Patient perceived quality of cirrhosis care- adjunctive nurse-based care versus standard medical care: a pragmatic multicentre randomised controlled study.

BACKGROUND: Cirrhosis treatment implies prevention and alleviation of serious disease events. Healthcare providers may, however, fail to meet patients' expectations of collaboration and specific needs of information and support. Individualised nursing care could meet patients' needs. The aim was thus to measure patient-perceived quality of care after adjunctive registered nurse-based intervention Quality Liver Nursing Care Model (QLiNCaM) compared with standard medical care. METHODS: This pragmatic multicentre study consecutively randomised patients to either adjunctive registered nurse-based care, or standard medical care for 24 months (ClinicalTrials.gov NCT02957253). Patients were allocated to either group at an equal ratio, at six Swedish outpatient clinics during 2016-2022. Using the questionnaire 'Quality of care from the patient's perspective', patients rated their perceived lack of quality for the adjunctive registered nurse-based intervention compared with the control group at 12 and 24 months, respectively. RESULTS: In total, 167 patients were recruited. Seven out of 22 items in the questionnaire supported the finding that 'lacking quality' decreased with adjunctive registered nurse-based care (p < 0.05) at 12 months follow-up; however, these differences could not be established at 24 months. CONCLUSION: Additional structured registered nurse-based visits in the cirrhosis outpatient team provided support for improved patient-perceived quality of care during the first 12 months. Registered nurses increase patient involvement and present easy access to cirrhosis outpatient care. Patients express appreciation for personalised information. This study reinforces registered nurses' role in the outpatient cirrhosis team, optimising patient care in compensated and decompensated cirrhosis. TRIAL REGISTRATION: Registered at Clinical Trials 18th of October 2016, [ https://www. CLINICALTRIALS: gov ], registration number: NCT02957253.

Intravenous S-ketamine's analgesic efficacy in third molar surgery. A randomized placebo-controlled double-blind clinical trial.

Background: In most cases, a combination of paracetamol and ibuprofen are the optimal treatment for postoperative pain in third molar surgery. If stronger analgesia is required, opioids are traditionally administered. In day-case, surgery; however, opioids should be avoided. Thus, the anaesthetic agent S-ketamine in analgesic doses might be preferred. Methods: The study was designed as a randomized placebo-controlled double-blind clinical trial. The study enrolled healthy subjects according to the American Society of Anaesthesiologists classification; I or II (ASA), aged 18 to 44 years, with a body weight between 50 and 100 kg. The patients were randomized into three groups where two doses of S-ketamine were compared (high: 0.25 mg/kg or low: 0.125 mg/kg) with placebo (saline). Results: A primary outcome of the study was that VAS at 4 h postoperatively, showed no significant difference between the placebo and high-dose S-ketamine group or in the low-dose group. We found a significant difference between the groups for the first 24 h, with a lower VAS-score in the high-dose S-ketamine group. The time to when 50% had taken their first rescue medication was 12 min later in the high-dose ketamine group. Conclusions: Pre-emptive S-ketamine 0.25 mg/kg gave a global significant reduction of pain by VAS during the first 24 h postoperatively. The time from end of surgery to first rescue medication were longer in the high-dose ketamine group compared to both low-dose ketamine and placebo groups.

Protocol for identifying and characterising critical physical tasks in the military: Development and validation.

BACKGROUND: When establishing Physical Employment Standards, validity is dependent on the correct identification and characterisation of critical job tasks. OBJECTIVE: To develop and validate a standardised protocol for the identification, characterisation, and documentation of critical physical job tasks in military occupational specialities in the Swedish Armed Forces (SwAF), and propose a definition of critical physical job tasks for use in the SwAF. METHODS: A protocol was drafted with three content domains, including a preliminary definition. Protocol content validity was iteratively assessed in two consecutive stages where ten subject experts rated relevance and simplicity. A consensus panel revised the protocol after each stage. Content validity index (CVI) was calculated as item-CVI (I-CVI) per each feature and as scale average (S-CVI/Ave) per content domain. Acceptable content validity thresholds were 0.78 and 0.90, respectively. RESULTS: The validated protocol consisted of 35 items with an I-CVI≥0.90 and≥0.80 for relevance and simplicity, respectively. The S-CVI/Ave was 0.97 for relevance and 0.98 for simplicity. The protocol was language reviewed, reorganised for easy use, and approved by the consensus panel. The final protocol includes: background and aim of the protocol, the accepted generic and critical physical job task definitions, protocol instructions, subject expert-qualifications, job task source and characteristics. CONCLUSION: A standardised protocol for identification and characterisation of critical job tasks in SwAF military occupational specialties was developed. The protocol content was rated relevant and simple by experts and will be of importance in future work establishing physical requirements in the SwAF.

Sickness Absence and Disability Pension Among Patients With Chronic Pain in Interdisciplinary Treatment or Unspecified Interventions.

Interdisciplinary treatment is a widely implemented strategy for the rehabilitation of patients with chronic pain. A primary treatment objective is to decrease the load on the social insurance system; however, it is questionable whether interdisciplinary treatment reduces sickness absence and disability pension (SA/DP). This register-based observational study compared SA and DP between patients in interdisciplinary treatment and unspecified interventions. With data from 7,752 Swedish specialist health care patients in their prime working age, we analyzed total net SA/DP days over 3 years from the first visit to a pain rehabilitation center. A zero-one-inflated beta model, adjusted for theoretically substantiated confounders, was used to estimate the mean differences in total days and the proportions of patients with both zero and maximum days. Compared with unspecified interventions, interdisciplinary treatment resulted in a mean (95% confidence interval) absolute increase of 50 (37, 62) total days, a 13.0% (11.3%, 14.6%) decrease in patients with zero days, and a 1.5% (.2%, 2.8%) decrease in patients with the maximum days. These findings support that interdisciplinary treatment increases SA/DP compared to less intensive interventions but reduces the risk of maximum days, implying that it is advantageous for patients with the highest absence. This highlights the need for improved patient selection procedures and the adaptation of interdisciplinary treatment programs to more adequately target SA/DP reduction. PERSPECTIVES: This study provides an accessible overview of SA/DP among working-age patients with chronic pain in Swedish specialist health care. It also shows that interdisciplinary treatment does not decrease SA/DP more than alternative treatments in most patients but is advantageous for the patients with the longest absence.

Acute exercise as active inference in chronic musculoskeletal pain, effects on gait kinematics and muscular activity in patients and healthy participants: a study protocol for a randomised controlled laboratory trial.

INTRODUCTION: Chronic musculoskeletal pain is a highly prevalent, complex and distressing condition that may negatively affect all domains of life. In view of an active inference framework, and resting on the concept of allostasis, human movement per se becomes a prerequisite for health and well-being while chronic pain becomes a sign of a system unable to attenuate an allostatic load. Previous studies on different subgroups of chronic pain conditions have demonstrated alterations in gait kinematics and muscle activity, indicating shared disturbances in the motor system from long-term allostatic load. We hypothesise that such alterations exist in heterogenous populations with chronic musculoskeletal pain, and that exposure to acute and controlled exercise may attenuate these alterations. Therefore, the main aim of this study is to investigate the acute effects of exercise on gait kinematics and activity of the back and neck muscles during diverse walking conditions in patients with chronic musculoskeletal pain compared with a reference sample consisting of healthy participants. METHODS AND ANALYSIS: This two-sample two-armed parallel randomised controlled laboratory trial will include 40 participants with chronic musculoskeletal pain (>3 months) and 40 healthy participants. Participants will be randomly allocated to either 30 min of aerobic exercise or rest. Primary outcomes are gait kinematics (walking speed, step frequency, stride length, lumbar rotation, gait stability) and muscular activity (spatial and temporal) of the back and neck during diverse walking conditions. Secondary outcomes are variability of gait kinematics and muscle activity and subjective pain ratings assessed regularly during the trial. ETHICS AND DISSEMINATION: The study has been approved by the Regional Ethics Review Board in Uppsala, Sweden (#2018/307). Findings will be disseminated via conference presentations, publications in peer-reviewed journals and engagement with patient support groups and clinicians. TRIAL REGISTRATION NUMBER: NCT03882333.

High- Versus Low-Dose Exercise Therapy for Knee Osteoarthritis : A Randomized Controlled Multicenter Trial.

BACKGROUND: The benefits of exercise in patients with knee osteoarthritis are well documented, but the optimal exercise dose remains unknown. OBJECTIVE: To compare high-dose versus low-dose exercise therapy with regard to knee function, pain, and quality of life (QoL) in patients with long-term symptomatic knee osteoarthritis. DESIGN: A Swedish and Norwegian multicenter randomized controlled superiority trial with multiple follow-ups up to 12 months after the intervention. (ClinicalTrials.gov: NCT02024126). SETTING: Primary health care facilities. PATIENTS: 189 patients with diagnosed knee osteoarthritis and a history of pain and decreased knee function were assigned to high-dose therapy (n = 98; 11 exercises; 70 to 90 minutes) or low-dose therapy (n = 91; 5 exercises; 20 to 30 minutes). INTERVENTION: Patient-tailored exercise programs according to the principles of medical exercise therapy. Global (aerobic), semiglobal (multisegmental), and local (joint-specific) exercises were performed 3 times a week for 12 weeks under supervision of a physiotherapist. MEASUREMENTS: The Knee Injury and Osteoarthritis Outcome Score (KOOS) was measured biweekly during the 3-month intervention period and at 6 and 12 months after the intervention. The primary end point was the mean difference in KOOS scores between groups at the end of the intervention (3 months). Secondary outcomes included pain intensity and QoL. The proportion of patients with minimal clinically important changes in primary and secondary outcomes was compared between groups. RESULTS: Both groups improved over time, but there were no benefits of high-dose therapy in most comparisons. One exception was the KOOS score for function in sports and recreation, where high-dose therapy was superior at the end of treatment and at 6-month follow-up. A small benefit in QoL at 6 and 12 months was also observed. LIMITATION: There was no control group that did not exercise. CONCLUSION: The results do not support the superiority of high-dose exercise over low-dose exercise for most outcomes. However, small benefits with high-dose exercise were found for knee function in sports and recreation and for QoL. PRIMARY FUNDING SOURCE: Swedish Rheumatic Fund.

Low-dose aspirin use in pregnancy and the risk of preterm birth: a Swedish register-based cohort study.

BACKGROUND: Preterm birth is the leading cause of neonatal mortality and morbidity. Women who have had a previous preterm birth are at increased risk for preterm birth in their subsequent pregnancies. Low-dose aspirin use reduces the risk for preterm birth among women at risk of developing preeclampsia, however, it is unclear whether low-dose aspirin may reduce the risk of recurrent preterm birth. OBJECTIVE: This study aimed to investigate the association between low-dose aspirin use and preterm birth among women with a previous preterm birth. STUDY DESIGN: We conducted a Swedish register-based cohort study and included women who had a first and second pregnancy between 2006 and 2019, with the first pregnancy ending in preterm birth (medically indicated or with spontaneous onset <37 weeks of gestation). The association between low-dose aspirin use and preterm birth in the second pregnancy was estimated via logistic regression via standardization and expressed as marginal relative risks with the 95% confidence interval. RESULTS: Among the study cohort (N=22,127), 3057 women (14%) were prescribed low-dose aspirin during their second pregnancy and 3703 women (17%) gave birth prematurely. Low-dose aspirin use was associated with a reduced risk for preterm birth, (marginal relative risk, 0.87; 95% confidence interval, 0.77-0.99). There were no statistically significant associations between low-dose aspirin use and an altered risk for moderate preterm birth, defined as birth between 32 and 36 weeks' gestation (marginal relative risk, 0.90; 95% confidence interval, 0.78-1.03), or very preterm birth, defined as birth <32 weeks' gestation (marginal relative risk, 0.75; 95% confidence interval, 0.54-1.04). Regarding the onset of preterm birth, low-dose aspirin use was associated with a reduced risk for spontaneous preterm birth (marginal relative risk, 0.70; 95% confidence interval, 0.57-0.86) but no reduction in the risk for medically indicated preterm birth (marginal relative risk, 1.09; 95% confidence interval, 0.91-1.30) was observed. CONCLUSION: Among women with a previous preterm birth, low-dose aspirin use was associated with a reduced risk for preterm birth. When investigating preterm birth by onset in the second pregnancy, low-dose aspirin use was associated with a reduced risk for spontaneous preterm birth. Our results suggest that low-dose aspirin may be an effective prophylaxis for recurrent preterm birth.

Effectiveness of the eVISualisation of physical activity and pain intervention (eVIS) in Swedish Interdisciplinary Pain Rehabilitation Programmes: study protocol for a registry-based randomised controlled clinical trial.

INTRODUCTION: Living with chronic pain often involves negative consequences. Interdisciplinary Pain Rehabilitation Programmes (IPRP) is considered superior to single-treatment measures in patients with chronic pain. Despite this, effects emerge suboptimal and more than 20% of patients deteriorate in patient-reported physical health outcomes after IPRP. A novel e-Health intervention, eVISualisation (eVIS) of physical activity and pain, was systematically developed to facilitate individualisation of physical activity levels. By adding elements of data collection, visualisation and communication of objectively measured physical activity and patient-reported outcomes (pain intensity, interference of pain, pharmaceutical consumption) to existing treatment modalities in IPRP, the IPRP team acquires prerequisites to adapt advice and physical activity prescriptions and to evaluate set activity goals. The overall aim is twofold. First, the aim is to evaluate the feasibility of the subsequent registry-based randomised controlled clinical trial (R-RCT). Second, the aim is to prospectively evaluate the effectiveness of the eVIS-intervention as a supplement to IPRP on our defined primary (physical health) and secondary outcomes. METHODS AND ANALYSIS: In the R-RCT, recruitment of 400 patients with chronic pain will be performed at 15 IPRP units. A random allocation to either IPRP + eVIS or to control group that will receive IPRP only will be performed. Data from the initial 30 participants completing the study period (6 months) will be included in a pilot study, where key feasibility outcomes (recruitment, randomisation, implementation, treatment integrity, data collection procedure, preliminary outcome measures) will be evaluated. Outcome variables will be extracted from the web application Pain And TRaining ON-line (PATRON) and from six national registries. Multivariate statistics and repeated measure analyses will be performed. Quality-adjusted life years and incremental cost-effectiveness ratio will be calculated for cost-effectiveness evaluation. ETHICS/DISSEMINATION: The Swedish Ethics Review Board granted approval (Dnr 2021/02109). Results will be disseminated through peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05009459. Protocol V.1.

The value of interdisciplinary treatment for sickness absence in chronic pain: A nationwide register-based cohort study.

BACKGROUND: Interdisciplinary treatment (IDT) is an internationally recommended intervention for chronic pain, despite inconclusive evidence of its effects on sickness absence. METHODS: With data from 25,613 patients in Swedish specialist healthcare, we compared sickness absence, in the form of both sick leave and disability pensions, over a 5-year period between patients either allocated to an IDT programme or to other/no interventions (controls). To obtain population-average estimates, a Markov multistate model with theory-based inverse probability weights was used to compute both the proportion of patients on sickness absence and the total sickness absence duration. RESULTS: IDT patients were more likely than controls to receive sickness absence benefits at any given time (baseline: 49% vs. 46%; 5-year follow-up: 36% vs. 35%), and thereby also had a higher total duration, with a mean (95% CI) of 67 (87, 48) more days than controls over the 5-year period. Intriguingly, sick leave was higher in IDT patients (563 [552, 573] vs. 478 [466, 490] days), whereas disability pension was higher in controls (152 [144, 160] vs. 169 [161, 178] days). CONCLUSION: Although sickness absence decreased over the study period in both IDT patients and controls, we found no support for IDT decreasing sickness absence more than other/no interventions in chronic pain patients. SIGNIFICANCE: In this large study of chronic pain patients in specialist healthcare, sickness absence is compared over a 5-year period between patients in an interdisciplinary treatment programme and other/no interventions. Sickness absence decreased over the study period in bothgroups; however, there was no support forthat it decreased more with interdisciplinary treatment than alternative interventions.

Predictors of Sickness Absence in a Clinical Population With Chronic Pain.

Chronic pain-related sickness absence is an enormous socioeconomic burden globally. Optimized interventions are reliant on a lucid understanding of the distribution of social insurance benefits and their predictors. This register-based observational study analyzed data for a 7-year period from a population-representative sample of 44,241 chronic pain patients eligible for interdisciplinary treatment (IDT) at specialist clinics. Sequence analysis was used to describe the sickness absence over the complete period and to separate the patients into subgroups based on their social insurance benefits over the final 2 years. The predictive performance of features from various domains was then explored with machine learning-based modeling in a nested cross-validation procedure. Our results showed that patients on sickness absence increased from 17% 5 years before to 48% at the time of the IDT assessment, and then decreased to 38% at the end of follow-up. Patients were divided into 3 classes characterized by low sickness absence, sick leave, and disability pension, with eight predictors of class membership being identified. Sickness absence history was the strongest predictor of future sickness absence, while other predictors included a 2008 policy, age, confidence in recovery, and geographical location. Information on these features could guide personalized intervention in the specialized healthcare. PERSPECTIVE: This study describes sickness absence in patients who visited a Swedish pain specialist interdisciplinary treatment clinic during the period 2005 to 2016. Predictors of future sickness absence are also identified that should be considered when adapting IDT programs to the patient's needs.

What Is the Effectiveness of Different Duration Interdisciplinary Treatment Programs in Patients with Chronic Pain? A Large-Scale Longitudinal Register Study.

Chronic pain is a leading cause of disability globally. Interdisciplinary multimodal pain rehabilitation (IMPR) targets pain with a bio-psycho-social approach, often delivered as composite programs. However, evidence of optimal program duration for the rehabilitation to succeed remains scarce. This study evaluated the effectiveness of different duration IMPR-programs-using within- and between-effects analyses in a pragmatic multicenter register-based controlled design. Using the Swedish Quality Registry for Pain Rehabilitation, data from fifteen clinics specialized in chronic pain rehabilitation across Sweden were retrieved. Participants were patients with chronic musculoskeletal pain who had taken part in short (4-9 weeks; n = 924), moderate (10 weeks; n = 1379), or long (11-18 weeks; n = 395) IMPR programs. Longitudinal patient-reported outcome data were assessed at baseline, post-intervention, and at a 12-month follow-up. Primary outcomes were health-related quality of life, presented as perceived physical and mental health (SF-36). Secondary outcomes included the Hospital Anxiety and Depression Scale (HADS), pain intensity (NRS 0-10), the Multidimensional Pain Inventory (MPI), and perceived health (EQ-5D). Overall, all groups showed improvements. No clinically important effect emerged for different duration IMPR. In conclusion, while our results showed that patients following IMPR report improvement across a bio-psycho-social specter, a longer program duration was no more effective than a shorter one.

Prognostic factors for improved physical and emotional functioning one year after interdisciplinary rehabilitation in patients with chronic pain: Results from a national quality registry in Sweden.

OBJECTIVE: To investigate prognostic factors for physical and emotional functioning following interdisciplinary multimodal pain rehabilitation, by targeting patients' baseline characteristics and health measures. METHODS: A prospective cohort of 2,876 patients from 38 specialist clinics across Sweden, who were completing interdisciplinary multimodal pain rehabilitation programmes, was followed through the Swedish Quality Registry for Pain Rehabilitation, from initial assessment to 12-month follow-up. Using logistic regression, baseline data were regressed to predict improvement in Physical functioning and Emotional functioning, fused by principal component analyses using the 36-item Short Form Health Survey (SF-36) and the Hospital Anxiety and Depression Scale (HADS). RESULTS: Employment status emerged as having the largest effect sizes in both Physical functioning and Emotional functioning; Working: odds ratio (OR) 2.05 (95% confidence interval (95% CI) 1.64-2.56) and OR 1.59 (95% CI 1.27-1.98), respectively. Strong beliefs in restored health, better initial emotional health, lower levels of pain and pain interference, and younger age all predicted Physical functioning. European origin, higher levels of general activity, and sense of life control all predicted Emotional functioning. Worse initial physical and emotional health predicted the corresponding dependent outcomes. CONCLUSION: Employment was consistently found to be an important prognostic factor, suggesting the significance of avoiding delay in interdisciplinary multimodal pain rehabilitation. A positive treatment expectancy was of importance. In general, multidimensional measures indicated that better initial status was more favourable; however, inconsistency implies a complex prognostic picture.

Low Back Pain in the Emergency Department: Prevalence of Serious Spinal Pathologies and Diagnostic Accuracy of Red Flags.

BACKGROUND: Very little evidence is available on the prevalence of serious spinal pathologies and the diagnostic accuracy of red flags in patients presenting to the emergency department (ED). This systematic review aims to investigate the prevalence of serious spinal pathologies and the diagnostic accuracy of red flags in patients presenting with low back pain to the ED. METHODS: We systematically searched MEDLINE, PUBMED, EMBASE, Cochrane Library, and SCOPUS from inception to January 2019. Two reviewers independently reviewed the references and evaluated methodological quality. RESULTS: We analyzed 22 studies with a total of 41,320 patients. The prevalence of any requiring immediate/urgent treatment was 2.5%-5.1% in prospective and 0.7%-7.4% in retrospective studies (0.0%-7.2% for vertebral fractures, 0.0%-2.1% for spinal cancer, 0.0%-1.9% for infectious disorders, 0.1%-1.9% for pathologies with spinal cord/cauda equina compression, 0.0%-0.9% for vascular pathologies). Examples of red flags which increased the likelihood for a serious condition were suspicion or history of cancer (spinal cancer); intravenous drug use, indwelling vascular catheter, and other infection site (epidural abscess). CONCLUSION: We found a higher prevalence of serious spinal pathologies in the ED compared to the reported prevalence in primary care settings. As the diagnostic accuracy of most red flags was reported only by a single study, further validation in high-quality prospective studies is needed.

Psychometric properties of Short Form-36 Health Survey, EuroQol 5-dimensions, and Hospital Anxiety and Depression Scale in patients with chronic pain.

Recent research has highlighted a need for the psychometric evaluation of instruments targeting core domains of the pain experience in chronic pain populations. In this study, the measurement properties of Short Form-36 Health Survey (SF-36),EuroQol 5-dimensions (EQ-5D) and Hospital Anxiety and Depression Scale (HADS) were analyzed within the item response-theory framework based on data from 35,908 patients. To assess the structural validity of these instruments, the empirical representations of several conceptually substantiated latent structures were compared in a cross-validation procedure. The most structurally sound representations were selected from each questionnaire and their internal consistency reliability computed as a summary of their precision. Finally, questionnaire scores were correlated with each other to evaluate their convergent and discriminant validity. Our results supported that SF-36 is an acceptable measure of 2 independent constructs of physical and mental health. By contrast, although the approach to summarize the health-related quality of life construct of EQ-5D as a unidimensional score was valid, its low reliability rendered practical model implementation of doubtful utility. Finally, rather than being separated into 2 subscales of anxiety and depression, HADS was a valid and reliable measure of overall emotional distress. In support of convergent and discriminant validity, correlations between questionnaires showed that theoretically similar traits were highly associated, whereas unrelated traits were not. Our models can be applied to score SF-36 and HADS in chronic pain patients, but we recommend against using the EQ-5D model due to its low reliability. These results are useful for researchers and clinicians involved in chronic pain populations because questionnaires' properties determine their discriminating ability in patient status assessment.