The effect of clinical guidelines on the utilisation of radiographs in chiropractic clinics in Denmark - an interrupted time series analysis.

BACKGROUND: In Denmark, chiropractors have a statutory right to use radiography and the government-funded national Health Insurance provides partial reimbursement. Danish National Clinical Guidelines recommends against routine use of imaging for uncomplicated spinal pain; however, it is not clear if clinical imaging guidelines recommendations have had an effect on the utilisation of spinal radiography. This study aimed to describe the utilisation rate of radiographs in Danish chiropractic clinics in the period from 2010 to 2020 and to assess the impact of clinical guidelines and policy changes on the utilisation of radiographs in Danish chiropractic clinics. METHODS: Anonymised data from January 1st, 2010, to December 31st, 2020, were extracted from the Danish Regions register on health contacts in primary care. Data consisted of the total number of patients consulting one of 254 chiropractic clinics and the total number of patients having or being referred for radiography. Data were used to investigate the radiography utilisation per month from 2010 to 2020. An 'interrupted time series' analysis was conducted to determine if two interventions, the dissemination of 1) Danish clinical imaging guidelines recommendations and policy changes related to referral for advanced imaging for chiropractors in 2013 and 2) four Danish clinical guidelines recommendations in 2016, were associated with an immediate change in the level and/or slope of radiography utilisation. RESULTS: In total, 336,128 unique patients consulted a chiropractor in 2010 of which 55,449 (15.4%) had radiography. In 2020, the number of patients consulting a chiropractor had increased to 366,732 of which 29,244 (8.0%) had radiography. The pre-intervention utilisation decreased by two radiographs per 10,000 patients per month. Little absolute change, but still statistically significant for Intervention 1, in the utilisation was found after the dissemination of the clinical guidelines and policy changes in 2013 or 2016. CONCLUSIONS: The proportion of Danish chiropractic patients undergoing radiography was halved in the period from 2010 to 2020. However, the dissemination of clinical imaging guidelines recommendations and policy changes related to referrals for advanced imaging showed little meaningful change in the monthly utilisation of radiographs in the same period.

Description of recurrent headaches in 7-14-year-old children: Baseline data from a randomized clinical trial on effectiveness of chiropractic spinal manipulation in children with recurrent headaches.

BACKGROUND: Headaches in children are poorly described and diagnosing can be challenging. Objectives are: (1) to describe headache characteristics and child characteristics, (2) to explore whether data can suggest a more diverse way to categorize headaches than traditionally. METHODS: Baseline data for a clinical trial included a questionnaire and a physical screening. Children's characteristics and detailed description of headache symptoms were provided. Children were classified for migraine or tension-type-headache based on questionnaire data reported by children and parents. This required to apply slightly modified classification criteria and a "non-classifiable" group was added. Severity and symptoms, related to the migraine versus tension type distinction, were investigated to define a migraine-tension-type-index. RESULTS: 253 children were included. Mean pain intensity was 5.9/10. Over 2/3 of the children had headache for > 1 year, and > 50% for several days/week. Half of the children were non-classifiable, 22% were classified as migraine and 23% as tension-type headache. A migraine-tension-type-index was constructed and describes a continuous spectrum rather than two distinct groups. CONCLUSIONS: Children with recurrent headaches are often severely affected. A questionnaire-based classification appeared feasible to distinguish between migraine and tension-type headaches in children but leaving many children unclassified. A migraine-tension-type-index can be generated allowing to regard the traditional distinction as a continuum (including mixed headache), and potentially serving as an instrument to improve headache management. Trial registration ClinicalTrials.gov, identifier NCT02684916.

Surgery rates for lumbar spinal stenosis in Denmark between 2002 and 2018: a registry-based study of 43,454 patients.

BACKGROUND AND PURPOSE: Over the last decades, many countries have shown increased surgery rates for lumbar spinal stenosis (LSS), but little information is available from Denmark. We describe the development in diagnosis and surgery of LSS in Denmark between 2002 and 2018. PATIENTS AND METHODS: We collected diagnostic ICD10-codes and surgical procedure codes from private and public hospitals in Denmark from the Danish National Patient Register. Patients diagnosed with LSS and those with surgical procedure codes for decompression surgery with or without fusion were identified. Annual surgery rates were stratified by age, sex, and type of surgery. RESULTS: During these 17 years, 132,138 patients diagnosed with LSS and 43,454 surgical procedures for LSS were identified. The number of surgical procedures increased by 144%, from 23 to 56 per 100,000 inhabitants. The proportion of patients diagnosed with LSS who received surgery was about 33%, which was almost stable over time. Decompression without fusion increased by 128% from 18 to 40 per 100,000 inhabitants and decompression with fusion increased by 199%, from 5 to 15 per 100,000. INTERPRETATION: Both the prevalence of LSS diagnoses and LSS surgery rates more than doubled in Denmark between 2002 and 2018. However, the proportion of patients diagnosed with LSS who received surgery remained stable. Decompression surgery with fusion increased at a higher rate than decompression without fusion, although recent evidence suggests no advantage of decompression plus fusion over decompression alone.

Reliability of reporting differences in degenerative MRI findings of the lumbar spine from the supine to the upright position.

OBJECTIVE: To determine the inter-rater reliability of identifying differences and types of differences in lumbar degenerative findings comparing supine and upright MRI. MATERIALS AND METHODS: Fifty-nine participants, low back pain patients (LBP) with or without leg pain and no-LBP individuals were consecutively enrolled to receive supine and upright MRI of the lumbar spine. Three raters independently evaluated the MRIs for degenerative spinal pathologies and compared for differences. Presence/absence of degenerative findings were recorded for all supine and upright images, and then differences from the supine to the upright positions were classified into no-change, appeared, disappeared, worsened, or improved at each individual disc level. Reliability and agreement were calculated using Gwet's agreement coefficients (AC1 or AC2) and absolute agreement. RESULTS: Inter-rater reliability of evaluating differences in eight degenerative lumbar findings comparing the supine and upright MRI position, ranged from 0.929 to 0.996 according to Gwet's agreement coefficients (AC2). The total number of positive MRI findings in the supine position ranged from 270 to 453, with an average of 366 per rater. Observed differences from supine to upright MRI ranged from 18 to 80, with an average of 56 per rater. CONCLUSION: Inter-rater reliability was found overall acceptable for classification of differences in eight types of degenerative pathology observed with supine and upright MRI of the lumbar spine. Results were primarily driven by high numbers and high reliability of rating negative findings, whereas agreement regarding positive findings and positive positional differences was lower.

The utilisation of regulated standardised care packages by Danish chiropractors: a mixed methods study.

BACKGROUND: In Denmark, chiropractors in primary care work as independent private contractors regulated by the Danish National Health Authorities. The regulation includes partial reimbursement intended for standardised care packages for lumbar and cervical radiculopathy and lumbar spinal stenosis. Random checks have shown lower use than expected. This study aimed to describe and explore the utilisation of standardised chiropractic care packages and identify barriers to uptake. METHODS: A convergent mixed-method design was conceptualised. The use of standardised care packages was collected by register data. Potential determinants of difference in utilisation were assessed using a modified version of the Determinants of Implementation Behaviour Questionnaire (DIBQ) divided into 13 domains and sent to chiropractors in private clinics in Denmark in 2019. An open-ended question was added to the questionnaire, and thematic content analysis was applied. Qualitative findings were used to expand on the DIBQ data providing further insight into the clinicians' perspective on standardised care packages. RESULTS: Registry data of 244 included chiropractic clinics showed limited and inconsistent use of the standardised chiropractic care packages. A total of 269 chiropractors (44%) answered the DIBQ, and 45 provided data for the qualitative analyses. At least 60% of the clinicians answered 'Strongly agree' or 'Agree' in 10 out of 13 DIBQ domains suggesting a positive attitude towards using the standardised care packages. Three domains were identified as 'problematic' as more than 20% of clinicians disagreed or strongly disagreed: 'Socio-political context', 'Goals' and 'Innovation'. Qualitative findings indicated that lack of usage of the standardised care packages was mainly related to the practical organization of standardised care, the chiropractor's role when managing patients, and the patient population of interest to the clinic (e.g., children, athletes). CONCLUSION: In general, Danish chiropractors displayed positive attitudes towards standardised packages of care. However, considerable variation in the use of the standardised care programs was observed. Low utilisation seemed mainly related to logistics, the chiropractor's role, collaboration with GPs, and the patient population of interest to the clinic. These findings should be further explored in more extensive qualitative studies to inform implementation initiatives to increase and rectify utility.

Manual joint mobilisation techniques, supervised physical activity, psychological treatment, acupuncture and patient education for patients with tension-type headache. A systematic review and meta-analysis.

BACKGROUND: Tension-type headache (TTH) has been ranked the second most prevalent health condition worldwide. Non-pharmacological treatments for TTH are widely used as a supplement or an alternative to medical treatment. However, the evidence for their effects are limited. Therefore, the aim of this study was to review the evidence for manual joint mobilisation techniques, supervised physical activity, psychological treatment, acupuncture and patient education as treatments for TTH on the effect of headache frequency and quality of life. METHODS: A systematic literature search was conducted from February to July 2020 for clinical guidelines, systematic reviews, and individual randomised controlled trials (RCT). The primary outcomes measured were days with headache and quality of life at the end of treatment along with a number of secondary outcomes. Meta-analyses were performed on eligible RCTs and pooled estimates of effects were calculated using the random-effect model. The overall certainty of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation approach (GRADE). In addition, patient preferences were included in the evaluation. RESULTS: In all, 13 RCTs were included. Acupuncture might have positive effects on both primary outcomes. Supervised physical activity might have a positive effect on pain intensity at the end of treatment and headache frequency at follow-up. Manual joint mobilisation techniques might have a positive effect on headache frequency and quality of life at follow-up. Psychological treatment might have a positive effect on stress symptoms at the end of treatment. No relevant RCTs were identified for patient education. The overall certainty of evidence was downgraded to low and very low. No serious adverse events were reported. A consensus recommendation was made for patient education and weak recommendations for the other interventions. CONCLUSION: Based on identified benefits, certainty of evidence, and patient preferences, manual joint mobilisation techniques, supervised physical activity, psychological treatment, acupuncture, and patient education can be considered as non-pharmacological treatment approaches for TTH. Some positive effects were shown on headache frequency, quality of life, pain intensity and stress symptoms. Few studies and low sample sizes posed a challenge in drawing solid conclusions. Therefore, high-quality RCTs are warranted.

European guidelines on radiographic image quality in chiropractic practice - proposal of a cross-sectional graded classification reporting principle.

BACKGROUND: The Commission of the European Communities (CEC) has published: European Guidelines on Quality Criteria for Diagnostic Radiographic Images. These guidelines are considered a gold standard, recommended for use in quality assurance protocols. The objectives of this study: 1) Propose a graded classification format for Danish chiropractic clinics according to the CEC-quality criteria for diagnostic radiographic images of the lumbar spine. 2) Propose a reporting principle for quality of radiographic images. 3) Document variation in radiation exposure among clinics. METHODS: This is a cross-sectional study of image quality based on random sampling from 148 chiropractic clinics. Clinics were included if using: 1) Digital radiography and 2) The chiropractic picture and archiving system (KirPACS) at the Nordic Institute of Chiropractic and Clinical Biomechanics (NIKKB) in Denmark. A sample of 296 lumbar spine series were randomly collected from KirPACS (January 2018). Two independent observers reviewed 50 lumbar spine series twice with a 4-week interval, testing intra- and inter-observer reproducibility. The same observers then reviewed the remaining 246 radiographic studies. All studies were evaluated using the CEC Quality Criteria. Patient radiation dose values were retrieved from KirPACS (First quarter of 2020). RESULTS: A reporting and classification principle of diagnostic image quality was used in 148 chiropractic clinics. Compliance with the 22 CEC Quality Criteria had proportions ranging from 0.72-0.96 for 18 criteria, while 4 criteria specifying detail and definition ranged between 0.20-0.66. The proposed rating system (A to E) revealed: 18 A clinics, 28 B clinics, 32 C clinics, 25 D clinics and 45 E clinics (A = highest quality; E = lowest quality). The patient radiation reference dose in Denmark is 7 mGy for the AP/PA lumbar spine. Very few clinics exceed the reference dose value, approximately 50% of clinics were below 5 mGy. CONCLUSION: A reporting principle is proposed for a graded classification format based on the CEC-quality criteria for diagnostic radiographic images of the lumbar spine. The Quality Criteria are for the most part met satisfactorily in 148 Danish chiropractic clinics, but important image details are compromised, in most cases, because of low patient radiation doses. The results of a patient radiation dose survey enabled documentation of variation in radiation exposure among chiropractic clinics.

The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial.

BACKGROUND: Chiropractic care is commonly used to treat infantile colic. However large trials with parental blinding are missing. Therefore, the purpose of this study is to evaluate the effect of chiropractic care on infantile colic. METHOD: This is a multicenter, single-blind randomized controlled trial conducted in four Danish chiropractic clinics, 2015-2019. Information was distributed in the maternity wards and by maternal and child health nurses. Children aged 2-14 weeks with unexplained excessive crying were recruited through home visits and randomized (1:1) to either chiropractic care or control group. Both groups attended the chiropractic clinic twice a week for 2 weeks. The intervention group received chiropractic care, while the control group was not treated. The parents were not present in the treatment room and unaware of their child's allocation. The primary outcome was change in daily hours of crying before and after treatment. Secondary outcomes were changes in hours of sleep, hours being awake and content, gastrointestinal symptoms, colic status and satisfaction. All outcomes were based on parental diaries and a final questionnaire. RESULTS: Of 200 recruited children, 185 completed the trial (treatment group n = 96; control group n = 89). Duration of crying in the treatment group was reduced by 1.5 h compared with 1 h in the control group (mean difference - 0.6, 95% CI - 1.1 to - 0.1; P = 0.026), but when adjusted for baseline hours of crying, age and chiropractic clinic, the difference was not significant (P = 0.066). The proportion obtaining a clinically important reduction of 1 h of crying was 63% in the treatment group and 47% in the control group (p = 0.037), and NNT was 6.5. We found no effect on any of the secondary outcomes. CONCLUSION: Excessive crying was reduced by half an hour in favor of the group receiving chiropractic care compared with the control group, but not at a statistically significant level after adjustments. From a clinical perspective, the mean difference between the groups was small, but there were large individual differences, which emphasizes the need to investigate if subgroups of children, e.g. those with musculoskeletal problems, benefit more than others from chiropractic care. TRIAL REGISTRATION: Clinical Trials NCT02595515 , registered 2 November 2015.

Identifying potential treatment effect modifiers of the effectiveness of chiropractic care to infants with colic through prespecified secondary analyses of a randomised controlled trial.

BACKGROUND: A recent trial identified large variation in effect of chiropractic care for infantile colic. Thus, identification of possible effect modifiers could potentially enhance the clinical reasoning to select infants with excessive crying for chiropractic care. Therefore, the aim of this study is to identify potential treatment effect modifiers which might influence the effect of chiropractic care for excessive crying in infancy. METHODS: Design: Prespecified secondary analyses of data from a randomised controlled trial. The analyses are partly confirmative and partly exploratory. SETTING: Four chiropractic clinics in Denmark. PARTICIPANTS: Infants aged 2-14 weeks with unexplained excessive crying. Of the 200 infants randomised (1:1), 103 were assigned to a chiropractic care group and 97 to a control group. INTERVENTION: Infants in the intervention group received chiropractic care for 2 weeks, while the control group was not treated. Main analyses: The outcome was change in daily hours of crying. Fifteen baseline variables and 6 general variables were selected as potential effect modifiers, and indices based on these were constructed. Factor analyses, latent class analyses and prognosis were used to construct other potentially modifying variables. Finally, an attempt at defining a new index aiming at optimal prediction of the treatment effect was made. The predictive value for all resulting variables were examined by considering the difference in mean change in crying time between the two treatment groups, stratified by the values of the candidate variables, i.e. interaction analyses. RESULTS: None of the predefined items or indices were shown to be useful in identifying colicky infants with potentially larger gain from manual therapy. However, more baseline hours of crying (p = 0.029), short duration of symptoms (p = 0.061) and young age (p = 0.089) were all associated with an increased effect on the outcome of hours of crying. CONCLUSION: Musculoskeletal indicators were not shown to be predictive of an increased benefit for colicky infants from chiropractic treatment. However, increased benefit was associated with early treatment and a high level of baseline crying, suggesting that the most severely affected infants have the greatest potential of benefiting from manual therapy. This finding requires validation by future studies. TRIAL REGISTRATION: Clinical Trials NCT02595515 , registered 2 November 2015.

The global summit on the efficacy and effectiveness of spinal manipulative therapy for the prevention and treatment of non-musculoskeletal disorders: a systematic review of the literature.

BACKGROUND: A small proportion of chiropractors, osteopaths, and other manual medicine providers use spinal manipulative therapy (SMT) to manage non-musculoskeletal disorders. However, the efficacy and effectiveness of these interventions to prevent or treat non-musculoskeletal disorders remain controversial. OBJECTIVES: We convened a Global Summit of international scientists to conduct a systematic review of the literature to determine the efficacy and effectiveness of SMT for the primary, secondary and tertiary prevention of non-musculoskeletal disorders. GLOBAL SUMMIT: The Global Summit took place on September 14-15, 2019 in Toronto, Canada. It was attended by 50 researchers from 8 countries and 28 observers from 18 chiropractic organizations. At the summit, participants critically appraised the literature and synthesized the evidence. SYSTEMATIC REVIEW OF THE LITERATURE: We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, the Cumulative Index to Nursing and Allied Health, and the Index to Chiropractic Literature from inception to May 15, 2019 using subject headings specific to each database and free text words relevant to manipulation/manual therapy, effectiveness, prevention, treatment, and non-musculoskeletal disorders. Eligible for review were randomized controlled trials published in English. The methodological quality of eligible studies was assessed independently by reviewers using the Scottish Intercollegiate Guidelines Network (SIGN) criteria for randomized controlled trials. We synthesized the evidence from articles with high or acceptable methodological quality according to the Synthesis without Meta-Analysis (SWiM) Guideline. The final risk of bias and evidence tables were reviewed by researchers who attended the Global Summit and 75% (38/50) had to approve the content to reach consensus. RESULTS: We retrieved 4997 citations, removed 1123 duplicates and screened 3874 citations. Of those, the eligibility of 32 articles was evaluated at the Global Summit and 16 articles were included in our systematic review. Our synthesis included six randomized controlled trials with acceptable or high methodological quality (reported in seven articles). These trials investigated the efficacy or effectiveness of SMT for the management of infantile colic, childhood asthma, hypertension, primary dysmenorrhea, and migraine. None of the trials evaluated the effectiveness of SMT in preventing the occurrence of non-musculoskeletal disorders. Consensus was reached on the content of all risk of bias and evidence tables. All randomized controlled trials with high or acceptable quality found that SMT was not superior to sham interventions for the treatment of these non-musculoskeletal disorders. Six of 50 participants (12%) in the Global Summit did not approve the final report. CONCLUSION: Our systematic review included six randomized clinical trials (534 participants) of acceptable or high quality investigating the efficacy or effectiveness of SMT for the treatment of non-musculoskeletal disorders. We found no evidence of an effect of SMT for the management of non-musculoskeletal disorders including infantile colic, childhood asthma, hypertension, primary dysmenorrhea, and migraine. This finding challenges the validity of the theory that treating spinal dysfunctions with SMT has a physiological effect on organs and their function. Governments, payers, regulators, educators, and clinicians should consider this evidence when developing policies about the use and reimbursement of SMT for non-musculoskeletal disorders.

Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years - a randomised clinical trial.

BACKGROUND: To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7-14 with recurrent headaches. METHODS: Design: A two-arm, single-blind, superiority randomised controlled trial. SETTING: One chiropractic clinic and one paediatric specialty practice in Denmark, November 2015 to August 2020. PARTICIPANTS: 199 children aged 7 to 14 years, with at least one episode of headache per week for the previous 6 months and at least one musculoskeletal dysfunction identified. INTERVENTIONS: All participants received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. Number and frequency of treatments were based on the chiropractor's individual evaluation in the active treatment group; the children in the control group received approximately eight visits during the treatment period. PRIMARY OUTCOME MEASURES: 'Number of days with headache', 'pain intensity' and 'medication' were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. 'Number of days with headache' and 'pain intensity' were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account. RESULTS: Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p = 0.019, NNT = 7 for 20% improvement) and better global perceived effect (dichotomized into improved/not improved, OR = 2.8 (95% CI: 1.5-5.3), NNT = 5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use. CONCLUSIONS: Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches. Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches. TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT02684916 , registered 02/18/2016 - retrospectively registered.

The Danish Chiropractic Low Back Pain Cohort (ChiCo): Description and Summary of an Available Data Source for Research Collaborations.

BACKGROUND: Back pain is among the most frequent reasons for care seeking globally. Observational clinical cohorts are useful for understanding why people seek care, the content of that care, and factors related to prognosis. This paper describes the Danish Chiropractic low back pain Cohort (ChiCo) and summarizes the primary characteristics of the population to inform the scientific community of the availability of these data as a resource for collaborative research projects. METHODS: Adults seeking chiropractic care for a new episode of non-specific back pain were enrolled at the initial visit and followed up after 2, 13, and 52 weeks, with a subpopulation having weekly follow-ups for 1 year. Patient-reported and clinical-reported data were collected in an electronic database using the REDCap software (REDCap Consortium, projectredcap.org). Variables were chosen to measure pre-defined research domains and questions and to capture information across health constructs deemed relevant for additional research. Non-responders at 13 and 52 weeks were contacted by phone to maximize follow-up data and explore differences on core outcomes between responders and non-responders. RESULTS: A total of 2848 patients (mean age 45 years, 59% men) were included from 10 clinics with 71%, 68% and 64% responding to follow-ups at 2, 13 and 52 weeks, respectively. Most participants (82%) were employed, nearly half reported current LBP for 1-7 days, and 83% had experienced LBP episodes previously. We did not identify indications of serious attrition bias. CONCLUSION: We have described the aims and procedures for establishing the ChiCo cohort, characteristics of the cohort, and available information about attrition bias. These data have the potential to be linked, at an individual participant level, to the extensive Danish population-based registries that measure diverse health and social characteristics.

Degenerative findings in lumbar spine MRI: an inter-rater reliability study involving three raters.

BACKGROUND: For diagnostic procedures to be clinically useful, they must be reliable. The interpretation of lumbar spine MRI scans is subject to variability and there is a lack of studies where reliability of multiple degenerative pathologies are rated simultaneously. The objective of our study was to determine the inter-rater reliability of three independent raters evaluating degenerative pathologies seen with lumbar spine MRI. METHODS: Fifty-nine people, 35 patients with low back pain (LBP) or LBP and leg pain and 24 people without LBP or leg pain, received an MRI of the lumbar spine. Three raters (one radiologist and two chiropractors) evaluated the MRIs for the presence and severity of eight degenerative spinal pathologies using a standardized format: Spondylolisthesis, scoliosis, annular fissure, disc degeneration, disc contour, nerve root compromise, spinal stenosis and facet joint degeneration. Findings were identified and classified at disc level according to type and severity. Raters were instructed to evaluate all study sample persons once to assess inter-rater reliability (fully crossed design). Reliability was calculated using Gwet's Agreement Coefficients (AC1 and AC2) and Cohen's Kappa (κ) and Conger's extension of Cohen's. Gwet's probabilistic benchmarking method to the Landis and Koch scale was used. MRI-findings achieving substantial reliability was considered acceptable. RESULTS: Inter-rater reliability for all raters combined, ranged from (Gwet's AC1 or AC2): 0.64-0.99 and according to probabilistic benchmarking to the Landis and Koch scale equivalent to moderate to almost perfect reliability. Overall reliability level for individual pathologies was almost perfect reliability for spondylolisthesis, spinal stenosis, scoliosis and annular fissure, substantial for nerve root compromise and disc degeneration, and moderate for facet joint degeneration and disc contour. CONCLUSION: Inter-rater reliability for 3 raters, evaluating 177 disc levels, was found to be overall acceptable for 6 out of 8 degenerative MRI-findings in the lumbar spine. Ratings of facet joint degeneration and disc contour achieved moderate reliability and was considered unacceptable.

Effectiveness of chiropractic manipulation versus sham manipulation on recurrent headaches in children aged 7-14 years, Protocol for a randomized clinical trial.

Background: Headache is one of the most common pain symptoms in childhood having a negative impact on many aspects of the lives of affected children, both short-term and long-term. Therefore, it is important to document safe and effective treatment options. Chiropractic spinal manipulation is a commonly used treatment option for these patients, although there are no randomized clinical trials documenting the effectiveness of this in pediatric headache. However, there is moderate evidence for effectiveness of spinal manipulation for adults with tension-type and cervicogenic headaches.This paper describes the protocol for a two-armed randomized superiority clinical trial aiming to investigate the effectiveness of chiropractic manipulation versus sham manipulation in the treatment of recurrent headache in children aged 7-14. Methods: Children with weekly headaches for at least six months will be included if they have indications for chiropractic manipulation. The participants will be randomized to either chiropractic manipulation or sham manipulation. Both children and parents will be blinded for allocation. There will be 100 children in each arm and they will answer weekly text messages four weeks prior to treatment and during a four months treatment period. Potential primary outcomes are weekly number of headaches, intensity of headache, medication use and global perceived effect. Secondary outcomes include side-effects and headache status after one year.An initial outcome data analysis will be performed to inform the choice of primary outcome (adaptive design). Intervention effects will be reported as the difference in mean values between the two treatment arms, Cohen's effect size and numbers needed to treat. Discussion: A major strength of this study is its pragmatic nature, where the active treatment group receives chiropractic manipulation according to their individual needs, while both groups continue their use of medication for headache according to their pre-trial habits. Other strengths include an elaborate sham procedure and the weekly outcome reports, reducing recall bias.If it is possible to develop effective treatment for headache in children, a life course of recurring problems may be altered with potential positive implications for both individuals and society. Trial registration: ClinicalTrials.gov, identifier NCT02684916.

European guidelines on quality criteria for diagnostic radiographic images of the lumbar spine - an intra- and inter-observer reproducibility study.

Background: The Commission of the European Communities has published guidelines to be used as a gold standard for quality assessment of diagnostic radiographic images. Image quality and radiation dose must be monitored and optimally balanced for diagnostic purposes on patients. The objective of the current study was to assess intra- and inter-observer reproducibility in less experienced observers using the proposed European Guidelines on Quality Criteria for Diagnostic Radiographic Images in a quality assessment of lumbar spine radiographs in primary chiropractic practice in Denmark. Methods: Two observers initially evaluated lumbar spine radiographs randomly selected from fifty chiropractic clinics, all connected to the national PACS server (KirPACS) in Denmark. All evaluations were performed twice by both observers using a four-week interval and for compliance with the European Quality Criteria for Diagnostic Radiographic Images. Inter- and intra-observer reproducibility was calculated using kappa statistics. In the interpretation of the kappa coefficient, the standards for strength of agreement reported by Landis and Koch were followed. Results: The strength of the inter-observer agreement of general image quality at baseline ranged from moderate agreement (k = 0.47) to substantial agreement (k = 0.68). After four weeks, the inter-observer agreement still ranged from moderate agreement (k = 0.59) to substantial agreement (k = 0.71), but with increased agreement for both kappa coefficients. In relation to intra-observer agreement of general image quality, the strength for observer A ranged from moderate (k = 0.58) to substantial (k = 0.72) and the strength for observer B overall was substantial (k = 0.63-0.75). Conclusion: The European Guidelines on Quality Criteria for Diagnostic Radiographic Images are considered a gold-standard and used in a method for quality assurance within the Danish chiropractic profession. The inter-rater and intra-rater agreements in this study, using the CEC-criteria, were found mostly acceptable. With appropriate attention to clear understanding of the individual criteria and sufficient training, this method is found to be reliable, even using less experienced observers, to carry out Diagnostic Radiographic Image Quality-assurance in primary care settings.

The effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled trial.

Background: Infantile colic is a common condition during early childhood affecting around one of six newborns. The condition is characterized by inconsolable crying and fussing in otherwise healthy and thriving infants. The most used definition is excessive crying for at least three hours a day for at least three days for at least three weeks. The cause of colic is still unknown although many hypotheses and thereby many different treatment modalities have been investigated. Chiropractic care is used increasingly in treatment of infants, including for infantile colic, although the evidence worldwide is sparse. A randomized, controlled trial was designed to evaluate the effect of chiropractic treatment on infantile colic. This paper describes the protocol as well as results from a pilot study examining the acceptability and feasibility of the intervention. Method: The study is designed as a single-blind randomized, controlled trial. The invited families are residents on the Island of Funen and information about the project is distributed from the maternity wards and health visitors. Children at the age of 2-14 weeks with unexplained excessive crying are screened for eligibility and recruited by the primary investigator through home visits. Eligible children are then randomized to chiropractic treatment or control. All children attend in the chiropractor clinic two times a week for two weeks. The parents are unaware of their child's allocation during the project period. The primary outcome measure is change in daily hours of crying based on the parental diaries.The study intends to include 200 children, and the intervention has, during a pilot study, been found acceptable and feasible among families with newborns. Discussion: In a single-blind randomized controlled design we will evaluate the effectiveness of chiropractic treatment on infantile colic. The study will contribute to determine the effect of chiropractic treatment on infantile colic in an area where limited evidence exists. Furthermore, the study aims to explore if subgroups of children with suspected musculoskeletal problems will benefit more from the intervention than others. If they obtain better results, this could imply the need for stratified care. Trial registration: Clinicaltrials.gov and Identifier: NCT02595515 (registered 2 November 2015).