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Tina Hovgaard Lützen,1 Charlotte Ulrikka Rask,2,3 Oleguer Plana-Ripoll,4 Bodil Hammer Bech,1 Lene Wulff Krogsgaard,1 Nanna Rolving,5,6 Dorte Rytter1 1Research Unit for Epidemiology, Department of Public Health, Aarhus University, Aarhus C 8000, Denmark; 2Research Unit, Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Aarhus N 8200, Denmark; 3Department of Clinical Medicine, Aarhus University, Aarhus N 8200, Denmark; 4National Centre for Register-Based Research, Department of Economics and Business Economics, Aarhus University, Aarhus V 8210, Denmark; 5University Clinic of Innovative Patient Pathways, Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg 8600, Denmark; 6DEFACTUM, Corporate Quality, Central Denmark Region, Aarhus N 8200, DenmarkCorrespondence: Tina Hovgaard Lützen Research Unit for Epidemiology, Department of Public HealthAarhus University, Bartholins Allé 2, Aarhus C 8000, DenmarkTel +45 22410722Email tina.lutzen@ph.au.dkAim: This study aimed to describe and compare general practitioner (GP) attendance patterns in the years surrounding HPV-vaccination among cases suspected to experience adverse events and their matched controls in order to determine if a potential larger change in GP attendance among cases was observed in temporal relation to vaccination.Methods: Register-based, matched case–control study. Cases were defined as women referred to specialized hospital settings (HPV-centers) for suspected adverse event between June 1st 2015 and December 31st 2015 (n=1458). Information on referral was obtained from the HPV-centers directly. Each case was matched with five controls on age at vaccination, region, time of first vaccine registration and total number of doses, resulting in a total study population of 8670 girls and women. Negative binomial regression analyses were used (i) to estimate mean yearly GP contacts among cases and controls, and (ii) to further investigate the relative difference in change in GP attendance following vaccination between cases and controls.Results: Overall, cases displayed higher GP attendance than controls from five years before vaccination up until five years after. Compared to controls, cases increased their GP attendance more in the years following HPV vaccination, corresponding to a 40% increase in the incidence rate ratios (IRR) from before to after vaccination (ratio-IRR = 1.40 [1.36; 1.44]). The change occurred in close proximity to vaccination, and the pattern was the same independently of the year of vaccination. However, for the later vaccination years cases displayed an additional increase in their GP attendance around time of extensive media attention.Conclusion: Girls and women being referred for suspected adverse events after HPV-vaccination changed their GP attendance pattern in close proximity to their first HPV-vaccination and not solely in temporal linkage to the onset of public debate.Keywords: HPV vaccination, general practice attendance, adverse effects, case–control

Objectives: The study aimed to evaluate the feasibility of a blood flow restriction (BFR) training regimen in patients with rheumatoid arthritis (RA); and to compare the effects of 4 weeks of BFR training with low-intensity strength training on muscle strength, muscle endurance, and joint pain in patients with RA.Method: In this non-blinded pilot randomized controlled trial, 18 women with RA aged 18-65 years performed low-intensity strength training for the lower limbs three times a week for 4 weeks, and were randomized to train with or without occlusion bands. The primary outcomes were registration of the recruitment process, compliance with training sessions, side effects, perceived pain, and a satisfaction survey. The secondary outcomes were changes in muscle strength, muscle endurance, and joint pain.Results: The findings of this pilot study included a challenging recruitment process, well tolerated training and test protocols, overall good patient satisfaction, no serious side effects, and high compliance. Both groups achieved significant improvements in knee extensor strength from baseline to follow-up, with a change of 11.5 kg [interquartile range (IQR) 9.8;13.0] in the intervention group and 8.4 kg (IQR 5.5;12.4) in the control group, and a significant between-group difference in favour of the intervention group (p = 0.0342).Conclusions: The feasibility results of this study indicated a challenging recruitment process, general satisfaction with the BFR and exercises, good compliance, and only expected non-serious side effects. BFR training may improve knee extensor strength in women with RA, compared low-intensity strength training without BFR. [ABSTRACT FROM AUTHOR]

Background: More than 50% of patients with pulmonary embolism (PE) experience persistent functional limitations. Despite guideline recommendations for a structured integrated care model for patients with PE, consensus on an optimal follow-up strategy is lacking, and evidence is insufficient., Objectives: To describe the development of a structured model for PE follow-up using coproduction methods., Methods: Coproduction of A structured integrated postPulmonary Embolism care (Attend-PE) model was conducted from October 2021 to June 2022, featuring participatory design techniques. This was combined with a stepwise approach based on Intervention Mapping to ensure that the developed model was evidence-based and theoretically grounded., Results: Development of the Attend-PE model included 1) a needs assessment mapping follow-up at 18 sites treating PE in Denmark; 2) definition of the overall goal and performance objectives of the Attend-PE model, based on the needs assessment in combination with a literature review; 3) coproduction of the Attend-PE model in workshops with patient representatives, healthcare professionals, and experts in the field; and 4) refinement of the structure and organization of the Attend-PE model and production of the patient education material. The Attend-PE model outlines a structured approach for in-hospital follow-up, involving group-based patient education, individual consultations, and patient-reported outcomes to assess physical and psychological well-being. The model supports a personalized posthospitalization care plan., Conclusion: The coproduction process was successful in developing a structured follow-up model aligned with patients' needs, health provider perspectives, and existing guidelines. The Attend-PE model is currently undergoing clinical evaluation to determine its effectiveness and usability., Competing Interests: Declaration of competing interests A.A.H. has been on the speaker bureaus for Bayer, Pfizer, Merck Sharp & Dohme, Leo Pharma, and Bristol-Myers Squibb and on the advisory board for Bayer and Merck Sharp & Dohme. E.L.G. has received speaker honoraria or consultancy fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Novo Nordisk, Lundbeck Pharma, and Organon. He is an investigator in clinical studies sponsored by AstraZeneca, Idorsia, or Bayer and has received unrestricted research grants from Boehringer Ingelheim. T.B.L. has served as an investigator for Janssen Scientific Affairs, Bayer AG LLC, and Boehringer Ingelheim and has served as a speaker for Bayer, Bristol-Myers Squibb/Pfizer, and Boehringer Ingelheim. N.R. has received speaker honoraria and consultancy fees from Bayer and the Bristol-Myers Squibb–Pfizer Alliance. All other authors have no competing interests to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Pulmonary embolism may have both physical and psychological consequences for the affected person. Guidelines recommend structured follow-up care, yet this is still not widely practised. Therefore, a national research project was initiated in Denmark in 2021, with the aim of developing, testing, implementing, and evaluating a structured post-pulmonary embolism follow-up care model, 'Attend-PE'. The objective of this feasibility study was to examine the fidelity, acceptability, and appropriateness of the Attend-PE model in a Danish hospital setting., Methods: This feasibility study was conducted in two Danish hospitals, using a prospective study design with six months' follow-up. The fidelity, acceptability, and appropriateness of the Attend-PE model's components were evaluated using surveys, registrations sheets, and interviews with two physicians, three nurses, and 29 patients. Qualitative data were analysed using a deductive content analysis, while quantitative data were analysed using descriptive statistics., Results: Fidelity with the Attend-PE model was good, with a high participation rate of patients in all components of the model. Acceptability was likewise good, as both patients and health care professionals expressed a high level of satisfaction with the model. The health care professionals considered the model to be relevant and suitable in a Danish hospital setting, confirming appropriateness of the model., Conclusion: This study showed that the Attend-PE model for patients with pulmonary embolism is feasible and acceptable in a Danish hospital setting., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Anette Arbjerg Hoejen reports financial support was provided by Novo Nordisk Foundation. Anette Arbjerg Hoejen reports financial support was provided by Heart Foundation. Anette Arbjerg Hoejen reports a relationship with Bayer AG that includes: consulting or advisory and speaking and lecture fees. Erik Lerkevang Grove reports a relationship with Bayer AG that includes: consulting or advisory and speaking and lecture fees. Nanna Rolving reports a relationship with Bayer AG that includes: consulting or advisory and speaking and lecture fees. Nanna Rolving reports a relationship with Bristol Myers Squibb that includes: consulting or advisory and speaking and lecture fees. Anette Arbjerg Hoejen reports a relationship with Bristol Myers Squibb that includes: consulting or advisory and speaking and lecture fees. Erik Lerkevang Grove reports a relationship with Bristol Myers Squibb that includes: consulting or advisory and speaking and lecture fees. Erik Lerkevang Grove reports a relationship with Boehringer Ingelheim that includes: funding grants. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Background: Standing frames are commonly used by healthcare professionals in their practice with children with cerebral palsy (CP) who do not have an independent standing function. A better understanding of healthcare professionals' attitudes and experiences with standing frames may impact practice and rehabilitation. Therefore, this study aimed to investigate the standing frame practice among healthcare professionals and expand their attitude and experience with the use of standing frames for children with CP., Methods: This is an explanatory sequential mixed methods study. A cross-sectional survey was conducted, providing quantitative data on 210 healthcare professionals' use of standing frames. The quantitative data were descriptively analysed. Subsequently, the results from the survey were followed up with five focus group interviews of healthcare professionals (n = 14). The qualitative data were analysed using thematic analysis, enabling integration between the quantitative and qualitative data., Results: When quantitative and qualitative data are integrated, expansion between the two datasets occurred. The quantitative dataset emphasised the use of GMFCS levels as a guideline for recommending standing frames, whereas the qualitative data showed that the healthcare professionals' recommendations were based on individual needs. Furthermore, the healthcare professionals expanded the quantitative data, showing that the healthcare professionals' considerations regarding age and dosage were based on clinical experience, and saw the standing frame as having many benefits., Conclusion: The healthcare professionals had a child-centred approach, where the child's need for using a standing frame was assessed based on the functional level, stage of development, cognitive level and clinical assessment. All of these considerations showed that the use of standing frames for children with CP was individualised, thereby making it difficult to make unified descriptions., (© 2024 The Author(s). Child: Care, Health and Development published by John Wiley & Sons Ltd.)

Objectives: To examine the effect of an early postsurgical intervention consisting of graded activity and pain education (GAPE) in patients with chronic low back pain (CLBP) undergoing lumbar spinal fusion (LSF) on sedentary behavior, disability, pain, fear of movement, self-efficacy for exercise and health-related quality of life (HRQoL) at 3-, 6-, and 12 months follow-up., Design: A parallel-group, observer-blinded randomized controlled trial., Setting: Department of Occupational- and Physiotherapy and the Centre for Rheumatology and Spine Diseases, Rigshospitalet, Denmark., Participants: In total, 144 participants undergoing an LSF for CLBP were randomly assigned to an intervention or a control group., Interventions: The intervention group received 9 sessions of GAPE, based on principles of operant conditioning., Main Outcome Measures: The primary outcome was reduction in time spent in sedentary behavior, measured by an accelerometer at 3 months. The secondary outcomes were reduction in time spent in sedentary behavior at 12 months and changes from baseline to 3-, 6-, and 12 months on disability, pain, fear of movement, self-efficacy for exercise, and HRQoL., Results: No difference in changes in sedentary behavior between groups was found 3 months after surgery. At 12 months after surgery, there was a significant difference between groups (mean difference: -25.4 min/d (95% confidence interval -49.1 to -1.7)) in favor of the intervention group., Conclusions: Compared with usual care, GAPE had no effect on short-term changes in sedentary behavior but GAPE had a statistical, but possibly not clinical significant effect on sedentary behavior 12 months after LSF. Further, the behavioral intervention was safe to perform., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Healthcare research emphasises involvement of patients in the research process, recognizing that this can enhance the relevance, quality, and implementation of research. This article highlights the need for more systematic planning to successfully involve patients in research projects and provides guidance on key aspects that researchers should consider in the planning of involving patients in research. The article accentuates the importance of establishing clear frameworks and guidelines to promote transparency and facilitate implementation., (Published under Open Access CC-BY-NC-BD 4.0. https://creativecommons.org/licenses/by-nc-nd/4.0/.)

Background: Low back pain is still the leading cause of disability and societal burden, with 619 million prevalent cases worldwide in 2020. Most countries produce clinical guidelines to support healthcare professionals in evidence-based care regarding low back pain. However, several studies have identified relatively poor uptake of guidelines. Tailored strategies to facilitate the implementation of guidelines have been argued to increase uptake. This study aimed to develop a contextually tailored implementation programme to enhance evidence-based low back pain care among Danish physiotherapists and chiropractors in primary care., Methods: A theory-driven implementation programme development study was conducted using the Behaviour Change Wheel, with high healthcare professional involvement. Data collection included four workshops with seven physiotherapists and six chiropractors from primary care clinics. The development process consisted of [1] establishing a theoretical frame, [2] involving participants, [3] understanding the behaviour, [4] designing the implementation programme, and [5] final implementation programme., Results: The target behaviours selected (guideline recommendations) for the implementation programme were (i) screening of psychosocial risk factors and (ii) offering patient education. The barriers and facilitators for the selected behaviours were described and linked to intervention functions and behavioural techniques. Finally, the implementation programme comprised five strategies: webinars, e-learning videos, communication exercises, peer learning, and group dialogue meetings. In addition, the programme consisted of implementation support: champions, a physical material folder, a weekly email reminder, a specially designed website and a visit from an implementation consultant. An essential element of the overall programme was that it was designed as a step-by-step implementation process consisting of 16 h of education and training distributed over 16 weeks., Conclusions: A programme for implementing low back pain guideline recommendations was developed based on behaviour change theory and four co-design workshops involving healthcare professionals to overcome the contextually identified barriers. A theory-driven approach involving healthcare professionals was useful in identifying relevant target behaviours and tailoring the programme to consider contextual barriers and facilitators for implementation. The effectiveness of the final implementation programme will be evaluated in the project's next phase., Trial Registration: Central Denmark Region, Registered November 11, 2021, act no. 1-16-02-93-19., (© 2024. The Author(s).)

Background and Aims: Rehabilitation targeting patients with cardiac conditions are evident and acknowledged in clinical guidelines. However, participation rates remain suboptimal, with only 50% of all patients with cardiac conditions participating in these programs across Europe. Considering the well-documented effects of rehabilitation, increasing the referral rate to cardiac rehabilitation would be desirable. This study aimed to evaluate the feasibility of a novel referral strategy that could potentially enhance enrollment in cardiac rehabilitation for patients with heart failure., Methods: This prospective feasibility study incorporating both quantitative and qualitative methods was conducted in an outpatient heart failure clinic and a municipal health care center. 106 patients with heart failure were referred to the heart failure clinic from September 2021 through July 2022. A 15-20 min face-to-face physiotherapy consultation was incorporated into usual care, evaluating patients' habitual and actual level of functioning, disability, and physical activity and assessing their potential need and motivation for cardiac rehabilitation. Three predefined quantitative feasibility outcomes: reach, referral rate, and data completeness were assessed. Additionally, semi-structured interviews explored acceptability among patients and health care professionals at the municipal health care center and the hospital. Finally, the potential effect was assessed based on the enrollment rate., Results: Physiotherapy consultations were offered to 86% of eligible patients; of these, 52% were referred to cardiac rehabilitation. Ninety-one percent data completeness was achieved. The intervention was well-accepted by patients and health care professionals. The enrollment rate reached 79%., Conclusion: The novel referral strategy proved feasible concerning reach and data completeness, although the referral rate suggested that further refinements are required before a full-scale trial. The novel referral strategy was well-accepted, and enrollment rate approached an acceptable level., Competing Interests: The authors declare no conflict of interest., (© 2024 The Authors. Health Science Reports published by Wiley Periodicals LLC.)

Introduction: Up to 50 % of patients surviving a pulmonary embolism (PE) report persisting shortness of breath, reduced physical capacity and psychological distress. As the PE population is heterogeneous compared to other cardiovascular patient groups, outcome measures for assessing physical capacity traditionally used in cardiac populations may not be reliable for the PE population as a whole. This scoping review aims to 1) map performance-based outcome measures (PBOMs) used for assessing physical capacity in PE research, and 2) to report the psychometric properties of the identified PBOMs in a PE population., Methods: The review was conducted according to the Joanna Briggs Institute framework for scoping reviews and reported according to the PRISMA-Extension for Scoping Reviews guideline., Results: The systematic search of five databases identified 4585 studies, of which 243 studies met the inclusion criteria. Of these, 185 studies focused on a subgroup of patients with chronic thromboembolic pulmonary hypertension. Ten different PBOMs were identified in the included studies. The 6-minute walk test (6MWT) and cardiopulmonary exercise test (CPET) were the most commonly used, followed by the (Modified) Bruce protocol and Incremental Shuttle Walk test. No studies reported psychometric properties of any of the identified PBOMs in a PE population., Conclusions: Publication of studies measuring physical capacity within PE populations has increased significantly over the past 5-10 years. Still, not one study was identified, reporting the validity, reliability, or responsiveness for any of the identified PBOMs in a PE population. This should be a priority for future research in the field., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: None related to this manuscript. The authors report the following general conflicts: ELG has received speaker honoraria or consultancy fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Lundbeck Pharma, Novo Nordisk and Organon. He is investigator in clinical studies sponsored by AstraZeneca, Idorsia or Bayer and has received unrestricted research grants from Boehringer Ingelheim. AAH has received consulting fees from Bayer and The Bristol-Myers Squibb-Pfizer Alliance, and speaker bureaus from Bayer, The Bristol-Myers Squibb-Pfizer Alliance. NR has received speaker honoraria for talks about PE and rehabilitation and consultancy fees for the development of patient information material on the same subject, both sponsored by Bayer and Bristol-Myers Squibb-Pfizer Alliance., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Purpose: Most patient-reported outcome (PROs) used in thrombosis research and clinical practice are delivered using technology like online questionnaires. However, only few have undergone formal electronic adaptation from paper to digital versions, threatening the validity and reliability of the PROs. The present study aimed to perform an electronic adaption and cross-cultural translation of two PROs measuring health-related quality of life in a Danish cohort of patients with venous thrombosis (VTE), specifically the VEINES-QoL/Sym questionnaire and the PEmb-QoL questionnaire., Methods: The electronic adaption and cross-cultural translation processes followed the international guidelines recommended by ISPOR. The migration of the questionnaires from paper to electronic versions was conducted in the Research Electronic Data Capture (REDCap). Following approval of the electronically adapted and translated versions, a pretest of the questionnaires was performed by cognitive interviewing patients with VTE recruited from a hospital setting., Results: Nine men and ten women between the age of 19 and 73 years participated in cognitive interviews. The questionnaires were successfully adapted from paper to electronic versions, and during the migration process only a few modifications to the content and format were made. Most comments were related to technicalities, e.g. touch functions and checkboxes. The cross-cultural translation of both questionnaires was satisfactory, as only minor rephrasing was required., Conclusions: The original and Danish version of VEINES-QoL/Sym and PEmb-QoL were successfully adapted into electronic versions and are ready to share for REDCap users. Furthermore, the Danish versions of the two questionnaires have shown satisfactory face validity., (© 2024. The Author(s).)

Purpose: Low back pain (LBP) is the leading cause of disability worldwide. Providing evidence-based practice (EBP) for patients with LBP is more cost-effective compared with non-EBP. To help health care professionals provide EBP, several clinical practice guidelines have been published. However, a relatively poor uptake of the guidelines has been identified across various countries. To enhance future implementation of EBP, the aim of this study was to explore barriers to using LBP guidelines in clinical practice., Materials and Methods: A qualitative constructivist grounded theory design was employed in order to gain an in-depth understanding of the barriers. Semi-structured interviews (+/- observations) of nine physiotherapists and nine chiropractors from primary care in the Central Denmark Region were conducted., Results: Two key barriers were found to using guidelines in practice: (1) a scepticism due to doubts about validity and applicability of the guidelines, which emerged particularly among physiotherapists; and (2) a deep biomechanical professional identity, due to perceived role, interest, lack of skills, and patient preferences, which emerged particularly among chiropractors., Conclusions: For guidelines to be better implemented in practice, these key barriers must be addressed in a tailored strategy. Furthermore, this study showed a difference in barriers between the two professions.

Objective: Up to 50 % of patients recovering from pulmonary embolism (PE) experience negative long-term outcomes. Patient-reported outcome measures (PROMs) are important in identifying what matters to patients. We aimed to identify PROMs used in clinical studies and recommended by the International Consortium of Health Outcomes (ICHOM) and compare individual items with factors considered important by patients recovering from PE., Methods: This was a convergent mixed-methods systematic review, including quantitative studies, using PROMs and qualitative studies with non-cancer-related PE patients. Items from each PROM and qualitative findings were categorised using an International Classification of Function linking process to allow for integrated synthesis., Results: A total of 68 studies using 34 different PROMs with 657 items and 13 qualitative studies with 408 findings were included. A total of 104 individual ICF codes were used, and subsequently sorted into 20 distinct categories representing patient concerns. Identified PROMs were found to adequately cover 17/20 categories, including anxiety, fear of bleeding, stress, depression, dizziness/nausea, sleep disturbance, pain, dyspnea, fatigue, activity levels, family and friends, socializing, outlook on life, and medical treatment. PROMs from the ICHOM core set covered the same categories, except for dizziness/nausea., Conclusions: No single PROM covered all aspects assessed as important by the PE population. PROMs recommended in the ICHOM core set cover 16/20 aspects. However, worrisome thoughts, hypervigilance around symptoms, and uncertainty of illness were experienced by patients with PE but were not covered by PROMS., Competing Interests: Declaration of competing interest None related to this manuscript. The authors report the following general conflicts: ELG has received speaker honoraria or consultancy fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, MSD, Lundbeck Pharma, Novo Nordisk and Organon. He is investigator in clinical studies sponsored by AstraZeneca, Idorsia or Bayer and has received unrestricted research grants from Boehringer Ingelheim. AAH has received consulting fees from Bayer and The Bristol-Myers Squibb-Pfizer Alliance, and speaker bureaus from Bayer, The Bristol-Myers Squibb-Pfizer Alliance. NR has received speaker honoraria for talks about PE and rehabilitation and consultancy fees for the development of patient information material on the same subject, both sponsored by Bayer and Bristol-Myers Squibb-Pfizer Alliance., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The pre-referral history of patients with low back pain referred to secondary care is poorly documented, and it is unclear whether it complies with clinical guideline recommendations; specifically, whether they have received appropriate treatment in primary care. This study describes the patient population referred to a spine clinic at a Danish hospital and investigates whether they have received an adequate course of treatment in primary care before referral. Furthermore, a possible association between primary care treatment and socioeconomic factors is estimated., Methods: We examined self-reported data from 1035 patients with low back pain of at least eight weeks duration referred to secondary care at a medical spine clinic using a cross-sectional design. As an approximation to national clinical guidelines, the definition of an adequate course of treatment in primary care was at least five visits to a physiotherapist or chiropractor prior to referral., Results: Patients were on average 53 years old, and 56% were women. The average Oswestry Disability Index score was 36, indicating a moderate level of disability. Nearly half of the patients reported pain for over a year, and 75% reported pain below knee level. Prior to referral, 33% of the patients had not received an adequate course of treatment in primary care. Based on multiple logistic regression with the three socioeconomic variables, age and sex in the model, those who were unemployed had an odds ratio of 2.35 (1.15-4.79) for not receiving appropriate treatment compared to employed patients. Similarly, the odds ratio for patients without vs. with health insurance was 1.71 (1.17-2.50). No significant association was observed with length of education., Conclusions: Despite national clinical guidelines recommending management for low back pain in primary care, one third of the patients had not received an adequate course of treatment before referral to secondary care. Moreover, the high probability of not having received recommended treatment for patients who were unemployed or lacked health insurance indicates an economic obstacle to adequate care. Therefore, reconsidering the compensation structure for the treatment of back pain patients is imperative to mitigate health inequality within low back pain management., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Physiotherapists (PTs) have an essential role in the facilitation of patients' mobilization after lumbar spinal fusion (LSF). The aim of this study is to investigate whether PTs can predict one-year post-surgery outcome based on their first meeting with the patient immediately after LSF., Method: A prospective cohort study with one-year follow-up was conducted. In the first days after surgery, the PTs from hospital wards were asked to predict the patients' overall LSF outcome one year after surgery. One year after surgery, the patients received a questionnaire including the Oswestry Disability Index (ODI), visual analogue scales (VAS) for leg and back pain, quality of life survey (EQ-5D-3 L), global perceived effect (GPA), and satisfaction with surgery outcome (SSO). Univariate and logistic regression were used to calculate the associations between the prognosis and predictive values., Results: The study included 170 patients. The analyses showed a significant association between the PTs' prognosis and the primary outcome ODI (p < .01), VAS leg and back, EQ-5D-3 L, and GPE one-year post-surgery (p ≤ .04). However, the predictive value of the PTs' prognosis was low (R 2  ≤ 0.09). There was no significant association between the PTs' prognosis and the patients' SSO (p = .17; R 2  = 0.01)., Conclusion: There were significant associations between the PTs' prognosis and disability, pain, health-related quality of life and global perceived effect one-year post-surgery, although the associations had low predictive values. There was no significant association between the PTs' prognosis and patients' SSO after one year. The PTs' prognosis should not be used as a single component in further rehabilitation planning.

Background: Return-to-work processes involve many stakeholders who need to cooperate to best support the person on sick leave. Yet, there is little knowledge of how workers sick listed due to back pain experience navigating between stakeholders., Objective: This study aimed to explore how Danish workers on sick leave due to back pain experience navigating between the involved stakeholders, focusing on settings related to social work, health care and workplace., Methods: Sixteen individual semi-structured interviews were conducted and data analysed using a thematic analysis approach., Results: Analysis resulted in three themes. 1) 'Meeting the system' where establishing a positive relationship with the social worker was hampered by a negative perception of the job centre. This perception was initiated by the convening letter and accentuated by physical meetings being experienced as a waste of time. 2) In 'Navigating between systems' some participants lacked support from professionals to navigate the role as messenger between the job centre and health care system. 3) In 'The workplace-a familiar arena' workers experience the workplace as a familiar arena, even if negative decisions were made. Analysis additionally revealed that patients' return-to-work processes could be divided into two types, namely complex and smooth., Conclusion: The initial contact from the job centre seems pivotal for the following return-to-work process. The main challenges experienced by sick listed workers were related to the job centre and to being a messenger between job centre and health care, not to their workplace and the decisions made there.

The concept of pulmonary embolism is evolving. Recent and emerging evidence on the treatment of specific patient populations, its secondary prevention, long-term complications, and the unmet need for rehabilitation has the potential to change clinical practice for the benefit of the patients. This review discusses the recent evidence from clinical trials, observational studies, and guidelines focusing on anticoagulation treatment, rehabilitation, emotional stress, quality of life, and the associated outcomes for patients with pulmonary embolism. Guidelines suggest that the type and duration of treatment with anticoagulation should be based on prevalent risk factors. Recent studies demonstrate that an anticoagulant treatment that is longer than two years may be effective and safe for some patients. The evidence for extended treatment in cancer patients is limited. Careful consideration is particularly necessary for pulmonary embolisms in pregnancy, cancer, and at the end of life. The rehabilitation and prevention of unnecessary deconditioning, emotional distress, and a reduced quality of life is an important, but currently they are unmet priorities for many patients with a pulmonary embolism. Future research could demonstrate optimal anticoagulant therapy durations, follow-ups, and rehabilitation, and effective patient-centered decision making at the end of life. A patient preferences and shared decision making should be incorporated in their routine care when weighing the benefits and risks with primary treatment and secondary prevention.

Introduction: To date, there exists no gold standard conservative treatment for lateral hip pain due to tendinopathy of the gluteus medius and/or minimus tendon (GT), a condition often complicated by pain and disability. Higher loads during everyday activities and exercise seems to be contraindicated with GT. The purpose of this study was to evaluate the feasibility of exercise with low-loads concurrent partial blood flow restriction (LL-BFR) and patient education for patients present GT., Methods: Recruitment took place at three hospitals in the Central Denmark Region. The intervention consisted of daily sessions for 8 weeks with one weekly supervised session. From week three patients exercised with applied partial blood flow restriction by means of a pneumatic cuff around the proximal thigh of the affected leg. Throughout the intervention patients received patient education on their hip condition. Sociodemographic and clinical variables were collected at baseline. The feasibility of LL-BFR was conducted by adherence to the exercise protocol and drop-out rate. Patient reported outcome measures (The Victorian Institute of Sport Assessment-Gluteal Questionnaire, EuroQol - 5 Dimensions-Visual Analogue Scale, Oxford Hip Score, Copenhagen Hip and Groin Outcome Score), maximal voluntary isometric hip abduction-, hip extension, and knee extension strength (Nm/kg) measured using a handheld dynamometer, and functional capacity tests (30 second chair-stand test and a stair-climb test) was conducted as secondary outcomes., Results: Sixteen women with a median (IQR) age of 51 (46-60) years were included. Median (IQR) Body Mass Index was 26.69 (23.59-30.46) kg/m2. Adherence to the total number of training sessions and the LL-BFR was 96.4 and 94.4%, respectively. Two patients dropped out due to (i) illness before initiation of LL-BFR and (ii) pain in the affected leg related to the LL-BFR-exercise. At follow-up both pain levels and patient-reported outcome measures improved. Isometric hip abduction-, hip extension-, and knee extension strength on both legs and functional performance increased. Conclusion: LL-BFR-exercise seems feasible for treatment of GT. At follow-up, a high adherence and low drop-out rate were observed. Further, patients reported clinically relevant reductions in pain, and showed significant increases in isometric hip and knee strength., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Høgsholt, Jørgensen, Rolving, Mechlenburg, Tønning and Bohn.)

Objective: To investigate the effects of a group-based cognitive behavioural intervention for patients with persistent low back pain (LBP) and psychological risk factors referred to secondary care., Design: A randomised controlled trial., Setting: Silkeborg Regional Hospital, Denmark., Subjects: A total of 136 participants with chronic LBP and psychological risk factors., Interventions: Participants were randomised to the standard care group, including examination by a rheumatologist and/or a physiotherapist, or the intervention group, including standard care plus a multidisciplinary group-based pain management programme., Main Measures: Patient-reported outcomes were collected at baseline and after 6 and 12 months. The primary outcome was disability (Roland Morris Disability Questionnaire). Secondary outcomes included low back pain intensity, pain catastrophising, health-related quality of life, and sick leave., Results: Among 136 participants, 68 (mean age: 41.7 years (SD 11.8)) were randomised to standard care and 68 (mean age: 46.0 years (SD 10.8)) were randomised to the intervention group. Except for age, baseline characteristics were comparable between groups. 12-month follow-up was completed by 92.6% in the intervention group and 80.9% in the standard care group. Both groups achieved significant improvements on disability, with a reduction of -4.8 points (SD 6.1) in the intervention group compared to -3.7 points (SD 5.2), resulting in an insignificant difference between groups. No significant differences were found in the secondary outcomes., Conclusion: A group-based pain management programme was no more effective than standard care for patients with persistent LBP and psychological risk factors.

Background: International guidelines do not recommend routine imaging, including magnetic resonance imaging (MRI), and seek to guide clinicians only to refer for imaging based on specific indications. Despite this, several studies show an increase in the use of MRI among patients with low back pain (LBP) and an imbalance between appropriate versus inappropriate use of MRI for LBP. This study aimed to investigate to what extent referrals from general practice for lumbar MRI complied with clinical guideline recommendations in a Danish setting, contributing to the understanding and approaches to lumbar MRI for all clinicians managing LBP in the primary sector., Materials and Methods: From 2014 to 2018, all referrals for lumbar MRI were included from general practitioners in the Central Denmark Region for diagnostic imaging at a public regional hospital. A modified version of the American College of Radiology Imaging Appropriateness Criteria for LBP was used to classify referrals as appropriate or inappropriate, based on the unstructured text in the GPs' referrals. Appropriate referrals included fractures, cancer, symptoms persisting for more than 6 weeks of non-surgical treatment, previous surgery, candidate for surgery or suspicion of cauda equina. Inappropriate referrals were sub-classified as lacking information about previous non-surgical treatment and duration., Results: Of the 3772 retrieved referrals for MRI of the lumbar spine, 55% were selected and a total of 2051 referrals were categorised. Approximately one quarter (24.5%) were categorised as appropriate, and 75.5% were deemed inappropriate. 51% of the inappropriate referrals lacked information about previous non-surgical treatment, and 49% had no information about the duration of non-surgical treatment. Apart from minor yearly fluctuations, there was no change in the distribution of appropriate and inappropriate MRI referrals from 2014 to 2018., Conclusion: The majority of lumbar MRI referrals (75.5%) from general practitioners for lumbar MRI did not fulfil the ACR Imaging Appropriateness Criteria for LBP based on the unstructured text of their referrals. There is a need for referrers to include all guideline-relevant information in referrals for imaging. More research is needed to determine whether this is due to patients not fulfilling guideline recommendations or simply the content of the referrals., (© 2022. The Author(s).)

Background: Research is often undertaken using patient-reported outcomes from questionnaires. Achieving a high response rate demands expensive and time-consuming methods like telephone reminders. However, it is unknown whether telephone reminders change outcome estimates or only affect the response rate in research of populations with low back pain (LBP). The aim is to compare baseline characteristics and the change in outcome between patients responding before and after receiving a telephone reminder., Methods: This is an ancillary analysis of data from a prospective cohort study employing questionnaires from 812 adults with LBP lasting more than 3 months. Patients not responding to the 52-week questionnaire were sent reminder emails after two and 3 weeks and delivered postal reminders after 4 weeks. Patients still not responding were contacted by telephone, with a maximum of two attempts. Patients were categorised into three groups: 1) patients responding before a telephone reminder was performed; 2) patients responding after the telephone reminder and 3) patients not responding at all. A positive outcome was defined as a 30% improvement on the Roland Morris Disability Questionnaire after 52 weeks., Results: A total of 695 patients (85.2%) responded. Of these, 643 patients were classified in Group 1 and 52 patients were classified in Group 2. One hundred seventeen were classified in Group 3. No differences in outcome or baseline characteristics was found. In Group 1, 41.3% had a positive outcome, and in Group 2 48.9% had a positive outcome (P = 0.297). In group 3, non-respondents were younger, more often unemployed, more often smokers, more often reported co-morbidity, and reported higher depression scores than respondents., Conclusions: Using a telephone reminder had no consequence on outcome estimates nor were there any differences in baseline characteristics between patients who responded before or after the telephone reminder., Trial Registration: The initial trial was registered in Clinicaltrials.gov ( NCT03058315 )., (© 2021. The Author(s).)

Objective: To present the theoretical foundation and methodological considerations for a group-based pain management programme for patients with persistent non-specific low back pain and psychosocial risk factors., Method: The Template for Intervention Description and Replication (TIDieR) checklist was used as a framework for describing the content, structure and context of the program. The theoretical rationale underlying the pain management programme was described using the first three steps of the Intervention Mapping framework. The Fear-avoidance model and the Self-efficacy Theory were identified as the two main theories. These were used to establish specific factors addressed by the pain management programme as well as expected outcomes., Intervention Description: A multidisciplinary, group-based programme using a cognitive-behavioural approach was developed. The programme consisting of six sessions of two hours duration, took place at a spine clinic at a regional hospital in Denmark. Psychoeducation and cognitive restructuring were specific strategies hypothesised to induce changes in outcome measures. The outcomes expected to change as a result of the intervention were disability, quality of life, sick leave and physical activity. A pilot study was performed, subsequent adjustments made and the final content and educational materials completed by January 2017., Conclusion: The theoretical foundation and underlying evidence for the hypothesised change mechanisms in the use of a cognitive-behavioural approach was presented. A theoretically sound and practically feasible intervention has been developed and its effectiveness is being determined in a randomised controlled trial, including 130 low back pain patients, which is currently underway.

Background: Managing low back pain (LBP) often involves MRI despite the fact that international guidelines do not recommend routine imaging. To allow us to explore the topic and use this knowledge in further research, a reliable method to review the MRI referrals is needed. Consequently, this study aimed to assess the inter-rater reliability of a method evaluating lumbar spine MRI referrals' appropriateness., Methods: Four inexperienced students (chiropractic master's students) and a senior clinician (chiropractor) were included as independent raters in this inter-rater reliability study. Lumbar spine MRI referrals from primary care on patients (> 18 years) with LBP with or without leg pain were included. The referrals were classified using a modified version of the American College of Radiology (ACR) imaging appropriateness criteria for LBP. Categories of appropriate referrals included; fractures, cancer, previous surgery, candidate for surgery or suspicion of cauda equina. Inappropriate referrals included lacking information on previous non-surgical treatment, no word on non-surgical treatment duration, or "other reasons" for inappropriate referrals. After two rounds of training and consensus sessions, 50 lumbar spine MRI referrals were reviewed independently by the five raters. Inter-rater reliability was quantified using unweighted Kappa statistics, and the observed agreement was calculated with both a pairwise comparison and an overall five-rater comparison., Results: Inter-rater reliability was substantial, with a Kappa value for appropriate vs. inappropriate referrals of 0.76 (95% CI: 0.55-0.89). When six and eight subcategories were evaluated, the Kappa values were 0.77 (95% CI: 0.58-0.91) and 0.82 (95% CI: 0.72-0.92), respectively. The overall percentage of agreement for appropriate and inappropriate referrals was 92% and ranged from 88 to 98% for the pairwise comparisons of the five raters' results. For the six and eight subcategories, the overall agreement was 92 and 88%, respectively, ranging from 88 to 98% and 84-92%, respectively, for the pairwise comparisons., Conclusion: The inter-rater reliability of the evaluation of the appropriateness of lumbar spine MRI referrals, according to the modified ACR-appropriateness criteria, was found to range from substantial to almost perfect and can be used for research and quality assurance purposes.

Background: International guidelines on pulmonary embolism (PE) management and rehabilitation have recently been published. However, the contained recommendation about an efficient follow-up strategy after PE is difficult for health care professionals to implement because limited research exists about what strategies are efficient., Objectives: The study aimed to 1) describe and explore perspectives and experiences of health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions., Patients/methods: The study was a multi-method study, nested in a larger randomized controlled trial, combining data from two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention., Results: Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations. In terms of rehabilitation, repeatedly testing physical performance, resuming exercise under the guidance and support of specialized personnel, and access to peer support, were considered important for increasing motivation and self-efficacy for engaging in physical activity again., Conclusions: This study offers suggestions for key elements to include in post-PE management and rehabilitation interventions, as well as the structuring of care. However, research still needs to be undertaken before solid recommendations for the content and structure of successful post-PE management and rehabilitation can be given., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Objective: The aim of the study was threefold: Firstly, to investigate the adherence to clinical practice guidelines for low back pain (LBP) among Danish physiotherapists with regard to three key domains: (a) activity, (b) work and (c) psychosocial risk factors. Secondly, to investigate whether adherence differed between physiotherapists working in private clinics (private physiotherapists) and physiotherapists working at public healthcare centres (public physiotherapists). Thirdly, to describe the physiotherapists' treatment modalities for patients with LBP., Methods: A cross-sectional online survey was conducted with 817 physiotherapists working in the Central Denmark Region. Adherence to the guideline domains was assessed using two vignettes. The difference in adherence between the groups was assessed using the Chi-squared test. Treatment modalities were reported using descriptive statistics., Results: A total of 234 physiotherapists responded, hereof 163 private physiotherapists and 71 public physiotherapists (response rate 29%). The proportions of physiotherapists managing the patients strictly in line with the guideline domains were 32% (activity), 16% (work) and 82% (psychosocial risk factors) for Vignette 1 and 6% (activity), 53% (work) and 60% (psychosocial risk factors) for Vignette 2. Public physiotherapists were more likely to manage patients strictly in line with guidelines for assessing the psychosocial risk factors compared to private physiotherapist (Vignette 1: 92% vs. 77% p = .030; Vignette 2:70% vs. 55% p = .035). Regarding the other two domains, there was no significant difference between the two groups in terms of adherence (p > .05). Concerning treatment modalities, the majority of physiotherapists instructed the patients in adopting an exercise program or informed the patients about the benign nature and prognosis of LBP., Conclusion: Overall, the participating Danish physiotherapists strictly adhered to only one out of three key domains. This underlines the importance of bringing focus on implementing the current guidelines' recommendations in clinical practice., (© 2020 The Authors. Physiotherapy Research International published by John Wiley & Sons Ltd.)

Background: Patients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgical rehabilitation. The primary objective of this randomized controlled trial (RCT) is to examine the effect of an early active intervention consisting of graded activity and pain education (GAPE) on sedentary behaviour in a population of patients undergoing LSF. The secondary objective is to examine the effect of GAPE on disability, pain, fear of movement, self-efficacy for exercise, and health-related quality of life., Methods: The study is an RCT planned to include 144 patients undergoing LSF at 1-2 levels for low back pain caused by degeneration of the lumbar spine. The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of nine individual physiotherapist-guided sessions over a 10-week period. The overall purpose is to reduce sedentary behaviour, by educating the patient about pain and, based on a cognitive behavioural perspective, gradually strengthen the patient's self-efficacy to be physically active and reduce fear of movement. The physiotherapist will plan the intervention in collaboration with the patient. Based on a semi-structured interview and observations of the patient in their home, they will set individually functional goals. The primary outcome will be a reduction in sedentary behaviour, measured by an accelerometer at baseline (pre-surgery) and at 3 and 12 months post-surgery. Secondary outcomes will include disability, pain, fear of movement, self-efficacy for exercise, and quality of life. Secondary outcome data will be collected at baseline (pre-surgery) and at 3, 6 and 12 months post-surgery., Discussion: We hypothesize that, compared with the "usual care group", GAPE will primarily lead to a significant reduction in sedentary behaviour, and secondarily a reduction in disability, pain intensity, and fear of movement; further, it will increase the patient's self-efficacy for exercise and quality of life., Trial Registration: www.clinicaltrials.gov NCT04103970 , Registered on 24 September 2019.

Introduction: Due to increased reporting of presumed side effects following human papilloma virus (HPV) vaccination, the Danish Health Authority established five HPV clinics aiming to improve the diagnostics and treatment of affected women. Here, we aimed to describe characteristics of affected women 1-2 years after they attended an HPV clinic and to explore whether women who believed their symptoms were caused by the HPV vaccine were less likely to report symptom improvement than those who did not., Methods: A hospital-based, cross-sectional study was conducted at the HPV clinic in Silkeborg, 2017-2018. Information on symptoms, HPV vaccination, basic characteristics, etc. was retrieved using a validated questionnaire. Data were analysed descriptively and by logistic regression., Results: A total of 120 women were included. The median age at the first vaccine dose and the first visit to the clinic was 15 years (interquartile range (IQR): 13-23) and 23 years (IQR: 20-27), respectively. The median time from the first visit to the time the questionnaire was completed was 1.3 years (IQR: 1-1.6). At the time of the questionnaire, most women reported a wide range of symptoms, with physical symptoms being more common than psychological symptoms, and 70% of the reported symptoms had not improved over time. Of note, 90% believed that their symptoms were caused by the HPV vaccine. No difference in symptom improvement was found between women who believed that their symptoms occurred because of the HPV vaccine and those who did not., Conclusions: Most women did not experience any improvement in their symptoms over time, and no association was found between lack of symptom improvement and believing that the HPV vaccine was causing the symptoms., Funding: funded by the Danish Cancer Society., Trial Registration: not relevant., (Articles published in the DMJ are “open access”. This means that the articles are distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits any non-commercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.)

Importance: Survivors of acute pulmonary embolism (PE) experience long-term negative physical and mental consequences, but the effects of rehabilitation on outcomes among these patients have not been investigated., Objective: To investigate the effect of a rehabilitation intervention, comprising an 8-week home-based exercise program and nurse consultations, on physical capacity and patient-reported outcomes among patients with acute PE., Design, Setting, and Participants: This multicenter randomized clinical superiority trial was conducted at 4 regional hospitals and 1 university hospital in Denmark. The 140 consecutively included participants had been diagnosed with an acute PE between April 2016 and February 2018 and had 6 months of follow-up. An intention-to-treat analysis was conducted., Intervention: Patients in the control group received a brief nurse consultation, while patients in the exercise group participated in an 8-week home-based exercise program in addition to receiving nurse consultations., Main Outcomes and Measures: The primary outcome was the Incremental Shuttle Walk Test, and secondary outcomes were the Pulmonary Embolism Quality of Life and the EuroQol-5 Dimensions-3 Levels questionnaires, self-reported number of sick-leave days, and self-reported use of psychotropic drugs., Results: A total of 140 patients (90 [64.3%] men) were included, with a mean (SD) age of 61 (11) years. Of 70 participants (50.0%) randomized to each group, 69 participants (49.3%) received the intervention and 68 (48.6%) received the control intervention. Both groups achieved improvements in all outcomes (eg, mean [SD] improvement on Incremental Shuttle Walk Test: control group, 78 (127) m; intervention group, 104 [106] m; median [interquartile range] improvement on Pulmonary Embolism Quality of Life: control group, -17 [-22 to -11] points; intervention group, -20 [-24 to -15] points). Between-group differences were nonsignificant. The mean differences between the intervention group and the control group were 25 m (95% CI, -20 to 70 m; P = .27) on the Incremental Shuttle Walk Test, 3.0 points (95% CI, -3.7 to 9.9 points; P = .39) on the Pulmonary Embolism Quality of Life questionnaire, and 0.017 point (95% CI, -0.032 to 0.065 point; P = .50) on the EuroQol-5 Dimensions-3 Levels questionnaire. Of the 27 patients in the intervention group on sick leave at baseline, 24 (88.9%) reported fit-for-duty at the 6-month follow-up, and of 18 patients in the control group on sick leave, 17 (94.4%) reported fit-for-duty at the 6-month follow up. The between-group risk difference was not significant (5.5 points; P = .49)., Conclusions and Relevance: An 8-week rehabilitation intervention with exercise added to nurse consultations did not show significantly better outcomes than nurse consultations alone. However, because of a ceiling effect on the primary outcome of physical capacity and an inclusion of patients with a low comorbidity burden and low PE disease severity, definitive conclusions could not be drawn. Initiating an exercise intervention shortly after pulmonary embolism was safe and without adverse events., Trial Registration: ClinicalTrials.gov Identifier: NCT02684721.

Background: According to clinical guidelines, advice to stay active despite experiencing pain is recommended to patients with non-specific low back pain (LBP). However, not all patients receive guideline-concordant information and advice, and some patients still believe that activity avoidance will help them recover. The purpose was to study whether guideline-concordant beliefs among patients and other explanatory variables were associated with recovery. The main aim was to investigate whether believing staying active despite having pain is associated with a better functional outcome., Methods: This was a prospective cohort study involving adults with non-specific LBP referred from general practices to the Spine Centre at Silkeborg Regional Hospital, Denmark. Patients reported on their beliefs about the importance of finding the cause, the importance of diagnostic imaging, perceiving to have received advice to stay active, pain duration, pain intensity, and STarT Back Tool. Agreeing to: 'An increase in pain is an indication that I should stop what I'm doing until the pain decreases' adjusted for age, gender, and education level was the primary explanatory analysis. A 30% improvement in the Roland Morris Disability Questionnaire (RMDQ) score after 52 weeks was the outcome., Results: 816 patients were included and 596 (73.0%) agreed that pain is a warning signal to stop being active. Among patients not considering pain as a warning signal, 80 (43.2%) had a favourable functional improvement of ≥30% on the RMDQ compared to 201 (41.2%) among patients considering pain a warning signal. No difference was found between the two groups (adjusted P = 0.542 and unadjusted P = 0.629). However, STarT Back Tool high-risk patients had a less favourable functional outcome (adjusted P = 0.003 and unadjusted P = 0.002). Chronic pain was associated with less favourable functional outcome (adjusted P < 0.001 and unadjusted P < 0.001), whereas beliefs about finding the cause, diagnostic imaging, perceiving to have received advice to stay active, or pain intensity were not significantly associated with outcome., Conclusions: Holding the single belief that pain is a warning signal to stop being active was not associated with functional outcome. However, patients characterised by having multiple psychological barriers (high-risk according to the STarT Back Tool) had a less favourable functional outcome., Trial Registration: Registered at ClinicalTrials.gov (registration number: NCT03058315), 20 February 2017.

Purpose: To investigate whether treatment by lactic acid bacteria for 100 days is associated with change of disability and pain in chronic low back pain (CLBP) patients with type 1 or mixed Modic changes (MC) during 1-year follow-up., Methods: Eighty-nine patients with CLBP and type 1 MC or mixed MC were randomized to receive either one capsule Lactobacillus Rhamnosis GG (6 billion colony-forming unit per capsule) twice daily or placebo capsules for 100 days., Results: Missing values at 1 year were 4% and 3% in the disability and pain variables, respectively. The predefined outcomes disability and back + leg pain only changed little during follow-up with no statistically significant differences between groups. At 1 year, back pain had on average decreased by 1.1 more on a 0-10 scale (95% confidence interval 0.20-1.97) in the group treated by lactic acid bacteria than in the control group. There were no differences regarding other predefined outcomes, i.e. global effect or percentage with minimal disability at 1 year. Nine per cent of the patients reported gastrointestinal side effects without difference between groups., Conclusions: No differences were found regarding the predefined outcomes. Overall, there was little improvement during the 1-year observation period. A small, though hardly clinically relevant, effect on back pain was seen after treatment by Lactobacillus Rhamnosis GG, and the treatment was without side effects in comparison with the control group.

Introduction: There is an increasing awareness that patients with acute pulmonary embolism (APE) suffer long-term consequences like fatigue, anxiety, and reduced physical capacity. However, we lack knowledge on how patients manage everyday life and physical activity following an APE. The study aimed to explore how patients experience and cope with daily life and physical activity in the first year following an APE., Materials and Methods: Semi-structured individual interviews were performed with 16 patients, 6-12 months after a first-time APE event. The methodological framework for the analysis was interpretive description., Results: Most participants had managed to return to their daily routines at the time of the interview, although some struggled more than others. They experienced their daily life and well-being to be negatively affected by fatigue, anxious thoughts and bodily hypervigilance, and were concerned about themselves, their family, friends and life situation. In many cases, they lacked advice from health professionals. Participants used various strategies for re-engaging in everyday life and physical activities, reflecting their physical and mental resources, contextual support, and different life situation. One central theme was the challenge of coming to terms with a more vulnerable identity, and adjusting this identity to established family and work roles., Conclusions: Most participants had managed to resume their everyday life 6-12 months after the APE event, but were still limited in their daily activities and found it difficult to sustain a sufficient level of physical activity. They described different barriers and facilitators, which should be addressed in future rehabilitation interventions., (Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The existing evidence base in pulmonary embolism (PE) is primarily focused on diagnostic methods, medical treatment, and prognosis. Only a few studies have investigated how everyday life is affected by PE, although many patients are negatively affected both physically and emotionally after hospital discharge. Currently, no documented rehabilitation options are available for these patients. We aim to examine whether an 8-week home-based exercise intervention can influence physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients medically treated for PE., Methods: One hundred forty patients with incident first-time PE will be recruited in five hospitals. After inclusion, patients will be randomly allocated to either the control group, receiving usual care, or the intervention group, who will be exposed to an 8-week home-based exercise program in addition to usual care. The intervention includes an initial individual exercise planning session with a physiotherapist, leading to a recommended exercise program of a minimum of three weekly training sessions of 30-60 minutes' duration. The patients have regular telephone contact with the physiotherapist during the 8-week program. At the time of inclusion, after 2 months, and after 6 months, the patients' physical capacity is measured using the Incremental Shuttle Walk test. Furthermore the patients' quality of life, sick leave, and use of psychotropic drugs is measured using self-reported questionnaires. In both randomization arms, all follow-up measurements and visits will take place at the hospital from which the patient was discharged. Levels of eligibility, consent, adherence, and retention will be used as indicators of study feasibility., Discussion: We expect that the home-based exercise program will improve the physical capacity and quality of life for the patients in the intervention group. The study will furthermore contribute significantly to the limited knowledge about the optimal rehabilitation of PE patients, and may thereby form the basis of future recommendations in this field., Trial Registration: ClinicalTrials.gov, NCT02684721 . Registered on 20 January 2016.

Background: Patients receiving lumbar spinal fusion surgery often have persisting postoperative pain negatively affecting their daily life. These patients may be helped by interdisciplinary cognitive-behavioral therapy which is recognized as an effective intervention for improving beneficial pain coping behavior, thereby facilitating the rehabilitation process of patients with chronic pain., Purpose: The purpose of this study was to describe the lived experience of patients recovering from lumbar spinal fusion surgery and to explore potential similarities and disparities in pain coping behavior between receivers and nonreceivers of interdisciplinary cognitive-behavioral group therapy., Methods: We conducted semistructured interviews with 10 patients; 5 receiving cognitive-behavioral therapy in connection with their lumbar spinal fusion surgery and 5 receiving usual care. We conducted a phenomenological analysis to reach our first aim and then conducted a comparative content analysis to reach our second aim., Results: Patients' postoperative experience was characterized by the need to adapt to the limitations imposed by back discomfort (coexisting with the back), need for recognition and support from others regarding their pain, a relatively long rehabilitation period during which they "awaited the result of surgery", and ambivalence toward analgesics. The patients in both groups had similar negative perception of analgesics and tended to abstain from them to avoid addiction. Coping behavior apparently differed among receivers and nonreceivers of interdisciplinary cognitive-behavioral group therapy. Receivers prevented or minimized pain by resting before pain onset, whereas nonreceivers awaited pain onset before resting., Conclusion: The postoperative experience entailed ambivalence, causing uncertainty, worry and insecurity. This ambivalence was relieved when others recognized the patient's pain and offered support. Cognitive-behavioral therapy as part of rehabilitation may have encouraged beneficial pain coping behavior by altering patients' pain perception and coping behavior, thereby reducing adverse effects of pain.

HPV vaccination offers protection against ~70% of cervical cancers, however, serious concerns have been raised about the possible side effects from HPV vaccination. Studies have found no increased risk of neurologic disease, autoimmune disorder, thromboembolic disease, postural orthostatic tachycardia syndrome, or complex regional pain syndrome in HPV-vaccinated persons compared to unvaccinated persons. Affected individuals should undergo a proper clinical examination to ensure a correct diagnosis and treatment, because symptoms might arise due to a somatic, psychiatric or functional disorder.

Background: Catastrophic thinking and fear-avoidance belief are negatively influencing severe acute pain following surgery causing delayed ambulation and discharge. We aimed to examine if a preoperative intervention of cognitive-behavioural therapy (CBT) could influence the early postsurgical outcome following lumbar spinal fusion surgery (LSF)., Methods: Ninety patients undergoing LSF due to degenerative spinal disorders were randomly allocated to either the CBT group or the control group. Both groups received surgery and postoperative rehabilitation. In addition, the CBT group received a preoperative intervention focussed on pain coping using a CBT approach. Primary outcome was back pain during the first week (0-10 scale). Secondary outcomes were mobility, analgesic consumption, and length of hospitalisation. Data were retrieved using self-report questionnaires, assessments made by physical therapists and from medical records., Results: No difference between the groups' self-reported back pain (p = 0.76) was detected. Independent mobility was reached by a significantly larger number of patients in the CBT group than the control group during the first three postoperative days. Analgesic consumption tended to be lower in the CBT group, whereas length of hospitalisation was unaffected by the CBT intervention., Conclusion: Participation in a preoperative CBT intervention appeared to facilitate mobility in the acute postoperative phase, despite equally high levels of self-reported acute postsurgical pain in the two groups, and a slightly lower intake of rescue analgesics in the CBT group. This may reflect an overall improved ability to cope with pain following participation in the preoperative CBT intervention., Trial Registration: The study was approved by the Danish Protection Agency (2011-41-5899) and the Ethics Committee of the Central Denmark Region (M-20110047). The trial was registered in Current Controlled Trials ( ISRCTN42281022 ).

Study Design: A cost-effectiveness analysis conducted alongside a randomized clinical trial., Objective: To assess the cost-effectiveness of a preoperative cognitive-behavioral therapy (CBT) intervention compared to usual care for patients undergoing lumbar spinal fusion surgery (LSF)., Summary of Background Data: The clinical effectiveness of a preoperative CBT intervention for patients undergoing LSF has been investigated in a randomized clinical trial. Economic evaluation is however essential for decision makers to make informed choices regarding allocation of scarce resources., Methods: 90 patients undergoing LSF were randomly allocated to usual care (control group) or usual care plus a preoperative CBT intervention (CBT group). Outcome parameters included quality-adjusted life years (QALY), based on the EQ-5D, and pain-related disability, based on the Oswestry disability index (ODI). Health care use and productivity loss were estimated from national registers., Results: One year after LSF the estimated QALY was significantly better for the CBT group with 0.710 (95% CI 0.670; 0.749) versus 0.636 (95% CI 0.5573; 0.687). For the ODI, the CBT group reported significantly larger disability reductions at 3 months (P = 0.003) and 6 months (P = 0.047), but not at 1 year (P = 0.082). There was no difference in the overall costs of the two groups (-€89 (95% CI -12,080; 11,902)), leading to a 70% probability of the CBT intervention being cost-effective at a willingness-to-pay of €40,000 for one additional QALY. For an additional gain of 15 ODI points the probability was 90% at a threshold of €10,000. These results remained largely unaffected by relevant sensitivity analyses, confirming the robustness of findings., Conclusion: Preoperative CBT appears to be more effective and cost neutral when considering the overall health care sector and labor market perspective, supporting the implementation of preoperative CBT in the course of treatment for LSF surgery in a Danish context.