Self-reported Outcome Measures Research Articles

Systematic review of patient and service outcome measures of remote digital technologies for cochlear implant and hearing aid users

IntroductionThe use of telehealth for cochlear implant (CI) and hearing aid service provision has the potential to provide efficient, effective, and equitable services to users. However, clinicians require evidence that remote technologies provide care that is equal, or superior to, standard delivery. There are many outcome measures used across audiology, however there is little consensus for a standardized approach to assessment. This systematic review aims to identify the outcome measures to assess remote technologies for CI and hearing aid users, as a first step in a larger project to develop a core outcome set for remote technologies in CI users.MethodsA systematic search of seven electronic databases was conducted using a search strategy defined by PICOTS for the research question. Eligible studies were in English and published in 2012 onwards. Search strategy, selection, and data collection followed PRISMA 2020 guidelines.ResultsThis systematic literature review of 49 articles revealed over 250 discrete outcomes. Outcome measures were grouped into core areas, outcome domains, and outcome sub-domains. Studies assessing remote technology for CI users assessed significantly more outcomes in the ear and labyrinth domain (43% vs. 10%) and studies assessing remote technology in hearing aid users assessed significantly more outcomes in the cognitive (28% vs. 5%) and emotional (35% vs. 10%) functioning domains. Outcome measures within the auditory functioning domain were also significantly different, with CI studies utilizing more speech perception measures (95% vs. 21%) and hearing aid studies utilizing significantly more self-reported outcome measures (73% vs. 19%).DiscussionThe inclusion of hearing aid studies was to ensure that all key outcome domains used within remote hearing rehabilitation were captured, as well as to compare differences in outcome domains between the two user groups. There were significant differences between studies of remote technologies for CI and hearing aid users. These results will inform the ongoing development of a core outcome set for remote technologies in CI users.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?RecordID=370171, identifier: CRD42022370171.

Association of circulating biomarkers with illness severity measures differentiates myalgic encephalomyelitis/chronic fatigue syndrome and post-COVID-19 condition: a prospective pilot cohort study.

Accumulating evidence suggests that autonomic dysfunction and persistent systemic inflammation are common clinical features in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID. However, there is limited knowledge regarding their potential association with circulating biomarkers and illness severity in these conditions. This single-site, prospective, cross-sectional, pilot cohort study aimed to distinguish between the two patient populations by using self-reported outcome measures and circulating biomarkers of endothelial function and systemic inflammation status. Thirty-one individuals with ME/CFS, 23 individuals with long COVID, and 31 matched sedentary healthy controls were included. All study participants underwent non-invasive cardiovascular hemodynamic challenge testing (10min NASA lean test) for assessment of orthostatic intolerance. Regression analysis was used to examine associations between outcome measures and circulating biomarkers in the study participants. Classification across groups was based on principal component and discriminant analyses. Four ME/CFS patients (13%), 1 with long COVID (4%), and 1 healthy control (3%) presented postural orthostatic tachycardia syndrome (POTS) using the 10-min NASA lean test. Compared with matched healthy controls, ME/CFS and long COVID subjects showed higher levels of ET-1 (p < 0.05) and VCAM-1 (p < 0.001), and lower levels of nitrites (NOx assessed as NO2- + NO3-) (p < 0.01). ME/CFS patients also showed higher levels of serpin E1 (PAI-1) and E-selectin than did both long COVID and matched control subjects (p < 0.01 in all cases). Long COVID patients had lower TSP-1 levels than did ME/CFS patients and matched sedentary healthy controls (p < 0.001). As for inflammation biomarkers, both long COVID and ME/CFS subjects had higher levels of TNF-α than did matched healthy controls (p < 0.01 in both comparisons). Compared with controls, ME/CFS patients had higher levels of IL-1β (p < 0.001), IL-4 (p < 0.001), IL-6 (p < 0.01), IL-10 (p < 0.001), IP-10 (p < 0.05), and leptin (p < 0.001). Principal component analysis supported differentiation between groups based on self-reported outcome measures and biomarkers of endothelial function and inflammatory status in the study population. Our findings revealed that combining biomarkers of endothelial dysfunction and inflammation with outcome measures differentiate ME/CFS and Long COVID using robust discriminant analysis of principal components. Further research is needed to provide a more comprehensive characterization of these underlying pathomechanisms, which could be promising targets for therapeutic and preventive strategies in these conditions.

Translation, contextual adaptation, and reliability of the Danish Concept of Pain Inventory (COPI-Adult (DK)) - A self-reported outcome measure.

Pain is a growing concern globally, and an individual and societal burden. Pain science education (PSE) is a promising avenue for managing chronic pain, but targeted PSE is needed. The Concept of Pain Inventory for Adults (COPI-Adult) is a newly developed self-reported outcome measure aimed at targeting PSE. It is currently unavailable in Danish and has unknown reliability. The aims of this study were (1) to translate and contextually adapt to Danish and (2) to determine reliability in terms of test-retest reliability, internal consistency, and measurement error. Step (1) was as follows: a dual panel approach was used to translate, contextually adapt into a Danish version. Step (2) was follows: a heterogenic sample of Danish adults >18 years (n = 150) was included in the test-retest analysis, test interval between 7 and 14 days, both answered via REDCap-link. Based on COSMIN recommendations, the following reliabilities were estimated: the test-retest using intraclass correlation coefficient (ICC2.1) and internal consistency using Cronbach's alpha level. Measurement error in terms of standard error of measurement (SEM) and smallest detectable change (SDC) were calculated. Step (1) was as follows: the first panel reached 100% consensus on the wording of the COPI-Adult (DK), with no alterations by the second panel. Step (2) was as follows: good to excellent test-retest reliability was found with ICC2.1 value (95% confidence interval) 0.88 (0.84-0.91), excellent internal consistency for the 13-item COPI-Adult (DK) with α = 0.939, SEM of 2.53, and SDC of 7.02. The COPI-Adult (DK) was successfully translated and contextually adapted. It is a reliable questionnaire with excellent internal consistency. The COPI-Adult (DK) shows promise in research and clinical practice.

Associations Between Supported Accommodation and Health and Re-offending Outcomes: a Retrospective Data Linkage Study.

Following release from prison, housing and health issues form a complex and mutually reinforcing dynamic, increasing reincarceration risk. Supported accommodation aims to mitigate these post-release challenges. We describe the impact of attending Rainbow Lodge (RL), a post-release supported accommodation service for men in Sydney, Australia, on criminal justice and emergency health outcomes. Our retrospective cohort study using linked administrative data includes 415 individuals referred to RL between January 2015 and October 2020. Outcomes of interest were rates of criminal charges, emergency department (ED) presentations and ambulance attendance; and time to first reincarceration, criminal charge, ED presentation and ambulance attendance. The exposure of interest was attending RL; covariates included demographic characteristics, release year and prior criminal justice and emergency health contact. Those who attended RL (n = 170, 41%) more commonly identified as Aboriginal or Torres Strait Islander (52% vs 41%; p = 0.025). There was strong evidence that attending RL reduced the incidence criminal charges (adjusted rate ratio [ARR] = 0.56; 95% confidence interval [CI] 0.340.86; p = 0.009). Absolute rates indicate a weak protective effect of RL attendance on ED presentation and ambulance attendance; however, adjusted analyses indicated no evidence of an association between attending RL and rates of ED presentations (ARR = 0.88; 95% CI = 0.65-1.21), or ambulance attendance (ARR = 0.82; 95% CI = 0.57-1.18). There was no evidence of an association between attending RL and time to first reincarceration, charge, ED presentation or ambulance attendance. Greater detail about reasons for emergency health service contact and other self-report outcome measures may better inform how supported accommodation is meeting its intended aims.

Dyspnea-Related Dimensions And Self-Efficacy: Associations With Well-Being in Advanced Lung Cancer

ContextDyspnea is a complex, multidimensional symptom comprising sensory-perceptual, affective, and functional domains that commonly persists in patients with lung cancer and impairs mental health and quality of life (QOL). However, data are lacking on how dyspnea's dimensions or self-efficacy to manage dyspnea are associated with patient outcomes. ObjectivesTo assess the associations of dyspnea dimensions (dyspnea-related sensory–perceptual experience, affective distress, and functional impact) and dyspnea self-efficacy with depression, anxiety, and QOL in patients with advanced lung cancer reporting dyspnea. MethodsWe conducted a secondary analysis of baseline clinical trial data testing a supportive care intervention for dyspnea. Patients with advanced lung cancer reporting at least moderate dyspnea (≥2 on the Modified Medical Research Council Dyspnea Scale) self-reported dyspnea and patient outcome measures. Hierarchical regressions tested the associations of the dyspnea dimensions with depressive and anxiety symptoms (Hospital Anxiety and Depression Scale) and QOL (Functional Assessment of Cancer Therapy-Lung) while adjusting for variables known to affect these outcomes. ResultsThe sensory–perceptual experience of dyspnea (effort) was associated with worse depressive symptoms (b = 0.21, P < 0.01) and QOL (b = −0.53, P = 0.01). Dyspnea self-efficacy was associated with improved depressive (b = −1.26, P < 0.01) and anxiety symptoms (b = −1.72, P < 0.01) and QOL (b = 3.66, P < 0.01). The affective and functional dimensions of dyspnea were not associated with the patient outcomes in the final models. ConclusionsDyspnea-related sensory–perceptual experience and self-efficacy were associated with mental health and QOL outcomes in patients with lung cancer. Examining the individual contributions of dyspnea's multiple dimensions provides a nuanced understanding of its patient impact.

Translation and Cross-Cultural Adaptation Process and Pilot Testing of the Arabic Version of the Patient Reported Impact of Spasticity Measure (PRISM-Arabic)

Context: The Patient Reported Impact of Spasticity Measure (PRISM) is a self-reported questionnaire that is used to assess the impact of spasticity on the quality of life of individuals with spinal cord injury (SCI). Its inclusion in the assessment process for patients living in a country such as Saudi Arabia, which has one of the highest incidences of SCI around the world, will be an integral addition. Aims: The aims for this study were to translate and cross-culturally adapt the PRISM into Arabic and pilot test the Arabic version on Arabic speakers with SCI in Saudi Arabia. Settings and Design: Translation process was administered according to the recommended guidelines used for cross-cultural adaptation of healthcare measures. Methods and Material: Pilot testing of the PRISM-Arabic was administered to 35 individuals with SCI presenting with spasticity. Participants were interviewed to assess the relevance of the questionnaire to the Arabic language and culture. Face and content validity of the PRISM-Arabic as well as its floor and ceiling effects were assessed. Results: During the translation process, the expert committee made changes in 14 occasions due to cultural equivalence differences. Pilot-testing showed eight items that needed further adaptation. After all were made, the cross-culturally adapted PRISM-Arabic showed adequate face and content validity and did not have flooring and ceiling effects. Conclusions: The PRISM has been successfully translated and cross-culturally adapted into Arabic language. Further assessments of its psychometric properties are recommended. Implications for its use in clinical practice and research were presented.&#x0D; Key-words: Spinal cord injury, Spasticity, Patient Reported Impact of Spasticity Measure, PRISM&#x0D; Key Messages: The PRISM was successfully translated and cross-culturally adapted for Arabic speakers with SCI reporting spasticity. The introduction of such spasticity-specific self-reported outcome measure into clinics in Saudi Arabia is the first of its kind. The PRISM will introduce a new area of research and clinical assessment related to patients with SCI.

Salivary Diurnal Cortisol Predicts Post-Traumatic Stress Symptoms in Parents of Infants With Congenital Heart Disease.

Parents of infants born with congenital heart disease (CHD) who require open heart surgery after birth are at risk for prolonged psychological distress. Even after their infants are discharged, parents may experience anxiety, depressive, and post-traumatic stress (PTS) symptoms; yet, it is unclear which parents are at greater risk for ongoing symptoms. The purpose of this study was to explore whether measures of the biomarker cortisol in parents during their infants' postoperative period were associated with subsequent psychological distress symptoms at three-month post discharge. This was a prospective, longitudinal exploratory study of 40 parents of infants with CHD after open heart surgery using consecutive enrollment. Parents provided diurnal saliva samples for two consecutive days in the postoperative period. Six predictors were summarized and generated including waking cortisol, bedtime cortisol, cortisol awaking response, area under curve with respect to the ground (AUCg), cortisol index, and cortisol slope. Self-report outcome measures on anxiety, depressive, and PTS symptoms were collected three-months post-discharge. Linear mixed models examined the associations between each predictor and each outcome while accounting for within-dyad variance using an unstructured covariance matrix. Cortisol AUCg was a predictor of PTS at three-months post-discharge (β = .34, p = .03, Cohen's d = 2.05). No significant relationships were found with the other cortisol measures. Findings suggest that cortisol area under curve may help to identify parents at risk for increased PTS in the months following their infants' hospitalization for cardiac surgery, serving as a foundation for future study in this area.

Exercise combined with electrical stimulation for the treatment of chronic ankle instability – A randomized controlled trial

PurposeTo compare the short, medium, and long-term effects of balance exercises combined with either peroneal neuromuscular electrical stimulation (NMES) or peroneal transcutaneous electrical nerve stimulation (TENS) on dynamic postural control and patient reported outcome measures (PROMs) in patients with chronic ankle instability (CAI). MethodsThirty-four participants with CAI were randomly assigned to a 12-session home based exercise program combined with NMES (Ex-NMES) or TENS (Ex- TENS). Baseline postural control was tested with the modified Star Excursion Balance Test (mSEBT) and time to stabilization (TTS) after a single-leg drop-jump. The self-reported function was measured using the Cumberland Ankle Instability Tool (CAIT), the Identification of Functional Ankle Instability (IdFAI), and the Sports subscale of the Foot and Ankle Ability Measure (FAAMSport). ResultsBoth groups showed significant improvements in all self-reported outcome measures at the 12-month follow-up. Subjects in the Ex-NMES group had significantly better IdFAI (-4.2 [95% CI −8.1, −0.2]) and FAAMSport (13.7 [95% CI 2.2, 25.2]) scores at 6- and 12-month follow-up, respectively, compared to the Ex-TENS group. Medium to large between-group effect sizes were observed in self-reported functional outcomes and the mSEBT. ConclusionThe consistent trend of improvement in self-reported functional outcomes when training is combined with NMES compared with training with TENS may indicate a potential benefit that should be further investigated as a treatment for patients with CAI.

The Relationship between Balance Confidence and Center of Pressure in Lower-Limb Prosthesis Users

Background: Agreement between the activities-specific balance confidence scale (ABC) and center of pressure (CoP) in prosthesis users is still very much unknown. The purpose of this study was to investigate the agreement between ABC and CoP in lower-limb prosthesis users. Methods: Twenty-one individuals with lower-limb prostheses were recruited. Participants were provided with the ABC scale and performed static balance tasks during eyes opened (EO) and eyes closed (EC) conditions whilst standing on a force platform. Pearson product moment coefficients between CoP displacements and ABC scores were performed. Participants were also stratified by those who had better (≥80 on ABC scale) and less (&lt;80 on ABC scale) perceived balance confidence. Displacement was compared using an independent t-test with Cohen’s d to estimate effect size with alpha set at 0.05 for these tests. Results: There was a significant inverse moderate relationship between eyes opened displacement (EOD) (18.3 ± 12.5 cm) and ABC (75.1 ± 18.3%), r = (19)−0.58, p = 0.006, as well as eyes closed displacement (ECD) (37.7 ± 22.1 cm) and ABC, r = (19)−0.56, p = 0.008. No significant difference in EOD (t(19) = 1.36, p = 0.189, d = 0.61) and ECD (t(19) = 1.47, p = 0.156, d = 0.66) was seen between those with greater and less balance confidence. Conclusions: Self-report and performance-based balance outcome measures are recommended when assessing lower-limb prostheses users.

Proposal for targeted, neo-evolutionary-oriented secondary prevention of early-onset endometriosis and adenomyosis. Part II: medical interventions.

According to consistent epidemiological data, the slope of the incidence curve of endometriosis rises rapidly and sharply around the age of 25 years. The delay in diagnosis is generally reported to be between 5 and 8 years in adult women, but it appears to be over 10 years in adolescents. If this is true, the actual onset of endometriosis in many young women would be chronologically placed in the early postmenarchal years. Ovulation and menstruation are inflammatory events that, when occurring repeatedly for years, may theoretically favour the early development of endometriosis and adenomyosis. Moreover, repeated acute dysmenorrhoea episodes after menarche may not only be an indicator of ensuing endometriosis or adenomyosis, but may also promote the transition from acute to chronic pelvic pain through central sensitization mechanisms, as well as the onset of chronic overlapping pain conditions. Therefore, secondary prevention aimed at reducing suffering, limiting lesion progression, and preserving future reproductive potential should be focused on the age group that could benefit most from the intervention, i.e. severely symptomatic adolescents. Early-onset endometriosis and adenomyosis should be promptly suspected even when physical and ultrasound findings are negative, and long-term ovulatory suppression may be established until conception seeking. As nowadays this could mean using hormonal therapies for several years, drug safety evaluation is crucial. In adolescents without recognized major contraindications to oestrogens, the use of very low-dose combined oral contraceptives is associated with a marginal increase in the individual absolute risk of thromboembolic events. Oral contraceptives containing oestradiol instead of ethinyl oestradiol may further limit such risk. Oral, subcutaneous, and intramuscular progestogens do not increase the thromboembolic risk, but may interfere with attainment of peak bone mass in young women. Levonorgestrel-releasing intra-uterine devices may be a safe alternative for adolescents, as amenorrhoea is frequently induced without suppression of the ovarian activity. With regard to oncological risk, the net effect of long-term oestrogen-progestogen combinations use is a small reduction in overall cancer risk. Whether surgery should be considered the first-line approach in young women with chronic pelvic pain symptoms seems questionable. Especially when large endometriomas or infiltrating lesions are not detected at pelvic imaging, laparoscopy should be reserved to adolescents who refuse hormonal treatments or in whom first-line medications are not effective, not tolerated, or contraindicated. Diagnostic and therapeutic algorithms, including self-reported outcome measures, for young individuals with a clinical suspicion of early-onset endometriosis or adenomyosis are proposed.

Construct validity, test–retest reliability, and responsiveness of the Arabic version of the upper limb functional index

BackgroundThe upper limb functional index (ULFI) is a widely used self-report outcome measure questionnaire with robust psychometric properties to assess the upper limb musculoskeletal disorders (UL-MSDs). This study aimed to investigate the psychometric properties of the Arabic version of ULFI (ULFI-Ar).MethodsIn this observational study, 139 patients (87 male, 52 females with mean age of 38.67 ± 13.04 year) with various UL-MSD’s, completed the ULFI-Ar, Disability of Arm, Shoulder, and Hand questionnaire (DASH-Arabic), and numeric pain rating scale (NPRS-Arabic). All participants determined the factor structure, and the construct validity. A subgroup of the participants determined test–retest reliability (n = 46) and responsiveness (n = 27).ResultsThe ULFI-Ar construct validity obtained by the expletory factor analysis as one-factor structure, demonstrated an excellent test–retest reliability [intraclass correlation coefficient (ICC2:1) = 0.95], measurement error [standard error of measurement (SEM) = 4.43%; minimal detectable change at 90% confidence interval (MDC90) = 10.34%], medium internal responsiveness [Cohen’s d = 0.62 and standard response of mean (SRM) = 0.67], strong external responsiveness DASH-Arabic (r =—0.90; p < 0.001), and negative strong correlation with NPRS-Arabic (r =—0.75, p < 0.001).ConclusionsThe ULFI-Ar is a valid, reliable, and responsive self-report questionnaire to assess UL-MSDs in Arabic speaking patients.

Operational changes to the lupus intervention fatigue trial as a result of COVID-19: An update to the study protocol

BackgroundThe coronavirus disease 2019 (COVID-19) global pandemic drastically impacted the health system and the research community. As a result, research institutions and funding agencies recommended a moratorium on conducting in-person research and study enrollment until protocol changes to protect participant safety were approved and implemented. We detail the operational modifications made to the Lupus Intervention Fatigue Trial (LIFT) protocol and summarize how we met the varied challenges created by COVID-19. MethodsWe evaluated study protocols and determined that scheduling, acquiring consent, in-person assessments and intervention baseline visits, patient reported outcomes, and data processing procedures needed modification. ResultsOperational modifications were made to ensure study progress while adhering to COVID-19 restrictions. Major changes included electronic consent, remote baseline visits for those in the intervention, self-report outcome measures at home via emailed weblinks, and telemedicine physician assessment visits. The collection of safety labs presented the largest challenge since this required an in-person visit to a laboratory. The study team elected to delay this up to one month after the physician assessment. All follow-up visits were completed, and no participants withdrew from the study. ConclusionLIFT was severely impacted by COVID-19. We provide insight into how our study protocol was modified without compromising the integrity of the primary and secondary outcomes of the study. The modifications utilized by the LIFT study resulted in efficiencies that will be included in a revised protocol and may serve as a useful example for other behavioral interventions to adapt their research studies.

Beyond the symptoms: Personalizing giant cell arteritis care through multidimensional patient reported outcome measure

BackgroundGiant Cell Arteritis (GCA) is the commonest form of systemic vasculitis in people over the age of 50. Published research highlighted the lack of a disease-specific patient reported outcomes (PROMs) for GCA. ObjectivesTo assess the validity, reliability and responsiveness to change of a devised disease specific patient self-reported outcome measures questionnaire for Giant Cell Arteritis (GCA). MethodsThe GCA-PROMs was conceptualized based on frameworks outlined in the OMERACT developed core set of Outcome Measures for Large-Vessel Vasculitis and the guiding principles of the FDA guidance. Initially, cognitive interviews were conducted to identify item pool of questions. Item selection and reduction was achieved based on patients as well as an interdisciplinary group of specialists. Rasch and internal consistency reliability analyses were implemented. ResultsA total of 54 GCA patients completed the questionnaire. The GCA-PROMs questionnaire was reliable as demonstrated by a high standardized alpha (0.878–0.983). Content construct assessment of the GCA-PROMs functional disability and QoL revealed significant correlation (p< 0.01) with both HAQ and EQ-5D. Changes in functional disability, QoL showed significant (p< 0.01) variation with diseases activity status in response to therapy. ConclusionsThe developed GCA-PROMs questionnaire is a reliable and valid instrument for assessment of GCA patients. A stratified treatment regimen depending on the individual patient's risk factors as well as preferences and associated comorbidities is the best approach to tailored patient management.

The association between cervical degenerative MRI findings and self-reported neck pain, disability and headache: a cross-sectional exploratory study

BackgroundNeck pain and headache are highly prevalent conditions and leading causes of disability worldwide. Although MRI is widely used in the management of these conditions, there is uncertainty about the clinical significance of cervical MRI findings in patients with neck pain or headache. Therefore, this study aims to investigate the association between cervical degenerative MRI findings and self-reported neck pain, neck disability, and headache.MethodsThis study was a secondary analysis of a cohort of patients with low back pain aged 18–40 years recruited from a non-surgical outpatient spine clinic. The cervical MRI and outcome measures used in this analysis were collected at a four-year follow-up (2014–2017). Self-reported outcome measures included neck pain intensity, neck disability as measured by the Neck Disability Index, and headache as measured by a single NDI item. Cervical MRI findings included disc degeneration, disc contour changes, and vertebral endplate signal changes (VESC). Multivariable logistic regression analyses, adjusted for age and sex, were used to analyse the associations between MRI findings and neck pain, neck disability, and headache.ResultsA total of 600 participants who underwent MRI and completed the relevant questionnaires at follow-up were included. The median age was 37 years (interquartile range 31–41) and 325 (54%) were female. Of the included participants, 181 (31%) had moderate or severe neck pain, 274 (59%) had moderate or severe neck disability, 193 (42%) reported headaches, and 211 (35%) had one or more cervical degenerative MRI findings. Cervical disc degeneration and disc contour changes were positively associated with moderate or severe neck pain with odds ratio 1.6 (95% CI 1.1–2.4) and 1.6 (1.1–2.3), respectively. VESC was associated with moderate or severe neck disability with odds ratio 3.3 (1.3–8.4). No statistically significant associations were found between the MRI findings assessed and headache.ConclusionsIn this cross-sectional exploratory study, we found that cervical disc degeneration and disc contour changes were associated with neck pain, and VESC was associated with neck disability. None of the MRI findings were associated with headache. The results suggest that cervical degenerative changes may contribute to the aetiology of neck symptoms, but the associations are modest and cannot guide clinical decisions.

Comparative Outcome Data Using Different Techniques for Posterior Lumbar Fusion: A Large Single-Center Study.

Retrospective single-center study. This study aims to evaluate perioperative and intermediate-term clinical outcomes of patients undergoing different lumbar fusion techniques. Various open and minimally invasive techniques for lumbar fusion are available, but previous studies comparing lumbar fusion techniques have heterogeneous data, making interpretation challenging. Between 2011 and 2018, data from 447 consecutive patients undergoing one/two-level lumbar fusion were analyzed. Posterior lumbar interbody fusion (PLIF) with bilateral muscle strip or Wiltse approach, open transforaminal lumbar interbody fusion (TLIF) and minimally invasive TLIF, and posterolateral fusion only were among the surgical techniques used. Core outcomes measure index (COMI) questionnaires were distributed before surgery and at 3 months, 1 year, and 2 years postoperatively to establish patient selfreported outcome measures. Demographic data (age, gender, and body mass index [BMI]) for each patient were also collected in addition to surgical indication, previous operative history, perioperative outcomes, and complications, and whether later revision surgery was required. Pearson's chi-square test, Kruskal-Wallis test, repeated measure mixed-effects models, and ordinal logistic regression were used for statistical analysis. Postoperative COMI scores improved across all procedures compared with pre-surgery (p<0.001). There was no significant difference between different postoperative COMI scores. Significant predictors of higher postoperative COMI score included higher pretreatment COMI score (p≤0.001), previous surgery (p≤0.04), younger age (p≤0.05), higher BMI (p≤0.005), and the indications of lytic spondylolisthesis (p=0.02) and degenerative disc disease (p<0.001). Patients undergoing minimally invasive TLIF had a significantly shorter post-surgery stay than patients undergoing open PLIF (Kruskal-Wallis test, p=0.03). At 2 years postoperatively, there was no significant difference in clinical outcomes between open and minimally invasive techniques. These findings suggest that the main determinant of surgical approach should be surgeon preference and training.

Exploring the efficacy and safety of a novel standardized ashwagandha (Withania somnifera) root extract (Witholytin®) in adults experiencing high stress and fatigue in a randomized, double-blind, placebo-controlled trial.

Stress is a state of homeostasis in the body being challenged, resulting in a systemic response. It has become more prevalent in recent years and affects mental and physical health. Evaluate the effects of ashwagandha on stress, fatigue, and sex hormones in overweight or mildly obese men and women with self-reported stress and fatigue. Two-arm, parallel-group, 12-week, randomized, double-blind, placebo-controlled trial on overweight or mildly obese men and women aged 40-75 years, supplementing with 200 mg of an ashwagandha root extract (Witholytin®) twice daily. Supplementation with ashwagandha was associated with a significant reduction in stress levels based on the Perceived Stress Scale (primary outcome); however, the improvements were not significantly different to the placebo group (p = 0.867). Based on the Chalder Fatigue Scale, there was a statistically significant reduction in fatigue symptoms in the ashwagandha group compared to the placebo group (p = 0.016), and participants taking ashwagandha also experienced a significant increase in heart rate variability (p = 0.003). However, there were no significant between-group differences in other self-report outcome measures. In the men taking ashwagandha, there was a significant increase in the blood concentrations of free testosterone (p = 0.048) and luteinizing hormone (p = 0.002) compared to the placebo group. The results of this study suggest that in overweight middle-to-older age adults experiencing high stress and fatigue, compared to the placebo, ashwagandha did not have a significantly greater impact on perceived stress levels. However, based on secondary outcome measures, it may have anti-fatigue effects. This may be via its impact on the autonomic nervous system. However, further research is required to expand on these current findings.

Changes in Self-Reported and Device-Measured Physical Activity Before Abdominal Resection Surgery: A Meta-Analysis

Objective To determine the effect of interventions on physical activity levels of patients awaiting abdominal resection surgery using self-reported as well as device-measured outcome measures. Data source PubMed and EMBASE databases were searched on the 18th of April 2023 up to April 2023 for studies on interventions to promote physical activity during the preoperative phase. Review methods Studies were included if pre- and post-intervention physical activity was measured between diagnosis and abdominal surgery. Risk of bias was assessed by the Physiotherapy Evidence Database (PEDro) assessment tool for trials. Meta-analyses were performed to assess the effect of the pre-surgery activity promoting interventions on self-reported and device-measured physical activity. Results Seventeen studies were included in the analysis with 452 subjects in the intervention groups. The random-effect meta-analysis showed a moderate improvement in intervention groups measures in pre-surgery physical activity levels compared to the baseline (SMD = 0.67, [CI = 0.30;1.03], I2 = 79%). The self-reported subgroup meta-analysis showed the largest increase in performed physical activity, (SMD = 0.78, [CI = 0.4;1.15], I2 = 79%) whilst non-significant increase was shown in the device-measured subgroup (SMD = 0.16, [CI = −0.64;0.97], I2 = 58%). Conclusion Increasing physical activity in the preoperative phase is feasible. Self-reported physical activity outcome measures show larger effects compared to device-measured outcome measures. More high-quality research should be performed utilizing objective measures.

Poor patient-reported mental health correlates with inferior patient-reported outcome measures following cervical disc replacement.

This study aims to assess the correlation between the patient-reported mental health and the self-reported outcome measures (PROMs) physical function, pain, and disability at different time points following disc replacement (CDR). A single-surgeon registry was searched for patients who had undergone CDR, excluding those with indication for infection, cancer, or trauma. One hundred fifty-one patients were included. PROMs were collected preoperatively as well as 6 weeks, 3 months, 6 months, and 1 year postoperatively. Mental health measures evaluated included 12-Item Short Form (SF-12), Mental Component Score (MCS), and Patient Health Questionnaire-9 (PHQ-9) which were individually assessed via Pearson's correlation tests in relation to Patient-Reported Outcome Measurement Information System Physical Function (PROMIS-PF), SF-12 Physical Component Score (PCS), visual analog scale (VAS) neck and arm pain, and Neck Disability Index (NDI). SF-12 MCS positively correlated with PROMIS-PF (range: r = 0.369-0.614) and SF-12 PCS (range: r = 0.208-0.585) with significance found at two or more time points for each (p ≤ 0.009, all). SF-12 MCS negatively correlated with VAS neck (range: r = - 0.259 to - 0.464), VAS arm (range: r = - 0.281 to - 0.567), and NDI (range: r = - 0.474 to - 831) with significance found at three or more time points (p ≤ 0.028, all). PHQ-9 significantly negatively correlated with PROMIS-PF (range: r = - 0.457 to - 0.732) and SF-12 PCS (range: r = - 0.332 to - 0.629) at all time points (p ≤ 0.013, all). PHQ-9 positively correlated with VAS neck (range: r = 0.351-0.711), VAS arm (range: r = 0.239-0.572), and NDI (range: r = 0.602-0.837) at four or more periods (p ≤ 0.032, all). Patients undergoing CDR who reported lower mental health scores via either SF-12 MCS or PHQ-9 were associated with increased perception of pain and disability. Disability level correlated with mental health at all time periods. Patients with optimized mental health may report higher outcome scores following CDR.

Correlation between Neck Muscle Endurance Tests, Ultrasonography, and Self-Reported Outcomes in Women with Low Cervical Disability and Neck Pain

Background: Neck pain (NP) is a frequent condition in women, characterized by exhibiting distinct clinical manifestations such as the presence of deep neck (DN) muscle weakness. Endurance and ultrasonography of the DN muscles, and patient-reported outcome measures, are commonly used outcomes in clinical practice. The aim of this study is to assess and correlate the endurance of the DN muscles and their morphological characteristics with pain intensity, neck disability and headache impact. Methods: An observational and correlational study was carried out. Eighty-two women were recruited, and endurance tests of neck flexor and extensor (chin tuck flexion test and neck extensor muscles endurance test), ultrasonography of the DN muscles, pain intensity, disability (neck disability index) and headache impact (HIT-6) were measured. Spearman’s rho was used to evaluate the correlation between the outcome variables, and a simple linear regression analysis was carried out to explain the model in detail. Results: Statistically significant negative correlations between the chin tuck neck flexion test and neck disability index (NDI) (r = −0.38; p &lt; 0.001) and HIT-6 (r = −0.26; p = 0.02) were found. The neck extensor muscles endurance test showed a negative correlation with NDI (r = −0.27; p = 0.01) and HIT-6 (r = −0.26; p = 0.02). The simple linear regression analysis showed an R squared of 26.7% and was statistically significant (NDI: R squared = 0.267; F = 3.13; p = 0.004) for NDI. Conclusion: A negative correlation between deep neck muscle endurance test results and self-reported outcome measures in women with low cervical disability and neck pain were observed. This suggests that lower endurance in the deep neck muscles may be associated with poorer self-reported symptoms and functionality in these patients. The chin tuck neck flexion test and deep extensor muscles endurance test could predict self-perceived neck disability in women with low cervical disability and NP.

Increased gut permeability and bacterial translocation are associated with fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome: implications for disease-related biomarker discovery.

There is growing evidence of the significance of gastrointestinal complaints in the impairment of the intestinal mucosal barrier function and inflammation in fibromyalgia (FM) and in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). However, data on intestinal permeability and gut barrier dysfunction in FM and ME/CFS are still limited with conflicting results. This study aimed to assess circulating biomarkers potentially related to intestinal barrier dysfunction and bacterial translocation and their association with self-reported symptoms in these conditions. A pilot multicenter, cross-sectional cohort study with consecutive enrolment of 22 patients with FM, 30 with ME/CFS and 26 matched healthy controls. Plasma levels of anti-beta-lactoglobulin antibodies (IgG anti-β-LGB), zonulin-1 (ZO-1), lipopolysaccharides (LPS), soluble CD14 (sCD14) and interleukin-1-beta (IL-1β) were assayed using ELISA. Demographic and clinical characteristics of the participants were recorded using validated self-reported outcome measures. The diagnostic accuracy of each biomarker was assessed using the receiver operating characteristic (ROC) curve analysis. FM patients had significantly higher levels of anti-β-LGB, ZO-1, LPS, and sCD14 than healthy controls (all P < 0.0001). In ME/CFS patients, levels of anti-β-LGB, ZO-1, LPS, and sCD14 were significantly higher than controls, but lower than in FM (all P < 0.01), while there was no significant difference in IL-1β level. In the FM and ME/CFS cohorts, both anti-β-LGB and ZO-1 correlated significantly with LPS and sCD14 (P < 0.001 for both). In the FM group, both anti-β-LGB and ZO-1 were correlated significantly with physical and mental health components on the SF-36 scale (P < 0.05); whereas IL-1β negatively correlated with the COMPASS-31 score (P < 0.05). In the ME/CFS cohort, ZO-1 was positively correlated with the COMPASS-31 score (P < 0.05). The ROC curve analysis indicated a strong ability of anti-β-LGB, ZO-1, LPS and sCD14 to predictively distinguish between FM and ME/CFS from healthy controls (P < 0.0001). Biomarkers of intestinal barrier function and inflammation were associated with autonomic dysfunction assessed by COMPASS-31 scores in FM and ME/CFS respectively. Anti-β-LGB antibodies, ZO-1, LPS, and sCD14 may be putative predictors of intestinal barrier dysfunction in these cohorts. Further studies are needed to assess whether these findings are causal and can therefore be applied in clinical practice.