Evaluation Of Outcome Measures Research Articles

Promoting Smoking Cessation Among Lesbian and Bisexual Women: Lessons Learned From a Location-Based Media Campaign in Western North Carolina.

Despite well-documented inequities in tobacco use for lesbian, gay, bisexual, and transgender populations, there is little practical guidance for local public health officials on developing and implementing media campaigns that prioritize lesbian, gay, bisexual, transgender, and queer (LGBTQ) communities. In this practice note article, we describe the development and lessons learned from a location-based media campaign to promote tobacco use cessation and raise awareness of QuitlineNC among lesbian and bisexual women in Western North Carolina. The campaign used a digital approach based on cell phone locations and marketing profiles to deliver messages across 4 years (2018-2021). Considerations for practitioners include how our project required messaging adaptation to meet Google's restrictions against using the word "yours" and the importance of addressing privacy protection concerns with state officials to enable collection of outcome evaluation measures via a conversion pixel (code for capturing metrics).

Clinical Outcomes in Routine Evaluation Measures for Patients Discharged from Acute Psychiatric Care: Four-Arm Peer and Text Messaging Support Controlled Observational Study.

Background: Peer support workers (PSW) and text messaging services (TxM) are supportive health services that are frequently examined in the field of mental health. Both interventions have positive outcomes, with TxM demonstrating clinical and economic effectiveness and PSW showing its utility within the recovery-oriented model. Objective: To evaluate the effectiveness of PSW and TxM in reducing psychological distress of recently discharged patients receiving psychiatric care. Methods: This is a prospective, rater-blinded, pilot-controlled observational study consisting of 181 patients discharged from acute psychiatric care. Patients were randomized into one of four conditions: daily supportive text messages only, peer support only, peer support plus daily text messages, or treatment as usual. Clinical Outcomes in Routine Evaluation—Outcome Measure (CORE-OM), a standardized measure of mental distress, was administered at four time points: baseline, six weeks, three months, and six months. MANCOVA was used to assess the impact of the interventions on participants’ scores on four CORE-OM subscales across the three follow-up time points. Recovery, clinical change, and reliable change in CORE-OM all-item analysis were examined across the four groups, and the prevalence of risk symptoms was measured. Results: A total of 63 patients completed assessments at each time point. The interaction between PSW and TxM was predictive of differences in scores on the CORE-OM functioning subscale with a medium effect size (F1,63 = 4.19; p = 0.045; ηp2 = 0.07). The PSW + TxM group consistently achieved higher rates of recovery and clinical and reliable improvement compared to the other study groups. Additionally, the text message group and the PSW + TxM group significantly reduced the prevalence of risk of self/other harm symptoms after six months of intervention, with 27.59% (χ2(1) = 4.42, p = 0.04) and 50% (χ2(1) = 9.03, p < 0.01) prevalence reduction, respectively. Conclusions: The combination of peer support and supportive text messaging is an impactful intervention with positive clinical outcomes for acute care patients. Adding the two interventions into routine psychiatric care for patients after discharge is highly recommended.

Measurement properties of the Swedish clinical outcomes in routine evaluation outcome measures (CORE-OM): Rasch analysis and short version for depressed and anxious out-patients in a multicultural area

IntroductionThe Swedish version of the patient-reported Clinical Outcomes in Routine Evaluation Outcome Measures (CORE-OM) has demonstrated high reliability and acceptable convergent validity in explanatory factor analyses. However, the fundamental scale properties have not yet been validated according to item response theory. The aim of this study was to analyze the measurement properties of the Swedish CORE-OM in a cohort of psychiatric out-patients with depression and anxiety in a multicultural area and to explore combinations of items based on shorter versions of the scale (CORE-10, CORE-6D) to improve measurement properties.MethodsData from CORE-OM assessments of 337 patients were analyzed using Rasch analysis. The patients had a mean age of 30 ± 14 years, the majority were women (72%). Requirements for measurement properties were checked: overall model fit, item fit residuals, targeting, internal consistency, differential item functioning and thresholds. Sensitivity to change was also analyzed.ResultsThe CORE-OM showed high internal consistency (person separation index = 0.947) and adequate targeting, but there was overall model misfit (item trait interaction χ2 = 917.53, p < 0.001), indication of local dependency, and differential item functioning in 9 items. The risk items showed problems with disordered thresholds. The emotional component of the shorter CORE-6D showed the best fit for our sample. Adding 3 items to include depressive and trauma-related content resulted in a unidimensional 8-item set with acceptable reliability, model fit, targeting and sensitivity to change.ConclusionFor out-patients with diagnosed depression or anxiety in a multicultural area, the Swedish CORE-OM showed high internal consistency, but also validity problems. Based on the shorter CORE-6D version, a unidimensional 8-item set could be an alternative brief measure of psychological distress for this population, but further validity studies are required. Qualitative studies exploring the CORE-OM items in non-native speakers are also warranted.

A systematic review to compare physiotherapy treatment programmes for atraumatic shoulder instability.

Optimal physiotherapy treatment is uncertain for atraumatic shoulder instability (ASI), the primary aim of this systematic scoping review was to compare physiotherapy treatment programmes for people with ASI. The secondary aims were to evaluate outcome measures used and to compare the effectiveness of these programmes. CINAHL, EMBASE and Medline databases were searched for studies, except single case studies, published between 1950 and July 2021. 12 critical appraisal items covered three domains; internal validity, transferability to wider population and reporting. Ten studies were included; one randomised controlled trial, 6 cohort studies and 3 case series. There were 491 participants. Treatment programmes included education, movement re-education, static posture correction, shoulder muscle strengthening, functional training, and adjuncts. All studies used patient reported outcome measures (PROMs), 7 of which reported a statistically significant improvement (p < 0.05) post-treatment. There was no clear relationship between programmes and outcomes. PROMs specific to shoulder instability were all found to detect statistically significant differences post-treatment. There does not appear to be one optimal physiotherapy treatment programme for ASI. Future studies should use PROMs that are valid in the shoulder instability population and use more outcome measures that are specific to impairments being targeted.

Patients With Autism Spectrum Disorder and Co-occurring Substance Use Disorder: A Clinical Intervention Study.

Background:The prevalence of substance use disorders (SUD) in individuals with autism spectrum disorders (ASD) appears to be higher than previously described. Attention has been drawn to developing new treatment approaches for this patient population, as they appear to do less well with traditional addiction treatment. There is very little research addressing treatment outcome. This study aims to introduce and evaluate a manualized group treatment intervention developed specifically for patients with ASD and co-occurring SUD.Methods:We developed a group treatment based on cognitive behavioural therapy (CBT) and evaluated outcome measures at the end of treatment and 3-month follow-up. Fifty-seven patients with ASD and co-occurring SUD were included of which 30 completed the group intervention, 27 of them also participated at 3-month follow-up.Results:The findings suggest that group treatment can work for patients with ASD and co-occurring SUD. Lower levels of alcohol use (t = 3.61, P = .002, d = 0.75), craving (t = 2.65, P = .013, d = 0.51), passive coping styles (t = 2.32, P = .030, d = 0.48), depression (t = 3.48, P = .002, d = 0.67), anxiety (t = 3.02, P = .006, d = 0.58), and stress (t = 2.62, P = .015, d = 0.51) symptoms were reported after completing the group intervention, with even stronger effects at 3 months follow-up.Conclusions:The present study shows promising results of a tailor-made group intervention in a heterogeneous patient population with ASD and co-occurring SUD with positive effects on both symptoms of ASD and SUD.

Clinical outcome measures and their evidence base in degenerative cervical myelopathy: a systematic review to inform a core measurement set (AO Spine RECODE-DCM)

ObjectivesTo evaluate the measurement properties of outcome measures currently used in the assessment of degenerative cervical myelopathy (DCM) for clinical research.DesignSystematic reviewData sourcesMEDLINE and EMBASE were searched through 4 August...

One-year outcomes in individual domains of the cerebral performance category extended

BackgroundPhysical and cognitive impairments are common after cardiac arrest, and recovery varies. This study assessed recovery of individual domains of the Cerebral Performance Category- Extended (CPC-E) 1-year after cardiac arrest. We hypothesized patients would have recovery in all CPC-E domains 1-year after the index cardiac arrest. MethodsProspective cohort study of cardiac arrest survivors evaluating outcome measures mRS, CPC, and CPC-E. Outcomes were assessed at discharge, 3-months, 6-months, and 1-year. We defined recovery of a CPC-E domain when >90% of patients had scores of 1-2 in that domain. ResultsOf 156 patients discharged, 57 completed the CPC-E at discharge, and were included in the analysis. 37 patients had follow-up at 3-months, and 23 patients had follow-up at 6 and 12 months. Only 16 patients had assessments at all four timepoints. Domains of alertness (N = 56, 98%) logical thinking (N = 56; 98%), and attention (N = 55; 96%) recovered by hospital discharge. BADL (N = 34; 92%) and motor skills (N = 36; 97%) recovered by 3-months. Most patients (N = 20; 87%) experienced slight-to-no disability or symptoms (mRS 0–2/CPC 1–2) at 1-year follow up. CPC-E domains of short term memory (78%), mood (87%), fatigue (22%), complex ADL (78%), and return to work (65%) did not recover by 1-year. ConclusionsCPC-E domains of alertness, logical thinking, and attention recover rapidly, while domains of short term memory, mood, fatigue, complex ADL and return to work remain chronically impaired 1-year after cardiac arrest. These deficits are not detected by mRS and CPC. Interventions to improve recovery in these domains are needed.

EP.TH.772Meta-analysis of laparoscopic mesh rectopexy versus posterior sutured rectopexy for management of complete rectal prolapse

Abstract Objectives To evaluate comparative outcomes of laparoscopic mesh rectopexy (LMR) and laparoscopic posterior sutured rectopexy (LPSR) in patients with rectal prolapse Methods We conducted a systematic search of electronic databases and bibliographic reference lists with application of a combination of free text and controlled vocabulary search adapted to thesaurus headings, search operators and limits. Recurrence, Cleveland Clinic Incontinence Score (CCIS), Cleveland Clinic Constipation Score (CCCS), surgical site infections, procedure time, and length of hospital stay were the evaluated outcome measures. Results We identified 5 comparative studies reporting a total of 307 patients evaluating outcomes of LMR (n = 160) or LPSR (n = 147) in patients with rectal prolapse. LMR was associated with significantly lower recurrence rate (OR:0.28, P = 0.009) but longer procedure time (MD:23.93, P &amp;lt; 0.0001) compared to LPSR. However, there was no significant difference in CCIS (MD:-1.02, P = 0.50), CCCS (MD:-1.54, P = 0.47), surgical site infection (OR:1.48, P = 0.71), and length of hospital stay (MD:-1.54, P = 0.47) between two groups. No mesh erosion was reported in any of the included studies at maximum follow-up point. Sub-group analyses with respect to ventral mesh rectopexy, posterior mesh rectopexy, randomised studies and adult patients were consistent with the main analysis. Conclusions LMR seems to be associated with lower recurrence but longer procedure time compared to LPSR. Although no mesh related complications have been reported by the included studies, no definitive conclusions can be made considering that the included studies were inadequately powered for such outcome. Future high quality randomised studies with adequate sample size are required.

Level 2a evidence comparing robotic versus laparoscopic left lateral hepatic sectionectomy: a meta-analysis.

To evaluate comparative outcomes of robotic and laparoscopic left lateral hepatic sectionectomy (LLS). A systematic search of PubMed, Web of Science, EMBASE and bibliographic reference lists with application of a combination of free text and controlled vocabulary search adapted to thesaurus headings, search operators and limits was conducted. Overall, minor (Clavien-Dindo grade < III) and major (Clavien-Dindo grade > III) postoperative complications, mortality, volume of blood loss, conversion to an open procedure, procedure time, length of hospital stay, cost-effectiveness and R1 resection were the evaluated outcome measures. Seven comparative observational studies reporting a total of 319 patients of whom 150 underwent robotic LLS and the remaining 169 patients underwent laparoscopic LLS were included. The robotic approach was associated with significantly longer procedure time (MD: 29.40min, p = 0.01) and higher cost (MD: $4170, p < 0.00001) compared to the laparoscopic approach. There was no significant difference in overall postoperative morbidity (OR: 1.29, p = 0.62), Clavien-Dindo grade < III (OR: 1.65, p = 0.49), Clavien-Dindo grade > III (OR: 1.18, p = 0.85), perioperative mortality (RD: 0.00, p = 1.00), volume of blood loss (MD: 1.96 mls, p = 0.91), conversion to an open procedure (RD: - 0.02, p = 0.46), length of hospital stay (MD: 0.22day, p = 0.52) or R1 resection (RD:0.00, p = 1.00) between two groups. Meta-analysis of the best available evidence (level 2) demonstrated that robotic LLS is associated with significantly longer procedure time and higher cost and similar perioperative outcomes compared to the laparoscopic approach. Future randomised studies are required to evaluate short-term perioperative, long-term oncological and surgeon-centred outcomes.

Therapeutic Alliance: A Comparison Study between Adolescent Patients and Their Therapists.

The aim of this study was to examine the congruence of adolescent- and therapist-rated therapeutic alliance, and to explore which rating or combination of ratings would predict treatment outcome or premature termination. We also studied whether the alliance changes over the course of treatment and if the change is related to the outcome or dropout. This study comprised 58 adolescents clinically referred for psychotherapeutic interventions. The alliance (Working Alliance Inventory, patient/therapist ratings) and treatment outcomes (Beck Depression Inventory, Clinical Outcomes in Routine Evaluation—Outcome Measure) were measured at baseline and at 3-, 6-, and 12-month follow-ups. The alliance did not change significantly over the course of therapy, but adolescent and therapist ratings did not correlate. Low values in the early assessment of adolescent-rated alliance and discrepancy between the ratings were significant predictors of undesirable treatment outcome. Weak adolescent- or therapist-rated alliance later in treatment and change for the worse in adolescent-rated alliance was associated with treatment dropout. As adolescent-rated alliance predicts treatment outcome better than therapist-rated alliance, therapists should frequently use assessments of therapeutic relationship within the therapy and pay attention if the adolescent feels the alliance is weakening or his/her evaluation is contrary to the therapist’s.

Finnish Version of the Eating Assessment Tool (F-EAT-10): A Valid and Reliable Patient-reported Outcome Measure for Dysphagia Evaluation

Our aim was to validate a Finnish version of the Eating Assessment Tool (F-EAT-10) for clinical use and to test its reliability and validity in a multicenter nationwide study. Normative data were acquired from 180 non-dysphagic participants (median age 57.0 years, 62.2% female). Dysphagia patients (n = 117, median age 69.7 years, 53.0% female) referred to fiberoptic endoscopic evaluation of swallowing (FEES) completed F-EAT-10 before the examination and after 2 weeks. Patients underwent the 100-ml water swallow test (WST) and FEES was evaluated using the following three scales: the Yale Pharyngeal Residue Severity Rating Scale, Penetration-Aspiration Scale, and the Dysphagia Outcome Severity Scale. An operative cohort of 19 patients (median age 75.8 years, 57.9% female) underwent an endoscopic operation on Zenker’s diverticulum, tight cricopharyngeal muscle diagnosed in videofluorography, or both. Patients completed the F-EAT-10 preoperatively and 3 months postoperatively. The cut-off score for controls was < 3 (sensitivity 94.0%, specificity 96.1%) suggesting that ≥ 3 is abnormal. Re-questionnaires for test–retest reliability analysis were available from 92 FEES patients and 123 controls. The intraclass correlation coefficient was excellent for the total F-EAT-10 score (0.93, 95% confidence interval 0.91–0.95). Pearson correlation coefficients were strong (p < 0.001) for each of the questions and the total score. Internal consistency as assessed by Cronbach’s alpha was excellent (0.95). Some correlations between findings in FEES and 100-ml WST with F-EAT-10 were observed. The change in subjective symptoms of operative patients paralleled the change in F-EAT-10. F-EAT-10 is a reliable, valid, and symptom-specific patient-reported outcome measure for assessing dysphagia among Finnish speakers.

Retrospective review of pyrocarbon radial head replacement

Radial head arthroplasty is the preferred surgical management for complex, unreconstructable radial head fractures. There has been increasing use of pyrocarbon prostheses, with potential tribology and modulus advantages over metallic counterparts. This study aims to assess clinical and radiological outcomes for radial head replacement after trauma using a modular, uncemented pyrocarbon prosthesis. Between September 2009 and March 2020, a consecutive series of 22 trauma cases were available for review. Patients underwent radial head arthroplasty using a pyrocarbon prosthesis (Ascension Modular Radial Head System, Austin, TX). Recorded outcomes included clinical assessment, radiological evaluation, and patient-reported outcome measures specific to elbow function. Twenty-two patients (7 male, 15 female) with an average age of 51 years (range 21-64) were analyzed with a minimum 12 months of follow-up. All patients had complex radial head fractures, categorized as a Mason 3 or 4 injury. At follow-up, mean elbow range of motion included flexion 130° (range 100°-150°), extension 19° (0-50°), pronation 73° (30°-90°), and supination 70° (10°-90°). The mean Mayo Elbow Performance Index score was 83 (55-100), and Disabilities of the Arm, Shoulder and Hand score was 22 (2.5-60). Radiological evaluation showed 14 patients with asymptomatic proximal neck resorption and two patients with radiological stem loosening. In total, 3 of 22 implants were revised-2 were excised, and 1 revised to a long stem for traumatic implant fracture. Pyrocarbon radial head arthroplasty provided reliable functional results for patients after unreconstructable radial head fracture. The unique potential for fracture of the prosthesis should be considered in long-term follow-up, with appropriate activity advice to patients.

Outcome measures used in clinical research evaluating prehospital blood component transfusion in traumatically injured bleeding patients: A systematic review.

Trial outcomes should be relevant to all stakeholders and allow assessment of interventions' efficacy and safety at appropriate timeframes. There is no consensus regarding outcome measures in the growing field of prehospital trauma transfusion research. Harmonization of future clinical outcome reporting is key to facilitate interstudy comparisons and generate cohesive, robust evidence to guide practice. The objective of this study was to evaluate outcome measures reported in prehospital trauma transfusion trials. Data Sources, Eligibility Criteria, Participants, and InterventionsWe conducted a scoping systematic review to identify the type, number, and definitions of outcomes reported in randomized controlled trials, and prospective and retrospective observational cohort studies investigating prehospital blood component transfusion in adult and pediatric patients with traumatic hemorrhage. Electronic database searching of PubMed, Embase, Web of Science, Cochrane, OVID, clinical trials.gov, and the Transfusion Evidence Library was completed in accordance with Preferred Reporting Items for Meta-analyses guidelines.Study Appraisal and Synthesis MethodsTwo review authors independently extracted outcome data. Unique lists of salutogenic (patient-reported health and wellbeing outcomes) and nonsalutogenic focused outcomes were established. A total of 3,471 records were identified. Thirty-four studies fulfilled the inclusion criteria: 4 military (n = 1,566 patients) and 30 civilian (n = 14,398 patients), all between 2000 and 2020. Two hundred twelve individual non-patient-reported outcomes were identified, which collapsed into 20 outcome domains with varied definitions and timings. All primary outcomes measured effectiveness, rather than safety or complications. Sixty-nine percent reported mortality, with 11 different definitions. No salutogenic outcomes were reported. There is heterogeneity in outcome reporting and definitions, an absence of patient-reported outcome, and an emphasis on clinical effectiveness rather than safety or adverse events in prehospital trauma transfusion trials. We recommend stakeholder consultation and a Delphi process to develop a clearly defined minimum core outcome set for prehospital trauma transfusion trials. Scoping systematic review, level III.

Effect of hyaluronate-based bioresorbable membrane (Seprafilm) on outcomes of abdominal surgery: a meta-analysis and trial sequential analysis of randomised controlled trials.

We aimed to evaluate comparative outcomes of abdominal surgery with and without hyaluronate-based bioresorbable membrane (Seprafilm).We conducted a systematic search of electronic databases and bibliographic reference lists with application of a combination of free text and controlled vocabulary search adapted to thesaurus headings, search operators and limits. Small bowel obstruction, anastomotic leak, surgical site infections, ileus, and severity of adhesions were the evaluated outcome measures. Thirteen randomised controlled trials reporting a total of 3665 patients evaluating outcomes of abdominal surgeries with (n = 1800) or without (n = 1865) use of Seprafilm were identified. Use of Seprafilm was associated with significantly lower risk of small bowel obstruction (RR 0.53, 95% CI 0.38-0.73, P = 0.0001) but significantly higher rate of anastomotic leak (RR 1.85, 95% CI 1.15-3.00 P = 0.01). Moreover, while Seprafilm resulted in significantly more adhesions-free patients (RR 5.57, 95% CI 3.37-9.19, P < 0.0001) compared to no Seprafilm, its use was associated with significantly lower grade 2 (RR 0.57, 95% CI 0.35-0.95, P = 0.003) or 3 (RR 0.31, 95% CI 0.17-0.55, P < 0.0001) adhesions. There was no significant difference in surgical site infection (RR: 1.21, 95 CI 0.86-1.70, P = 0.28), intra-abdominal abscess (RR 1.46, 95 CI 0.92-2.32, P = 0.11) or paralytic ileus (RR 0.97, 95 CI 0.68-1.38, P = 0.87) between two groups. The trial sequential analysis demonstrated that the meta-analysis findings are conclusive. Our meta-analysis demonstrated that Seprafilm reduces the risk of small bowel obstruction and severity of adhesions after abdominal surgery. However, it may increase the risk of anastomotic leak. We recommend use of Seprafilm in any abdominal surgery which does not involve an anastomosis.

Effectiveness of a Brief Group Intervention Program for Young Adults with Gaming-Related Problems

Excessive digital gaming can have unfavorable effects on gamers’ well-being and everyday functioning. The aims of this study were to investigate the effects of a novel group intervention “Limitless Gaming Bootcamp” on (i) gaming disorder (GD) tendencies, (ii) the amount of time spent on leisure activities, and (iii) subjective well-being among Finnish young adults, and to determine the persistence of the intervention’s influence over time. A one-group pre- and post-test design with no control group was used. Thirty-seven participants were enrolled in the study. The inclusion criteria were being between the ages of 18 and 29; self-reported excessive gaming; a willingness to get support in monitoring one’s gaming behaviour; and a fluency in Finnish. Participants completed a 10-session group intervention designed to enhance conscious gaming behavior and well-being. Baseline, post-test, and six month follow-up measurements were conducted to gather data. Variables measured included background variables, gaming disorder tendencies (Problematic Online Gaming Questionnaire, POGQ), self-reported time spent on various leisure activities, and subjective well-being (Short Form of the Clinical Outcomes in Routine Evaluation Outcome Measure, CORE-SF/A). The time spent on gaming decreased from pre- to post-intervention measurement and further to the six month follow-up, and participants exhibited less severe GD symptoms during the post-intervention phase and six months after the intervention. Gradual improvements in subjective well-being were also observed. The group intervention was found to be particularly effective at reducing the severity of GD symptoms.

Initial experience with del Nido cardioplegia solution at a Pediatric and Congenital Cardiac Surgery Program in Brazil.

The aim of this study was to evaluate outcome measures between our standard multidose cardioplegia protocol and a del Nido cardioplegia protocol in congenital heart surgery patients. Retrospective single-center study including 250 consecutive patients that received del Nido cardioplegia (DN group) with a mandatory reperfusion period of 30% of cross clamp time and 250 patients that received a modified St. Thomas' solution (ST group). Groups were matched by age, weight, gender, and Risk Adjustment for Congenital Heart Surgery (RACHS-1) scores. Preoperative hematocrit and oxygen saturation were also recorded. Outcomes analyzed were the vasoactive inotropic score (VIS), lactate, ventilation time, ventricular dysfunction with low cardiac output syndrome (LCOS), intensive care unit (ICU) length of stay (LOS), hospital LOS, bypass and aortic cross-clamp times, and in-hospital mortality. Both groups were comparable demographically. Statistically significant differences (p ⩽ 0.05) were noted for cardiac dysfunction with LCOS, hematocrit at end of surgery (p = 0.0038), VIS on ICU admission and at end of surgery (p = 0.0111), and ICU LOS (p = 0.00118) with patients in the DN group having more desirable values for those parameters. Other outcome measures did not reach statistical significance. In our congenital cardiac surgery population, del Nido cardioplegia strategy was associated with less ventricular dysfunction with LCOS, a lower VIS and decreased ICU LOS compared with patients that received our standard myocardial protection using a modified St. Thomas' solution. Despite the limitation of this study, including its retrospective nature and cohort size, these data supported our transition to incorporate del Nido cardioplegia solution with a mandatory reperfusion period as the preferred myocardial protection method in our program.

Effectiveness and cost effectiveness of interpersonal community psychiatric treatment (ICPT) for people with long-term severe non-psychotic mental disorders: a multi-Centre randomized controlled trial

BackgroundLong-term community mental health treatment for non-psychotic disorder patients with severe mental illness (SMI) who are perceived as difficult by clinicians, is poorly developed and lacks a structured, goal-centred approach. This study compares (cost-)effectiveness of Interpersonal Community Psychiatric Treatment (ICPT) with Care As Usual (CAU) on quality of life and clinician perceived difficulty in the care for non-psychotic disorder SMI-patients. A multi-centre cluster-randomized clinical tria was conducted in which Community Mental Health Nurses (Clinicians) in three large community mental health services in the Netherlands were randomly allocated to providing either ICPT or CAU to included patients. A total of 56 clinicians were randomized, who treated a total of 93 patients (59 in ICPT-group and 34 in CAU-group).MethodsPrimary outcome measure is patient-perceived quality of life as measured by the Manchester Short Assessment of Quality of Life (MANSA). Secondary outcome measures include clinician-perceived difficulty, general mental health, treatment outcomes, illness management and recovery, therapeutic relationship, care needs and social network. Patients were assessed at baseline, during treatment (6 months), after treatment (12 months) and at 6 months follow-up (18 months). Linear mixed-effects models for repeated measurements were used to compare mean changes in primary and secondary outcomes between intervention and control group of patients over time on an intention to treat basis. Potential efficiency was investigated from a societal perspective. Economic evaluation was based on general principles of a cost-effectiveness analysis. Outcome measures for health economic evaluation, were costs, and Quality Adjusted Life Years (QALYs).ResultsHalf of the intended number of patients were recruited. There was no statistically significant treatment effect found in the MANSA (0.17, 95%-CI [− 0.058,0.431], p = 0.191). Treatment effects showed significant improvement in the Different Doctor-Patient Relationship Questionnaire-scores and a significant increase in the Illness Management and Recovery–scale Client-version scores). No effects of ICPT on societal and medical costs nor QALYs were found.ConclusionsThis is the first RCT to investigate the (cost)-effectiveness of ICPT. Compared with CAU, ICPT did not improve quality of life, but significantly reduced clinician-perceived difficulty, and increased subjective illness management and recovery. No effects on costs or QALY’s were found.Trial registrationNTR 3988, registered 13 May 2013.

Systematic Review of Outcome Measures Used After Proximal Hamstring Repair.

Background:Patient-reported outcome measures are important to determine outcomes after orthopaedic procedures. There is currently no standard for outcome measures in the evaluation of patient outcomes after proximal hamstring repair.Purpose:To identify and evaluate outcome measures used after proximal hamstring repair.Study Design:Systematic review; Level of evidence, 4.Methods:A systematic review was performed to identify all English-language articles assessing outcomes after proximal hamstring repair in PubMed, Embase, CINAHL via EBSCOhost, MEDLINE via OvidSP, and Web of Science between 2000 and 2019. After duplicates were removed, studies were selected using eligibility criteria established by the authors. Image reviews, anatomic/histology studies, literature reviews, surgical technique reports, systematic reviews, narrative reviews, case studies, and studies with <5 patients were excluded. Extraction, synthesis, and analysis of outcome measure data were performed using Microsoft Excel. Quality assessment of included studies was performed using Methodological Index for Non-Randomized Studies criteria.Results:After duplicate articles were removed, a total of 304 unique articles were identified and 27 met the inclusion criteria. The mean number of patients with proximal hamstring repairs per study was 40. The most frequently reported outcome measures were return to sport (14/27; 51.9%), custom survey/questionnaire (13/27; 48.1%), and isokinetic hamstring strength testing (13/27; 48.1%). Six of the 10 most commonly used outcome measures were validated and included Lower Extremity Functional Scale, 12-Item Short Form Health Survey, visual analog scale for pain, Perth Hamstring Assessment Tool (PHAT), Single Assessment Numeric Evaluation, and Tegner Activity Scale. Of those, PHAT was the only validated outcome measure designed for proximal hamstring repair.Conclusion:There is currently no consensus on the best outcome measurements for the evaluation of patients after proximal hamstring repair. We recommend an increased commitment to the use of return to sport, isokinetic strength testing, Lower Extremity Functional Scale, and PHAT when assessing such injuries. Future studies should aim to define the most reliable methods of outcome measurement in this patient population through consistent use of tools that are clinically relevant and important to patients and can easily be employed in a variety of clinical scenarios.

Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management.

BackgroundVirtual reality (VR) and augmented reality (AR) interventions are emerging as promising tools in the treatment of pediatric chronic pain conditions. However, in this young field, there is little consensus to guide the process of engaging in the development and evaluation of targeted VR-based interventions.ObjectiveThe INOVATE-Pain (Interdisciplinary Network on Virtual and Augmented Technologies for Pain management) consortium aims to advance the field of VR for pediatric chronic pain rehabilitation by providing guidance for best practices in the design, evaluation, and dissemination of VR-based interventions targeting this population.MethodsAn interdisciplinary meeting of 16 academics, clinicians, industry partners, and philanthropy partners was held in January 2020.ResultsReviewing the state of the field, the consortium identified important directions for research-driven innovation in VR and AR clinical care, highlighted key opportunities and challenges facing the field, and established a consensus on best methodological practices to adopt in future efforts to advance the research and practice of VR and AR in pediatric pain. The consortium also identified important next steps to undertake to continue to advance the work in this promising new area of digital health pain interventions.ConclusionsTo realize the promise of this realm of innovation, key ingredients for success include productive partnerships among industry, academic, and clinical stakeholders; a uniform set of outcome domains and measures for standardized evaluation; and widespread access to the latest opportunities, tools, and resources. The INOVATE-Pain collaborative hopes to promote the creation, rigorous yet efficient evaluation, and dissemination of innovative VR-based interventions to reduce pain and improve quality of life for children.

Robenacoxib shows efficacy for the treatment of chronic\xa0degenerative joint disease-associated pain in cats: a randomized and blinded pilot clinical trial

The main objective of this pilot clinical trial was to evaluate outcome measures for the assessment of the nonsteroidal anti-inflammatory drug (NSAID) robenacoxib in cats with degenerative joint disease-associated pain (DJD-pain). Otherwise healthy cats (n = 109) with DJD-pain entered a parallel group, randomized, blinded clinical trial. Cats received placebo (P) or robenacoxib (R) for two consecutive 3-week periods. Treatment groups were PP, RR, and RP. Actimetry and owner-assessment data were collected. Data were analyzed using mixed-effects and generalized mixed-effects linear models. Activity data showed high within-cat and between-cat variability, and 82.4% of the values were zero. Compared to placebo, mean total activity was higher (5.7%) in robenacoxib-treated cats (p = 0.24); for the 80th percentile of activity, more robenacoxib-treated cats had a > 10% increase in activity after 3 (p = 0.046) and 6 weeks (p = 0.026). Robenacoxib treatment significantly decreased owner-assessed disability, (p = 0.01; 49% reduction in disability; effect size ~ 0.3), and improved temperament (p = 0.0039) and happiness (p = 0.021) after 6 weeks. More robenacoxib-treated cats were successes at 6 weeks (p = 0.018; NNT: 3.8). Adverse effect frequencies were similar across groups. Results identified suitable endpoints for confirmatory studies, while also indicating efficacy of robenacoxib in cats with DJD-pain.