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Background: Eight percent of all child and adolescent general practice consultations are due to musculoskeletal conditions, with pain as the most frequent symptom. Despite the commonality of musculoskeletal pain, limited knowledge exists about care-seeking children and adolescents with musculoskeletal pain. The purpose of this study was to describe characteristics of children and adolescents consulting their general practitioner with musculoskeletal pain. Methods: This is a cross-sectional study based on baseline data from the child and adolescent musculoskeletal pain cohort study (ChiBPS), carried out in 17 Danish general practice clinics. Patients aged 8–19 years who had musculoskeletal pain when consulting their general practitioner were recruited. Participants completed a questionnaire on demographics, physical activity, pain impact, psychosocial factors, and expectations of their general practitioner. Descriptive statistics were used to summarize data. Normally distributed continuous data were described using mean and standard deviation while non-normally data were described using median and interquartile range (IQR). Results: We included 100 participants (54% female, median age 13 [IQR: 12–16.5 years]). Frequent pain sites limiting activity were knee (56%), back (20%), ankle (19%), and neck (13%). Most participants (63%) consulted their general practitioner due to inability to use their body as usual, due to pain. Median pain duration at consultation was 5 months [IQR: 3 weeks-1 year]. More than a third were often/sometimes nervous (34%), worried or anxious (33%), and took pain medication (33%). Pain impeded ability to participate in sport activities at school (79%) and disturbed spare time activities (88%). Pain also made it difficult to concentrate for 58%, and to fall asleep for 38%. Only 38% expected a pain free long-term future. Conclusion: This study demonstrates the bio-psycho-social impact of musculoskeletal pain in care-seeking children and adolescents. Demographics, pain characteristics, psychosocial characteristics, and physical characteristics should be included in addressing children and adolescents with musculoskeletal pain. Trial registration: The ChiBPS study was pre-registered before participant recruitment (ClinicalTrials.gov Identifier: NCT03678922) date: 09.20.18. [ABSTRACT FROM AUTHOR]

Background: The use of antibiotics is a key driver of antimicrobial resistance and is considered a major threat to global health. In Denmark, approximately 75% of antibiotic prescriptions are issued in general practice, with acute lower respiratory tract infections (LRTIs) being one of the most common indications. Adults who present to general practice with symptoms of acute LRTI often suffer from self-limiting viral infections. However, some patients have bacterial community-acquired pneumonia (CAP), a potential life-threatening infection, that requires immediate antibiotic treatment. Importantly, no single symptom or specific point-of-care test can be used to discriminate the various diagnoses, and diagnostic uncertainty often leads to (over)use of antibiotics. At present, general practitioners (GPs) lack tools to better identify those patients who will benefit from antibiotic treatment. The primary aim of the PLUS-FLUS trial is to determine whether adults who present with symptoms of an acute LRTI in general practice and who have FLUS performed in addition to usual care are treated less frequently with antibiotics than those who only receive usual care. Methods: Adults (≥ 18 years) presenting to general practice with acute cough (< 21 days) and at least one other symptom of acute LRTI, where the GP suspects a bacterial CAP, will be invited to participate in this pragmatic randomized controlled trial. All participants will receive usual care. Subsequently, participants will be randomized to either the control group (usual care) or to an additional focused lung ultrasonography performed by the GP (+ FLUS). The primary outcome is the proportion of participants with antibiotics prescribed at the index consultation (day 0). Secondary outcomes include comparisons of the clinical course for participants in groups. Discussion: We will examine whether adults who present with symptoms of acute LRTI in general practice, who have FLUS performed in addition to usual care, have antibiotics prescribed less frequently than those given usual care alone. It is highly important that a possible reduction in antibiotic prescriptions does not compromise patients' recovery or clinical course, which we will assess closely. [ABSTRACT FROM AUTHOR]

The aim of the study was to describe changes in postoperative fatigue, quality of life, physical performance, and body composition in patients undergoing laparoscopic colonic cancer surgery. Material and methods. In a follow-up study from 2009-2011 at two regional hospitals in Denmark we examined 62 patients having a right hemicolectomy ora sigmoid resection performed. The main outcome measures were fatigue level subjectively scored from 1 ('fit') to 10 ('fatigued') on a modified visual analogue scale and by objective measurements of hand grip and knee extension strength, work capacity, weight, and lean body mass. Quality of life was assessed using the SF-36 questionnaire and pain using an ordinal scale. Patients were examined preoperatively, 1-2 and 4 weeks postoperatively. Results. Eight patients (13%) were converted to open surgery and the median bleeding (95% confidence interval of the median) was 75 (50-100) ml. One to two weeks after surgery the fatigue level and pain when moving had increased significantly (p=0.0011 and p=0.0002 respectively) and the SF-36 physical component quality of life score decreased (p<0.0001) when compared to preoperatively. However, at 4 weeks postoperatively fatigue level, pain, and quality of life scores were at the preoperative level. There were no significant changes from preoperatively to postoperatively in any of the measures of physical performance, whereas there was a slight reduction in weight and lean body mass after the operation. Conclusions. Laparoscopic colonic cancer surgery was associated with a short lasting increased fatigue and pain and reduced quality of life, but no significant reduction in physical performance after surgery. [ABSTRACT FROM AUTHOR]

Background: Artificial intelligence (AI) is increasingly used to support general practice in the early detection of disease and treatment recommendations. However, AI systems aimed at alleviating time-consuming administrative tasks currently appear limited. This scoping review thus aims to summarize the research that has been carried out in methods of machine learning applied to the support and automation of administrative tasks in general practice. Methods: Databases covering the fields of health care and engineering sciences (PubMed, Embase, CINAHL with full text, Cochrane Library, Scopus, and IEEE Xplore) were searched. Screening for eligible studies was completed using Covidence, and data was extracted along nine research-based attributes concerning general practice, administrative tasks, and machine learning. The search and screening processes were completed during the period of April to June 2022. Results: 1439 records were identified and 1158 were screened for eligibility criteria. A total of 12 studies were included. The extracted attributes indicate that most studies concern various scheduling tasks using supervised machine learning methods with relatively low general practitioner (GP) involvement. Importantly, four studies employed the latest available machine learning methods and the data used frequently varied in terms of setting, type, and availability. Conclusion: The limited field of research developing in the application of machine learning to administrative tasks in general practice indicates that there is a great need and high potential for such methods. However, there is currently a lack of research likely due to the unavailability of open-source data and a prioritization of diagnostic-based tasks. Future research would benefit from open-source data, cutting-edge methods of machine learning, and clearly stated GP involvement, so that improved and replicable scientific research can be done. [ABSTRACT FROM AUTHOR]

Background: Spotting and light vaginal bleeding are common and usually harmless symptoms in early pregnancy. Still, vaginal bleeding may be the first sign of an abortion and often causes distress to pregnant women and leads to an expectation of an ultrasonography examination of the uterus. As point-of-care ultrasonography (POCUS) is increasingly being integrated into general practice, these patients may be clinically evaluated and managed by general practitioners (GPs). This can potentially reduce referrals of patients from the primary to the secondary healthcare sector resulting in societal cost-savings. The primary purpose of this study was to investigate whether the accessibility of POCUS in general practice for patients with vaginal bleeding in early pregnancy is cost-saving compared to usual practice where GPs do not have access to POCUS. A secondary purpose of this study was to estimate a remuneration for GPs performing POCUS on these patients in general practice.Methods: A cost-minimisation analysis was based on a decision tree model reflecting the two alternatives: general practice with and without GPs having access to POCUS. The robustness of the model results was investigated using probabilistic sensitivity analysis and the following deterministic sensitivity analyses: one-way analyses for the model input parameters and a scenario analysis with a change from a societal to a healthcare sector perspective. An expected remuneration reflecting the add-on cost of Danish GPs performing POCUS was estimated based on the related costs: cost of an ultrasonography scanner, GP's time consumption, ultrasonography training, and utensils per scanning.Results: The difference in average cost between the two alternatives from a societal perspective was estimated to be €110, in favour of general practice with GPs using POCUS. The deterministic sensitivity analyses demonstrated robustness of the results to plausible changes in the input parameters. The expected remuneration for performing POCUS in this specific setting was estimated to be €32 per examination.Conclusion: Having GPs perform POCUS on patients with vaginal bleeding in early pregnancy is cost-saving compared to usual practice. The results should be taken with caution as this study was based on early modelling with uncertainties associated with the input parameters in the model. [ABSTRACT FROM AUTHOR]

To explore the perspectives of general practitioners (GPs) on facilitators and barriers in diagnosing rheumatoid arthritis (RA). Qualitative study based on focus group interviews, and using latent thematic analysis. General practices from Central Region Denmark. Eleven GPs participated in three different focus groups. Forty percent were female, the mean age was 53 years (range 37–64), and the mean since medical licensing was 16 years (range 5–23). Sixty percent of the GPs worked in an area served by a university hospital, and 40% were served by a regional hospital. Themes describing experiences and reflections about facilitators and barriers in diagnosing Rheumatoid Arthritis. Four themes emerged: (A) If the patient is not a textbook example, (B) The importance of maintaining the gatekeeper function, (C) Difficulties in referral of patients to the rheumatologist, and (D) Laboratory tests—can they be trusted? Barriers were identified in all themes, but facilitators only in A, C, and D. The overarching theme was Like finding a needle in a haystack. The GPs found several barriers for diagnosing RA (symptom awareness, GP's gatekeeper function, suboptimal collaboration with rheumatologists and limitations in laboratory tests). They identified education, more specific tests and better access to rheumatologists as possible facilitators for diagnosing RA. To facilitate earlier referral of suspected RA in general practice and strengthen mutual information and collaboration, future research should focus on these facilitators and barriers. Early diagnosis is essential for the prognosis of RA, and the diagnostic process begins in general practice. Suggested facilitators: training courses in interpretation of laboratory tests and the clinical manifestation of RA, and videos on joint examinations. Suggested barriers: compliance with the gatekeeper function, suboptimal collaboration with rheumatologists, limitations of laboratory tests, and diversity of clinical manifestations. [ABSTRACT FROM AUTHOR]

Isometric exercise is commonly recommended for immediate pain relief in individuals suffering from lower limb tendinopathies, despite the limited evidence supporting its analgesic effect. Due to the similarities between plantar fasciopathy and tendinopathies, the aim of this trial was to investigate the acute effect of isometric exercise on pain, compared to isotonic exercise, or walking, in individuals with plantar fasciopathy. We recruited 20 individuals with plantar fasciopathy for this prospectively‐registered, participant‐blinded, randomized, superiority crossover trial (ClinicalTrials.gov: NCT03264729). Participants attended three exercise sessions (isometric, isotonic, or walking) in a randomized order, within a 2‐week period. Both isometric and isotonic exercises were performed standing with the forefoot on a step bench, while walking was performed barefoot. The primary outcome was pain (measured on a 0‐100‐mm VAS) during a pain‐aggravating activity. Secondary outcomes included pressure pain threshold (PPT) under the heel, and plantar fascia thickness (PFT). All outcomes were measured before and after each exercise session. There were no significant differences between the three exercises on pain (P = 0.753), PPTs (P = 0.837), or PFT (P = 0.718). Further, there was no change in pain from before to after any of the exercises (isometric exercise 2.7 mm [95% CI: −12.2; 6.8], isotonic exercise −3.4 mm [95% CI: −5.0; 11.8], or walking 1.6 mm [95% CI: −16.1; 12.9]). Contrary to expectations, isometric exercise was no better than isotonic exercise or walking at reducing pain in individuals with plantar fasciopathy. None of the exercises induced any systematic analgesic effect. [ABSTRACT FROM AUTHOR]

Background: Due to more elderly and patients with complex illnesses, there is an increasing pressure on the healthcare system. General practice especially feels this pressure as being the first point of contact for the patients. Developments in digitalization have undergone fast progress and data-driven artificial intelligence (AI) has shown great potential for use in general practice. To develop AI as a support tool for general practitioners (GPs), access to patients' health data is needed, but patients have concerns regarding data sharing. Furthermore, studies show that trust is important regarding the patient-GP relationship, data sharing, and AI. The aim of this paper is to uncover patient perspectives on trust regarding the patient-GP relationship, data sharing and AI in general practice. Method: This study investigated 10 patients' perspectives through qualitative interviews and written vignettes were chosen to elicit the patients (interviewees) perspectives on topics that they were not familiar with prior to the interviews. The study specifically investigated perspectives on 1) The patient-GP relationship, 2) data sharing regarding developing AI for general practice, and 3) implementation and use of AI in general practice using thematic analysis. The study took place in the North Denmark Region and the interviewees included had to be registered in general practice and be above 18 years in age. We included four men between 25 to 74 years in age and six women between 27 to 46 years in age. Results: The interviewees expressed a high level of trust towards their GP and were willing to share their health data with their GP. The interviewees believed that AI could be a great help to GPs if used as a support tool in general practice. However, it was important for the interviewees that the GP would still be the primary decision maker. Conclusion: Patients may be willing to share health data to help implement and use AI in general practice. If AI is implemented in a way that preserves the patient-GP relationship and used as a support tool for the GP, our results indicate that patients may be positive towards the use of AI in general practice. [ABSTRACT FROM AUTHOR]

Introduction: Variable eligibility criteria across studies on plantar heel pain may result in compromising the generalisability of meta-analyses when heterogeneity is not accounted for. We aimed to explore: (i) heterogeneity of participant eligibility criteria in studies that have investigated plantar heel pain, and (ii) associations between key eligibility criteria and the characteristics of the participants included in the study. Methods: In this systematic review with narrative synthesis, we extracted participant eligibility criteria, and participants' age, body mass index (BMI), symptom duration and pain level from published studies on plantar heel pain. We performed a content analysis of criteria and aligned overarching criteria to the International Classification of Functioning, Disability and Health (ICF). We pooled studies that used the same thresholds for participant eligibility criteria into sub-groups. We also pooled and reported studies that did not have any eligibility criteria for the quantitative characteristics to use their data for reference values and pooled studies that did not have any eligibility criteria for the characteristics as reference. Results: Two hundred and fourteen articles were included. The most reported participant eligibility criteria (as aligned to the ICF) related to body structures/function and personal factors. Age, BMI, symptom duration and pain level were used with various ranges and/or thresholds across studies (age was reported in 23 different ways across 97 studies; BMI 7/13; symptom duration 14/100; and pain level 8/31). When eligibility criteria included thresholds close to the reference value of a participant characteristic, characteristics were associated with criteria (e.g., younger participants when an upper age threshold was used). Conclusion: Participant eligibility criteria in studies on plantar heel pain vary widely; studies differed substantially in their use of quantitative thresholds. Participant characteristics of samples in studies were associated with the criteria used. This study emphasises a need for adjusting for participant heterogeneity in systematic reviews to improve their validity. [ABSTRACT FROM AUTHOR]

Purpose: Researchers aimed to describe general practitioners' understanding of appropriate ultrasound use, to record actual scanning practices of early adopters in general practice, and to identify differences between attitudes and actual practice via a mixed methods analysis.Methods: This study was part of a larger multistage mixed methods research framework exploring the use of ultrasound in general practice in Denmark. We used an exploratory sequential approach in the data collection with initial qualitative findings from an interview study applied to building a quantitative questionnaire utilized in a cohort study. In addition, we merged the qualitative and quantitative data using joint display analysis to compare and contrast the results from the 2 stages of the study.Results: In the interviews, general practitioners described appropriate ultrasound use as point-of-care examinations with a clear purpose and limited to predefined specific conditions within delimited anatomic areas. They stated that general practitioners should receive formalized ultrasound training and be skilled in the examinations they perform. In the cohort study, general practitioners performed ultrasound examinations of anatomic areas with or without a defined clinical suspicion. Some performed ultrasound examinations for which they had no previous training or skills.Conclusions: We found a difference between the ideas about the appropriate uses for ultrasound in general practice and the actual use by early adopters in clinical practice. Our findings suggest a need for evidence-based guidelines to support general practitioners in choosing which examinations to perform and strategies for developing and maintaining scanning competency. [ABSTRACT FROM AUTHOR]

Point-of-care ultrasonography (POCUS) is increasingly used in general practice despite the lack of official educational programmes or guidelines for general practitioners (GPs). To explore how GPs have learnt to use POCUS and which barriers they have encountered in their learning process. Qualitative study conducted in office-based general practice in Denmark. Semi-structured interviews were conducted with 13 GPs who had implemented POCUS without supporting guidelines or regulations. Analysis was carried out using systematic text condensation. The interview data for this study were collected along with data used in a previous study. The participating GPs described having composed their own ultrasound education following a continuous learning process. Basic POCUS competences were achieved through formalized training sessions at hospital departments or courses. The GPs further developed and expanded their scanning skills through additional courses and continuous self-study practice on patients often while consulting internet sources, textbooks or colleagues. Lack of available ultrasound courses, supervision, and clinical guidelines together with time constraints and financial aspects were mentioned as barriers to their ultrasound training. This study showed how GPs had composed their own ultrasound education individually and differently, guided by their own experiences and beliefs about good clinical practice. Formalized ultrasound training was considered a prerequisite for achieving basic ultrasound competences while continuous practice was considered paramount to develop and maintain scanning skills. There were several obstacles to overcome in the learning process including lack of supervision, guidance, and opportunity for practicing skills. Little is known about the educational needs of general practitioners striving to achieve ultrasound competences. General practitioners described using formalized training to achieve basic scanning competences and continuous self-study and practice to further develop their skills. Lack of time, supervision, clinical guidelines and ultrasound courses were considered barriers in the learning process together with financial aspects. [ABSTRACT FROM AUTHOR]

Objective: To systematically review and synthesize the published literature regarding the education of general practitioners (GPs) and GPs in training (GPTs) in the use of ultrasonography.Design: This systematic review was prospectively registered in PROSPERO, conducted according to the Cochrane recommendations. We combined studies identified in a previous systematic review with studies from an updated literature search using the same search string. We searched the following databases: MEDLINE via Pubmed, EMBASE via OVID, Cinahl via Ebsco, Web of Science and Cochrane Register of Controlled Trials using the words 'ultrasonography' and 'general practice'. Two reviewers independently screened articles, extracted data and assessed the quality of included papers according to the Down and Black quality assessment tool. Disagreements were resolved by involving a third reviewer.Results: Thirty-three papers were included. Ultrasound training was described to include both theoretical and practical training sessions. Theoretical training was achieved through introductory e-learning and/or didactic lectures. Practical training included focussed hands-on training sessions, while some papers described additional longitudinal practical training through proctored scans during clinical work or through self-study practice with continuous feedback on recorded scans.Conclusion: There was a large variation in ultrasound training programs for GPs and GPTs, with an overall emphasis on focussed practical training. Few studies included a longitudinal learning process in the training program. However, diagnostic accuracy seemed to improve with hours of practical training, and studies including continuous feedback on scans conducted during clinical patient encounters showed superior results. [ABSTRACT FROM AUTHOR]

Background: Despite the commonality of adolescent knee pain, there are no tools to support medical doctors to correctly diagnose knee pain. This study aimed to develop and evaluate a support tool for diagnosing the most common types of non-traumatic adolescent knee pain. Method: A systematic search on Medline identified the literature on clinical tests and diagnoses of adolescent knee pain. The search was supplemented by textbooks and transformed into a diagnostic flowchart based on onset, symptoms, and pain localisation. This tool was revised based on feedback from general practitioners and experts in sports medicine. The tool was evaluated on two separate days with blinded assessors. Overall, 27 participants (aged 10–17 years) with non-traumatic knee pain were included. All participants were diagnosed by medical doctors or medical students, without and with the use of the tool. Diagnoses were compared to a gold standard (expert clinician). An interview to inform optimisations of the tool was performed with the assessors. Percentage agreement with the gold standard, and Kappa statistic for interrater reliability were calculated. Results: The final tool improved diagnostic agreement with the gold standard from 22.7% (95% CI 10.3–35.1) to 77.3% (95% CI 64.9–89.7). Inter-rater reliability increased from poor agreement k = − 0.04 (95% CI, − 0.12-0.04) to moderate agreement k = 0.56 (95% CI, 0.40–0.72). Conclusion: This simple diagnostic tool is quick to use and may assist doctors in diagnosing non-traumatic knee pain in adolescents. [ABSTRACT FROM AUTHOR]

Background: The use of point-of-care ultrasonography (POCUS) performed by general practitioners (GPs) in primary care settings is increasing. Previous studies have focused on GP-reported outcomes and little is known about patients' perspectives on the use of POCUS technology within the general practice consultation. The purpose of this study was to examine patients' experiences with POCUS in general practice within the areas where GPs have indicated that POCUS affected aspects of the consultation. Methods: A questionnaire was developed using a mixed methods sequential design. Analytical themes from interviews with GPs were converted into items in a questionnaire by the research team. The questionnaire was then further developed in several rounds of pilot tests involving both patients and GPs. The final questionnaire was used in a cohort study conducted in 18 Danish office-based general practice clinics from January 2018 to August 2018. All patients examined with POCUS were asked to complete the questionnaire on tablets immediately after their consultation. Results: Out of 691 patients examined, 564 (81.6%) questionnaires were available for analysis. The patients reported that they were well informed about the purpose (98%) and the results (97%) of the POCUS examination; however, 29% reported that they were not informed about the difference between POCUS and an imaging-specialist's ultrasound examination. Almost all patients (99%) reported that POCUS was integrated naturally into the consultation, and 45% reported that POCUS improved the doctor-patient relationship. The majority of patients felt that they had been more thoroughly examined (92%) and taken more seriously (58%) when POCUS was part of the consultation. They felt POCUS gave them a better understanding of their health problem (82%), made them feel more secure (86%) and increased their trust in the physician's assessment (65%). Moreover, the patients reported that POCUS use improved the level of service (95%) they experienced and the quality of care (94%) in general practice. Conclusion: We found that an examination including POCUS in general practice was a positive experience overall for the majority of patients. Future research should further explore reasons for patient confidence in POCUS and whether or not the reassuring value of POCUS is valid. Trial registration: ClinicalTrials.gov Identifier: NCT03416608 [ABSTRACT FROM AUTHOR]

Introduction: Multi-site pain has not been investigated among adolescents suffering from knee pain. This study aimed to examine the trajectory of pain in adolescents with knee-pain, to determine if multi-site pain in adolescents together with other established prognostic factors (frequency of pain, sex, sports participation, Health Related Quality of Life (HRQoL)) was associated with five-year prognosis of knee-pain and function. Methods: This prospective cohort study included 504 adolescents with knee pain and 252 controls. At five-year follow-up, participants responded to an questionnaire which documented prescence and severity of knee pain and co-occurring pain. Results: At follow-up, 358 (71.0%) of those with knee-pain at baseline, and 182 (72.2%) controls responded. Female sex, low HRQoL, daily pain, and multi-site pain were associated with an increased odds of knee pain after 5 years (odds ratio: 1.41–3.37). Baseline multi-site pain was not associated with problems running at follow-up, whereas higher sports participation at baseline was associated with less problems running at follow-up (odd ratio 0.49). Among those with knee-pain at inclusion, the number of pain sites increased from a median of 2 (IQR 1–3) to 4 (IQR 2–6) at follow-up (P<0.05). Those with multi-site pain at follow-up score significantly worse in self-reported knee function, compared to those with one pain site only. Conclusion: This study identified a set of factors that appeared to be associated with an increased risk of knee pain at five years follow up. Research is needed to understand and help direct treatment of adolescents with multi-site pain. [ABSTRACT FROM AUTHOR]

Background: Point-of-care ultrasonography (PoCUS) is increasingly used across the medical field. PoCUS is also being implemented in general practice despite a lack of clinical guidelines and training programs for general practitioners (GPs).Objectives: This study aimed to elucidate the employment of PoCUS by Danish GPs following a short training program.Methods: Thirty GPs were enrolled in a short ultrasound training program and taught how to perform 22 selected scanning modalities. In the following 3 months, the GPs registered all performed PoCUS examinations according to the Audit Project Odense method. After 5 months, the GPs were invited to participate in an evaluation seminar, where questionnaires were distributed.Results: During the registration period, 1598 patients were examined with PoCUS. A total of 1948 scanning modalities were registered, including 207 examinations outside the taught curriculum. The majority of the ultrasound examinations were performed within 10 minutes (89%), most were considered to be conclusive (87%) and/or to increase diagnostic certainty (67%), whereas one in four examinations entailed a change in patient management. Most GPs attending the evaluation seminar continued to use PoCUS and found the scanning modalities included in the course curriculum relevant in their daily work.Conclusion: The GPs found several indications for performing PoCUS following the attendance of a 2-day basic training program. The majority of examinations were registered to be conclusive and/or increase diagnostic certainty. However, few GPs used PoCUS on a daily basis and not all examinations were registered to have an impact on patient care. [ABSTRACT FROM AUTHOR]

Introduction: Plantar fasciopathy, characterised by plantar heel pain, affects one in ten in a lifetime. Heavy-slow resistance training (HSR) is an emerging treatment, but it often takes considerable time before the effect starts to manifest. Combining HSR with a corticosteroid injection (known for its short-term pain relief) could potentially improve outcomes in both short and long term. As this combination is yet to be investigated, we aimed to evaluate the feasibility of combining HSR with a corticosteroid injection for individuals with plantar fasciopathy before investigating the efficacy in a clinical trial. Materials and methods: We recruited 20 participants with plantar fasciopathy for this prospectively registered feasibility study (ClinicalTrials.gov: NCT03535896). Participants received an ultrasound-guided injection and performed heel raises on a step every second day for 8 weeks. To assess participant acceptability of the combined interventions and exercise compliance, we used a 7-point Likert scale dichotomised to "unacceptable" (categories 1–2) or "acceptable" (categories 3–7) and training diaries. Greater than or equal to 10/20 had to rate the combination "acceptable", ≥ 15/20 had to perform ≥ 20 training sessions, and ≥ 15/20 had to start exercising ≤ 7 days after injection to confirm feasibility. Results: Eighteen out of 20 rated the combination acceptable. Five training diaries could not be retrieved. Ten out of 15 participants performed ≥ 20 training sessions, and 15/15 started exercising ≤ 7 days after injection. Conclusions: Based on participant acceptability and time to exercise start, combining HSR with corticosteroid injection is feasible and the efficacy should be investigated in a future trial. Due to loss of 5/20 training diaries, firm conclusions regarding exercise compliance could not be drawn. Trial registration: ClinicalTrials.gov, NCT03535896 [ABSTRACT FROM AUTHOR]

Background: Albuminuria level is associated with cardiovascular events and mortality in patients with diabetes. However, little is known about the association between albuminuria level in diabetes patients without overt cardiovascular disease. We aimed to examine the association between albuminuria level and the risk of ischemic stroke, myocardial infarction, and all-cause mortality in patients with type 2 diabetes without overt cardiovascular disease.Methods: We linked Danish nationwide registries to identify patients with type 2 diabetes without cardiovascular disease from May 2005 through June 2015. Patients were followed for the outcomes ischemic stroke, myocardial infarction, and all-cause mortality until December 31, 2015. Albuminuria level was based on 2 consecutive measurements of the urinary albumin excretion rate or albumin-to-creatinine ratio. Associations between albuminuria level and incidence of cardiovascular disease and mortality were evaluated with Cox proportional hazard regression.Results: The study population consisted of 69,532 patients with type 2 diabetes without cardiovascular disease. When comparing patients with microalbuminuria to patients with normoalbuminuria, in an analysis adjusted for cardiovascular risk factors, we found hazard ratios of 1.28 (95% confidence interval [CI], 1.07-1.52), 1.34 (95% CI, 1.10-1.62), and 1.48 (95% CI, 1.36-1.61) for ischemic stroke, myocardial infarction, and all-cause mortality, respectively. For macroalbuminuria, the hazard ratios were 1.81 (95% CI, 1.46-2.23), 1.99 (95% CI, 1.59-2.48), and 1.83 (95% CI, 1.64-2.04). Similar results were found after adjusting for concomitant medication.Conclusions: This study showed that albuminuria level is associated with higher risk of incident ischemic stroke, myocardial infarction, and all-cause mortality in Type 2 diabetes patients without overt cardiovascular disease. [ABSTRACT FROM AUTHOR]

Objective: The aim of the study was to achieve consensus among a group of ultrasound proficient general practitioners (GPs) from Denmark, Norway, Sweden and Finland on which ultrasound scanning modalities and ultrasound-guided procedures are essential to GPs in their daily work for the purpose of including them in a basic ultrasound curriculum. Design: The Delphi methodology was used to obtain consensus. Subjects: Sixty Scandinavian GPs with more than two years of point-of-care ultrasound (POCUS) experience were invited to join the Delphi expert panel. Main outcome measures: In the first Delphi round each member of the panel was asked to produce a list of scanning modalities and procedures which they found relevant to include in a basic ultrasound curriculum. In Delphi round two, these suggestions were presented to the entire panel who assessed whether they found them essential in their daily work. Items not reaching consensus in round two, were presented to the panel in a third and final round. Items reaching more than 67% agreement were included. Results: Forty-five GPs were included in the study and 41 GPs completed all rounds. Agreement was obtained on 30 scanning modalities and procedures primarily within the musculoskeletal (8), abdominal (5), obstetric (5) and soft tissue (3) diagnostic areas. Four ultrasound-guided procedures were also agreed upon. Conclusion: A prioritized list of 30 scanning modalities and procedures was agreed upon by a group of ultrasound proficient GPs. This list could serve as a guideline when planning future POCUS educational activities for GPs. Point-of-care ultrasound (POCUS) is increasingly being used by general practitioners (GPs), but little is known about which ultrasound applications are most used. We performed a systematic needs assessment among a group of ultrasound proficient GPs using the Delphi methodology for the purpose of establishing a basic POCUS curriculum. The process resulted in a prioritized list of 30 scanning modalities and ultrasound guided procedures. Our study provides the basis for an evidence-based basic POCUS curriculum for GPs. [ABSTRACT FROM AUTHOR]

Objective: In a future full-scale randomised controlled trial, we plan to compare satisfaction with a standard website versus satisfaction with a participatory driven web-application. The participatory driven web-application may facilitate the delivery of targeted evidence-based advice and information to patients with low back pain in general practice (ClinicalTrials.gov Identifier: NCT03088774). This feasibility study is intended to inform a future randomised controlled trial. The aim is to report on the lessons learned from recruitment to report on reasons for loss to follow-up. Results: We recruited 12 women and 8 men from two general practices with each practice recruiting for 3 months. Full follow-up data was available in only three patients (15%). Based on the high loss to follow-up, we do not consider it feasible to conduct the full-scale confirmatory trial as planned. Modifying inclusion criteria to include only patients expressing an interest in using online health information or randomising patients directly at the general practice, supporting them in accessing the web-application, and letting patients respond with their immediate satisfaction may improve the speed of recruitment and follow-up rates. Furthermore, the participatory driven web-application can be included in a larger multi-faceted intervention, making the combined intervention seem more relevant to study participants. [ABSTRACT FROM AUTHOR]

Background: Plantar fasciopathy has a lifetime prevalence of 10%. Patients experience sharp pain under the heel, often for several months or years. Multiple treatments are available, but no single treatment appears superior to the others. A corticosteroid injection offers short-term pain relief but is no better than placebo in the longer term (> 8 weeks). Heavy-slow resistance training has shown potentially positive effects on long-term outcomes (> 3 months), and combining exercises with an injection may prove to be superior to exercises alone. However, the effect of heavy-slow resistance training compared with a simpler approach of patient advice (e.g., load management) and insoles is currently unknown. This trial compares the efficacy of patient advice with patient advice plus heavy-slow resistance training and with patient advice plus heavy-slow resistance training plus a corticosteroid injection in improving the Foot Health Status Questionnaire pain score after 12 weeks in patients with plantar fasciopathy.Methods: In this randomised superiority trial, we will recruit 180 patients with ultrasound-confirmed plantar fasciopathy and randomly allocate them to one of three groups: (1) patient advice and an insole (n = 60); (2) patient advice, an insole, and self-dosed heavy-slow resistance training consisting of heel raises (n = 60); or (3) patient advice, an insole, heavy-slow resistance training, and an ultrasound-guided corticosteroid injection (n = 60). All participants will be followed for 1 year, with the 12-week follow-up considered the primary endpoint. The primary outcome is the Foot Health Status questionnaire pain domain score. Secondary outcomes include the remaining three domains of the Foot Health Status Questionnaire, a 7-point Global Rating of Change, the Pain Self-Efficacy Questionnaire, physical activity level, health-related quality of life measured by the EQ-5D-5L, and Patient Acceptable Symptom State, which is the point at which participants feel no further need for treatment. Additionally, a health economic evaluation of the treatments will be carried out.Discussion: This trial will test if adding heavy-slow resistance training to fundamental patient advice and an insole improves outcomes and if a corticosteroid injection adds even further to that effect in patients with plantar fasciopathy.Trial Registration: ClinicalTrials.gov, NCT03804008. Prospectively registered on January 15, 2019. [ABSTRACT FROM AUTHOR]

Background: General practitioners increasingly use point-of-care ultrasonography despite a lack of evidence-based guidelines for their appropriate use in primary care. Little is known about the integration of ultrasonography in general practice consultations and the impact of its use on patient care. The purpose of this study was to explore general practitioners' experiences of using ultrasonography in the primary care setting. Methods: Adopting an explorative phenomenological approach, we performed semi-structured interviews with general practitioners who used ultrasonography in their daily work. Thirteen general practitioners were recruited stepwise, aiming for maximum variation in background characteristics. Interviews were conducted at the general practitioner's own clinic. Transcription and systematic text condensation analysis began immediately after conducting each interview. Results: The general practitioners described using ultrasonography for both selected focused examinations and for explorative examinations. The two types of examinations were described differently for each of the following emerging themes: motivation for using ultrasonography, ultrasonography as part of the consultation, selection of an ultrasound catalogue, and consequences of the general practitioner's ultrasound examination. The general practitioners had chosen and integrated their own individual ultrasound catalogue of focused examinations as a natural part of their consultations. The focused examinations were used to answer simple clinical questions and they had a significant impact on the patients' diagnoses, clinical pathways and treatments. The general practitioners considered their own catalogue of focused examinations as their comfort zone. However, they also performed explorative ultrasound examinations outside their catalogue. These scans were performed to train, gain or maintain ultrasound competences or as explorative examinations driven by curiosity. The explorative ultrasound examinations rarely had an impact on patient care. Conclusions: This study describes how general practitioners found their own way of using ultrasonography in general practice and selected a personal catalogue of ultrasound examinations that was applicable, relevant and meaningful for their daily clinical routines. This study may serve to inform implementation strategies in general practice by offering insights into central aspects that drive general practitioners' behaviours. [ABSTRACT FROM AUTHOR]

Background: Tendinopathies of the lower extremity (e.g. Achilles, patellar, and plantar heel pain) are common in both general and sporting populations. However, the prevalence and incidence in Danish general practice is unknown. The aim was to determine the prevalence and incidence rate of lower-extremity tendinopathies in a Danish general practice.Methods: In this registry-based study, we extracted data from the electronic patient files of all patients in a single Danish general practice. The practice included 8836 patients. We searched ICPC-2 codes to identify patients with either of the following lower-extremity tendinopathies: plantar heel pain; Achilles tendinopathy; patellar tendinopathy; greater trochanteric pain syndrome or adductor tendinopathy. We defined an incident and prevalent case as a patient with a consultation because of tendinopathy in 2016 only. A prevalent, but not incident case was a patient with consultations in both 2015 and 2016. Incidence and prevalence were expressed as the number of patients with a tendinopathy per 1000 registered patients.Results: The prevalence and incidence rate were 16.6 and 7.9 per 1000 registered patients, respectively. Plantar heel pain was the most prevalent tendinopathy and accounted for 39% of lower-extremity tendinopathies. Patients with tendinopathies were significantly older than all registered patients (46.0 years (95%CI: 43.3;48.7) versus 38.8 years (95%CI: 38.4;39.3), respectively).Conclusions: Lower-extremity tendinopathies, especially plantar heel pain, had a high prevalence and incidence rate in a Danish general practice. In a typical general practice with 5000 patients, general practitioners should expect to see more than 80 patients with a lower-extremity tendinopathy every year. [ABSTRACT FROM AUTHOR]

Objective: To identify general practitioners' (GPs) barriers and facilitators regarding the use of health information technology (HIT) in the treatment of patients with low back pain (LBP). Design: A qualitative study employing a participatory design approach, with an inductive analytical thematic approach utilising semi-structured interviews. Empirical data was analysed using the qualitative data analysis software (QDAS) Nvivo. Setting: General practices in Denmark. Subjects: Eight interviews were conducted with an average duration of 60 min. The interviewees were GPs from different geographical settings and different organisational structures, varying in age and professional interests. Main outcome measures: Barriers and facilitators for future use of the HIT application for patients with LBP. Results: Through the inclusion of healthcare professionals in the design process, this study found that in order for GPs to recommend a HIT application it is essential to target the application towards their patients. Furthermore, GPs required that the HIT application should support patient self-management. Additionally, the content of the HIT application should support the initiated treatment and it should be easy for GPs to recommend the HIT application. Finally, healthcare professionals need to be involved in the design process. Conclusion: When designing health IT applications for patients with LBP in general practice it is important to include both patients and GPs in the design process. GPs would be more willing to recommend a HIT application that: applies content in line with frequently used recommendations; targets patients; supports patients' self-management; and supports the patients' needs. KEY POINTS: Online information is currently applied in general practice to some patients with low back pain Online information cannot replace the GP, but can rather be a bonding tool between the patient and the GP It is important to address both GP and patient barriers to applying new technology and to consider the literacy level Participatory methods could play a central role in the future development of online information material [ABSTRACT FROM AUTHOR]

Purpose: Ultrasound examinations are currently being implemented in general practice. This study aimed to systematically review the literature on the training in and use of point-of-care ultrasound (POCUS) by general practitioners.Methods: We followed the Cochrane guidelines for conduct and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for reporting. We searched the databases MEDLINE (via PubMed), EMBASE, CINAHL, Web of Science, and Cochrane Central Register of Controlled Trials using the key words ultrasonography and general practice in combination and using thesaurus terms. Two reviewers independently screened articles for inclusion, extracted data, and assessed the quality of included studies using an established checklist.Results: We included in our review a total of 51 full-text articles. POCUS was applied for a variety of purposes, with the majority of scans focused on abdominal and obstetric indications. The length of training programs varied from 2 to 320 hours. Competence in some types of focused ultrasound scans could be attained with only few hours of training. Focused POCUS scans were reported to have a higher diagnostic accuracy and be associated with less harm than more comprehensive scans or screening scans. The included studies were of a low quality, however, mainly because of issues with design and reporting.Conclusions: POCUS has the potential to be an important tool for the general practitioner and may possibly reduce health care costs. Future research should aim to assess the quality of ultrasound scans in broader groups of general practitioners, further explore how these clinicians should be trained, and evaluate the clinical course of patients who undergo scanning by general practitioners. [ABSTRACT FROM AUTHOR]

Introduction: Knee pain is common in adolescents and adults and is associated with an increased risk of developing knee osteoarthritis. The aim of this systematic review was to gather and appraise the cost-effectiveness of treatment approaches for non-osteoarthritic knee pain conditions. Method: A systematic review was conducted according to the PRISMA guidelines and registered on PROSPERO (CRD42016050683). The literature search was done in MEDLINE via PubMed, EMBASE, The Cochrane Library, and the National Health Service Economic Evaluation Database. Study selection was carried out by two independent reviewers and data were extracted using a customized extraction form. Study quality was assessed using the Consensus on Health Economic Criteria list. Results: Fifteen studies were included. The majority regarded the treatment of anterior cruciate ligament (ACL) injuries, but we also identified studies evaluating other knee pain conditions such as meniscus injuries, cartilage defects, and patellofemoral pain syndrome. Study interventions were categorized as surgical or non-surgical interventions. The surgical interventions included ACL reconstruction, chondrocyte implantation, meniscus scaffold procedure, meniscal allograft transplantation, partial meniscectomy, microfracture, and different types of autografts and allografts. The non-surgical management consisted of physical therapy, rehabilitation, exercise, counselling, bracing, and advice. In general, for ACL injuries surgical management alone or in combination with rehabilitation appeared to be cost-effective. The quality of the economic evaluations was of moderate to high quality. Conclusion: There was insufficient evidence to give a firm overview of cost-effective interventions for non-osteoarthritic knee pain, but surgical treatment of acute ACL injury appeared cost-effective. There is very little data regarding the cost-effectiveness of non-surgical interventions for non-traumatic knee conditions. [ABSTRACT FROM AUTHOR]

Purpose: To summarise recommendations about 20 non-surgical interventions for recent onset (<12 weeks) non-specific low back pain (LBP) and lumbar radiculopathy (LR) based on two guidelines from the Danish Health Authority.Methods: Two multidisciplinary working groups formulated recommendations based on the GRADE approach.Results: Sixteen recommendations were based on evidence, and four on consensus. Management of LBP and LR should include information about prognosis, warning signs, and advise to remain active. If treatment is needed, the guidelines suggest using patient education, different types of supervised exercise, and manual therapy. The guidelines recommend against acupuncture, routine use of imaging, targeted treatment, extraforaminal glucocorticoid injection, paracetamol, NSAIDs, and opioids.Conclusion: Recommendations are based on low to moderate quality evidence or on consensus, but are well aligned with recommendations from international guidelines. The guideline working groups recommend that research efforts in relation to all aspects of management of LBP and LR be intensified. [ABSTRACT FROM AUTHOR]

Background: Low back pain (LBP) is a common cause of contact with the primary healthcare sector. In some patients, symptoms quickly resolve, but others develop long-lasting pain and disability. To improve the care pathway for patients with LBP, the STarT Back Tool (STarT) questionnaire has been developed. It helps initial decision-making by subgrouping patients on the basis of their prognosis and helps to target treatment according to prognosis. An assumption behind the use of STarT is the ability to predict functional improvement. This assumption has never been tested in a population that consists exclusively of patients enrolled when consulting a Danish general practitioner for LBP. The aim of this study was to investigate STarT's ability to predict a 30% improvement in the Roland Morris Disability Questionnaire (RMDQ) score.Methods: This was an ancillary analysis using data from a Danish guideline implementation study (registered at ClinicalTrials.gov NCT01699256). An inclusion criterion was age 18 to 65 years of age. Exclusion criteria were pregnancy, fractures, and signs of underlying pathology. Patient-reported STarT score and the Roland Morris Disability Questionnaire were administered at baseline and again after 4, 8, and 52 weeks.Results: Between January 2013 and July 2014, 475 patients from the original trial participated with questionnaires. From this subpopulation, 441 (92.8%) patients provided information regarding STarT. Baseline and eight-week RMDQ data were available for 304 (64.0%) patients. After 8 weeks, 61 (65.6%) in the low-risk group, 67 (54.9%) in the medium-risk group, and 33 (37.1%) in the high-risk group had achieved a 30% improvement in the RMDQ score. After 8 weeks, high-risk patients were at 61% (95% CI: 20-125%, P < 0.001) higher risk of not achieving a 30% improvement in the RMDQ score compared with patients in either the low-risk group or the medium-risk group.Conclusion: STarT was predictive for functional improvement in patients from general practice with LBP.Trial Registration: ClinicalTrials.gov NCT01699256 , Nov 29, 2016 (registered retrospectively). [ABSTRACT FROM AUTHOR]

In connection with the publication of a clinical practice guideline on the management of low back pain (LBP) in general practice in Denmark, a cluster randomised controlled trial was conducted. In this trial, a multifaceted guideline implementation strategy to improve general practitioners' treatment of patients with LBP was compared with a usual implementation strategy. The aim was to determine whether the multifaceted strategy was cost effective, as compared with the usual implementation strategy. The economic evaluation was conducted as a cost-utility analysis where cost collected from a societal perspective and quality-adjusted life years were used as outcome measures. The analysis was conducted as a within-trial analysis with a 12-month time horizon consistent with the follow-up period of the clinical trial. To adjust for a priori selected covariates, generalised linear models with a gamma family were used to estimate incremental costs and quality-adjusted life years. Furthermore, both deterministic and probabilistic sensitivity analyses were conducted. Results showed that costs associated with primary health care were higher, whereas secondary health care costs were lower for the intervention group when compared with the control group. When adjusting for covariates, the intervention was less costly, and there was no significant difference in effect between the 2 groups. Sensitivity analyses showed that results were sensitive to uncertainty. In conclusion, the multifaceted implementation strategy was cost saving when compared with the usual strategy for implementing LBP clinical practice guidelines in general practice. Furthermore, there was no significant difference in effect, and the estimate was sensitive to uncertainty. [ABSTRACT FROM AUTHOR]

Background In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners' adherence to the guidelines. In addition to usual dissemination, the extended implementation strategy is composed of visits from a guideline facilitator, stratification tools, and feedback on guideline adherence. The aim of this paper is to provide the considerations on the design of the health economic evaluation. Methods/design The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region. An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled. The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis. Effectiveness measures include referral to secondary care, health-related quality of life measured by EQ-5D-5 L, and disability measured by the Roland Morris disability questionnaire. Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation. The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon. Discussion It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care. It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patientrelated outcomes, thereby rendering the extended implementation strategy cost-effective. Trial registration ClinicalTrials.gov: NCT01699256 [ABSTRACT FROM AUTHOR]

Background Evidence-based clinical practice guidelines may improve treatment quality, but the uptake of guideline recommendations is often incomplete and slow. Recently new low back pain guidelines are being launched in Denmark. The guidelines are considered to reduce personal and public costs. The aim of this study is to evaluate whether a complex, multifaceted implementation strategy of the low back pain guidelines will reduce secondary care referral and improve patient outcomes compared to the usual simple implementation strategy. Methods/design In a two-armed cluster randomised trial, 100 general practices (clusters) and 2,700 patients aged 18 to 65 years from the North Denmark region will be included. Practices are randomly allocated 1:1 to a simple or a complex implementation strategy. Intervention practices will receive a complex implementation strategy, including guideline facilitator visits, stratification tools, and quality reports on low back pain treatment. Primary outcome is referral to secondary care. Secondary outcomes are pain, physical function, health-related quality of life, patient satisfaction with care and treatment outcome, employment status, and sick leave. Primary and secondary outcomes pertain to the patient level. Assessments of outcomes are blinded and follow the intention-to-treat principle. Additionally, a process assessment will evaluate the degree to which the intervention elements will be delivered as planned, as well as measure changes in beliefs and behaviours among general practitioners and patients. Discussion This study provides knowledge concerning the process and effect of an intervention to implement low back pain guidelines in general practice, and will provide insight on essential elements to include in future implementation strategies in general practice. [ABSTRACT FROM AUTHOR]

Background: Low back pain (LBP) is the most common musculoskeletal disorder and a leading cause of disability worldwide. It impacts daily life and work capacity and is the most common reason for consulting a general practitioner (GP). According to international guidelines, information, reassurance, and advice are key components in the management of people with LBP; however, the consultation time available in general practice for each patient is often limited. Therefore, new methods to support the delivery of information and advice are needed and online technologies provide new opportunities to extend the consultation beyond the GP's office. However, it is not known whether GPs and people consulting their GP because of LBP will accept online technologies as part of the consultation. By involving patients in the development of online information, we may produce more user-friendly content and design, and improve patient acceptance and usage, optimising satisfaction and clinical outcomes. The purpose is to study satisfaction in people consulting their GP with LBP depending on whether they are randomised to receive supporting information through a new participant-driven web application or a standard reference website containing guideline-based information on LBP. It is hypothesised that patients offered information in a new web application will be more satisfied with the online information after 12 weeks compared to patients allocated to a standard website.Methods: Two hundred patients with LBP aged ≥ 18 years consulting Danish general practice will be randomly allocated 1:1 to either the new web application or standard online information in permuted blocks of two, four, and six. Patients with serious spinal diseases (cancer, fractures, spinal stenosis, spondyloarthritis), those without Danish reading skills or without online access, and pregnant women will not be included in the trial. Patient satisfaction measured by the Net Promotor Score after 12 weeks is the primary outcome. Patients will be aware of their allocation. GPs will be blinded unless informed by the patient. Assessors are blinded.Discussion: To our knowledge, this is the first trial evaluating whether involving LBP patients in the development of an online web application will result in higher patient satisfaction.Trial Registration: ClinicalTrials.gov NCT03088774 . Registered on 23 March 2017. Last updated on 14 March 2018. [ABSTRACT FROM AUTHOR]

Background: Guidelines are often slowly adapted into clinical practice. However, actively supporting healthcare professionals in evidence-based treatment may speed up guideline implementation. Danish low back pain (LBP) guidelines focus on primary care treatment of LBP, to reduce referrals from primary care to secondary care. The primary aim of this project was to reduce secondary care referral within 12 weeks by a multifaceted implementation strategy (MuIS).Methods: In a cluster randomised design, 189 general practices from the North Denmark Region were invited to participate. Practices were randomised (1:1) and stratified by practice size to MuIS (28 practices) or a passive implementation strategy (PaIS; 32 practices). Included were patients with LBP aged 18 to 65 years who were able to complete questionnaires, had no serious underlying pathology, and were not pregnant. We developed a MuIS including outreach visits, quality reports, and the STarT Back Tool for subgrouping patients with LBP. Both groups were offered the usual dissemination of guidelines, guideline-concordant structuring of the medical record, and a new referral opportunity for patients with psycho-social problems. In an intention-to-treat analysis, the primary and secondary outcomes pertained to the patient, and a cost-effectiveness analysis was performed from a healthcare sector perspective. Patients and the assessment of outcomes were blinded. Practices and caregivers delivering the interventions were not blinded.Results: Between January 2013 and July 2014, 60 practices were included, of which 54 practices (28 MuIS, 26 PaIS) included 1101 patients (539 MuIS, 562 PaIS). Follow-up data for the primary outcome were available on 100 % of these patients. Twenty-seven patients (5.0 %) in the MuIS group were referred to secondary care vs. 59 patients (10.5 %) in the PaIS group. The adjusted odds ratio (AOR) was 0.52 [95 % CI 0.30 to 0.90; p = 0.020]. The MuIS was cost-saving £-93.20 (£406.51 vs. £499.71 per patient) after 12 weeks. Conversely, the MuIS resulted in less satisfied patients after 52 weeks (AOR 0.50 [95 % CI 0.31 to 0.81; p = 0.004]).Conclusions: Using a MuIS changed general practice referral behaviour and was cost effective, but patients in the MuIS group were less satisfied. This study supports the application of a MuIS when implementing guidelines.Trial Registration: ClinicalTrials.gov, NCT01699256. [ABSTRACT FROM AUTHOR]

Background: In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners' adherence to the guidelines. In addition to usual dissemination, the extended implementation strategy is composed of visits from a guideline facilitator, stratification tools, and feedback on guideline adherence. The aim of this paper is to provide the considerations on the design of the health economic evaluation.Methods/design: The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region. An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled. The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis. Effectiveness measures include referral to secondary care, health-related quality of life measured by EQ-5D-5L, and disability measured by the Roland Morris disability questionnaire. Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation. The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon.Discussion: It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care. It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes, thereby rendering the extended implementation strategy cost-effective.Trial Registration: ClinicalTrials.gov: NCT01699256. [ABSTRACT FROM AUTHOR]

Background: Evidence-based clinical practice guidelines may improve treatment quality, but the uptake of guideline recommendations is often incomplete and slow. Recently new low back pain guidelines are being launched in Denmark. The guidelines are considered to reduce personal and public costs. The aim of this study is to evaluate whether a complex, multifaceted implementation strategy of the low back pain guidelines will reduce secondary care referral and improve patient outcomes compared to the usual simple implementation strategy.Methods/design: In a two-armed cluster randomised trial, 100 general practices (clusters) and 2,700 patients aged 18 to 65 years from the North Denmark region will be included. Practices are randomly allocated 1:1 to a simple or a complex implementation strategy. Intervention practices will receive a complex implementation strategy, including guideline facilitator visits, stratification tools, and quality reports on low back pain treatment. Primary outcome is referral to secondary care. Secondary outcomes are pain, physical function, health-related quality of life, patient satisfaction with care and treatment outcome, employment status, and sick leave. Primary and secondary outcomes pertain to the patient level. Assessments of outcomes are blinded and follow the intention-to-treat principle. Additionally, a process assessment will evaluate the degree to which the intervention elements will be delivered as planned, as well as measure changes in beliefs and behaviours among general practitioners and patients.Discussion: This study provides knowledge concerning the process and effect of an intervention to implement low back pain guidelines in general practice, and will provide insight on essential elements to include in future implementation strategies in general practice.Trial Registration: Registered as NCT01699256 on ClinicalTrials.gov. [ABSTRACT FROM AUTHOR]