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ObjectivePatient-reported outcome measures are essential for assessing health-related quality of life (HRQoL) in both research and clinical practice. The Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire is a disease-specific instrument designed to measure HRQoL in patients with pulmonary embolism (PE). This study aimed to evaluate the psychometric properties of the Danish electronic version of the PEmb-QoL questionnaire.DesignPsychometric validation study.SettingEligible patients received a digital mail 6 months after their diagnosis, with an invitation to complete an online questionnaire. A subset of patients completed a second time 7–10 days following the initial completion.ParticipantsAdult patients diagnosed with PE in Denmark between March 2022 and May 2023 were included in the study.Main outcome measureThe main outcome measure was the PEmb-QoL summary score. Validation procedures included assessments of targeting, internal reliability (IR), test–retest reliability, differential item functioning (DIF) and concurrent validity.ResultsThe study included 1017 patients. The Danish PEmb-QoL demonstrated robust IR (IR=0.95 for the total score) and adequate test–retest reliability for most domains (relative G-coefficients>0.7). However, DIF analysis revealed subgroup differences for some items, particularly those related to daily activity limitations and pain. Targeting analysis indicated moderate alignment between latent score distributions and item response distributions, with ceiling effects noted in several domains. The PEmb-QoL exhibited strong correlations with the Post-Venous Thromboembolism Functional Status Scale (r=0.82) and EuroQol-5 Domain (r=0.73), and moderate correlations with Generalised Anxiety Disorder Questionnaire (r=0.47) and Patient Health Questionnaire (r=0.57), confirming its concurrent validity.ConclusionWhile some items in the PEmb-QoL instrument performed inadequately on DIF and targeting, the expected overall score and the concurrent validity did not seem to be compromised by these issues. Thus, it is likely that a reduced version of the electronic Danish PEmb-QoL will possess suitable psychometric properties for measuring HRQoL in patients with PE.

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.

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 ).

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.

IntroductionPatients with pulmonary embolism (PE) experience impaired functional ability and reduced quality of life long after discharge from the hospital. However, there are no structured follow-up programmes in Denmark for these patients, and there is considerable variation in practice patterns of post-PE management. No studies have investigated the effectiveness of structured follow-up care models in patients with PE. This study aims to investigate the effect and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE) compared with usual care. The Attend-PE model outlines a structured approach for in-hospital follow-up, involving group-based patient education, individual consultations and systematic use of patient-reported outcome measures to assess the patient’s physical and psychological well-being.Methods and analysisThe study is conducted in Denmark, where the healthcare system is tax-funded and services are freely available for all citizens, with an expected inclusion of 2000 patients in total. A pre-post-intervention study design is used to compare outcomes in the post-implementation cohort with the pre-implementation cohort. The co-primary outcomes are (1) health-related quality of life (patient-reported outcome, PRO) and (2) adherence to medical treatment (register-based data). Secondary outcomes include PROs on disability, treatment satisfaction, self-management, anxiety, depression and work productivity, and register-based outcomes, including recurrent PE, bleeding, mortality and healthcare use. Register-based data will be assessed at baseline (date of PE event), 6 and 12 months, while PRO-data will be assessed at 6 and 12 months after the PE event. The health economic evaluation of the Attend-PE model will include a cost-effectiveness analysis and a cost-utility analysis.Ethics and disseminationThe project will be conducted by the Declaration of Helsinki. In accordance with the Danish Act on Health Research Ethics §14, the study is exempt from approval. The use of survey responses in research (in anonymous form) is, however, contingent on participants’ consent, and the invitation letter therefore included information about the purpose of the study and participants’ rights to withdraw consent at any time, and that completion of the questionnaire is considered as consent to their survey data to be included in research.Study findings will be disseminated in scientific peer-reviewed journals, at national and international conferences, and for staff and decision-makers at participating hospitals and patients and relatives via the Danish Heart Association.Trial registration numberClinicaltrials.gov NCT06037096.

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.

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

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.

Background Low back pain (LBP) is the primary contributor to disability worldwide, leading to a significant healthcare burden. Implementing evidence-based practice (EBP) can reduce this burden, as healthcare professionals (HCPs) working evidence-based reduce the number of treatments, the use of imaging and medication compared to HCPs not working evidence-based. Clinical practice guidelines have been published to help HCPs implement research evidence into practice. Unfortunately, studies have consistently shown a lack of adherence to guidelines in LBP care. This study aimed to investigate the implementation outcomes of a tailored programme for implementing key recommendations from LBP guidelines among Danish physiotherapists and chiropractors working in primary care. Methods This study was conducted as a 'pre-post' implementation study among 80 physiotherapists and chiropractors from 15 primary care clinics. The implementation object was the two key guideline recommendations: 1) screening of psychosocial risk factors and 2) patient education, including reassuring information. The programme comprised multipronged strategies and was designed as a step-by-step implementation process comprising 16 hours of activities distributed over 16 weeks. Adoption was measured as changes in self-reported behaviour and perceptions of the professional role and culture from baseline to follow-up at 16 weeks. Acceptability and appropriateness of the programme were measured weekly using a four-point Likert scale. Feasibility was measured at 16-week follow-up using a five-point Likert scale. Fidelity was measured as the number of strategies and implementation support delivered as planned and registered by the research team. Results An increase in the adoption of screening of psychosocial factors and offering patient education, including reassuring information, was seen in 38% and 33% of participants, respectively. Most participants reported that the programme was partly or overall acceptable and appropriate. The feasibility of the implementation programme was assessed as moderate to high, and the fidelity of the implementation programme was determined as high. Conclusion The tailored implementation programme enhanced the adoption of the guidelines and changed the participants’ professional identity and culture. Most participants found the programme partly or overall acceptable and appropriate. The programme was feasible, but the perspective requires refinements, as most participants rated it moderately feasible. Trial registration Central Denmark Region, Registered November 11, 2021, act no. 1–16-02–93-19.

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.