External validation and diagnostic value of the Elderly Functional Index version 2.0 for assessing functional status and frailty in older Danish patients with gastrointestinal cancer receiving chemotherapy: A prospective, clinical study.

INTRODUCTION: Patient perspectives on functioning are often overlooked in oncology practice. This study externally validates the ELderly Functional Index (ELFI), a patient-reported measure for assessing multidimensional functioning, in older patients with gastrointestinal cancer receiving chemotherapy. The study compares ELFI scoring methods, evaluates its diagnostic value with geriatric oncology tools, and proposes a cut-off point for clinical use. MATERIALS AND METHODS: Danish patients aged ≥70 years with gastrointestinal cancer undergoing chemotherapy from a prospective, observational study were included. Two ELFI scoring methods, item-based and domain-based, were compared. Internal consistency reliability, validity, and correlations between ELFI, its component scales, and measures of functioning/frailty (including Eastern Cooperative Oncology Group Performance Status [ECOG-PS], Geriatric-8 [G8], Vulnerable Elders Survey-13 [VES-13], Timed-Up-and-Go [TUG], and 30-s chair stand test [30CST]) were investigated. Sensitivity and specificity analyses evaluated the ability of ELFI to predict frailty outcomes and identified frailty thresholds. Receiver operating characteristic analyses assessed the diagnostic ability of ELFI, alongside other measures, for oncological outcomes and frailty differentiation. Equipercentile equating methods enabled ECOG-PS, ELFI, and G8 mapping. RESULTS: One hundred fifty-four patients (median age 73.5 years, range 70-85) undergoing curative- or palliative-intent chemotherapy (49%) were included. ELFI demonstrated good internal consistency (Cronbach's alpha = 0.82) and acceptable convergent, structural, and discriminant validity. ELFI showed moderate to very strong correlations with its component scales (r = 0.40-0.93), and weaker correlations with frailty measures (r = 0.02-0.60). ELFI score < 80 indicated frailty risk, with almost fivefold risk of ECOG-PS 2 at follow-up (odds ratio[OR] = 4.8, 95% confidence interval [CI] 1.4-15.9), and predicted G8, VES-13, TUG, and 30CST frailty at follow-up, not completing planned chemotherapy (OR = 3.1; 95%CI 1.5-6.2), mono-therapy (OR = 3.5; 95%CI 1.5-8.1), initial dose reduction (OR = 4.9; 95%CI 2.0-12.1), and shorter overall survival (hazard ratio = 2.0, 95%CI 1.4-3.0). A preliminary crosswalk between ECOG-PS, ELFI, and G8 was established. DISCUSSION: ELFI was validated as a concise patient-reported measure of functional status in older patients with cancer and its relationship to frailty. ELFI demonstrated comparable predictive ability to other tools for oncological outcomes. Both scoring methods yielded similar results, with the domain-based method (ELFI v2.0) endorsed for consistency. ELFI v2.0 score of 80 was suggested as the frailty threshold in this population, supporting its clinical utility.

Carfilzomib and dexamethasone maintenance following salvage ASCT in multiple myeloma: A randomised phase 2 trial by the Nordic Myeloma Study Group.

OBJECTIVE: We investigated the efficacy and safety of carfilzomib-containing induction before salvage high-dose melphalan with autologous stem-cell transplantation (salvage ASCT) and maintenance with carfilzomib and dexamethasone after salvage ASCT in multiple myeloma. METHODS: This randomised, open-label, phase 2 trial included patients with first relapse of multiple myeloma after upfront ASCT who were re-induced with four cycles of carfilzomib, cyclophosphamide and dexamethasone. Two months after salvage, ASCT patients were randomised to either observation or maintenance therapy with iv carfilzomib 27 â†’ 56 mg/sqm and p.o. dexamethasone 20 mg every second week. The study enrolled 200 patients of which 168 were randomised to either maintenance with carfilzomib and dexamethasone (n = 82) or observation (n = 86). RESULTS: Median time to progression (TTP) after randomisation was 25.1 months (22.5-NR) in the carfilzomib-dexamethasone maintenance group and 16.7 months (14.4-21.8) in the control group (HR 0.46, 95% CI 0.30-0.71; P = .0004). The most common adverse events during maintenance were thrombocytopenia, anaemia, hypertension, dyspnoea and bacterial infections. CONCLUSION: In summary, maintenance therapy with carfilzomib and dexamethasone after salvage ASCT prolonged TTP with 8 months. The maintenance treatment was in general well-tolerated with manageable toxicity.

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force.

AIMS: Proxy reports are often used when patients are unable to self-report. It is unclear how proxy measures are currently in use in adult health care and research settings. We aimed to describe how proxy reports are used in these settings, including the use of measures developed specifically for proxy reporting in adult health populations. METHODS: We systematically searched Medline, PsycINFO, PsycTESTS, CINAHL and EMBASE from database inception to February 2018. Search terms included a combination of terms for quality of life and health outcomes, proxy-reporters, and health condition terms. The data extracted included clinical context, the name of the proxy measure(s) used and other descriptive data. We determined whether the measures were developed specifically for proxy use or were existing measures adapted for proxy use. RESULTS: The database search identified 17,677 possible articles, from which 14,098 abstracts were reviewed. Of these, 11,763 were excluded and 2335 articles were reviewed in full, with 880 included for data extraction. The most common clinical settings were dementia (30%), geriatrics (15%) and cancer (13%). A majority of articles (51%) were paired studies with proxy and patient responses for the same person on the same measure. Most paired studies (77%) were concordance studies comparing patient and proxy responses on these measures. DISCUSSION: Most published research using proxies has focused on proxy-patient concordance. Relatively few measures used in research with proxies were specifically developed for proxy use. Future work is needed to examine the performance of measures specifically developed for proxies. SYSTEMATIC REVIEW REGISTRATION: PROSPERO No. CRD42018103179.

The Danish wound-quality of life (Wound-QoL) questionnaire: Translation and psychometric properties.

Hard to heal (HTH) wounds often result in a prolonged and painful healing process that affects different dimensions of patients' quality of life. Currently, there is no Danish patient-reported instrument to help professionals and patients identify and measure these different aspects of quality of life. Wound-quality of life (Wound-QoL) is a German 17-item questionnaire measuring dimensions of wound-specific quality of life. The aim was to translate and cross-culturally adapt the Wound-QoL into Danish and to evaluate its psychometric properties. Translation was conducted in accordance with international guidelines. Validity, reliability and responsiveness were evaluated in accordance with the COSMIN guideline. The Wound-QoL was successfully translated to Danish and content validity showed to be very good in a Danish context. A total of 172 patients with HTH wounds were included in the study and all participants completed the Wound-QoL. Out of these, respectively 54 and 155 patients were included in the analyses of test-retest reliability and responsiveness. Correlations for construct validity (EQ-5D-5L vs. Wound-QoL) ranged between 0.64 and 0.73. Cronbach's alpha values for internal consistency ranged between 0.77 and 0.92. Intra-class-correlation coefficients for test-rest reliability ranged between 0.73 and 0.88. Smallest detectable change scores at individual and group level ranged from 0.77 to 1.26 and 0.10 to 0.17, respectively. Minimal important change scores ranged from 1.20 to 1.33. Results of the responsiveness analyses showed sensitivity and specificity values between 56.1 to 62.2 and 57.7 to 63.2, respectively. In conclusion, the Danish Wound-QoL is a valid and reliable patient-reported outcome measure for assessing aspects of health-related quality of life in patients with hard ho heal wounds. However, the Wound-QoL demonstrated limited ability to discriminate between patients with clinically relevant improvements and patients that showed no changes. Thus, the responsiveness of the Wound-QoL should be taken into consideration if to be used as treatment effect measure.

Quality of Life in Vulnerable Older Patients with Metastatic Colorectal Cancer Receiving Palliative Chemotherapy-The Randomized NORDIC9-Study.

Quality of life data from randomized trials are lacking in older patients with metastatic colorectal cancer (mCRC). In the randomized NORDIC9-study, reduced-dose S1+oxaliplatin (SOx) showed superior efficacy compared to full-dose S1 monotherapy. We hypothesized that treatment with SOx does not result in inferior quality of life. Patients with mCRC aged ≥70 years and that were not a candidate for standard combination chemotherapy were included and randomly assigned to receive either S1 or SOx. The EORTC QLQ-C30 questionnaire was completed at baseline, after 9, and 18 weeks. The primary endpoint was global Quality of Life (QoL) at 9 weeks. For statistical analysis, a non-inferiority design was chosen applying linear mixed effects models for repeated measurements. The results were interpreted according to statistical significance and anchor-based, clinically relevant between-group minimally important differences (MID). A total of 160 patients aged (median (Interquartile range (IQR))) 78 years (76-81) were included. The QLQ-C30 questionnaire was completed by 150, 100, and 60 patients at baseline, at 9, and 18 weeks, respectively. The difference at 9 weeks in global QoL was 6.85 (95%CI-1.94; 15.65) and 7.37 (0.70; 14.05) in the physical functioning domain in favor of SOx exceeding the threshold for MID. At 18 weeks, the between-group MID in physical functioning was preserved. Dose-reduced combination chemotherapy may be recommended in vulnerable older patients with mCRC, rather than full-dose monotherapy.

The translated Danish version of the Western Ontario Meniscal Evaluation Tool (WOMET) is reliable and responsive.

PURPOSE: The purpose of this study was to translate and cross-culturally adapt the Western Ontario Meniscal Evaluation Tool (WOMET) for use in Denmark and evaluate its test-retest reliability and comparative responsiveness. METHODS: Sixty patients (mean age 50 years (range 19-71 years), females 57%) with meniscal injury scheduled for arthroscopic meniscal surgery at a small Danish hospital in the period from September 2017 to February 2018 were included in this study. The WOMET was translated into Danish using forward and backward translation. The WOMET was completed at baseline (pre-surgery), at 3 and 6 months postoperatively. Additionally, reliability was assessed at 3 months and 3 months plus 1 week, for patients with a stable symptom state (global response question) between test and retest. Comparative responsiveness was assessed between the WOMET and the Knee Injury and Osteoarthritis Outcome Score (KOOS4-aggregate score of 4 of the 5 KOOS subscales). RESULTS: The Danish version of WOMET showed excellent test-retest reliability, intraclass correlation coefficient of 0.88 (95% CI 0.84-0.92) for the total score. The standard error of measurement was 125 points and the minimal detectable change was 347 points (i.e. 8% and 22% of the total score, respectively). The WOMET was responsive with an effect size (ES) of 1.12 at 6 months after surgery, which was comparable to the KOOS4 (ES 1.10). CONCLUSION: The Danish version of the WOMET is a reliable and responsive measure of health-related quality of life in patients with meniscal pathology. LEVEL OF EVIDENCE: Level II.

Health-related quality of life of patients with haematologic cancer during COVID-19 and their opinions on telehealth consultations - a Danish single site cross-sectional survey.

INTRODUCTION: During the COVID-19 pandemic, high-risk patient groups might have practiced social distancing and sheltering, and hospitals may have changed or postponed treatments and examinations. We aimed to explore health-related quality of life (QoL) in patients with haematological diseases during the early phase of the pandemic and their acceptability of using telehealth. PATIENTS AND METHODS: We performed a cross-sectional survey among patients at the Department of Haematology, Odense University Hospital, Denmark. Eligible participants were patients receiving either active treatment or survivors in a follow-up program. The survey was open from 22 May to 13 June 2020. The survey contained questions on concerns and the impact of COVID-19 and acceptability on telehealth in addition to the assessment of health-related QoL. The later was assessed by the European Organisation for Research and Treatment of Cancer core QoL (EORTC QLQ-C30) questionnaire with the subdomains Global QoL, emotional functioning (EF) and social functioning (SF) being of primary interest. Further, anxiety during COVID-19 was assessed by use of an adapted version of the generalised anxiety disorder (GAD-7) questionnaire. RESULTS: 4420 patients were eligible to participate. The response rate was 53% (n = 2239) of which 37% where in a treatment program and 63% where in a follow-up program. The majority (80%) of patients were concerned about contracting COVID-19. The global QoL score (69.0, ±SD 22.6) was markedly lower than EF (84.5, ±SD 18.9) and SF (85.0, ±SD 23.4). Regression analysis showed that being concerned (a little, moderately, very, extremely) about contracting COVID-19 correlated with lower scores of global QoL (-3.86 to -22.76), EF (-3.81 to -26.41) and SF (-1.14 to -22.49). The GAD-7 score showed that approximately 20% of patients had symptoms of COVID-19 associated generalised anxiety. Finally, 67% of the patients were positive towards replacing face-to-face consultancies with phone calls, but video consultations were less preferred (47%). CONCLUSION: Danish patients with haematological cancer presented with low global QoL during the early phase of COVID-19, and 20% of the patients showed symptoms of generalised anxiety. Patients were overall positive towards the implementation of telehealth consultancies.

Feasibility of the SINEX program for patients with traumatic anterior shoulder instability.

BACKGROUND: An optimal treatment for traumatic anterior shoulder instability (TASI) remains to be identified. A shoulder instability neuromuscular exercise (SINEX) program has been designed for patients with TASI, but has not yet been tested in patients eligible for surgery. The purpose of this study was to investigate and evaluate the feasibility and safety of the SINEX program for patients diagnosed with TASI and eligible for surgery. METHODS: A feasibility study with an experimental, longitudinal design using both quantitative and qualitative research methods. A total of seven participants underwent the SINEX program, a 12-week exercise program including physiotherapist-supervised sessions. Feasibility data on recruitment, retention, compliance, acceptability and safety was collected through observation and individual semi-structured interviews. Clinical tests and self-report questionnaires were completed at baseline and 12 weeks follow-up. Clinical assessments included apprehension and relocation tests, shoulder joint position sense (SJPS), shoulder sensorimotor control measured by center of pressure path length (COPL) on a force platform, isometric strength measured by Constant Score-Isometric Maximal Voluntary Contraction (CS-iMVC), self-report questionnaires including Western Ontario Shoulder Instability Index (WOSI), Tampa Scale of Kinesiophobia (TSK) and Global Perceived Effect questionnaire (GPE). RESULTS: With one participant recruited every 2 weeks, the recruitment rate was 50% lower than expected. Two of seven participants achieved compliance, defined as at least 66% completion of the scheduled home exercises and at least 50% attendance for the physiotherapist supervised sessions. Barriers for successful compliance were (1) inability to take along exercise equipment when travelling, (2) sick leave, (3) holidays and (4) lack of time/busy days. Four adverse events occurred, one of which was related to the intervention (patellar redislocation). All participants expressed satisfaction with the intervention and felt safe during the exercises. All participants improved in the GPE. Change greater than minimal detectable change (MDC) was reported in four participants in some of the outcome assessments. One of the seven participants declined surgery. CONCLUSION: Further assessment is required on several areas before performing an RCT evaluating the efficacy of the SINEX program for patients with TASI considered eligible for surgery. No adverse events suggest that the program is safe, but patients with general hypermobility may need additional adjustments to prevent adverse events in other areas of the body. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04152304, retrospectively registered.

Neuromuscular Exercises Improve Shoulder Function More Than Standard Care Exercises in Patients With a Traumatic Anterior Shoulder Dislocation: A Randomized Controlled Trial.

BACKGROUND: There is an important gap in knowledge about the effectiveness of nonoperative treatment (exercise) for patients with traumatic primary and recurrent anterior shoulder dislocations (ASDs). PURPOSE/HYPOTHESIS: The purpose of this study was to assess the efficacy and safety of physical therapist-supervised, shoulder instability neuromuscular exercise (SINEX) versus self-managed, home-based, standard care shoulder exercise (HOMEX) in patients with traumatic ASDs. The hypothesis was that SINEX would have a larger effect and fewer adverse events compared with HOMEX. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: A total of 56 participants with radiographically verified, trauma-initiated primary or recurrent ASDs and self-reported decreased shoulder function were randomized to 12 weeks of either SINEX or HOMEX. The SINEX program consisted of 7 exercises, individually progressing from basic (2 × 20 repetitions each day) to elite (2 × 10 repetitions, 3 times weekly). The HOMEX program included 5 shoulder exercises performed 3 times weekly (2 × 10 repetitions). The primary outcome was the Western Ontario Shoulder Instability Index (WOSI) score, ranging from 0 (best possible) to 2100. The between-group minimal clinically important difference at 12 weeks was 250 points. Secondary outcomes included WOSI subdomain scores, patient-reported ratings of kinesiophobia and pain, objective shoulder function, patient satisfaction, and number of adverse events. RESULTS: The between-group mean difference in the WOSI total score at 12 weeks significantly favored SINEX over HOMEX (-228.1 [95% CI, -430.5 to -25.6]). SINEX was furthermore superior to HOMEX in most of the secondary outcomes (3/4 subdomains of the WOSI and pain level during the past 7 days as well as clinical signs of anterior shoulder instability). Also, although not statistically significant, less than half the proportion of the SINEX patients compared with the HOMEX patients (3/27 [11%] vs 6/24 [25%], respectively; P = .204) underwent or were referred for shoulder stabilizing surgery. Satisfaction with both exercise programs was high, and no serious adverse events were reported. CONCLUSION: Neuromuscular shoulder exercise (SINEX) was superior to standard care exercise (HOMEX) in patients with traumatic ASDs. Further long-term follow-ups on treatment effects are needed. REGISTRATION: NCT02371928 (ClinicalTrials.gov identifier).

Clinical assessment methods for scapular position and function. An inter-rater reliability study.

Introduction: The aim of this study was to assess the inter-rater reliability of selected static, semi-dynamic, and dynamic test assessment methods for evaluation of scapular positioning and function. Methods: A standardized three-phase (i.e. training, overall agreement, and actual study) protocol for reliability studies was applied on 41 overhead sports participants, aged 18-56 (22 with obvious scapular winging, classified as visibility of the medial or inferior angle border of scapula). Ten scapular test assessment methods (two static, three semi-dynamic, and five dynamic) were evaluated. Results: Bland-Altman plots showed no funnel effects, although systematic bias and significant differences between raters were present in three of the methods. ICC values ranged from 0.71 to 0.80 for the static test assessment methods and from 0.25-0.92 for the semi-dynamic test assessment methods. Three of the five dynamic test assessment methods had ICCs of 0.47-0.68. For the two remaining dynamic test assessment methods, kappa varied between -0.034 and 0.71. Using PABAK, kappa increased to 0.54-0.86. Conclusion: Four scapular test assessment methods (Upper horizontal distance, Lower horizontal distance at max shoulder flexion, Acromial distance, and Winging scapula) showed satisfactory inter-rater reliability. Simple visual observational methods and quantitative distance measurements have better reliability between clinicians than more complex measurements and may be better suited for use in clinical practice.

Pressure pain sensitivity in patients with traumatic first-time and recurrent anterior shoulder dislocation: a cross-sectional analysis.

Background and aims Traumatic anterior shoulder dislocation (ASD) is frequent in active populations and associated with a 39% higher risk of recurrent dislocation, which may cause persistent shoulder problems, pain, and impaired shoulder-related quality of life. While local and distant pressure pain sensitivity has been demonstrated in other shoulder conditions, little is known about the link between pressure pain sensitivity and ASD. The interesting aspect is whether recurrent dislocation - resulting in symptoms of longer duration - is associated with more pronounced pressure pain sensitivity, or if presence of pressure pain sensitivity may be part of the reasons why patients develop recurrent dislocation. Therefore, this study aimed at evaluating whether patients with recurrent ASD display greater pressure pain sensitivity and more painful body sites than patients with first-time ASD. Methods This was a cross-sectional analysis of baseline data from a randomized controlled trial including 34 patients with first-time ASD [82% male, mean (SD) age 26 (7) years] and 22 patients with recurrent ASD [96% male, mean (SD) age 25 (5) years]. Patients were assessed as follows: (1) assessment of local and distant pressure pain sensitivity evaluated by pressure pain thresholds (PPTs) using a handheld algometer on mm. trapezius superior, levator scapula, pectorales major, deltoideus, and tibialis anterior, (2) pain intensity at rest during the previous 24 h, (3) number of ASD, and (4) number of painful body sites on a region-divided body chart. Results The PPTs were not significantly different between first-time and recurrent ASD [mean (SD) kPa for m. trapezius superior 264 (110) vs. 261 (88), m. levator scapula 301 (157) vs. 325 (163), m. pectorales major 234 (163) vs. 269 (130), m. deltoideus 290 (166) vs. 352 (173), m. tibialis anterior 420 (202) vs. 449 (184)], two-way ANCOVA, adjusted for sex and age, F (4,263) = 0.29, p = 0.88. For both groups, the PPTs were lower at the shoulder sites than at m. tibialis anterior (difference 117-184 kPa, 95% CI range 33-267). Females had lower PPTs than males (difference 124 kPa, 95% CI 64-183). The number (SD) of painful body sites were 2.2 (1.9) for first-time ASD and 2.6 (5.4) for recurrent ASD, with no between-group differences, one-way ANCOVA, adjusted for sex and age, F (1, 52) = 0.24, p = 0.63. There was a strong correlation between PPTs at the shoulder and lower leg, r = 0.84, p < 0.01. Conclusions This study demonstrated no differences in local and distant pressure pain sensitivity or number of painful body sites between patients with first-time and recurrent ASD. Females had lower PPTs than males, and a strong correlation was found between PPTs at the shoulder and lower leg. Implications Patients with first-time and recurrent ASD seem to have similar pressure pain sensitivity, but lower PPTs compared to existing normative data, suggesting that it is relevant to evaluate the status of the pain system in these patients to prevent triggering or worsening of their symptoms. However, it remains unanswered how these changes affect the patients' ability to undergo rehabilitation, symptom response and long-term shoulder function.

Positive effects of neuromuscular shoulder exercises with or without EMG-biofeedback, on pain and function in participants with subacromial pain syndrome - A randomised controlled trial.

BACKGROUND: The aim was to investigate the effect of Electromyography (EMG)-biofeedback guided exercises (BIONEX) on shoulder pain and function in participants with subacromial pain syndrome (SPS). METHODS: Twenty-five women and 24 men (19-67 years), diagnosed with SPS, were randomised to BIONEX or the same exercises without EMG-biofeedback (NEX). Primary outcome was shoulder pain during the past 7 days (Numeric Pain Rating Scale (NPRS)). Secondary outcomes included self-reported (Disability of Arm Shoulder and Hand (DASH), Oxford Shoulder Score (OSS)), and measured shoulder function (surface EMG from upper trapezius, lower trapezius and serratus anterior) in mean and ratios of % of maximum voluntary EMG (%MVE) and onset time (msec), during arm tasks with 0, 1 and 3 kg. RESULTS: There was no group difference (BIONEX versus NEX) in changed shoulder pain (NPRS, mean difference 0.18 (95% CI. -1.56; 1.19)), self-reported or measured shoulder function. Both groups, however, showed significant within-group improvements on self-reported outcomes (NPRS, DASH, OSS), only clinically relevant on NPRS (BIONEX 2.23 (SD 2.47); NEX 2.04 (SD 2.29)). CONCLUSION: BIONEX and NEX were both effective in reducing pain to a clinically relevant level, while EMG-biofeedback did not make a difference. The current neuromuscular shoulder exercise protocol is recommended.

Patients with non-operated traumatic primary or recurrent anterior shoulder dislocation have equally poor self-reported and measured shoulder function: a cross-sectional study.

BACKGROUND: Patients with non-operated traumatic primary anterior shoulder dislocation (PASD) are assumed to have less shoulder impairment than patients with recurrent anterior shoulder dislocations (RASD). This may impact treatment decision strategy. The aim was to study whether patients with non-operated traumatic PASD have less shoulder impairment than those with RASD. METHODS: In a cross-sectional study baseline data from patients with PASD and RASD in a randomised controlled trial of non-operative shoulder exercise treatment were used. Shoulder function was self-reported (Western Ontario Shoulder Instability (WOSI), Tampa Scale of Kinesiophobia (TSK), General Health (EQ-5D-VAS), Numeric Pain Rating Scale (NPRS)), and measured (Constant-Murley shoulder Score (CMS total), CMS - Range of Motion (CMS-ROM, CMS - strength, proprioception, clinical tests). RESULTS: In total, 56 patients (34 (28 men) with PASD and 22 (21 men) with RASD) (mean age 26 years) participated. WOSI total was 1064 and 1048, and TSK above 37 (indicating high re-injury fear) was present in 33 (97%) and 21 (96%) of the groups with PASD and RASD, with no group difference. CMS total (66.4 and 70.4), CMS-ROM (28.7 and 31.5), CMS-strength (injured shoulder: 7.6 kg and 9.1 kg), proprioception and clinical tests were the same. Furthermore, 26 (76%) with PASD and 13 (59%) with RASD reported not to have received non-operative shoulder treatment. CONCLUSIONS: Non-operated patients with PASD and self-reported shoulder trouble three-six weeks after initial injury do not have less shoulder impairment (self-reportedly or objectively measured) than non-operated patients RASD and self-reported shoulder trouble three-six weeks after their latest shoulder dislocation event.

Sensorimotor control and neuromuscular activity of the shoulder in adolescent competitive swimmers with generalized joint hypermobility.

INTRODUCTION: Shoulder pain is highly prevalent in competitive swimmers, and generalized joint hypermobility (GJH) is considered a risk factor. Sensorimotor control deficiencies and altered neuromuscular activation of the shoulder may represent underlying factors. RESEARCH QUESTION: To investigate whether competitive swimmers with GJH including shoulder hypermobility (GJHS) differ in shoulder sensorimotor control and muscle activity from those without GJH and no shoulder hypermobility (NGJH). METHODS: Competitive swimmers (aged 13-17) were recruited. GJHS or NGJH status was determined using the Beighton score (0-9) and Rotès-Quérol test (positive/negative). Inclusion criteria for GJHS were a Beighton score ≥5 and minimum one hypermobile shoulder, while NGJH was defined as a Beighton score ≤3 and no shoulder hypermobility. Three prone lying, upper-extremity weight-bearing shoulder stabilometric tests were performed on a force platform: Bilateral upper-extremity support eyes open (BL-EO) and eyes closed (BL-EC) and unilateral upper-extremity support eyes open (UL-EO). Surface electromyography (SEMG) was measured from the upper trapezius, lower trapezius, serratus anterior, infraspinatus and pectoralis major muscles. SEMG was normalized using maximal voluntary isometric contractions and presented relative to maximal voluntary SEMG (%MVE). Co-contraction index (CCI) was calculated for the following muscle pairs: upper trapezius-lower trapezius, upper trapezius-serratus anterior, and infraspinatus-pectoralis major. Between-group differences in stabilometric parameters, %MVE, and CCI were analyzed with a mixed effects model. RESULTS: Thirty-eight swimmers were enrolled as GJHS (n = 19) or NGJH (n = 19). There were no group differences in stabilometric parameters or CCI. GJHS displayed significantly decreased (29%) pectoralis major activity during BL-EO compared to NGJH (5.35 ±â€¯1.77%MVE vs. 7.51 ±â€¯1.96%MVE; p = 0.043). SIGNIFICANCE: Adolescent competitive swimmers with GJHS displayed no shoulder sensorimotor control deficiencies and no generally altered shoulder muscle activity pattern, except for decreased pectoralis major activity in BL-EO. Longitudinal studies are needed to investigate whether decreased pectoralis major activation contributes to the development of shoulder pain in swimmers with GJHS.

Intertester reliability of clinical shoulder instability and laxity tests in subjects with and without self-reported shoulder problems.

OBJECTIVE: First, to investigate the intertester reliability of clinical shoulder instability and laxity tests, and second, to describe the mutual dependency of each test evaluated by each tester for identifying self-reported shoulder instability and laxity. METHODS: A standardised protocol for conducting reliability studies was used to test the intertester reliability of the six clinical shoulder instability and laxity tests: apprehension, relocation, surprise, load-and-shift, sulcus sign and Gagey. Cohen's kappa (κ) with 95% CIs besides prevalence-adjusted and bias-adjusted kappa (PABAK), accounting for insufficient prevalence and bias, were computed to establish the intertester reliability and mutual dependency. RESULTS: Forty individuals (13 with self-reported shoulder instability and laxity-related shoulder problems and 27 normal shoulder individuals) aged 18-60 were included. Fair (relocation), moderate (load-and-shift, sulcus sign) and substantial (apprehension, surprise, Gagey) intertester reliability were observed across tests (κ 0.39-0.73; 95% CI 0.00 to 1.00). PABAK improved reliability across tests, resulting in substantial to almost perfect intertester reliability for the apprehension, surprise, load-and-shift and Gagey tests (κ 0.65-0.90). Mutual dependencies between each test and self-reported shoulder problem showed apprehension, relocation and surprise to be the most often used tests to characterise self-reported shoulder instability and laxity conditions. CONCLUSIONS: Four tests (apprehension, surprise, load-and-shift and Gagey) out of six were considered intertester reliable for clinical use, while relocation and sulcus sign tests need further standardisation before acceptable evidence. Furthermore, the validity of the tests for shoulder instability and laxity needs to be studied.

Translation, adaptation and measurement properties of an electronic version of the Danish Western Ontario Shoulder Instability Index (WOSI).

OBJECTIVES: To translate and adapt the Western Ontario Shoulder Instability (WOSI) questionnaire into Danish and, to evaluate measurement properties of an electronic Danish WOSI version. METHODS: The Swedish WOSI version was used for translation and adaptation into Danish followed by examination of test-retest reproducibility (14-day interval) besides concurrent and construct validity. Concurrent validity was examined by comparing WOSI in paper version with an electronic version, whereas construct validity was examined by comparing WOSI with Numeric Pain Rating Scale (NPRS) and the Oxford Shoulder Score (OSS). Reproducibility was evaluated with Intraclass correlations (ICC), Standard Error of Measurement (SEM), minimal detectable change (MDC) and limits of agreement (LOA). Validity was evaluated with Pearson's (r) and Concordance Correlation Coefficients (CCC). RESULTS: 41 subjects (median age 34, range 18-57) were included in the analysis of reproducibility. An ICC of 0.97 (95% CI 0.95 to 0.99) for the total WOSI score was found. SEM was 100.1, resulting in an MDC of 277.5 and LOAs within the range of -246.4 and 308.6. 25 subjects (median age 34, range 18-72) were included in the analysis of concurrent validity obtaining a CCC of 0.96 (95% CI 0.91 to 0.98). Construct validity was investigated in 62 subjects (median age 31, range 18-72) obtaining correlations of 0.83 (95% CI 0.68 to 0.97) (NPRS) and 0.79 (95% CI 0.62 to 0.94) (OSS). CONCLUSIONS: An electronic Danish version of WOSI presented excellent test-retest reproducibility and acceptable measurement errors. Also, concurrent validity between paper and electronic version was highly satisfactory as was the construct validity. Surprisingly, though, the NPRS correlated more with WOSI than OSS.

A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study).

BACKGROUND: Anterior shoulder dislocation is a common injury and may have considerable impact on shoulder-related quality of life (QoL). If not warranted for initial stabilising surgery, patients are mostly left with little to no post-traumatic rehabilitation. This may be due to lack of evidence-based exercise programmes. In similar, high-impact injuries (e.g. anterior cruciate ligament tears in the knee) neuromuscular exercise has shown large success in improving physical function and QoL. Thus, the objective of this trial is to compare a nonoperative neuromuscular exercise shoulder programme with standard care in patients with traumatic anterior shoulder dislocations (TASD). METHODS/DESIGN: Randomised, assessor-blinded, controlled, multicentre trial. Eighty patients with a TASD will be recruited from three orthopaedic departments in Denmark. Patients with primary or recurrent anterior shoulder dislocations due to at least one traumatic event will be randomised to 12 weeks of either a standardised, individualised or physiotherapist-supervised neuromuscular shoulder exercise programme or standard care (self-managed shoulder exercise programme). Patients will be stratified according to injury status (primary or recurrent). Primary outcome will be change from baseline to 12 weeks in the patient-reported QoL outcome questionnaire, the Western Ontario Shoulder Instability Index (WOSI). DISCUSSION: This trial will be the first study to compare the efficacy and safety of two different nonoperative exercise treatment strategies for patients with TASD. Moreover, this is also the first study to investigate nonoperative treatment effects in patients with recurrent shoulder dislocations. Lastly, this study will add knowledge to the shared decision-making process of treatment strategies for clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02371928 . Registered on 9 February 2015 at the National Institutes of Health Clinical Trials Protocol Registration System.