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Concept: Outcome


Thrombocytosis, often considered a marker of normal inflammatory reaction of infections, has been recently associated with increased mortality in hospitalized patients with community-acquired pneumonia (CAP). We assessed the characteristics and outcomes of patients with CAP and thrombocytosis (platelet count ≥ 4 × 105/mm3) compared with thrombocytopenia (platelet count < 105/mm3) and normal platelet count.

Concepts: Inflammation, Pneumonia, Platelet, Thrombocytopenia, Outcome


In today’s healthcare environment it is increasingly important to be able to quantify the amount of change associated with a given intervention; this can be accomplished using one or more appropriate outcome measures. However, the selection and integration of outcome measures within clinical practice requires careful consideration. This includes identification of the measure construct which can be assisted by the International Classification of Functioning, Disability, and Health; selection of outcome measures based on need, appropriateness and feasibility; and careful use in regular clinical practice including data collection, analysis and re-assessment of the process. We describe this process, focusing on orthotic management of stroke, in particular the improvement of mobility as a common goal. Clinical relevance The growing emphasis on improved documentation of patient care and outcomes requires that clinicians integrate clinically relevant outcome measures into their practice. We suggest a process to assist clinicians integrate outcome measures into clinical practice with a particular emphasis on the orthotic management of stroke.

Concepts: Health care, Health, Clinical trial, Medical ethics, Hospital, Integral, Morality, Outcome


: In the adult population, rotator cuff tears are common and established treatment methods yield satisfactory results. In adolescents, however, these injuries are uncommon and few treatment methods and outcome reports exist. The purpose of this study was to examine a series of adolescent rotator cuff tears, identify associated pathology, and report treatment outcomes.

Concepts: Biology, Report, Outcome, Rotator cuff, Rotator cuff tear


BACKGROUND: Prior studies have suggested that patients with workers' compensation (WC) related injuries have less successful postsurgical outcomes compared to the general population. The purpose of this study was to determine the functional outcome and return to work for WC patients who have undergone distal biceps tendon repair (DBTR). A group of patients without a WC claim (non-WC) served as a control. METHODS: From July 2002 to December 2009, 60 WC patients and 63 non-WC patients who underwent unilateral, acute (<6 weeks) DBTR and had a minimum of 12 months of postoperative follow-up were contacted. Data pertaining to patient age, sex, handedness, smoking status, occupation, time to return to work, and ability to return to original occupation were obtained. Functional outcomes were primarily assessed with the DASH, DASH-Work Module, and DASH Sports/Performance Arts Module questionnaires. Outcomes in the WC group were compared to the non-WC group. RESULTS: Average length of follow-up was 3.55 years (range, 1.5-8.9) in the WC group and 3.64 years (range, 2.2-8.0) in the non-WC group. Mean DASH, DASH-Work Module, and Sports/Performance Arts Module scores were significantly greater (poorer outcome) in the WC group than in the non-WC group. Average time to return to full duty was 3.95 months in the WC group and 1.35 months in the non-WC group. CONCLUSION: WC patients who underwent distal biceps tendon repair took longer to return to work and had worse DASH scores than non-WC patients.

Concepts: Vector space, Group, Outcome, Workers' compensation, Group action, Simple module


INTRODUCTION: Warfarin treatment with a high time in therapeutic range (TTR) is correlated to fewer complications. The TTR in Sweden is generally high but varies partly depending on local expertise and traditions. A dosing algorithm could minimize variations and increase treatment quality. Here we evaluate the performance of a computerized dosing algorithm. MATERIALS AND METHODS: 53.779 warfarin treated patients from 125 centers using the Swedish national quality registry AuriculA. If certain criteria are met, the algorithm gives one of seven possible dose suggestions, which can be unchanged, decreased or increased weekly dose by 5, 10 or 15%. The outcome evaluated by the resulting INR value was compared between dose suggestions arising from the algorithm that were accepted and those that were manually changed. There were no randomization, and outcomes were retrospectively analyzed. RESULTS: Both the algorithm-based and the manually changed doses had worse outcome if only two instead of three previous INR values were available. The algorithm suggestions were superior to manual dosing regarding percent samples within the target range 2-3 (hit-rate) or deviation from INR 2.5 (mean error). Of the seven possible outcomes from the algorithm, six were significantly superior and one equal to the manually changed doses when three previous INR:s were present. CONCLUSIONS: The algorithm-based dosing suggestions show better outcome in most cases. This can make dosing of warfarin easier and more efficient. There are however cases where manual dosing fares better. Here the algorithm will be improved to further enhance its dosing performance in the future.

Concepts: Algorithm, Warfarin, Dose, Computer-aided design, Outcome, Equals sign, Prothrombin time, Manual transmission


Indications for laparoscopic inguinal hernia repair in infants and children remain controversial. The purpose of this study is to compare clinical features and outcome of laparoscopic inguinal hernia repair in infants with older children.

Concepts: Surgery, Inguinal hernia, Hernia, Outcome, Hernias


Plantar fasciitis is a common cause of heel pain in the U.S. Army soldier, resulting in a significant loss of man hours. Given the heavy operations tempo of the U.S. military, successful treatment options need to be considered and used as quickly as possible. Plantar fasciitis can be successfully treated in up to 90% of patients using conservative measures. Operative intervention might need to be considered for those in whom conservative measures have failed. The present report is a review of 105 consecutive uniport endoscopic plantar fascial release procedures performed by the principal investigator during a 9-year period. The following data were collected and analyzed: gender, age, weight, height, body mass index, medical treatment facility, procedure laterality, preoperative pain levels, postoperative pain levels at 3 months, first ambulatory day in the controlled ankle motion boot, return to activity as tolerated, and complications. Three major points were of interest: evidence of improvement in chronic plantar fasciitis when treated with uniport endoscopic procedures; the patient attributes associated with self-reported pain levels 90 days postoperatively; and the patient attributes associated with the average time until patients were able to return to activities as tolerated in a controlled ankle motion boot. It was noted that 44.5% of those with a body mass index of 29.80 kg/m(2) or greater reported a postoperative pain level of 0; and 96.3% of those with a body mass index of 25.53 kg/m(2) or less reported postoperative pain levels of 0. The analyzed data were used to characterize the clinical outcomes of the procedure, identify changes in outcome with surgeon experience, and identify whether certain patient subgroups have better outcomes, allowing surgeons to identify which patient might be the best candidates for an endoscopic release procedure.

Concepts: Patient, Mass, Physician, Body mass index, Patience, Outcome, United States Army, Plantar fasciitis


PURPOSE: To determine, through a 10-year review, (1) the prevalence of residents in difficulty, (2) characteristics of these residents, (3) areas of residents' weakness, and (4) outcomes of residents who undergo remediation. METHOD: A retrospective review of resident records for the University of Toronto Faculty of Medicine’s (UT-FOM) Board of Examiners for Postgraduate Programs (BOE-PG) was done from July 1, 1999 to June 30, 2009 using predetermined data elements entered into a standardized form and analyzed for trends and significance. Outcomes for residents in difficulty were tracked through university registration systems and licensure databases. RESULTS: During 10 years, 103 UT-FOM residents were referred to the BOE-PG, representing 3% of all residents enrolled. The annual prevalence of residents referred to the BOE-PG ranged from 0.2% to 1.5%. The CanMEDS framework was used to classify areas of residents' weaknesses and organize remediation plans. All 100 residents studied had either medical expertise (85%) or professionalism (15%) weaknesses or both. Residents had difficulties with an average of 2.6 CanMEDS Roles, with highest frequencies of Medical Expert (85%) Professional (51%), Communicator (49%), Manager (43%), and Collaborator (20%). Often, there were multiple remediation periods, with an average of six months' duration. Usually, remediation was successful; 78% completed residency education, 17% were unsuccessful, and 5% remained in training. CONCLUSION: Residents in difficulty have multiple areas of weakness. The CanMEDS framework is an effective approach to classifying problems and designing remediation plans. Successful completion of residency education after remediation is the most common outcome.

Concepts: Retrospective, Physician, Management, Medical school, Outcome, Resident


AIM: There is a wealth of evidence suggesting that patients with schizophrenia tend to respond to life stressors using less effective coping skills, which are in turn related to poor outcome. However, the contribution of coping strategies to outcome in youth at clinical high risk (CHR) for developing psychosis has not been investigated. METHODS: This longitudinal study followed CHR youth over a 12-month period, using the Brief COPE questionnaire. CHR subjects (n = 88) were compared at baseline with a healthy control sample (n = 53), and then mixed models were used to explore the relationship of coping strategies to clinical and psychosocial outcomes in CHR subjects over time (n = 102). RESULTS: Cross-sectional analyses revealed that, in comparison with healthy controls, CHR youth reported using more maladaptive coping strategies (P < 0.001) and fewer adaptive coping strategies (P < 0.01). Longitudinal analyses within the CHR group showed significant decreases in maladaptive coping and symptom severity over time, with corresponding improvements in social and role functioning. Adaptive coping was associated with better concurrent social functioning and less severe symptomatology (both P < 0.001). Over time, more maladaptive coping was associated with more severe positive and negative symptoms (both P < 0.005). CONCLUSIONS: Youth at risk for psychosis report using fewer adaptive and more maladaptive coping strategies relative to healthy controls. Over 1-year follow-up, more adaptive coping styles are associated with less severe clinical symptomatology and better social functioning. These findings suggest that teaching adaptive coping styles may be an important target for intervention in youth at high risk for psychosis.

Concepts: Cohort study, Longitudinal study, Epidemiology, Cross-sectional study, Sociology, Outcome, Adaptive Behavior, Coping skill


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

Concepts: Academic publishing, Peer review, Cultural studies, Outcome, Peer-to-peer, Mixed martial arts, 2016, 2015