measure users. Confidence administering the Timed Up and Go and Amputee Mobility Predictor prior to training was low-to-moderate across the study sample. Training significantly (p < 0.0001) improved prosthetists' confidence in administering both instruments. Prosthetists in this study reported limited use of and confidence with standardized outcome measures. Interactive training resulted in a statistically significant increase of prosthetists' confidence in administering the Timed Up and Go and Amputee Mobility Predictor and may facilitate use of outcome measures in clinical practice. Frequency of outcome measure use in the care of persons with limb loss has not been studied. Study results suggest that prosthetists may not regularly use standardized outcome measures and report limited confidence in administering them. Training enhances confidence and may encourage use of outcome measures in clinical practice. © The International Society for Prosthetics and Orthotics 2014.

A third of systematic reviews changed or did not specify the primary outcome: a PROSPERO register study.

PubMed

Tricco, Andrea C; Cogo, Elise; Page, Matthew J; Polisena, Julie; Booth, Alison; Dwan, Kerry; MacDonald, Heather; Clifford, Tammy J; Stewart, Lesley A; Straus, Sharon E; Moher, David

2016-11-01

To examine outcome reporting bias of systematic reviews registered in PROSPERO. Retrospective cohort study. The primary outcomes from systematic review publications were compared with those reported in the corresponding PROSPERO records; discrepancies in the primary outcomes were assessed as upgrades, additions, omissions, or downgrades. Relative risks (RRs) and 95% confidence intervals (CI) were calculated to determine the likelihood of having a change in primary outcome when the meta-analysis result was favorable and statistically significant. Ninety-six systematic reviews were published. A discrepancy in the primary outcome occurred in 32% of the included reviews and 39% of the reviews did not explicitly specify a primary outcome(s); 6% of the primary outcomes were omitted. There was no significant increased risk of adding/upgrading (RR, 2.14; 95% CI: 0.53, 8.63) or decreased risk of downgrading (RR, 0.76; 95% CI: 0.27, 2.17) an outcome when the meta-analysis result was favorable and statistically significant. As well, there was no significant increased risk of adding/upgrading (RR, 0.89; 95% CI: 0.31, 2.53) or decreased risk of downgrading (RR, 0.56; 95% CI: 0.29, 1.08) an outcome when the conclusion was positive. We recommend review authors carefully consider primary outcome selection, and journals are encouraged to focus acceptance on registered systematic reviews. Copyright © 2016 Elsevier Inc. All rights reserved.

Risk factors for adverse outcomes in older adults with blunt chest trauma: A systematic review.

PubMed

Sawa, Jake; Green, Robert S; Thoma, Brent; Erdogan, Mete; Davis, Philip J

2017-08-11

The objective of this study was to systematically review the published literature for risk factors associated with adverse outcomes in older adults sustaining blunt chest trauma. EMBASE and MEDLINE were searched from inception until March 2017 for prognostic factors associated with adverse outcomes in older adults sustaining blunt chest trauma using a pre-specified search strategy. References were independently screened for inclusion by two reviewers. Study quality was assessed using the Quality in Prognostic Studies tool. Where appropriate, descriptive statistics were used to evaluate study characteristics and predictors of adverse outcomes. Thirteen cohort studies representing 79,313 patients satisfied our selection criteria. Overall, 26 prognostic factors were examined across studies and were reported for morbidity (8 studies), length of stay (7 studies), mortality (6 studies), and loss of independence (1 study). No studies examined patient quality of life or emergency department recidivism. Prognostic factors associated with morbidity and mortality included age, number of rib fractures, and injury severity score. Although age and rib fractures were found to be associated with adverse outcomes in more than 3 studies, meta-analysis was not performed due to heterogeneity amongst included studies in how these variables were measured. While blunt chest wall trauma in older adults is relatively common, the literature on prognostic factors for adverse outcomes in this patient population remains inadequate due to a paucity of high quality studies and lack of consistent reporting standards.

Wound healing outcomes: Using big data and a modified intent-to-treat method as a metric for reporting healing rates.

PubMed

Ennis, William J; Hoffman, Rachel A; Gurtner, Geoffrey C; Kirsner, Robert S; Gordon, Hanna M

2017-08-01

Chronic wounds are increasing in prevalence and are a costly problem for the US healthcare system and throughout the world. Typically outcomes studies in the field of wound care have been limited to small clinical trials, comparative effectiveness cohorts and attempts to extrapolate results from claims databases. As a result, outcomes in real world clinical settings may differ from these published studies. This study presents a modified intent-to-treat framework for measuring wound outcomes and measures the consistency of population based outcomes across two distinct settings. In this retrospective observational analysis, we describe the largest to date, cohort of patient wound outcomes derived from 626 hospital based clinics and one academic tertiary care clinic. We present the results of a modified intent-to-treat analysis of wound outcomes as well as demographic and descriptive data. After applying the exclusion criteria, the final analytic sample includes the outcomes from 667,291 wounds in the national sample and 1,788 wounds in the academic sample. We found a consistent modified intent to treat healing rate of 74.6% from the 626 clinics and 77.6% in the academic center. We recommend that a standard modified intent to treat healing rate be used to report wound outcomes to allow for consistency and comparability in measurement across providers, payers and healthcare systems. © 2017 by the Wound Healing Society.

Maternal and cord blood vitamin D status and childhood infection and allergic disease: a systematic review

PubMed Central

Fried, David A.; Rhyu, Jane; Odato, Karen; Blunt, Heather; Karagas, Margaret R.

2016-01-01

Context: It is unclear how in utero vitamin D deficiency affects the extraskeletal health of children, despite the known risks for adverse pregnancy/birth outcomes. Objective: This systematic review seeks to assess the effect of in utero vitamin D exposure on childhood allergy and infection outcomes using the PRISMA guidelines. Data Sources: MEDLINE, Cochrane Library, and Web of Science databases were searched. Study Selection: Literature published through April 2015 was searched for studies reporting on the association between maternal pregnancy or cord blood vitamin D status and childhood allergy and infection. Data Extraction: Of 4175 articles identified, 43 studies met the inclusion criteria. They examined a wide variety of outcomes, using many different vitamin D cutoff values in their analyses. Data Synthesis: For most outcomes, results were inconsistent, although there appeared to be a protective effect between higher in utero vitamin D status and childhood lower respiratory tract infection (5 of 10 studies). Conclusions: More research is needed on childhood allergy and infection outcomes, and future studies should standardize outcome reporting, especially with regard to cutoff values for vitamin D concentrations. Evidence of a protective association between in utero vitamin D exposure and lower respiratory tract infection was found, while the other outcomes were either understudied or showed inconsistent results. PROSPERO registration no. CRD42013006156. PMID:27083486

Employment and educational outcomes in early intervention programmes for early psychosis: a systematic review.

PubMed

Bond, G R; Drake, R E; Luciano, A

2015-10-01

Young adults with early psychosis want to pursue normal roles - education and employment. This paper summarises the empirical literature on the effectiveness of early intervention programmes for employment and education outcomes. We conducted a systematic review of employment/education outcomes for early intervention programmes, distinguishing three programme types: (1) those providing supported employment, (2) those providing unspecified vocational services and (3) those without vocational services. We summarised findings for 28 studies. Eleven studies evaluated early intervention programmes providing supported employment. In eight studies that reported employment outcomes separately from education outcomes, the employment rate during follow-up for supported employment patients was 49%, compared with 29% for patients receiving usual services. The two groups did not differ on enrolment in education. In four controlled studies, meta-analysis showed that the employment rate for supported employment participants was significantly higher than for control participants, odds ratio = 3.66 [1.93-6.93], p < 0.0001. Five studies (four descriptive and one quasi-experimental) of early intervention programmes evaluating unspecified vocational services were inconclusive. Twelve studies of early intervention programmes without vocational services were methodologically heterogeneous, using diverse methods for evaluating vocational/educational outcomes and precluding a satisfactory meta-analytic synthesis. Among studies with comparison groups, 7 of 11 (64%) reported significant vocational/education outcomes favouring early intervention over usual services. In early intervention programmes, supported employment moderately increases employment rates but not rates of enrolment in education. These improvements are in addition to the modest effects early programmes alone have on vocational/educational outcomes compared with usual services.

The Implementation and Evaluation of Health Promotion Services and Programs to Improve Cultural Competency: A Systematic Scoping Review.

PubMed

Jongen, Crystal Sky; McCalman, Janya; Bainbridge, Roxanne Gwendalyn

2017-01-01

Cultural competency is a multifaceted intervention approach, which needs to be implemented at various levels of health-care systems to improve quality of care for culturally and ethnically diverse populations. One level of health care where cultural competency is required is in the provision of health promotion services and programs targeted to diverse patient groups who experience health-care and health inequalities. To inform the implementation and evaluation of health promotion programs and services to improve cultural competency, research must assess both intervention strategies and intervention outcomes. This scoping review was completed as part of a larger systematic literature search conducted on evaluations of cultural competence interventions in health care in Canada, the United States, Australia, and New Zealand. Seventeen peer-reviewed databases, 13 websites and clearinghouses, and 11 literature reviews were searched. Overall, 64 studies on cultural competency interventions were found, with 22 being health promotion programs and services. A process of thematic analysis was utilized to identify key intervention strategies and outcomes reported in the literature. The review identified three overarching strategies utilized in health promotion services and programs to improve cultural competency: community-focused strategies, culturally focused strategies, and language-focused strategies. Studies took different approaches to delivering culturally competent health interventions, with the majority incorporating multiple strategies from each overarching category. There were various intermediate health-care and health outcomes reported across the included studies. Most commonly reported were positive reports of patient satisfaction, patient/participant service access, and program/study retention rates. The health outcome results indicate positive potential of health promotion services and programs to improve cultural competency to impact cardiovascular disease and mental health outcomes. However, due to measurement and study quality issues, it is difficult to determine the extent of the impacts. Examined together, these intervention strategies and outcomes provide a framework that can be used by service providers and researchers in the implementation and evaluation of health promotion services and programs to improve cultural competency. While there is evidence indicating the effectiveness of such health promotion interventions in improving intermediate and health outcomes, further attention is needed to issues of measurement and study quality.

Predicting medical school and internship success: does the quality of the research and clinical experience matter?

PubMed

Paolino, Nathalie D; Artino, Anthony R; Saguil, Aaron; Dong, Ting; Durning, Steven J; DeZee, Kent J

2015-04-01

This article explores specific aspects of self-reported clinical and research experience and their relationship to performance in medical training. This is a retrospective cohort study conducted at the Uniformed Services University. The American Medical College Application Service application was used to discern students' self-reported clinical and research experience. Two authors applied a classification scheme for clinical and research experience to the self-reported experiences. Study outcomes included medical school grade point average (GPA), U.S. Medical Licensing Examination (USMLE) scores, and intern expertise and professionalism scores. A linear regression analysis was conducted for each outcome while controlling for prematriculation GPA. Data were retrieved on 1,020 matriculants. There were several statistically significant but small differences across outcomes when comparing the various categories of clinical experience with no clinical experience. The technician-level experience group had a decrease of 0.1 in cumulative GPA in comparison to students without self-reported clinical experience (p = 0.004). This group also performed 5 points lower on the USMLE Step 2 than students who did not report clinical experience (p = 0.013). The various levels of self-reported research experience were unrelated to success in medical school and graduate medical education. These findings indicate that self-reported technician-level clinical experience is related to a small reduction in typically reported outcomes in medical school. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

The Association Between Professional Burnout and Engagement With Patient Safety Culture and Outcomes: A Systematic Review.

PubMed

Mossburg, Sarah E; Dennison Himmelfarb, Cheryl

2018-06-25

In the last 20 years, there have been numerous successful efforts to improve patient safety, although recent research still shows a significant gap. Researchers have begun exploring the impact of individual level factors on patient safety culture and safety outcomes. This review examines the state of the science exploring the impact of professional burnout and engagement on patient safety culture and safety outcomes. A systematic search was conducted in CINAHL, PubMed, and Embase. Studies included reported on the relationships among burnout or engagement and safety culture or safety outcomes. Twenty-two studies met inclusion criteria. Ten studies showed a relationship between both safety culture and clinical errors with burnout. Two of 3 studies reported an association between burnout and patient outcomes. Fewer studies focused on engagement. Most studies exploring engagement and safety culture found a moderately strong positive association. The limited evidence on the relationship between engagement and errors depicts inconsistent findings. Only one study explored engagement and patient outcomes, which failed to find a relationship. The burnout/safety literature should be expanded to a multidisciplinary focus. Mixed results of the relationship between burnout and errors could be due to a disparate relationship with perceived versus observed errors. The engagement/safety literature is immature, although high engagement seems to be associated with high safety culture. Extending this science into safety outcomes would be meaningful, especially in light of the recent focus on an abundance-based approach to safety.

Outcomes After Diagnostic Hip Injection.

PubMed

Lynch, T Sean; Steinhaus, Michael E; Popkin, Charles A; Ahmad, Christopher S; Rosneck, James

2016-08-01

To provide a comprehensive review of outcomes associated with local anesthetic (LA) or LA and corticosteroid (CS) diagnostic hip injections, and how well response predicts subsequent operative success. A systematic review from database (PubMed, Medline, Scopus, Embase) inception to January 2015 for English-language articles reporting primary patient outcomes data was performed, excluding studies with >50% underlying osteoarthritis. Studies were assessed by 2 reviewers who collected pertinent data. Seven studies were included, reporting on a total 337 patients undergoing diagnostic hip injection. The mean age was 34.4 years, with 5 studies reporting 94 (35.2%) males and 173 (64.8%) females. One study examined the rate of pain relief with LA (92.5%); 2 CS studies reported relief on a scale from 0% to 100% (no to complete relief), ranging from 61% to 82.3%; and 3 studies used 10-point pain scales, with a CS study noting a pain score of 1.0, an LA study with a score of 3.03, and 1 study using either CS or LA scores of 3 to 5.6. Duration of pain relief was 9.8 (CS) and 2.35 days (LA). By pathology, greatest relief was achieved in acetabular chondral injury (93.3%) and least in cam impingement (81.6%), with clinical and imaging findings being unreliable predictors of relief. One study showed nonresponse to be a strong predictor of negative surgical outcome for femoroacetabular impingement. Diagnostic hip injections provide substantial pain relief for patients with various hip pathologies, with limited data to suggest greatest relief for those with chondral injury. Clinical and imaging findings are unreliable predictors of injection response, and nonresponse to injection is a strong negative predictor of surgical outcome. Future research should focus on elucidating differences by underlying pathology and predicting future operative success. Level IV, systematic review. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Health Outcomes of Sexual-Minority Youth in Canada: An Overview

PubMed Central

Blais, Martin; Bergeron, Félix-Antoine; Duford, Julie; Boislard, Marie-Aude; Hébert, Martine

2016-01-01

Objectives The objectives of this review are to (1) document health outcomes among sexual-minority youth (SMY) in Canada; and (2) identify sexual-minority-specific risk and protective factors Data Sources We conducted a review of Canadian data published after 2005 on the mental, physical and sexual health outcomes of SMY using relevant keywords. A total of 19 empirical studies and 2 research reports was included. Data Synthesis The study reviewed included 53 to 30 588 respondents (total = 81 567). SMY counted for 15.86% of the total sample. Overall, SMY in Canada show negative health outcomes in proportions varying from 7% to 69.4%, the most common issues being psychological distress and maladjustment. SMY are more likely than their heterosexual peers to report psychological distress/malfunctioning, suicidality, substance misuse, condomless intercourse, pregnancy involvement. Main SMY-specific risk factors were family rejection of one’s minority sexual orientation, homophobic bullying and victimization, and internalized homophobia. Among the few protective factors that were reported, school and family connectedness, school safety, parental support and sports involvement decreased the odds of negative health outcomes. Conclusions Canadian data show that SMY are more likely to experience negative health outcomes than their heterosexual peers. These results are consistent with data from around the world. Recommendations for research and intervention are discussed. PMID:28111592

Asperger syndrome and nonverbal learning difficulties in adult males: self- and parent-reported autism, attention and executive problems.

PubMed

Hagberg, Bibbi; Billstedt, Eva; Nydén, Agneta; Gillberg, Christopher

2015-08-01

A specific overlap between Asperger syndrome (AS) and nonverbal learning difficulties (NLD) has been proposed, based on the observation that, as a group, people with AS tend to have significantly higher verbal IQ (VIQ) than performance IQ (PIQ), one of the core features of NLD. The primary aim was to assess the longer term outcome of NLD--broken down into persistent and transient forms. The present study of 68 individuals was performed in the context of a larger prospective longitudinal study to late adolescence/early adult life of 100 boys with AS. Using self- and parent-report measures, we studied the longer term outcome of the NLD (defined as VIQ > PIQ by 15 points) as regards social communication, repetitive behaviour, attention, and executive function (EF) was studied. Three subgroups were identified: (1) Persistent NLD (P-NLD), (2) Childhood "only" NLD (CO-NLD) and (3) Never NLD (NO-NLD). The P-NLD group had the worst outcome overall. The CO-NLD group had better reported EF scores than the two other AS subgroups. There were no differences between the subgroups regarding social communication, repetitive behaviour, or attentional skills. Low PIQ increased the risk of ADHD symptoms. In the context of AS in males, P-NLD carries a relatively poor outcome, particularly with regard to self-reported EF. However, CO-NLD appears to entail a significantly better outcome. The results underscore the importance of analysing the cognitive profile both at diagnosis and after several years, so as to be able to formulate a realistic prognosis.

Failure mode and effective analysis ameliorate awareness of medical errors: a 4-year prospective observational study in critically ill children.

PubMed

Daverio, Marco; Fino, Giuliana; Luca, Brugnaro; Zaggia, Cristina; Pettenazzo, Andrea; Parpaiola, Antonella; Lago, Paola; Amigoni, Angela

2015-12-01

Errors in are estimated to occur with an incidence of 3.7-16.6% in hospitalized patients. The application of systems for detection of adverse events is becoming a widespread reality in healthcare. Incident reporting (IR) and failure mode and effective analysis (FMEA) are strategies widely used to detect errors, but no studies have combined them in the setting of a pediatric intensive care unit (PICU). The aim of our study was to describe the trend of IR in a PICU and evaluate the effect of FMEA application on the number and severity of the errors detected. With this prospective observational study, we evaluated the frequency IR documented in standard IR forms completed from January 2009 to December 2012 in the PICU of Woman's and Child's Health Department of Padova. On the basis of their severity, errors were classified as: without outcome (55%), with minor outcome (16%), with moderate outcome (10%), and with major outcome (3%); 16% of reported incidents were 'near misses'. We compared the data before and after the introduction of FMEA. Sixty-nine errors were registered, 59 (86%) concerning drug therapy (83% during prescription). Compared to 2009-2010, in 2011-2012, we noted an increase of reported errors (43 vs 26) with a reduction of their severity (21% vs 8% 'near misses' and 65% vs 38% errors with no outcome). With the introduction of FMEA, we obtained an increased awareness in error reporting. Application of these systems will improve the quality of healthcare services. © 2015 John Wiley & Sons Ltd.

The Dialysis Outcomes and Practice Patterns Study (DOPPS) in Turkey.

PubMed

Ecder, Tevfik; Utas, Cengiz; Ates, Kenan; Bieber, Brian; Robinson, Bruce M; Pisoni, Ronald L; Süleymanlar, Gültekin

2017-07-01

Turkey has one of the largest treated end-stage renal disease (ESRD) patient populations in Europe (N = 66,711). In 2013, the international Dialysis Outcomes and Practice Patterns Study (DOPPS), a prospective study of hemodialysis (HD) practices and outcomes, initiated data collection in Turkey. Here we provide comparisons of HD patients in DOPPS-Turkey with other international regions and with patients in the Registry of Turkish Nephrology, Dialysis and Transplantation. DOPPS-Turkey study sites were randomly selected from all Turkish HD units treating ≥25 in-center chronic HD patients. Detailed patient- and facility-level data were collected for 20-30 randomly selected prevalent HD patients per facility. Demographic and comorbidity profiles for DOPPS-Turkey patients were similar to HD patients overall in the 2013 Turkish Registry Report. In Turkey: diabetes was the most common ESRD cause (37%); arteriovenous fistula use was 83%; mean single pool Kt/V was 1.61. Compared with other international regions, Turkey had the highest mean hemoglobin (11.5 g/dL), ferritin (771 ng/mL), and interdialytic weight gain (3.28%), while Turkey had the lowest mean systolic blood pressure (127 mmHg) and erythropoiesis stimulating agent prescription (57%). Turkish patients also reported the highest depression scores. In this first DOPPS-Turkey report, the DOPPS sample agrees well with national Turkish Registry data. Treatment and laboratory data, and patient-reported outcomes, demonstrate similarities and previously unrecognized contrasts to DOPPS findings in Europe, Japan, and North America. Long-term follow-up of these patients will describe how these differences relate to clinical outcomes within Turkey. © 2016 International Society for Hemodialysis.

The patient perspective on remote monitoring of patients with an implantable cardioverter defibrillator: Narrative review and future directions.

PubMed

Timmermans, Ivy; Meine, Matias; Zitron, Edgar; Widdershoven, Jos; Kimman, Geert; Prevot, Sébastien; Rauwolf, Thomas; Anselme, Frédéric; Szendey, Istvan; Romero Roldán, Javier; Mabo, Philippe; Schaer, Beat; Denollet, Johan; Versteeg, Henneke

2017-07-01

Studies have shown that remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) is at least comparable to in-clinic follow-up with regard to clinical outcomes and might be cost-effective, yet RPM is not standard clinical practice within Europe. Better insight into the patient perspective on RPM may aid in its acceptance, implementation, and reimbursement. This narrative review (1) summarizes existing evidence on the impact of RPM on patient-reported outcomes and (2) discusses future directions in examining the patient perspective. Literature review indicated that only five randomized trials on RPM in ICD patients included patient-reported outcomes, with inconclusive results. Observational studies show a trend toward good patient satisfaction and acceptation of RPM. Yet, results should be interpreted with caution due to a number of limitations including a potential selection bias, use of generic/nonvalidated questionnaires, relatively short follow-up durations, and a lack of subgroup identification. Although RPM seems to be safe, effective, timely, and efficient, the patient perspective has received little attention so far. The scarce evidence on patient-reported outcomes in RPM studies seems to be positive, but future trials with a follow-up of ≥12 months and validated patient-reported outcome measures are needed. The REMOTE-CIED study from our group is the first prospective randomized controlled trial primarily designed to examine the patient perspective on RPM, and is powered to identify characteristics associated with RPM satisfaction and benefit. Results are expected in 2018 and will add valuable information to the current evidence. © 2017 Wiley Periodicals, Inc.

Variation in definitions of urinary tract infections in spina bifida patients: a systematic review.

PubMed

Madden-Fuentes, Ramiro Jose; McNamara, Erin Rebekah; Lloyd, Jessica Catherine; Wiener, John Samuel; Routh, Jonathan Charles; Seed, Patrick Casey; Ross, Sherry Sedberry

2013-07-01

Urinary tract infections (UTIs) are a common source of morbidity among children with spina bifida (SB) and are a frequently reported outcome in studies of this patient population. However, the criteria for a diagnosis of UTI are often not stated. We evaluated the literature on SB patients for the criteria that authors use to define parameters in reporting UTI outcomes. Embase and Medline were queried with the medical subject heading terms “spinal dysraphism,” “myelomeningocele,” “infection,”and “urinary tract infection.” A second search with the exploded term“spina bifida” and “urinary tract infection” was performed. Original research studies reporting a UTI outcome in SB patients were included and evaluated by 2 independent reviewers for the presence of a UTI definition and diagnostic criteria. We identified 872 publications, of which 124 met inclusion criteria. Forty-five of 124 (36.3%) studies reporting UTI as an outcome provided a definition of UTI. Of 124 studies, 28 (22.6%) were published in pediatric journals and 69 (55.6%) in urology journals. A definition of UTI was provided in 11 (39.3%) and 26 (37.7%) studies, respectively. “Fever,culture, and symptoms” defined a UTI in 17 of 45 studies. Journal category and presence of UTI definitions did not correlate (P = .71). Explicit definitions for UTI are heterogeneous and infrequently applied in studies of SB patients, limiting study reliability and estimates of true UTI rates in this population. Future studies will benefit from the development and application of a standard definition for UTI in this population.

Media Coverage, Journal Press Releases and Editorials Associated with Randomized and Observational Studies in High-Impact Medical Journals: A Cohort Study.

PubMed

Wang, Michael T M; Bolland, Mark J; Gamble, Greg; Grey, Andrew

2015-01-01

Publication of clinical research findings in prominent journals influences health beliefs and medical practice, in part by engendering news coverage. Randomized controlled trials (RCTs) should be most influential in guiding clinical practice. We determined whether study design of clinical research published in high-impact journals influences media coverage. We compared the incidence and amount of media coverage of RCTs with that of observational studies published in the top 7 medical journals between 1 January 2013 and 31 March 2013. We specifically assessed media coverage of the most rigorous RCTs, those with >1000 participants that reported 'hard' outcomes. There was no difference between RCTs and observational studies in coverage by major newspapers or news agencies, or in total number of news stories generated (all P>0.63). Large RCTs reporting 'hard' outcomes did not generate more news coverage than small RCTs that reported surrogate outcomes and observational studies (all P>0.32). RCTs were more likely than observational studies to attract a journal editorial (70% vs 46%, P = 0.003), but less likely to be the subject of a journal press release (17% vs 50%, P<0.001). Large RCTs that reported 'hard' outcomes did not attract an editorial more frequently than other studies (61% vs 58%, P>0.99), nor were they more likely to be the subject of a journal press release (14% vs 38%, P = 0.14). The design of clinical studies whose results are published in high-impact medical journals is not associated with the likelihood or amount of ensuing news coverage.

The relationship between intimate partner violence reported at the first antenatal booking visit and obstetric and perinatal outcomes in an ethnically diverse group of Australian pregnant women: a population-based study over 10 years

PubMed Central

Dahlen, Hannah Grace; Munoz, Ana Maria; Schmied, Virginia; Thornton, Charlene

2018-01-01

Objectives Intimate partner violence (IPV) is a global health issue affecting mainly women and is known to escalate during pregnancy and impact negatively on obstetric and perinatal outcomes. The aim of this study is to determine the incidence of IPV in a pregnant multicultural population and to determine the relationship between IPV reported at booking interview and maternal and perinatal outcomes. Design This is a retrospective population-based data study. We analysed routinely collected data (2006–2016) from the ObstetriX system on a cohort of pregnant women. Setting and participants 33 542 women giving birth in a major health facility in Western Sydney. Primary outcomes Incidence of IPV, association with IPV and other psychosocial variables and maternal and perinatal outcomes. Result 4.3% of pregnant women reported a history of IPV when asked during the routine psychosocial assessment. Fifty-four per cent were not born in Australia, and this had increased significantly over the decade. Women born in New Zealand (7.2%) and Sudan (9.1%) were most likely to report IPV at the antenatal booking visit, with women from China and India least likely to report IPV. Women who reported IPV were more likely to report additional psychosocial concerns including Edinburgh Postnatal Depression Scale scores > 13 (7.6%), thoughts of self-harm (2.4%), childhood abuse (23.6%), and a history of anxiety and depression (34.2%). Women who reported IPV were more likely to be Australian born, smoke and be multiparous and to have been admitted for threatened preterm labour (Adjusted Odds Ratio (AOR) 1.8, 95% CI 1.28 to 2.39). Conclusions A report of IPV at the first antenatal booking visit is associated with a higher level of reporting on all psychosocial risks, higher antenatal admissions, especially for threatened preterm labour. More research is needed regarding the effectiveness of current IPV screening for women from other countries. PMID:29695386

Community College Students: Goals, Academic Preparation, and Outcomes. Postsecondary Education Descriptive Analysis Reports.

ERIC Educational Resources Information Center

Hoachlander, Gary; Sikora, Anna C.; Horn, Laura

This document profiles the goals, preparation, and outcomes of community college students using three data sources: the 1999-2000 National Postsecondary Student Aid Study, the 1996/01 Beginning Postsecondary Students Longitudinal Study, and the National Educational Longitudinal Study of 1988, Fourth Follow-up. This study addresses the following…

U.S. dental hygiene faculty perceptions of learner outcomes in distance education courses.

PubMed

Corum, Kathrine A; Gadbury-Amyot, Cynthia C; Johnson, Kerry; Strait, Tia M

2014-04-01

The purpose of this study was to determine perceptions of full-time, entry-level dental hygiene educators regarding the ability to achieve interaction in their distance education courses and the impact of interaction on learning outcomes. The specific interactions explored were student-instructor, student-content, and student-student. A survey was developed, pilot tested, revised, and mailed to 287 educators across the United States, generating an overall response rate of 22.3 percent. The majority of respondents perceived interaction to be achievable in their distance courses, to increase through technology, and to positively influence learning outcomes. Nearly 90 percent reported student-instructor interaction as achievable, 95.3 percent reported student-content interaction as achievable, and 79.7 percent reported student-student interaction as achievable. Learning outcomes were defined in this study as the student's achievement of course objectives and competencies at course completion. Approximately 81 percent of the respondents reported a positive influence from student-instructor interaction, 79.7 percent from student-content interaction, and 70.3 percent from student-student interaction. This study also examined which modalities were perceived as being most influential in achieving interaction. The results demonstrated a prevalence of discussion board posting in an environment in which numerous Web 2.0 tools are available and respondents were not as positive about their ability to achieve student-student interaction in the distance learning environment. The authors conclude that faculty development is critical in achieving quality outcomes in dental hygiene distance education courses.

Osteoarthritis Year in Review 2015: Clinical

PubMed Central

Sharma, Leena

2015-01-01

The purpose of this review is to highlight clinical research in osteoarthritis. A literature search was conducted using PubMed (http://www.ncbi.nlm.nih.gov/pubmed/) with the search terms “osteoarthritis [All Fields] AND treatment [All Fields]” and the following limits activated: humans, English language, all adult 19+ years, published between April 1, 2014 and April 1, 2015. A second literature search was then conducted with the search terms “osteoarthritis [All Fields] AND epidemiology [All Fields]”, with the same limits. Reports of surgical outcome, case series, surgical technique, tissue sample or culture studies, trial protocols, and pilot studies were excluded. Of 1523, 148 were considered relevant. Among epidemiologic and observational clinical studies, themes included physical activity, early knee OA, and confidence/instability/falls. Symptom outcomes of pharmacologic treatments were reported for methotrexate, adalimumab, anti-nerve growth factor monoclonal antibodies, strontium ranelate, bisphosphonates, glucosamine, and chondroitin sulfate, and structural outcomes of pharmacologic treatments for strontium ranelate, recombinant human fibroblast growth factor 18, and glucosamine and chondroitin sulfate. Symptom outcomes of non-pharmacologic interventions were reported for: neuromuscular exercise, quadriceps strengthening, weight reduction and maintenance, TENS, therapeutic ultrasound, stepped care strategies, cognitive behavior therapy for sleep disturbance, acupuncture, gait modification, booster physical therapy, a web-based therapeutic exercise resource center for knee OA; hip physical therapy for hip OA; and joint protection and hand exercises for hand OA. Structure outcomes of non-pharmacologic interventions were reported for patellofemoral bracing. PMID:26707991

Long-term behavioral outcomes after attendance at a secondary prevention clinic for cardiac patients.

PubMed

Worcester, Marian Una Christine; Stojcevski, Zlatko; Murphy, Barbara; Goble, Alan James

2003-01-01

Secondary prevention interventions, including hospital clinics, can help patients improve their risk factors and lifestyles after an acute cardiac event. This study aimed to investigate the long-term behavioral outcomes of attending and nonattending patients consecutively enrolled in a trial of a family-based clinic providing screening, advice, and support 3 months after hospital admission. The study also aimed to identify predictors of long-term smoking status, dietary habit, and physical activity. Semistructured interviews were conducted an average of 30 months after the acute cardiac event with 83 of the 103 nonattending patients and a random sample of 96 patients who had attended the clinic. Behavioral outcomes were investigated, and self-reported risk factors at the time of the acute illness were documented. The patients who had attended the clinic were significantly more likely than nonattenders to report positive dietary changes and, among former smokers, successful cessation of smoking. Furthermore, they reported being more physically active than nonattenders. Using logistic regression, clinic attendance was identified as a significant and independent predictor of all three outcomes. The results of this observational study suggest that attendance at a secondary prevention clinic facilitates maintenance of improved long-term health behaviors, although this finding is based on self-report. Factors possibly responsible for favorable outcomes include strong physician advice and support from a multidisciplinary team of health professionals. Furthermore, the timing of the intervention may have been appropriate for enrollment in a secondary prevention clinic.

Effects of deworming on child and maternal health: a literature review and meta-analysis.

PubMed

Thayer, Winter Maxwell; Clermont, Adrienne; Walker, Neff

2017-11-07

Soil-transmitted helminth infections are widespread. Many studies have been published on the topic of deworming. The Lives Saved Tool (LiST) is a software package that uses a deterministic mathematical model to estimate the effect of scaling up interventions on maternal and child health outcomes. This review investigates the scope of available evidence for benefits of deworming treatments in order to inform a decision about possible inclusion of deworming as an intervention in LiST. We searched PubMed, the Cochrane Library, and Google Scholar. We included studies that reported pre/post data in children younger than 5 years or pregnant women for outcomes related to mortality and growth. We excluded studies that compared different anthelminthic treatments but did not include a placebo or non-treatment group, and those that did not report post-intervention outcomes. We categorized articles by treated population (children younger than 5 years and pregnant women), experimental versus observational, mass drug administration (MDA) versus treatment, and reported outcome. We identified 58 relevant trials; 27 investigated children younger than 5 years and 11 investigated pregnant women; one reported on both children younger than 5 years and pregnant women. We conducted meta-analyses of relevant outcomes in children younger than 5 years. Deworming did not show consistent benefits for indicators of mortality, anemia, or growth in children younger than five or women of reproductive age. We do not recommend including the effect of deworming in the LiST model.

Health professionals' reports of information given to parents following the prenatal diagnosis of sex chromosome anomalies and outcomes of pregnancies: a pilot study.

PubMed

Hall, Sue; Abramsky, Lenore; Marteau, Theresa M

2003-07-01

To examine the association between the information health professionals report providing parents about sex chromosome anomalies (SCAs) and the outcomes of affected pregnancies. Telephone interviews were conducted with health professionals who disclosed the prenatal diagnosis of an SCA to parents. The statements they reported providing to parents about the condition were coded as positive, neutral or negative. Outcomes of the pregnancies were obtained from medical records. Six of the 23 pregnancies were terminated. Health professionals reported giving parents of these six cases a greater amount of negative information about an SCA than did the health professionals reporting on the information given to the parents who continued with their pregnancies. Health professionals reported giving a similar amount of positive and neutral information to both groups of parents. The results of this pilot study suggest that there is a positive association between the amount of negative information parents are given initially about a sex chromosome anomaly and the decision to terminate the affected pregnancy. This study is limited by its small sample size and reliance on health professionals' self-reports of information provided to parents. Larger, prospective studies in which consultations are tape-recorded and linked to parents' subsequent decision making and adjustment are needed. Copyright 2003 John Wiley & Sons, Ltd.

A Systematic Review of Measurement Properties of Patient-Reported Outcome Measures Used in Patients Undergoing Total Knee Arthroplasty.

PubMed

Gagnier, Joel J; Mullins, Megan; Huang, Hsiaomin; Marinac-Dabic, Danica; Ghambaryan, Anna; Eloff, Benjamin; Mirza, Faisal; Bayona, Manuel

2017-05-01

While clinical research on total knee arthroplasty (TKA) outcomes is prevalent in the literature, studies often have poor methodological and reporting quality. A high-quality patient-reported outcome instrument is reliable, valid, and responsive. Many studies evaluate these properties, but none have done so with a systematic and accepted method. The objectives of this study were to identify patient-reported outcome measures (PROMs) for TKA, and to critically appraise, compare, and summarize their psychometric properties using accepted methods. MEDLINE, EMBASE, SCOPUS, Web of Science, PsycINFO, and SPORTDiscus were systematically searched for articles with the following inclusion criteria: publication before December 2014, English language, non-generic PRO, and evaluation in the TKA population. Methodological quality and evidence of psychometric properties were assessed with the COnsensus-based standards for the selection of health Status Measurement INstruments (COSMIN) checklist and criteria for psychometric evidence proposed by the COSMIN group and Terwee et al. One-hundred fifteen studies on 32 PROMs were included in this review. Only the Work, Osteoarthritis or joint-Replacement Questionnaire, the Oxford Knee Score, and the Western Ontario and McMaster Universities Arthritis Index had 4 or more properties with positive evidence. Most TKA PROMs have limited evidence for their psychometric properties. Although not all the properties were studied, the Work, Osteoarthritis or joint-Replacement Questionnaire, with the highest overall ratings, could be a useful PROM for evaluating patients undergoing TKA. The methods and reporting of this literature can improve by following accepted guidelines. Published by Elsevier Inc.

Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort's Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study.

PubMed

Barger, Diana; Leleux, Olivier; Conte, Valérie; Sapparrart, Vincent; Gapillout, Marie; Crespel, Isabelle; Erramouspe, Marie; Delveaux, Sandrine; Dabis, Francois; Bonnet, Fabrice

2018-06-07

Effective antiretroviral therapy has greatly reduced HIV-related morbidity and mortality, dramatically changing the demographics of the population of people living with HIV. The majority of people living with HIV in France are well cared for insofar as their HIV infection is concerned but remain at risk for age-associated comorbidities. Their long-term, potentially complex, and growing care needs make the routine, longitudinal assessment of health-related quality of life and other patient-reported outcomes of relevance in the current treatment era. We aim to describe the development of a Web-based electronic patient-reported outcomes system for people living with HIV linked to the ANRS CO3 Aquitaine cohort's data capture and visualization system (ARPEGE) and designed to facilitate the electronic collection of patient-reported data and ultimately promote better patient-physician communication and quality of care (both patient satisfaction and health outcomes). Participants who meet the eligibility criteria will be invited to engage with the Web-based electronic patient-reported outcomes system and provided with the information necessary to create a personal patient account. They will then be able to access the electronic patient-reported outcomes system and complete a set of standardized validated questionnaires covering health-related quality of life (World Health Organization's Quality of Life Instrument in HIV infection, named WHOQOL-HIV BREF) and other patient-reported outcomes. The information provided via questionnaires will ultimately be presented in a summary format for clinicians, together with the patient's HIV care history. The prototype of the Web-based electronic patient-reported outcome system will be finalized and the first 2 formative research phases of the study (prototyping and usability testing) will be conducted from December 2017 to May 2018. We describe the sequential processes planned to ensure that the proposed electronic patient-reported outcome system is ready for formal pilot testing, referred to herein as phases 1a and 1b. We also describe the planned pilot-testing designed to evaluate the acceptability and use of the system from the patient's perspective (phase 2). As the underlying information technology solution, ARPEGE, has being developed in-house, should the feasibility study presented here yield promising results, the panel of services provided via the proposed portal could ultimately be expanded and used to experiment with health-promoting interventions in aging people living with HIV in hospital-based care or adapted for use in other patient populations. ClinicalTrials.gov NCT03296202; https://clinicaltrials.gov/ct2/show/NCT03296202 (Archived by WebCite at http://www.webcitation.org/6zgOBArps). RR1-10.2196/9439. ©Diana Barger, Olivier Leleux, Valérie Conte, Vincent Sapparrart, Marie Gapillout, Isabelle Crespel, Marie Erramouspe, Sandrine Delveaux, Francois Dabis, Fabrice Bonnet. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.06.2018.

Predictors of satisfaction and quality of life following post-mastectomy breast reconstruction.

PubMed

Matthews, Hannah; Carroll, Natalie; Renshaw, Derek; Turner, Andrew; Park, Alan; Skillman, Jo; McCarthy, Kate; Grunfeld, Elizabeth A

2017-11-01

Breast reconstruction is associated with multiple psychological benefits. However, few studies have identified clinical and psychological factors associated with improved satisfaction and quality of life. This study examined factors, which predict satisfaction with breast appearance, outcome satisfaction and quality of life following post-mastectomy breast reconstruction. Women who underwent post-mastectomy breast reconstruction between 2010 and 2016 received a postal questionnaire consisting of The BREAST-Q Patient Reported Outcomes Instrument, The European Organisation for Research and Treatment of Cancer QLQ-30 Questionnaire, The Patient and Observer Scar Assessment Scale, and a series of Visual-Analogue Scales. One hundredforty-eight women completed the questionnaire, a 56% response rate. Hierarchical multiple regression analyses revealed psychosocial factors accounted for 75% of the variance in breast satisfaction, 68% for outcome satisfaction, and 46% forquality of life. Psychosocial well-being emerged as a significant predictor of satisfaction with breast appearance (β = .322) and outcome satisfaction (β = .406). Deep inferior epigastric perforator flap patients reported greater satisfaction with breast appearance (β = .120) and outcome satisfaction (β = .167). This study extends beyond the limited research by distinguishing between satisfaction with breast appearance and outcome satisfaction. The study provides evidence for the role of psychosocial factors predicting key patient reported outcomes and demonstrates the importance of psychosocial well-being and reconstruction type. The findings also highlight the need for healthcare providers to consider the psychosocial well-being of patients both preoperatively and post operatively and provide preliminary evidence for the use of deep inferior epigastric perforator reconstructions over other types of reconstructive procedures. Copyright © 2017 John Wiley & Sons, Ltd.

Reporting of clinical trials: a review of research funders' guidelines

PubMed Central

Dwan, Kerry; Gamble, Carrol; Williamson, Paula R; Altman, Douglas G

2008-01-01

Background Randomised controlled trials (RCTs) represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias and outcome reporting bias. National and international organisations and charities give recommendations for good research practice in relation to RCTs but to date no review of these guidelines has been undertaken with respect to reporting bias. Methods National and international organisations and UK based charities listed on the Association for Medical Research Charities website were contacted in 2007; they were considered eligible for this review if they funded RCTs. Guidelines were obtained and assessed in relation to what was written about trial registration, protocol adherence and trial publication. It was also noted whether any monitoring against these guidelines was undertaken. This information was necessary to discover how much guidance researchers are given on the publication of results, in order to prevent study publication bias and outcome reporting bias. Results Seventeen organisations and 56 charities were eligible of 140 surveyed for this review, although there was no response from 12. Trial registration, protocol adherence, trial publication and monitoring against the guidelines were often explicitly discussed or implicitly referred too. However, only eleven of these organisations or charities mentioned the publication of negative as well as positive outcomes and just three of the organisations specifically stated that the statistical analysis plan should be strictly adhered to and all changes should be reported. Conclusion Our review indicates that there is a need to provide more detailed guidance for those conducting and reporting clinical trials to help prevent the selective reporting of results. Statements found in the guidelines generally refer to publication bias rather than outcome reporting bias. Current guidelines need to be updated and include the statement that all primary and secondary outcomes prespecified in the protocol should be fully reported and should not be selected for inclusion in the final report based on their results. PMID:19032743

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

Exclusion of participants based on substance use status: Findings from randomized controlled trials of treatments for PTSD.

PubMed

Leeman, Robert F; Hefner, Kathryn; Frohe, Tessa; Murray, Adrian; Rosenheck, Robert A; Watts, Bradley V; Sofuoglu, Mehmet

2017-02-01

Individuals with posttraumatic stress disorder (PTSD) are more than four times as likely as those without PTSD to have substance use disorder (SUD), making it critical to understand the interaction of substance use status and PTSD outcomes. Using the broader treatment literature, we examined PTSD treatment effects, with and without co-morbid SUD, by extending a published meta-analysis to include recent studies. From reports of 156 Randomized Controlled Trials (RCTs), we extracted exclusion criteria based on substance use and findings involving substance use as a predictor or outcome. Almost three-quarters of RCT designs excluded participants based on substance use status. Only 29.5% reported descriptive statistics characterizing substance use within the study sample and only 7.7% reported substance use-related outcomes. There was no clear relationship between exclusion criteria based on substance use and PTSD outcome or participant retention, suggesting either that SUD does not impede treatment effects, or that available studies lack sufficient data for these analyses. Importantly, no studies reported significant increases in substance use in the course of PTSD treatment. We conclude that patients with PTSD and co-morbid SUD have been largely neglected in PTSD RCTs; thus findings may not be fully applicable to those meeting criteria for both conditions. Copyright © 2016 Elsevier Ltd. All rights reserved.

The Effect of Gender and Race Intersectionality on Student Learning Outcomes in Engineering

ERIC Educational Resources Information Center

Ro, Hyun Kyoung; Loya, Karla I.

2015-01-01

Women and underrepresented minorities in traditionally White and male-dominated disciplines tend to report lower learning outcomes than their White peers. Adopting a feminist intersectionality framework, this study looks at the intersections of gender and race to investigate differences in self-assessed learning outcomes in engineering…

Knowledge translation and implementation in spinal cord injury: a systematic review

PubMed Central

Noonan, VK; Wolfe, DL; Thorogood, NP; Park, SE; Hsieh, JT; Eng, JJ

2015-01-01

Objective To conduct a systematic review examining the effectiveness of knowledge translation (KT) interventions in changing clinical practice and patient outcomes. Methods MEDLINE/PubMed, CINAHL, EMBASE and PsycINFO were searched for studies published from January 1980 to July 2012 that reported and evaluated an implemented KT intervention in spinal cord injury (SCI) care. We reviewed and summarized results from studies that documented the implemented KT intervention, its impact on changing clinician behavior and patient outcomes as well as the facilitators and barriers encountered during the implementation. Results A total of 13 articles featuring 10 studies were selected and abstracted from 4650 identified articles. KT interventions included developing and implementing patient care protocols, providing clinician education and incorporating outcome measures into clinical practice. The methods (or drivers) to facilitate the implementation included organizing training sessions for clinical staff, introducing computerized reminders and involving organizational leaders. The methodological quality of studies was mostly poor. Only 3 out of 10 studies evaluated the success of the implementation using statistical analyses, and all 3 reported significant behavior change. Out of the 10 studies, 6 evaluated the effect of the implementation on patient outcomes using statistical analyses, with 4 reporting significant improvements. The commonly cited facilitators and barriers were communication and resources, respectively. Conclusion The field of KT in SCI is in its infancy with only a few relevant publications. However, there is some evidence that KT interventions may change clinician behavior and improve patient outcomes. Future studies should ensure rigorous study methods are used to evaluate KT interventions. PMID:24796445

Evaluating Cost-effectiveness of Interventions That Affect Fertility and Childbearing: How Health Effects Are Measured Matters.

PubMed

Goldhaber-Fiebert, Jeremy D; Brandeau, Margaret L

2015-10-01

Current guidelines for economic evaluations of health interventions define relevant outcomes as those accruing to individuals receiving interventions. Little consensus exists on counting health impacts on current and future fertility and childbearing. Our objective was to characterize current practices for counting such health outcomes. We developed a framework characterizing health interventions with direct and/or indirect effects on fertility and childbearing and how such outcomes are reported. We identified interventions spanning the framework and performed a targeted literature review for economic evaluations of these interventions. For each article, we characterized how the potential health outcomes from each intervention were considered, focusing on quality-adjusted life-years (QALYs) associated with fertility and childbearing. We reviewed 108 studies, identifying 7 themes: 1) Studies were heterogeneous in reporting outcomes. 2) Studies often selected outcomes for inclusion that tend to bias toward finding the intervention to be cost-effective. 3) Studies often avoided the challenges of assigning QALYs for pregnancy and fertility by instead considering cost per intermediate outcome. 4) Even for the same intervention, studies took heterogeneous approaches to outcome evaluation. 5) Studies used multiple, competing rationales for whether and how to include fertility-related QALYs and whose QALYs to include. 6) Studies examining interventions with indirect effects on fertility typically ignored such QALYs. 7) Even recent studies had these shortcomings. Limitations include that the review was targeted rather than systematic. Economic evaluations inconsistently consider QALYs from current and future fertility and childbearing in ways that frequently appear biased toward the interventions considered. As the Panel on Cost-Effectiveness in Health and Medicine updates its guidelines, making the practice of cost-effectiveness analysis more consistent is a priority. Our study contributes to harmonizing methods in this respect. © The Author(s) 2015.

Evaluating Cost-Effectiveness of Interventions that Affect Fertility and Childbearing: How Health Effects are Measured Matters

PubMed Central

Goldhaber-Fiebert, Jeremy D.; Brandeau, Margaret L.

2015-01-01

Background Current guidelines for economic evaluations of health interventions define relevant outcomes as those accruing to individuals receiving interventions. Little consensus exists on counting health impacts on current and future fertility and childbearing. Objective To characterize current practices for counting such health outcomes. Design We developed a framework characterizing health interventions with direct and/or indirect effects on fertility and childbearing and how such outcomes are reported. We identified interventions spanning the framework and performed a targeted literature review for economic evaluations of these interventions. For each article, we characterized how the potential health outcomes from each intervention were considered, focusing on QALYs associated with fertility and childbearing. Results We reviewed 108 studies, identifying seven themes: 1) Studies were heterogeneous in reporting outcomes. 2) Studies often selected outcomes for inclusion that tend to bias toward finding the intervention to be cost-effective. 3) Studies often avoided the challenges of assigning QALYs for pregnancy and fertility by instead considering cost per intermediate outcome. 4) Even for the same intervention, studies took heterogeneous approaches to outcome evaluation. 5) Studies employed multiple, competing rationales for whether and how to include fertility-related QALYs and whose QALYs to include. 6) Studies examining interventions with indirect effects on fertility typically ignored such QALYs. 7) Even recent studies had these shortcomings. Limitations The review was targeted rather than systematic. Conclusions Economic evaluations inconsistently consider QALYs from current and future fertility and childbearing in ways that frequently appear biased towards the interventions considered. As the Panel on Cost-Effectiveness in Health and Medicine updates its guidelines, making the practice of cost-effectiveness analysis more consistent is a priority. Our study contributes to harmonizing methods in this respect. PMID:25926281

Effectiveness of IT-based diabetes management interventions: a review of the literature.

PubMed

Costa, Beth M; Fitzgerald, Kristine J; Jones, Kay M; Dunning Am, Trisha

2009-11-17

Information technology (IT) is increasingly being used in general practice to manage health care including type 2 diabetes. However, there is conflicting evidence about whether IT improves diabetes outcomes. This review of the literature about IT-based diabetes management interventions explores whether methodological issues such as sample characteristics, outcome measures, and mechanisms causing change in the outcome measures could explain some of the inconsistent findings evident in IT-based diabetes management studies. Databases were searched using terms related to IT and diabetes management. Articles eligible for review evaluated an IT-based diabetes management intervention in general practice and were published between 1999 and 2009 inclusive in English. Studies that did not include outcome measures were excluded. Four hundred and twenty-five articles were identified, sixteen met the inclusion criteria: eleven GP focussed and five patient focused interventions were evaluated. Nine were RCTs, five non-randomised control trials, and two single-sample before and after designs. Important sample characteristics such as diabetes type, familiarity with IT, and baseline diabetes knowledge were not addressed in any of the studies reviewed. All studies used HbA1c as a primary outcome measure, and nine reported a significant improvement in mean HbA1c over the study period; only two studies reported the HbA1c assay method. Five studies measured diabetes medications and two measured psychological outcomes. Patient lifestyle variables were not included in any of the studies reviewed. IT was the intervention method considered to effect changes in the outcome measures. Only two studies mentioned alternative possible causal mechanisms. Several limitations could affect the outcomes of IT-based diabetes management interventions to an unknown degree. These limitations make it difficult to attribute changes solely to such interventions.

Benchmarking surgical incident reports using a database and a triage system to reduce adverse outcomes.

PubMed

Antonacci, Anthony C; Lam, Steven; Lavarias, Valentina; Homel, Peter; Eavey, Roland D

2008-12-01

To study the profile of incidents affecting quality outcomes after surgery by developing a usable operating room and perioperative clinical incident report database and a functional electronic classification, triage, and reporting system. Previously, incident reports after surgery were handled on an individual, episodic basis, which limited the ability to perceive actuarial patterns and meaningfully improve outcomes. Clinical incident reports were experientially generated in the second largest health care system in New York City. Data were entered into a functional classification system organized into 16 categories, and weekly triage meetings were held to electronically review and report summaries on 40 to 60 incident reports per week. System development and deployment reviewed 1041 reports after 19,693 operative procedures. During the next 4 years, 3819 additional reports were generated from 83,988 operative procedures and were reported electronically to the appropriate departments. Number of incident reports generated annually. A significant decrease in volume-adjusted clinical incident reports occurred (from 53 to 39 reports per 1000 procedures) from 2001 to 2005 (P < .001). Reductions in incident reports were observed for ambulatory conversions (74% reduction), wasted implants (65%), skin breakdown (64%), complications in the operating room (42%), laparoscopic conversions (32%), and cancellations (23%) as a result of data-focused process and clinical interventions. Six of 16 categories of incident reports accounted for more than 88% of all incident reports. These data suggest that effective review, communication, and summary feedback of clinical incident reports can produce a statistically significant decrease in adverse outcomes.

Recommendations for reporting economic evaluations of haemophilia prophylaxis: a nominal groups consensus statement on behalf of the Economics Expert Working Group of The International Prophylaxis Study Group.

PubMed

Nicholson, A; Berger, K; Bohn, R; Carcao, M; Fischer, K; Gringeri, A; Hoots, K; Mantovani, L; Schramm, W; van Hout, B A; Willan, A R; Feldman, B M

2008-01-01

The need for clearly reported studies evaluating the cost of prophylaxis and its overall outcomes has been recommended from previous literature. To establish minimal ''core standards'' that can be followed when conducting and reporting economic evaluations of hemophilia prophylaxis. Ten members of the IPSG Economic Analysis Working Group participated in a consensus process using the Nominal Groups Technique (NGT). The following topics relating to the economic analysis of prophylaxis studies were addressed; Whose perspective should be taken? Which is the best methodological approach? Is micro- or macro-costing the best costing strategy? What information must be presented about costs and outcomes in order to facilitate local and international interpretation? The group suggests studies on the economic impact of prophylaxis should be viewed from a societal perspective and be reported using a Cost Utility Analysis (CUA) (with consideration of also reporting Cost Benefit Analysis [CBA]). All costs that exceed $500 should be used to measure the costs of prophylaxis (macro strategy) including items such as clotting factor costs, hospitalizations, surgical procedures, productivity loss and number of days lost from school or work. Generic and disease specific quality of lífe and utility measures should be used to report the outcomes of the study. The IPSG has suggested minimal core standards to be applied to the reporting of economic evaluations of hemophilia prophylaxis. Standardized reporting will facilitate the comparison of studies and will allow for more rational policy decisions and treatment choices.

Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials.

PubMed

Hodkinson, Alex; Gamble, Carrol; Smith, Catrin Tudur

2016-04-22

The quality of harms reporting in journal publications is often poor, which can impede the risk-benefit interpretation of a clinical trial. Clinical study reports can provide more reliable, complete, and informative data on harms compared to the corresponding journal publication. This case study compares the quality and quantity of harms data reported in journal publications and clinical study reports of orlistat trials. Publications related to clinical trials of orlistat were identified through comprehensive literature searches. A request was made to Roche (Genentech; South San Francisco, CA, USA) for clinical study reports related to the orlistat trials identified in our search. We compared adverse events, serious adverse events, and the reporting of 15 harms criteria in both document types and compared meta-analytic results using data from the clinical study reports against the journal publications. Five journal publications with matching clinical study reports were available for five independent clinical trials. Journal publications did not always report the complete list of identified adverse events and serious adverse events. We found some differences in the magnitude of the pooled risk difference between both document types with a statistically significant risk difference for three adverse events and two serious adverse events using data reported in the clinical study reports; these events were of mild intensity and unrelated to the orlistat. The CONSORT harms reporting criteria were often satisfied in the methods section of the clinical study reports (70-90 % of the methods section criteria satisfied in the clinical study reports compared to 10-50 % in the journal publications), but both document types satisfied 80-100 % of the results section criteria, albeit with greater detail being provided in the clinical study reports. In this case study, journal publications provided insufficient information on harms outcomes of clinical trials and did not specify that a subset of harms data were being presented. Clinical study reports often present data on harms, including serious adverse events, which are not reported or mentioned in the journal publications. Therefore, clinical study reports could support a more complete, accurate, and reliable investigation, and researchers undertaking evidence synthesis of harm outcomes should not rely only on incomplete published data that are presented in the journal publications.

A Systematic Review of the Outcomes of Posterolateral Corner Knee Injuries, Part 2: Surgical Treatment of Chronic Injuries.

PubMed

Moulton, Samuel G; Geeslin, Andrew G; LaPrade, Robert F

2016-06-01

There are a variety of reported surgical techniques outcomes of chronic grade III posterolateral corner (PLC) knee injuries. It is unknown if outcomes differ among the various surgical treatments. To systematically review the literature and report subjective and objective outcomes for surgical treatment strategies for chronic grade III PLC injuries to determine the optimal surgical technique. Systematic review; Level of evidence, 4. A systematic review of the literature including Cochrane, PubMed, Medline, and Embase was performed. The following search terms were used: posterolateral corner knee, posterolateral knee, posterolateral instability, multiligament knee, and knee dislocation. Inclusion criteria were outcome studies of surgical treatment for chronic PLC knee injuries with a minimum 2-year follow-up, subjective outcomes, objective outcomes including varus stability, and subgroup data on PLC injuries. Two investigators independently reviewed all abstracts. Accepted definitions of varus stability on examination or stress radiographs, and the need for revision surgery, were used to categorically define success and failure. Fifteen studies with a total of 456 patients were included in this study. The 15 studies included 5 with level 3 evidence and 10 with level 4 evidence. The mean age of the patients in each study ranged from 25.2 to 40 years, the reported mean time to surgery ranged from 5.5 to 52.8 months, and the mean follow-up duration ranged from 2 to 16.3 years. Mean postoperative Lysholm scores ranged from 65.5 to 91.8; mean postoperative International Knee Documentation Committee (IKDC) scores ranged from 62.6 to 86.0. Based on objective stability, there was an overall success rate of 90% and a 10% failure rate of PLC reconstruction. A variety of surgical techniques were reported. Chronic PLC injuries were reconstructed in all studies, and while techniques varied, the surgical management of chronic PLC injuries had a 90% success rate and a 10% failure rate according to the individual investigators' examination or stress radiographic assessment of objective outcomes. More than half of the 456 patients had a combined posterior cruciate ligament-PLC injury. Surgical techniques included variations of fibular slings, capsular shifts, and anatomic-based techniques (fibular tunnel and tibial tunnel). Further research is needed to determine the optimal surgical technique for treating chronic grade III PLC injuries. © 2015 The Author(s).

Preimplant Histologic Acute Tubular Necrosis and Allograft Outcomes

PubMed Central

Hall, Isaac E.; Reese, Peter P.; Weng, Francis L.; Schröppel, Bernd; Doshi, Mona D.; Hasz, Rick D.; Reitsma, William; Goldstein, Michael J.; Hong, Kwangik

2014-01-01

Background and objectives The influence of deceased-donor AKI on post-transplant outcomes is poorly understood. The few published studies about deceased-donor preimplant biopsy have reported conflicting results regarding associations between AKI and recipient outcomes. Design, setting, participants, & measurements This multicenter study aimed to evaluate associations between deceased-donor biopsy reports of acute tubular necrosis (ATN) and delayed graft function (DGF), and secondarily for death-censored graft failure, first adjusting for the kidney donor risk index and then stratifying by donation after cardiac death (DCD) status. Results Between March 2010 and April 2012, 651 kidneys (369 donors, 4 organ procurement organizations) were biopsied and subsequently transplanted, with ATN reported in 110 (17%). There were 262 recipients (40%) who experienced DGF and 38 (6%) who experienced graft failure. DGF occurred in 45% of kidneys with reported ATN compared with 39% without ATN (P=0.31) resulting in a relative risk (RR) of 1.13 (95% confidence interval [95% CI], 0.9 to 1.43) and a kidney donor risk index–adjusted RR of 1.11 (95% CI, 0.88 to 1.41). There was no significant difference in graft failure for kidneys with versus without ATN (8% versus 5%). In stratified analyses, the adjusted RR for DGF with ATN was 0.97 (95% CI, 0.7 to 1.34) for non-DCD kidneys and 1.59 (95% CI, 1.23 to 2.06) for DCD kidneys (P=0.02 for the interaction between ATN and DCD on the development of DGF). Conclusions Despite a modest association with DGF for DCD kidneys, this study reveals no significant associations overall between preimplant biopsy-reported ATN and the outcomes of DGF or graft failure. The potential benefit of more rigorous ATN reporting is unclear, but these findings provide little evidence to suggest that current ATN reports are useful for predicting graft outcomes or deciding to accept or reject allograft offers. PMID:24558049

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

Propensity-score matching in the cardiovascular surgery literature from 2004 to 2006: a systematic review and suggestions for improvement.

PubMed

Austin, Peter C

2007-11-01

I conducted a systematic review of the use of propensity score matching in the cardiovascular surgery literature. I examined the adequacy of reporting and whether appropriate statistical methods were used. I examined 60 articles published in the Annals of Thoracic Surgery, European Journal of Cardio-thoracic Surgery, Journal of Cardiovascular Surgery, and the Journal of Thoracic and Cardiovascular Surgery between January 1, 2004, and December 31, 2006. Thirty-one of the 60 studies did not provide adequate information on how the propensity score-matched pairs were formed. Eleven (18%) of studies did not report on whether matching on the propensity score balanced baseline characteristics between treated and untreated subjects in the matched sample. No studies used appropriate methods to compare baseline characteristics between treated and untreated subjects in the propensity score-matched sample. Eight (13%) of the 60 studies explicitly used statistical methods appropriate for the analysis of matched data when estimating the effect of treatment on the outcomes. Two studies used appropriate methods for some outcomes, but not for all outcomes. Thirty-nine (65%) studies explicitly used statistical methods that were inappropriate for matched-pairs data when estimating the effect of treatment on outcomes. Eleven studies did not report the statistical tests that were used to assess the statistical significance of the treatment effect. Analysis of propensity score-matched samples tended to be poor in the cardiovascular surgery literature. Most statistical analyses ignored the matched nature of the sample. I provide suggestions for improving the reporting and analysis of studies that use propensity score matching.

Systematic survey of randomized trials evaluating the impact of alternative diagnostic strategies on patient-important outcomes.

PubMed

El Dib, Regina; Tikkinen, Kari A O; Akl, Elie A; Gomaa, Huda A; Mustafa, Reem A; Agarwal, Arnav; Carpenter, Christopher R; Zhang, Yuchen; Jorge, Eliane C; Almeida, Ricardo A M B; do Nascimento Junior, Paulo; Doles, Joao Vitor P; Mustafa, Ahmad A; Sadeghirad, Behnam; Lopes, Luciane C; Bergamaschi, Cristiane C; Suzumura, Erica A; Cardoso, Marília M A; Corrente, José Eduardo; Stone, Samuel B; Schunemann, Holger J; Guyatt, Gordon H

2017-04-01

To provide a perspective on the current practice of randomized clinical trials (RCTs) of diagnostic strategies focusing on patient-important outcomes. We conducted a comprehensive search of MEDLINE and included RCTs published in full-text reports that evaluated alternative diagnostic strategies. Of 56,912 unique citations, we sampled 7,500 and included 103 eligible RCTs, therefore suggesting that MEDLINE includes approximately 781 diagnostic RCTs. The 103 eligible trials reported on: mortality (n = 41; 39.8%); morbidities (n = 63; 61.2%); symptoms/quality of life/functional status (n = 14; 13.6%); and on composite end points (n = 10; 9.7%). Of the studies that reported statistically significant results (n = 12; 11.6%), we judged 7 (58.3%) as at low risk of bias with respect to missing outcome data and 4 (33.3%) as at low risk of bias regarding blinding. Of the 41 RCTs that reported on mortality, only one (2.4%) reported statistically significant results. Of 63 RCTs addressing morbidity outcomes, 11 (17.5%) reported statistically significant results, all of which reported relative effects of greater than 20%. RCTs of diagnostic tests are not uncommon, and sometimes suggest benefits on patient-important outcomes but often suffer from limitations in sample size and conduct. Copyright © 2017 Elsevier Inc. All rights reserved.

Patient-Reported Disease-Modifying Therapy Adherence in the Clinic: A Reliable Metric?

PubMed

Conway, Devon S; Cecilia Vieira, Maria; Thompson, Nicolas R; Parker, Kaila N; Meng, Xiangyi; Fox, Robert J

2018-01-01

Adherence to multiple sclerosis (MS) disease-modifying therapy (DMT) is commonly assessed through patient reporting, but patient-reported adherence is rarely studied. To determine rates of DMT adherence reported from patient to clinician, reasons for nonadherence, and relationships between adherence and outcomes. We identified relapsing-remitting MS patients on DMT for ≥3 months. DMT adherence was defined as taking ≥80% of doses. Linear and logistic regression models were created used to determine the association of baseline adherence with several patient reported outcomes and the timed 25-foot walk at 6 months, 1 year, 2 years, and 3 years after the index visit. The analysis included 1148 patients, of whom 501 had data at 6 months, 544 at 1 year, 331 at 2 years, and 247 at 3 years. Baseline adherence was 94.9% and overall adherence was 93.1%. Forgetting was the most common reason for missed doses. In the adjusted models, adherence was not associated with the outcomes. Higher than expected adherence and a lack of association between adherence and outcomes suggests patient reported adherence may not be reliable. Further research is needed to clarify the relationship between patient-reported adherence and relapses or new lesion formation.

Do research studies in the UK reporting child neurodevelopment adjust for the variability of assessors: a systematic review.

PubMed

Khalid, Rahila; Willatts, Peter; Williams, Fiona L R

2016-02-01

Neurodevelopment is a key outcome for many childhood trials and observational studies. Clinically important decisions may rest on finding relatively small differences in neurodevelopment between groups receiving complex and costly interventions. Our purpose was to determine whether studies which measure neurodevelopment report the numbers, training, and auditing of assessors and, for multiple assessor studies, whether the results were adjusted and if so by which method? Electronic searches were conducted using Medline, Embase, Cinahl, PsycINFO, and the Cochrane Library. A study was eligible if it reported neurodevelopmental outcome in children resident in the UK, less than or equal to 18 years and was published between 2000 and 2015. Trials and observational studies were included. Three hundred and seven full papers were reviewed: 52% of papers did not report the number of assessors used; 21% used a single assessor; and 27% used multiple assessors. Thirty-five per cent mentioned that assessors were trained in the use of the neurodevelopmental tool; 13% of assessors were audited; and only 1% of studies adjusted statistically for the number of assessors. At the very least, the quality of reporting the use of assessors in these research publications is poor, while at worst, the variability of assessors may mask the true relationship between an intervention/observation and neurodevelopmental outcome. © 2015 Mac Keith Press.

Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery: An Empirical Study.

PubMed

Probst, Pascal; Knebel, Phillip; Grummich, Kathrin; Tenckhoff, Solveig; Ulrich, Alexis; Büchler, Markus W; Diener, Markus K

2016-07-01

Industry sponsorship has been identified as a source of bias in several fields of medical science. To date, the influence of industry sponsorship in the field of general and abdominal surgery has not been evaluated. A systematic literature search (1985-2014) was performed in the Cochrane Library, MEDLINE, and EMBASE to identify randomized controlled trials in general and abdominal surgery. Information on funding source, outcome, and methodological quality was extracted. Association of industry sponsorship and positive outcome was expressed as odds ratio (OR) with 95% confidence interval (CI). A χ test and a multivariate logistic regression analysis with study characteristics and known sources of bias were performed. A total of 7934 articles were screened and 165 randomized controlled trials were included. No difference in methodological quality was found. Industry-funded trials more often presented statistically significant results for the primary endpoint (OR, 2.44; CI, 1.04-5.71; P = 0.04). Eighty-eight of 115 (76.5%) industry-funded trials and 19 of 50 (38.0%) non-industry-funded trials reported a positive outcome (OR, 5.32; CI, 2.60-10.88; P < 0.001). Industry-funded trials more often reported a positive outcome without statistical justification (OR, 5.79; CI, 2.13-15.68; P < 0.001). In a multivariate analysis, funding source remained significantly associated with reporting of positive outcome (P < 0.001). Industry funding of surgical trials leads to exaggerated positive reporting of outcomes. This study emphasizes the necessity for declaration of funding source. Industry involvement in surgical research has to ensure scientific integrity and independence and has to be based on full transparency.

Association between eczema and major cardiovascular outcomes in population-based studies: a systematic review protocol.

PubMed

Ascott, Anna; Yu, Ashley M; Schmidt, Morten; Abuabara, Katrina; Smeeth, Liam; Langan, Sinéad M

2017-09-29

Chronic inflammatory diseases such as eczema (also known as atopic dermatitis) have been inconsistently linked to cardiovascular disease and stroke in both mechanistic and epidemiological studies. There is a need to review the existing epidemiological data examining the association between eczema and major cardiovascular outcomes, including angina, myocardial infarction, coronary revascularisation, heart failure, cardiac arrhythmias, stroke and cardiovascular death, in order to improve our understanding of the comorbidities of eczema. We will systematically review population-based studies, including cohort, case-control and cross-sectional studies, reporting on the association between eczema and cardiovascular outcomes. We will search Medline, Embase and Global Health, from their date of inception to April 2017, using a comprehensive search strategy formulated with the help of a librarian. Two reviewers will independently screen titles and abstracts in duplicate, followed by independent data extraction and quality assessment. We will group studies by the cardiovascular outcome under study and synthesise them narratively. If sufficient numbers of homogeneous studies are returned, we will perform meta-analyses to obtain pooled effect estimates. Preferred Reporting Items for Systematic Review and Meta-Analysis will be used to inform the reporting of this study. CRD42017060359. © 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 Patient-Reported Information to Improve Clinical Practice.

PubMed

Schlesinger, Mark; Grob, Rachel; Shaller, Dale

2015-12-01

To assess what is known about the relationship between patient experience measures and incentives designed to improve care, and to identify how public policy and medical practices can promote patient-valued outcomes in health systems with strong financial incentives. Existing literature (gray and peer-reviewed) on measuring patient experience and patient-reported outcomes, identified from Medline and Cochrane databases; evaluations of pay-for-performance programs in the United States, Europe, and the Commonwealth countries. We analyzed (1) studies of pay-for-performance, to identify those including metrics for patient experience, and (2) studies of patient experience and of patient-reported outcomes to identify evidence of influence on clinical practice, whether through public reporting or private reporting to clinicians. First, we identify four forms of "patient-reported information" (PRI), each with distinctive roles shaping clinical practice: (1) patient-reported outcomes measuring self-assessed physical and mental well-being, (2) surveys of patient experience with clinicians and staff, (3) narrative accounts describing encounters with clinicians in patients' own words, and (4) complaints/grievances signaling patients' distress when treatment or outcomes fall short of expectations. Because these forms vary in crucial ways, each must be distinctively measured, deployed, and linked with financial incentives. Second, although the literature linking incentives to patients experience is limited, implementing pay-for-performance systems appears to threaten certain patient-valued aspects of health care. But incentives can be made compatible with the outcomes patients value if: (a) a sufficient portion of incentives is tied to patient-reported outcomes and experiences, (b) incentivized forms of PRI are complemented by other forms of patient feedback, and (c) health care organizations assist clinicians to interpret and respond to PRI. Finally, we identify roles for the public and private sectors in financing PRI and orchestrating an appropriate balance among its four forms. Unless public policies are attentive to patients' perspectives, stronger financial incentives for clinicians can threaten aspects of care that patients most value. Certain policy parameters are already clear, but additional research is required to clarify how best to collect patient narratives in varied settings, how to report narratives to consumers in conjunction with quantified metrics, and how to promote a "culture of learning" at the practice level that incorporates patient feedback. © Health Research and Educational Trust.

Surrogate outcomes in health technology assessment: an international comparison.

PubMed

Velasco Garrido, Marcial; Mangiapane, Sandra

2009-07-01

Our aim was to review the recommendations given by health technology assessment (HTA) institutions in their methodological guidelines concerning the use of surrogate outcomes in their assessments. In a second step, we aimed at quantifying the role surrogate parameters take in assessment reports. We analyzed methodological papers and guidelines from HTA agencies with International Network of Agencies for Health Technology Assessment membership as well as from institutions related to pharmaceutical regulation (i.e., reimbursement, pricing). We analyzed the use of surrogate outcomes in a sample of HTA reports randomly drawn from the HTA database. We checked methods, results (including evidence tables), and conclusions sections and extracted the outcomes reported. We report descriptive statistics on the presence of surrogate outcomes in the reports. We identified thirty-four methodological guidelines, twenty of them addressing the issue of outcome parameter choice and the problematic of surrogate outcomes. Overall HTA agencies call on caution regarding the reliance on surrogate outcomes. None of the agencies has provided a list or catalog of acceptable and validated surrogate outcomes. We extracted the outcome parameter of 140 HTA reports. Only around half of the reports determined the outcomes for the assessment prospectively. Surrogate outcomes had been used in 62 percent of the reports. However, only 3.6 percent were based upon surrogate outcomes exclusively. All of them assessed diagnostic or screening technologies and the surrogate outcomes were predominantly test characteristics. HTA institutions seem to agree on a cautious approach to the use of surrogate outcomes in technology assessment. Thorough assessment of health technologies should not rely exclusively on surrogate outcomes.

Reporting and Handling Missing Outcome Data in Mental Health: A Systematic Review of Cochrane Systematic Reviews and Meta-Analyses

ERIC Educational Resources Information Center

Spineli, Loukia M.; Pandis, Nikolaos; Salanti, Georgia

2015-01-01

Objectives: The purpose of the study was to provide empirical evidence about the reporting of methodology to address missing outcome data and the acknowledgement of their impact in Cochrane systematic reviews in the mental health field. Methods: Systematic reviews published in the Cochrane Database of Systematic Reviews after January 1, 2009 by…

The Relationship between Components of the Ohio Local School District Report Card and the Outcome of a School Tax Levy

ERIC Educational Resources Information Center

Wheatley, Vicki Ann

2012-01-01

The relationship between components of the local school district report card, school district typology, and the outcome of public school tax levy requests were examined in this study. A correlation research design was used to measure the relationship between the independent variables (performance index, average yearly progress, value added,…

Higher forgotten joint score for fixed-bearing than for mobile-bearing total knee arthroplasty.

PubMed

Thienpont, E; Zorman, D

2016-08-01

To compare the postoperative subjective outcome for fixed- and mobile-bearing total knee arthroplasty (TKA) by using the forgotten joint score (FJS-12), a new patient-reported outcome score of 12 questions evaluating the potential of a patient to forget about his operated joint. The hypothesis of this study was that a mobile-bearing TKA would have a higher level of forgotten joint than a fixed-bearing model of the same design. A retrospective cohort study was conducted in 100 patients who underwent TKA at least 1 year [mean (SD) 18 (5) months] before with either a fixed-bearing (N = 50) or a mobile-bearing (N = 50) TKA from the same implant family. Clinical outcome was evaluated with the knee society score and patient-reported outcome with the forgotten joint score. No difference was observed for demographics in between both study groups. The mean (SD) postoperative FJS-12 for the fixed-bearing TKA was 71 (28) compared to a mean (SD) of 56.5 (30) for the mobile-bearing TKA. The clinical relevance of the present retrospective study is that it shows for the first time a significant difference between fixed- and mobile-bearing TKA by using a new patient-reported outcome score. The hypothesis that mobile-bearing TKA would have a higher degree of forgotten joint than a fixed-bearing TKA could not be confirmed. A level I prospective study should be set up to objectivise these findings. IV.

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

A preliminary evaluation of synthetic cannabinoid use among adolescent cannabis users: Characteristics and treatment outcomes.

PubMed

Blevins, Claire E; Banes, Kelsey E; Stephens, Robert S; Walker, Denise D; Roffman, Roger A

2016-12-01

Little is known regarding the use of synthetic cannabinoids (SC), particularly use among adolescent substance users who may be at higher risk. The present exploratory study seeks to describe SC use and subjective effects among cannabis-using adolescents as well as compare the characteristics of cannabis users who do and do not use SC. Exploratory analyses evaluated cannabis treatment outcomes among SC users and non-users. Participants enrolled in a randomized, controlled intervention for cannabis-using high school students aged 14-19 (N=252) completed questionnaires regarding their use of SC and other substances. Those who used SC in the past 60days reported subjective effects of SC, consequences, and SC use disorder symptoms. Baseline characteristics, alcohol and other drug use, and treatment outcomes of SC users were compared to participants who never tried SC. Within this sample 29% had tried SC, and 6% used SC recently. Although most reported use at a relatively low rate, 43% of recent SC users reported SC use-disorder symptoms. Positive and negative subjective effects of SC were endorsed, with positive subjective effects reported more often. SC use was associated with more cannabis use, but not more alcohol or other (non-SC and non-cannabis) drug use. SC users did not differ from non-users on cannabis treatment outcomes. This exploratory study described SC use, and compared characteristics and treatment outcomes among SC users and non-users. Negative subjective effects of SC were reported as occurring less often, but SC use was associated with use disorder psychopathology. SC use was associated with more problematic cannabis use at baseline, but was not associated with use of other substances or differences in treatment outcome. Copyright © 2016 Elsevier Ltd. All rights reserved.

A prospective cohort study investigating the effect of generalized joint hypermobility on outcomes after arthroscopic anterior shoulder stabilization.

PubMed

Koyonos, Loukas; Kraeutler, Matthew J; O'Brien, Daniel F; Ciccotti, Michael G; Dodson, Christopher C

2016-11-01

Generalized joint laxity has been proposed as a significant risk factor for failure after arthroscopic anterior shoulder stabilization. The purpose of this study was to prospectively measure joint mobility in patients undergoing arthroscopic anterior shoulder stabilization and to determine whether hypermobility is a risk factor for worse outcomes compared with patients having normal joint mobility. Patients with anterior shoulder instability were prospectively enrolled. Generalized joint hypermobility was measured using the Beighton Hypermobility Score and the Rowe, UCLA, SANE, SST, and WOSI scores were administered and reported as patient outcomes preoperatively and following arthroscopic anterior shoulder stabilization at 6 weeks, 6 months, 12 months, and 24 months postoperatively. Patients were stratified into two groups based on their Beighton Hypermobility Score, with scores ≥ 4/9 indicative of joint hypermobility. Sixteen patients with joint hypermobility (JH) and 18 non-hypermobile patients (NJH) were enrolled. At baseline, there were no significant differences in demographic characteristics or baseline patient-reported outcomes. Significantly more patients in the NJH group had SLAP tears (n = 10) compared to the JH group (n = 2) (p = .013). At all follow-up times, there were no significant differences between the NJH and JH groups with regard to patient-reported outcome scores (p > .05). In the JH group, 17% of patients reported recurrent instability at two years postoperatively compared to 25% of patients in the NJH group. There was no significant difference in failure rate (p = .67). There was no significant difference in patient-reported outcomes or recurrent instability in patients with versus without joint hypermobility undergoing arthroscopic anterior shoulder stabilization.

Culture shock and synergy. Academic/managed care/corporate alliances in outcomes management.

PubMed

Berman, W H; Darling, H; Hurt, S W; Hunkeler, E M

1994-01-01

The Behavioral Health Outcomes Study is a partnership in conducting outcomes measurement involving a corporate healthcare purchaser, five managed behavioral healthcare organizations and academic researchers. The goals of this study are to: evaluate the feasibility of incorporating patient self-reported data in outcomes research; identify factors that may be predictors of outcome; and evaluate the effectiveness of an employee-sponsored aftercare program. The differing perspectives and needs of the three partners have created a number of challenges in the areas of goals, confidentiality, proprietary vs. open access issues and methodology. However, after the study's first year, it is clear not only that outcomes research can be conducted under such a partnership, but that the partnership generates a kind of synergy in problem-solving.

Development through Dissent: Campus Activism as Civic Learning

ERIC Educational Resources Information Center

Biddix, J. Patrick

2014-01-01

This chapter traces two decades of published research on learning outcomes related to campus activism and reports results from a speculative study considering civic outcomes from participation in campus political and war demonstrations.

Comparing indicators of health and development of singleton young adults conceived with and without assisted reproductive technology.

PubMed

Halliday, Jane; Wilson, Cate; Hammarberg, Karin; Doyle, Lex W; Bruinsma, Fiona; McLachlan, Robert; McBain, John; Berg, Turi; Fisher, Jane R; Amor, David

2014-04-01

To compare outcomes for young adults conceived by assisted reproductive technology (ART) with non-ART-conceived young adults. Cohort study. Not applicable. Mothers and their offspring (aged 18-28 years) conceived by ART; mothers and their non-ART-conceived offspring, randomly selected from the same source population. Structured telephone interviews, one with mothers and another with their young adult offspring. Maternal report on young adult offspring hospitalizations and chronic illness accumulated over the first 18 years of their lives; young adult self-report on perceived current quality of life, body mass index, pubertal development, and educational achievement. Of 1,480 eligible ART mothers, 80% were traced and contacted. Of those, 656 (55%) participated, reporting on 705 ART-conceived offspring; 269 (23%) declined participation and 262 (22%) did not respond. Of the participants, 84% consented to contact with their young adult offspring, of whom 547 (92%) participated. Random-digit dialing recruited 868 non-ART mothers and 549 offspring. Compared with non-ART young adults, the ART group had significant increases in three maternally reported outcomes: 1) hospital admissions, including those in the secondary school years; 2) atopic respiratory conditions; and 3) combined endocrine, nutritional, and metabolic disease ICD-10 category. Young adult reported outcomes were similar for both groups. This study addresses gaps in knowledge of outcomes beyond adolescence for those conceived by ART. Results show few adverse outcomes in this large cohort of young adults, but additional assessment through clinical review is required to address issues unable to be examined in this study. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Validation of a model of family caregiver communication types and related caregiver outcomes.

PubMed

Wittenberg, Elaine; Kravits, Kate; Goldsmith, Joy; Ferrell, Betty; Fujinami, Rebecca

2017-02-01

Caring for the family is included as one of the eight domains of quality palliative care, calling attention to the importance of the family system and family communications about cancer during care and treatment of the disease. Previously, a model of family caregiver communication defined four caregiver communication types-Manager, Carrier, Partner, Lone-each with a unique communication pattern. The purpose of the present study was to extend the model of family caregiver communication in cancer care to further understand the impact of family communication burden on caregiving outcomes. This mixed-method study employed fieldnotes from a family caregiver intervention focused on quality of life and self-reported caregiver communication items to identify a specific family caregiver type. Caregiver types were then analyzed using outcome measures on psychological distress, skills preparedness, family inventory of needs, and quality-of-life domains. Corroboration between fieldnotes and self-reported communication for caregivers (n = 21, 16 women, mean age of 53 years) revealed a definitive classification of the four caregiver types (Manager = 6, Carrier = 5, Partner = 6, Lone = 4). Mean scores on self-reported communication items documented different communication patterns congruent with the theoretical framework of the model. Variation in caregiver outcomes measures confirmed the model of family caregiver communication types. Partner and Lone caregivers reported the lowest psychological distress, with Carrier caregivers feeling least prepared and Manager caregivers reporting the lowest physical quality of life. This study illustrates the impact of family communication on caregiving and increases our knowledge and understanding about the role of communication in caregiver burden. The research provides the first evidence-based validation for a family caregiver communication typology and its relationship to caregiver outcomes. Future research is needed to develop and test interventions that target specific caregiver types.

Determination of patellofemoral pain sub-groups and development of a method for predicting treatment outcome using running gait kinematics.

PubMed

Watari, Ricky; Kobsar, Dylan; Phinyomark, Angkoon; Osis, Sean; Ferber, Reed

2016-10-01

Not all patients with patellofemoral pain exhibit successful outcomes following exercise therapy. Thus, the ability to identify patellofemoral pain subgroups related to treatment response is important for the development of optimal therapeutic strategies to improve rehabilitation outcomes. The purpose of this study was to use baseline running gait kinematic and clinical outcome variables to classify patellofemoral pain patients on treatment response retrospectively. Forty-one individuals with patellofemoral pain that underwent a 6-week exercise intervention program were sub-grouped as treatment Responders (n=28) and Non-responders (n=13) based on self-reported measures of pain and function. Baseline three-dimensional running kinematics, and self-reported measures underwent a linear discriminant analysis of the principal components of the variables to retrospectively classify participants based on treatment response. The significance of the discriminant function was verified with a Wilk's lambda test (α=0.05). The model selected 2 gait principal components and had a 78.1% classification accuracy. Overall, Non-responders exhibited greater ankle dorsiflexion, knee abduction and hip flexion during the swing phase and greater ankle inversion during the stance phase, compared to Responders. This is the first study to investigate an objective method to use baseline kinematic and self-report outcome variables to classify on patellofemoral pain treatment outcome. This study represents a significant first step towards a method to help clinicians make evidence-informed decisions regarding optimal treatment strategies for patients with patellofemoral pain. Copyright © 2016 Elsevier Ltd. All rights reserved.

Pediatric Mania: The Controversy between Euphoria and Irritability

PubMed Central

Serra, Giulia; Uchida, Mai; Battaglia, Claudia; Casini, Maria Pia; De Chiara, Lavinia; Biederman, Joseph; Vicari, Stefano; Wozniak, Janet

2017-01-01

Abstract: Pediatric Bipolar Disorder (BD) is a highly morbid pediatric psychiatric disease, consistently associated with family psychiatric history of mood disorders and associated with high levels of morbidity and disability and with a great risk of suicide. While there is a general consensus on the symptomatology of depression in childhood, the phenomenology of pediatric mania is still highly debated and the course and long-term outcome of pediatric BD still need to be clarified. We reviewed the available studies on the phenomenology of pediatric mania with the aim of summarizing the prevalence, demographics, clinical correlates and course of these two types of pediatric mania. Eighteen studies reported the number of subjects presenting with either irritable or elated mood during mania. Irritability has been reported to be the most frequent clinical feature of pediatric mania reaching a sensitivity of 95–100% in several samples. Only half the studies reviewed reported on number of episodes or cycling patterns and the described course was mostly chronic and ultra-rapid whereas the classical episodic presentation was less common. Few long-term outcome studies have reported a diagnostic stability of mania from childhood to young adult age. Future research should focus on the heterogeneity of irritability aiming at differentiating distinct subtypes of pediatric psychiatric disorders with distinct phenomenology, course, outcome and biomarkers. Longitudinal studies of samples attending to mood presentation, irritable versus elated, and course, chronic versus episodic, may help clarify whether these are meaningful distinctions in the course, treatment and outcome of pediatric onset bipolar disorder. PMID:28503110

Pediatric Mania: The Controversy between Euphoria and Irritability.

PubMed

Serra, Giulia; Uchida, Mai; Battaglia, Claudia; Casini, Maria Pia; De Chiara, Lavinia; Biederman, Joseph; Vicari, Stefano; Wozniak, Janet

2017-04-01

Pediatric Bipolar Disorder (BD) is a highly morbid pediatric psychiatric disease, consistently associated with family psychiatric history of mood disorders and associated with high levels of morbidity and disability and with a great risk of suicide. While there is a general consensus on the symptomatology of depression in childhood, the phenomenology of pediatric mania is still highly debated and the course and long-term outcome of pediatric BD still need to be clarified. We reviewed the available studies on the phenomenology of pediatric mania with the aim of summarizing the prevalence, demographics, clinical correlates and course of these two types of pediatric mania. Eighteen studies reported the number of subjects presenting with either irritable or elated mood during mania. Irritability has been reported to be the most frequent clinical feature of pediatric mania reaching a sensitivity of 95-100% in several samples. Only half the studies reviewed reported on number of episodes or cycling patterns and the described course was mostly chronic and ultra-rapid whereas the classical episodic presentation was less common. Few long-term outcome studies have reported a diagnostic stability of mania from childhood to young adult age. Future research should focus on the heterogeneity of irritability aiming at differentiating distinct subtypes of pediatric psychiatric disorders with distinct phenomenology, course, outcome and biomarkers. Longitudinal studies of samples attending to mood presentation, irritable versus elated, and course, chronic versus episodic, may help clarify whether these are meaningful distinctions in the course, treatment and outcome of pediatric onset bipolar disorder.

A systematic review and meta-analysis of quantitative interviewing tools to investigate self-reported HIV and STI associated behaviours in low- and middle-income countries.

PubMed

Phillips, Anna E; Gomez, Gabriella B; Boily, Marie-Claude; Garnett, Geoffrey P

2010-12-01

Studies identifying risks and evaluating interventions for human immunodeficiency virus (HIV) and other sexually transmitted infections often rely on self-reported measures of sensitive behaviours. Such self-reports can be subject to social desirability bias. Concerns over the accuracy of these measures have prompted efforts to improve the level of privacy and anonymity of the interview setting. This study aims to determine whether such novel tools minimize misreporting of sensitive information. Systematic review and meta-analysis of studies in low- and middle-income countries comparing traditional face-to-face interview (FTFI) with innovative tools for reporting HIV risk behaviour. Crude odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. Cochran's chi-squared test of heterogeneity was performed to explore differences between estimates. Pooled estimates were determined by gender, region, education, setting and question time frame using a random effects model. We found and included 15 data sets in the meta-analysis. Most studies compared audio computer-assisted self interview (ACASI) with FTFI. There was significant heterogeneity across studies for three outcomes of interest: 'ever had sex' (I(2) = 93.4%, P < 0.001), non-condom use (I(2) = 89.3%, P < 0.001), and number of partners (I(2) = 75.3%, P < 0.001). For the fourth outcome, 'forced sex', there was homogenous increased reporting by non-FTFI methods (OR 1.47; 95% CI 1.11-1.94). Overall, non-FTFI methods were not consistently associated with a significant increase in the reporting of all outcomes. However, there was increased reporting associated with non-FTFI with region (Asia), setting (urban), education (>60% had secondary education) and a shorter question time frame. Contrary to expectation, differences between FTFI and non-interviewer-administered interview methods for the reported sensitive behaviour investigated were not uniform. However, we observed trends and variations in the level of reporting according to the outcome, study and population characteristics. FTFI may not always be inferior to innovative interview tools depending on the sensitivity of the question as well as the population assessed.

Evaluation of outcome measures for use in clinical practice for adults with musculoskeletal conditions of the knee: a systematic review.

PubMed

Howe, Tracey E; Dawson, Lesley J; Syme, Grant; Duncan, Louise; Reid, Judith

2012-04-01

This systematic review reported on the clinimetric properties of outcome measures for use in clinical practice for adults with musculoskeletal conditions of the knee. A systematic search was performed in Medline, EMBASE, Cinahl and AMED to identify studies examining the clinimetric properties of outcome measures for adults undergoing conservative treatment of ligament injuries, meniscal lesions, patellofemoral pain and osteoarthritis of the knee. Outcomes measures taking less than 20 min to administer and requiring minimal equipment and space were included. Pairs of authors used a checklist to record the characteristics of the outcome measures, their reported clinimetric properties and the demographics of the study populations. The OMERACT filters of 'truth' and 'discrimination' were applied to the data for each outcome measure by an expert panel. Forty-seven studies were included evaluating 37 outcome measures. Ten outcome measures had adequate supporting evidence for 'truth' and 'discrimination': AAOS, AKPS, goniometer measurement, IKDC, KOOS, LEFS, Lysholm, Tegner, WOMAC and WOMET. However none of the outcome measures had been comprehensively tested across all clinimetric properties. Despite the widespread use of some outcome measures in clinical practice and primary research, data on the clinimetric properties were available for only 37 and of these only 10 had adequate supporting evidence for use in this population. However, before a core set of outcome measures can be recommended use in clinical practice, for adults with musculoskeletal conditions of the knee, consensus should be obtained on 'feasibility' in terms of burden on the clinician and the participant. Copyright © 2011 Elsevier Ltd. All rights reserved.