Involvement of patients in the research process.

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.

The Effect of Graded Activity and Pain Education After Lumbar Spinal Fusion on Sedentary Behavior 3 and 12 Months Postsurgery: A Randomized Controlled Trial.

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.

Developing a low back pain guideline implementation programme in collaboration with physiotherapists and chiropractors using the Behaviour Change Wheel: a theory-driven design study.

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.

A novel referral strategy to enhance the enrollment of patients with heart failure in cardiac rehabilitation: A feasibility study.

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.

Performance-based outcome measures for assessing physical capacity in patients with pulmonary embolism: A scoping review.

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.

Electronic adaptation and danish cross-cultural translation of PEmb-QoL and VEINES-QoL/Sym for patients with venous thromboembolism.

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.

Comparison of important factors to patients recovering from pulmonary embolism and items covered in patient-reported outcome measures: A mixed-methods systematic review.

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.

Guideline adherence and socioeconomic factors in Danish patients referred to secondary care for low back pain: a cross sectional study.

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.

Navigating between stakeholders in return-to-work processes: A qualitative study exploring experiences of workers on sick leave due to back pain.

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.

Physiotherapists' prognosis of 1-year outcome after lumbar spinal fusion - A prospective cohort study.

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 (R2 ≤ 0.09). There was no significant association between the PTs' prognosis and the patients' SSO (p = .17; R2 = 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.

Barriers to the use of clinical practice guidelines: a qualitative study of Danish physiotherapists and chiropractors.

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.

It is important that physiotherapists and chiropractors reflect on what constitutes their core task and professional identity if the implementation of the biopsychosocial model is to be successful.To overcome the barrier of scepticism towards guidelines, the applicability of the guidelines could be improved by elaborating on how the recommendations could be individualised.It is important to incorporate the biopsychosocial model into the programs of educational institutions and provide training to improve those skills in physiotherapists and chiropractors.

Long-Term Management of Pulmonary Embolism: A Review of Consequences, Treatment, and Rehabilitation.

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.

Exercise With Low-Loads and Concurrent Partial Blood Flow Restriction Combined With Patient Education in Females Suffering From Gluteal Tendinopathy: A Feasibility Study.

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.

Appropriateness of referrals from primary care for lumbar MRI.

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.

Does group-based cognitive therapy improve functional ability, pain, catastrophic thoughts and quality of life in patients with persistent low back pain and psychological risk factors? A randomised controlled trial in a secondary care setting.

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.

Does the use of telephone reminders to increase survey response rates affect outcome estimates? An ancillary analysis of a prospective cohort study of patients with low back pain.

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 ).

Categorisation of lumbar spine MRI referrals in Denmark as compliant or non-compliant to international imaging guidelines: an inter-rater reliability study.

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.

Description of content, structure and theoretical model of a group-based pain management programme in the treatment of patients with persistent non-specific low back pain and psychological risk factors in a secondary sector setting.

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.

General Practitioner Attendance in Proximity to HPV Vaccination: A Nationwide, Register-Based, Matched Case-Control Study.

AIM: 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.

The effect of graded activity and pain education (GAPE): an early post-surgical rehabilitation programme after lumbar spinal fusion-study protocol for a randomized controlled trial.

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.