USE OF BIOMARKERS AS SECONDARY OR PRIMARY OUTCOME MEASURES IN ALCOHOLISM TREATMENT TRIALS.

2004 ◽  
Vol 28 (Supplement) ◽  
pp. 56A
Author(s):  
M Salaspuro
Keyword(s):  
Outcome Measures ◽  
Primary Outcome ◽  
Alcoholism Treatment ◽  
Treatment Trials

scholarly journals Effect of Core Stabilizing Training on Young Individuals Presenting Different Stages of Degenerative Disc Disease—Preliminary Report

2021 ◽  
Vol 18 (7) ◽  
pp. 3499
Author(s):  
Tomasz Kuligowski ◽  
Błażej Cieślik ◽  
Natalia Kuciel ◽  
Agnieszka Dębiec-Bąk ◽  
Anna Skrzek
Keyword(s):  
Lumbar Spine ◽  
Outcome Measures ◽  
Degenerative Disc Disease ◽  
Preliminary Report ◽  
Primary Outcome ◽  
Core Stability ◽  
Post Intervention ◽  
Disc Disease ◽  
Degenerative Disc

The aim of this study was to assess the efficacy of stabilizing training for the deep core muscles of the lumbar spine in subjects with degenerative disc disease. This study was conducted on 38 participants. The participants were divided into two groups: the extrusion group (EXT, n = 17) and the protrusion group (PRO, n = 21). All the subjects underwent a four-week-long core stability exercise-based treatment (five sessions/week). Clinical outcome measures were assessed pre-intervention (pre), post-intervention (post) and four weeks after the intervention (follow-up). The primary outcome measures were the spinal range of motion (ROM; Spinal Mouse® device) and the Oswestry Disability Index (ODI). In the PRO group, the ROM decreased from 88.52° pre-intervention to 83.33° post-intervention and to 82.82° at follow-up (p = 0.01), while the ODI decreased from 16.14 points pre-intervention to 6.57 points post-intervention, with 9.42 points at follow-up (p < 0.01). In the EXT group, the ROM decreased from 81.00° pre-intervention to 77.05° post-intervention, then increased to 77.94° at follow-up (p = 0.03), while the ODI decreased from 22.58 points pre-intervention to 15.41 points post-intervention and to 14.70 points at follow-up (p < 0.001). Although the stabilizing exercise sessions improved the clinical outcomes in each group, we cannot make conclusions as to whether the type of intervertebral disc damage significantly affects the results of stabilizing exercise-based treatment.

scholarly journals Patterns of multimorbidity and their effects on adverse outcomes in rheumatoid arthritis: a study of 5658 UK Biobank participants

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e038829
Author(s):  
Ross McQueenie ◽  
Barbara I Nicholl ◽  
Bhautesh D Jani ◽  
Jordan Canning ◽  
Sara Macdonald ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Adverse Outcomes ◽  
Major Adverse Cardiovascular Events ◽  
Uk Biobank ◽  
Long Term Conditions ◽  
Increased Risk ◽  
All Cause Mortality ◽  
Clinical Records

ObjectiveTo investigate how the type and number of long-term conditions (LTCs) impact on all-cause mortality and major adverse cardiovascular events (MACE) in people with rheumatoid arthritis (RA).DesignPopulation-based longitudinal cohort study.SettingUK Biobank.ParticipantsUK Biobank participants (n=502 533) aged between 37 and 73 years old.Primary outcome measuresPrimary outcome measures were risk of all-cause mortality and MACE.MethodsWe examined the relationship between LTC count and individual comorbid LTCs (n=42) on adverse clinical outcomes in participants with self-reported RA (n=5658). Risk of all-cause mortality and MACE were compared using Cox’s proportional hazard models adjusted for lifestyle factors (smoking, alcohol intake, physical activity), demographic factors (sex, age, socioeconomic status) and rheumatoid factor.Results75.7% of participants with RA had multimorbidity and these individuals were at increased risk of all-cause mortality and MACE. RA and >4 LTCs showed a threefold increased risk of all-cause mortality (HR 3.30, 95% CI 2.61 to 4.16), and MACE (HR 3.45, 95% CI 2.66 to 4.49) compared with those without LTCs. Of the comorbid LTCs studied, osteoporosis was most strongly associated with adverse outcomes in participants with RA compared with those without RA or LTCs: twofold increased risk of all-cause mortality (HR 2.20, 95% CI 1.55 to 3.12) and threefold increased risk of MACE (HR 3.17, 95% CI 2.27 to 4.64). These findings remained in a subset (n=3683) with RA diagnosis validated from clinical records or medication reports.ConclusionThose with RA and other LTCs, particularly comorbid osteoporosis, are at increased risk of adverse outcomes, although the role of corticosteroids could not be evaluated in this study. These results are clinically relevant for the monitoring and management of RA across the healthcare system, and future clinical guidelines for RA should acknowledge the importance of multimorbidity.

scholarly journals A Virtual Reality-Based Self-Help Intervention for Dealing with the Psychological Distress Associated with the COVID-19 Lockdown: An Effectiveness Study with a Two-Week Follow-Up

2021 ◽  
Vol 18 (15) ◽  
pp. 8188
Author(s):  
Giuseppe Riva ◽  
Luca Bernardelli ◽  
Gianluca Castelnuovo ◽  
Daniele Di Lernia ◽  
Cosimo Tuena ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Psychological Distress ◽  
Outcome Measures ◽  
Perceived Stress ◽  
Social Connectedness ◽  
Primary Outcome ◽  
Post Intervention ◽  
Stress Levels ◽  
Secondary Outcomes

The aim of this study is to investigate the effectiveness of a novel self-administered at-home daily virtual reality (VR)-based intervention (COVID Feel Good) for reducing the psychological burden experienced during the COVID-19 lockdown in Italy. A total of 40 individuals who had experienced at least two months of strict social distancing measures followed COVID Feel Good between June and July 2020 for one week. Primary outcome measures were depression, anxiety, and stress symptoms, perceived stress levels, and hopelessness. Secondary outcomes were the experienced social connectedness and the level of fear experienced during the COVID-19 pandemic. Linear mixed-effects models were fitted to evaluate the effectiveness of the intervention. Additionally, we also performed a clinical change analysis on primary outcome measures. As concerning primary outcome measures, participants exhibited improvements from baseline to post-intervention for depression levels, stress levels, general distress, and perceived stress (all p < 0.05) but not for the perceived hopelessness (p = 0.110). Results for the secondary outcomes indicated an increase in social connectedness from T0 to T1 (p = 0.033) but not a significant reduction in the perceived fear of coronavirus (p = 0.412). Among these study variables, these significant improvements were maintained from post-intervention to the 2-week follow-up (p > 0.05). Results indicated that the intervention was associated with good clinical outcomes, low-to-no risks for the treatment, and no adverse effects or risks. Globally, evidence suggests a beneficial effect of the proposed protocol and its current availability in 12 different languages makes COVID Feel Good a free choice for helping individuals worldwide to cope with the psychological distress associated with the COVID-19 crisis, although large scale trials are needed to evaluate its efficacy.

scholarly journals Evaluating measures of quality of life in adult scoliosis: a protocol for a systematic review and narrative synthesis

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
James E. Archer ◽  
Charles Baird ◽  
Adrian Gardner ◽  
Alison B. Rushton ◽  
Nicola R. Heneghan
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Outcome Measures ◽  
Study Design ◽  
Systematic Reviews ◽  
Primary Outcome ◽  
Adult Scoliosis ◽  
Measurement Properties ◽  
Narrative Synthesis

Abstract Background Adult scoliosis represents a distinct subgroup of scoliosis patients for whom the diagnosis can have a large impact on their health-related quality of life (HR-QOL). Therefore, HR-QOL patient-reported outcome measures (PROMs) are essential to assess disease progression and the impact of interventions. The objective of this systematic review is to evaluate the measurement properties of HR-QOL PROMs in adult scoliosis patients. Methods We will conduct a literature search, from their inception onwards, of multiple electronic databases including AMED, CINAHL, EMBASE, Medline, PsychINFO and PubMed. The searches will be performed in two stages. For both stages of the search, participants will be aged 18 and over with a diagnosis of scoliosis. The primary outcome of interest in the stage one searches will be studies which use PROMs to investigate HR-QOL as defined by the Core Outcome Measures in Effectiveness Trials (COMET) taxonomy, the secondary outcome will be to assess the frequency of use of the various PROMs. In stage two, the primary outcome of interest will be studies which assess the measurement properties of the HR-QOL PROMs identified in stage one. No specific measurement property will be given priority. No planned secondary outcomes have been identified but will be reported if discovered. In stage one, the only restriction on study design will be the exclusion of systematic reviews. In Stage two the only restriction on study design will be the exclusion of full-text articles not available in the English language. Two reviewers will independently screen all citations and abstract data. Potential conflicts will be resolved through discussion. The study methodological quality (or risk of bias) will be appraised using the Consensus-based Standards for the selection of Health Measurement Instruments (COSMIN) checklist. The overall strength of the body of evidence will then be assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. A narrative synthesis will be provided with information presented in the main text and tables to summarise and explain the characteristics and findings of the included studies. The narrative synthesis will explore the evidence for currently used PROMs in adult scoliosis patients and any areas that require further study. Discussion The review will help clinicians and researchers identify a HR-QOL PROM for use in patients with adult scoliosis. Findings from the review will be published and disseminated through a peer-reviewed journal and conference presentations. Systematic review registration This systematic review has been registered with the International Prospective Register of Systematic Reviews (PROSPERO), reference number: CRD42020219437

Abstract 219: Out-of-Hospital Cardiac Arrest in Vienna 2014

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Markus Keferböck ◽  
Philip Datler ◽  
Mario Krammel ◽  
Elisabeth Lobmeyer ◽  
Alexander Nürnberger ◽  
...  
Keyword(s):  
Cardiac Arrest ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Sudden Cardiac Arrest ◽  
Cerebral Performance Category ◽  
Medical Personnel ◽  
Shockable Rhythm ◽  
Initial Rhythm ◽  
Bystander Cpr ◽  
Hospital Cardiac Arrest

Background: Sudden cardiac arrest (SCA) and especially the out of hospital cardiac arrest (OHCA) is always an urgent situation, which requires well trained medical personnel. The emergency medical system (EMS) in Vienna took part in the Circulation Improving Care (CIRC) trial form 2008 to 2010. In this time they had an additional training. Therefore we revaluated the outcome of OHCA nowadays. Method: Interim report of a prospective observational study of all humans over eighteen, who suffer an OHCA resuscitated by the EMS in Vienna from August 2013 - April 2014. For those patients, who survived 30 days, a cerebral performance category score (CPC) was evaluated. Results: During nine months 701 patients could be investigated and 625 achieved the protocol for this trial. The median age of the patients was 68 years (IQR 59-79) and 399 (64%) were male. Witnessed by bystanders was the cardiac arrest in 359 (57%) patients. In the latter patients restoration of spontaneous circulation (n=223, 36%)(ROSC) and 30 day survival (n=166, 27%) was significantly more often achieved than in patients with non-witnessed cardiac arrest. Bystanders provided chest compressions in 284 (45%) cases and in this subgroup a shockable initial rhythm was more often (p<0.0001). Still in 189 (53%) of the patients where the cardiac arrest was witnessed, bystander resuscitation wasn′t attempted. An initial shockable rhythm was found in 146 (24%) patients with significant better outcome in all primary outcome measures. Of the 62 (10%) 30-days-survivors, 33 (6%) had good neurological outcome with a CPC 1-2.In 12 (2%) cases the CPC was missing. Conclusion: The results are comparable to findings of our previous studies. A significant better result in all primary outcome measures could be found for witnessed OHCA with an initial shockable rhythm. Furthermore those patients with bystander CPR had significant more often a shockable initial rhythm. Therefore more efforts have to be invested into encouraging the community to start with a bystander CPR if an OHCA is witnessed.

scholarly journals Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial

BMJ ◽  
2020 ◽  
pp. m1309 ◽  
Author(s):  
Joseph Shalhoub ◽  
Rebecca Lawton ◽  
Jemma Hudson ◽  
Christopher Baker ◽  
Andrew Bradbury ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
High Risk ◽  
Confidence Interval ◽  
Outcome Measures ◽  
Lower Limb ◽  
Primary Outcome ◽  
Elective Surgery ◽  
Compression Stockings ◽  
Graduated Compression Stockings ◽  
Randomised Controlled

AbstractObjectivesTo investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery.DesignOpen, multicentre, randomised, controlled, non-inferiority trial.SettingSeven National Health Service tertiary hospitals in the United Kingdom.Participants1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate.InterventionParticipants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS.Outcome measuresThe primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality.ResultsBetween May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval −0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior.ConclusionsFor patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery.Trial registrationISRCTN13911492.

scholarly journals Reactivating Ovarian Function through Autologous Platelet-Rich Plasma Intraovarian Infusion: Pilot Data on Premature Ovarian Insufficiency, Perimenopausal, Menopausal, and Poor Responder Women

2020 ◽  
Vol 9 (6) ◽  
pp. 1809 ◽  
Author(s):  
Konstantinos Sfakianoudis ◽  
Mara Simopoulou ◽  
Sokratis Grigoriadis ◽  
Agni Pantou ◽  
Petroula Tsioulou ◽  
...  
Keyword(s):  
Pilot Study ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Platelet Rich Plasma ◽  
Premature Ovarian Insufficiency ◽  
Cycle Performance ◽  
Routine Practice ◽  
Ovarian Insufficiency ◽  
Pilot Studies ◽  
Pilot Data

Intraovarian platelet-rich plasma (PRP) infusion was recently introduced in the context of addressing ovarian insufficiency. Reporting on its effectiveness prior to adopting in clinical routine practice is imperative. This study aims to provide pilot data regarding PRP application for ovarian rejuvenation. Four pilot studies were conducted on poor ovarian response (POR), premature ovarian insufficiency (POI), perimenopause, and menopause, respectively. Each pilot study reports on thirty patients, 120 participants were recruited in total. All participants provided written informed consent prior to treatment. Primary outcome measures for the POR pilot study were levels of anti-müllerian hormone (AMH), antral follicle count (AFC) and oocyte yield. For the POI, perimenopausal and menopausal pilot studies primary outcome measures were restoration of menstrual cycle, and Follicle Stimulating Hormone (FSH) levels. A significant improvement on the hormonal profile and the ovarian reserve status was noted, along with improved intracytoplasmic sperm injection (ICSI) cycle performance concerning POR participants. Menstruation recovery was observed in 18 out of 30 POI patients, along with a statistically significant improvement on levels of AMH, FSH, and AFC. Similarly, 13 out of 30 menopausal women positively responded to PRP treatment. Finally, menstruation regularity, improved hormonal levels and AFC were reported for 24 out of 30 perimenopausal women. To conclude, PRP infusion appears to convey promising results in addressing ovarian insufficiency.

Facilitating access to iCBT: a randomized controlled trial assessing a translated version of an empirically validated program using a minimally monitored delivery model

2019 ◽  
Vol 48 (2) ◽  
pp. 185-202
Author(s):  
Miguel Robichaud ◽  
France Talbot ◽  
Nickolai Titov ◽  
Blake F. Dear ◽  
Heather D. Hadjistavropoulos ◽  
...  
Keyword(s):  
Treatment Group ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Anxiety And Depression ◽  
Control Group ◽  
Access To Treatment ◽  
Delivery Model

AbstractBackground:Despite its established efficacy, access to internet-delivered CBT (iCBT) remains limited in a number of countries. Translating existing programs and using a minimally monitored model of delivery may facilitate its dissemination across countries.Aims:This randomized control trial aims to evaluate the efficacy of an iCBT transdiagnostic program translated from English to French and offered in Canada using a minimally monitored delivery model for the treatment of anxiety and depression.Method:Sixty-three French speakers recruited in Canada were randomized to iCBT or a waiting-list. A French translation of an established program, the Wellbeing Course, was offered over 8 weeks using a minimally monitored delivery model. Primary outcome measures were the Generalized Anxiety Disorder-7 (GAD-7) and the Patient Health Questionnaire-9 (PHQ-9), which were obtained pre-treatment, post-treatment and at 3-month follow-up.Results:Mixed-effects models revealed that participants in the treatment group had significantly lower PHQ-9 and GAD-7 scores post-treatment than controls with small between-groups effect sizes (d = 0.34 and 0.37, respectively). Within-group effect sizes on primary outcome measures were larger in the treatment than control group. Clinical recovery rates on the PHQ-9 and GAD-7 were significantly higher among the treatment group (40 and 56%, respectively) than the controls (13 and 16%, respectively).Conclusions:The provision of a translated iCBT program using a minimally monitored delivery model may improve patients’ access to treatment of anxiety and depression across countries. This may be an optimal first step in improving access to iCBT before sufficient resources can be secured to implement a wider range of iCBT services.

scholarly journals Comparison of Alternative Primary Outcome Measures for Use in Lupus Nephritis Clinical Trials

2013 ◽  
Vol 65 (6) ◽  
pp. 1586-1591 ◽  
Author(s):  
David Wofsy ◽  
Jan L. Hillson ◽  
Betty Diamond
Keyword(s):  
Clinical Trials ◽  
Lupus Nephritis ◽  
Outcome Measures ◽  
Primary Outcome
Sign in / Sign up

Export Citation Format

Share Document