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Central sensitization cannot be directly demonstrated in humans and thus a gold standard is missing. Therefore, we used human assumed central sensitization (HACS) when associated with humans. The central sensitization inventory (CSI) is a screening questionnaire for addressing symptoms that are associated with HACS. This cross-sectional study compared patients with chronic pain and at least one central sensitivity syndrome with healthy, pain-free controls via ROC analyses. Analyses were performed for all participants together and for each sex separately. Regression analyses were performed on patients with chronic pain with and without central sensitivity syndromes. Based on 1730 patients and 250 healthy controls, cutoff values for the CSI for the total group were established at 30 points: women: 33 points; men: 25 points. Univariate and multivariate regression analyses were used to identify possible predictors for the CSI score in 2890 patients with chronic pain. The CSI score is associated with all independent factors and has a low association with pain severity in women and a low association with pain severity, age, and body mass index in men. The newly established CSI cutoff values are lower than in previous studies and different per sex, which might be of clinical relevance in daily practice and importance in research. [ABSTRACT FROM AUTHOR]

Background: The PainDETECT-Questionnaire (PDQ) helps to identify neuropathic components in patients suffering from pain. It can be used by clinicians in daily practice and in clinical trials. Aim: The aim of this study is to perform a translation and cross-cultural adaptation of the PDQ for use in the Netherlands and Belgium. Methods: The first phase was to translate and cross-culturally adapt the PDQ to Dutch. The second phase was to assess the face validity in the Netherlands and Belgium using qualitative and quantitative data collection. Results: The length, the readability, and the clarity of the questionnaire were good for all patients. The questionnaire was judged to have a good layout and to be clearly organized. Conclusion: The PDQ Dutch language Version is a well translated and cross-culturally adapted questionnaire, which might be useful for screening for neuropathic components of pain in the Netherlands and Belgium.▪ [ABSTRACT FROM AUTHOR]

Purpose: A scoping review was conducted with the objective to identify and map the available evidence from long-term studies on chronic non-specific low back pain (LBP), to examine how these studies are conducted, and to address potential knowledge gaps. Method: We searched MEDLINE and EMBASE up to march 2021, not restricted by date or language. Experimental and observational study types were included. Inclusion criteria were: participants between 18 and 65 years old with non-specific sub-acute or chronic LBP, minimum average follow-up of > 2 years, and studies had to report at least one of the following outcome measures: disability, quality of life, work participation, or health care utilization. Methodological quality was assessed using the Effective Public Health Practice Project quality assessment. Data were extracted, tabulated, and reported thematically. Results: Ninety studies met the inclusion criteria. Studies examined invasive treatments (72%), conservative (21%), or a comparison of both (7%). No natural cohorts were included. Methodological quality was weak (16% of studies), moderate (63%), or strong (21%) and generally improved after 2010. Disability (92%) and pain (86%) outcomes were most commonly reported, followed by work (25%), quality of life (15%), and health care utilization (4%). Most studies reported significant improvement at long-term follow-up (median 51 months, range 26 months–18 years). Only 10 (11%) studies took more than one measurement > 2 year after baseline. Conclusion: Patients with persistent non-specific LBP seem to experience improvement in pain, disability and quality of life years after seeking treatment. However, it remains unclear what factors might have influenced these improvements, and whether they are treatment-related. Studies varied greatly in design, patient population, and methods of data collection. There is still little insight into the long-term natural course of LBP. Additionally, few studies perform repeated measurements during long-term follow-up or report on patient-centered outcomes other than pain or disability. [ABSTRACT FROM AUTHOR]

BACKGROUND: Central sensitization cannot be demonstrated directly in humans. Therefore, studies used different proxy markers (signs, symptoms and tools) to identify factors assumed to relate to central sensitization in humans, that is, Human Assumed Central Sensitization (HACS). The aims of this systematic review were to identify non-invasive objective markers of HACS and the instruments to assess these markers in patients with fibromyalgia (FM). METHODS: A systematic review was conducted with the following inclusion criteria: (1) adults, (2) diagnosed with FM, and (3) markers and instruments for HACS had to be non-invasive. Data were subsequently extracted, and studies were assessed for risk of bias using the quality assessment tools developed by the National Institute of Health. RESULTS: 78 studies (n = 5234 participants) were included and the findings were categorized in markers identified to assess peripheral and central manifestations of HACS. The identified markers for peripheral manifestations of HACS, with at least moderate evidence, were pain after-sensation decline rates, mechanical pain thresholds, pressure pain threshold, sound 'pressure' pain threshold, cutaneous silent period, slowly repeated evoked pain sensitization and nociceptive flexion reflex threshold. The identified markers for central manifestations of HACS were efficacy of conditioned pain modulation with pressure pain conditioning and brain perfusion analysis. Instruments to assess these markers are: pin-prick stimulators, cuff-algometry, repetitive pressure stimulation using a pressure algometer, sound, electrodes and neuroimaging techniques. CONCLUSIONS: This review provides an overview of non-invasive markers and instruments for the assessment of HACS in patients with FM. Implementing these findings into clinical settings may help to identify HACS in patients with FM. [ABSTRACT FROM AUTHOR]

Background: Neuropathic pain is defined as pain caused by a lesion or disease of the somatosensory nervous system and is a major therapeutic challenge. Several screening tools have been developed to help physicians detect patients with neuropathic pain. These have typically been validated in populations pre-stratified for neuropathic pain, leading to a so called "Catch-22 situation:" "a problematic situation for which the only solution is denied by a circumstance inherent in the problem or by a rule". The validity of screening tools needs to be proven in patients with pain who were not pre-stratified on basis of the target outcome: neuropathic pain or non-neuropathic pain. This study aims to assess the validity of the Dutch PainDETECT (PainDETECT-Dlv) in a large population of patients with chronic pain.Methods: A cross-sectional multicentre design was used to assess PainDETECT-Dlv validity. Included where patients with low back pain radiating into the leg(s), patients with neck-shoulder-arm pain and patients with pain due to a suspected peripheral nerve damage. Patients' pain was classified as having a neuropathic pain component (yes/no) by two experienced physicians ("gold standard"). Physician opinion based on the Grading System was a secondary comparison.Results: In total, 291 patients were included. Primary analysis was done on patients where both physicians agreed upon the pain classification (n = 228). Compared to the physician's classification, PainDETECT-Dlv had a sensitivity of 80% and specificity of 55%, versus the Grading System it achieved 74 and 46%.Conclusion: Despite its internal consistency and test-retest reliability the PainDETECT-Dlv is not an effective screening tool for a neuropathic pain component in a population of patients with chronic pain because of its moderate sensitivity and low specificity. Moreover, the indiscriminate use of the PainDETECT-Dlv as a surrogate for clinical assessment should be avoided in daily clinical practice as well as in (clinical-) research. Catch-22 situations in the validation of screening tools can be prevented by not pre-stratifying the patients on basis of the target outcome before inclusion in a validation study for screening instruments.Trial Registration: The protocol was registered prospectively in the Dutch National Trial Register: NTR 3030 . [ABSTRACT FROM AUTHOR]

Background: In a Dutch hospital, unexpectedly, safer perioperative care was found in non-western ethnic minority patients compared to Dutch ethnic majority patients undergoing high-risk surgery with a mortality risk >1%. We explored determinants in order to find tools for nurses and physicians to improve patients' safety and safety experience during the perioperative period. Methods: A qualitative grounded theory design was applied to understand patients' perspective on their needs and safety in the perioperative period we interviewed patients (n = 17). Results: Three themes emerged: 'Nurse & physician behaviour', 'Team performance', and 'Patient behaviour'. In the first theme 'Nurse and physicians' behaviour', positive determinants related to an attitude of experienced professionals that provide patients with trust. On the other hand, negative determinants provide patients with experiences of unsafety. In the second theme 'Team performance', positive determinants involved effective communication and coordinated care of the nurses and physicians. Negative determinants related to visible disagreement about the treatment. In the third theme 'Patient behaviour', positive determinants related to seeking support from nurses, physicians, and family to recover and to endure an anxious period. Negative determinants related to missing appointments or not consulting the information provided. Conclusion and practice implications: 'Nurse & physician behaviour' and 'Team performance' are relevant determinants that contribute to patients' experiences of safe care. Stimulating an active attitude of patients in seeking support may contribute to experiences of safe care. These results can be used to improve patients' experience of safe care in an uncertain and vulnerable perioperative period. [ABSTRACT FROM AUTHOR]

Patients with the genetic blistering skin condition epidermolysis bullosa (EB) report severe pain as a consequence of skin and mucous membrane lesions including blisters, wounds, and scars. Adequate symptom alleviation is not often achieved using conventional pharmacologic interventions. Finding novel approaches to pain care in EB is imperative to improve the quality of life of patients living with EB. There are several anecdotal reports on the use of cannabinoid-based medicines (CBMs) by EB patients to reduce the burden of symptoms. However, controlled clinical investigations assessing these reported effects are lacking. As the pain quality "unpleasantness" delineates EB pain, we hypothesize the modulation of affective pain processing in the brain by way of intervention with CBMs comprising the cannabinoids Δ-9-tetrahydrocannabinol and cannabidiol—objectified by functional magnetic resonance imaging (fMRI). The C4EB study is an investigator-initiated, single-centre, randomized, double-blind, placebo-controlled and crossover trial. Adult patients with the diagnosis epidermolysis bullosa, reporting chronic pain will be eligible to participate. Following baseline measurements, participants will be randomized to receive the sublingually administered interventions placebo and Transvamix® in forward or reversed orders, each for two weeks and separated by a washout. The primary outcome is the difference in numeric rating scale pain scores between grouped interventions, using affective descriptors within the Short-form McGill Pain Questionnaire-2. Secondary outcomes include pain self-efficacy, concomitant analgesic medication-use and adverse events. Additionally, fMRI will be employed to assess brain connectivity related to neuroanatomic pain circuits at baseline, placebo and Transvamix® interventions. The study was approved by the ethical committee at the University Medical Center of Groningen in the Netherlands. Results will be submitted for publication in a peer-reviewed journal. Trial registration number: Netherlands Trial Register: NL9347 (Acronym: C4EB). [ABSTRACT FROM AUTHOR]

Background: Inconsistent descriptions of Lumbar multifidus (LM) morphology were previously identified, especially in research applying ultrasonography (US), hampering its clinical applicability with regard to diagnosis and therapy. The aim of this study is to determine the LM-sonoanatomy by comparing high-resolution reconstructions from a 3-D digital spine compared to standard LM-ultrasonography.Methods: An observational study was carried out. From three deeply frozen human tissue blocks of the lumbosacral spine, a large series of consecutive photographs at 78 μm interval were acquired and reformatted into 3-D blocks. This enabled the reconstruction of (semi-)oblique cross-sections that could match US-images obtained from a healthy volunteer. Transverse and oblique short-axis views were compared from the most caudal insertion of LM to L1.Results: Based on the anatomical reconstructions, we could distinguish the LM from the adjacent erector spinae (ES) in the standard US imaging of the lower spine. At the lumbosacral junction, LM is the only dorsal muscle facing the surface. From L5 upwards, the ES progresses from lateral to medial. A clear distinction between deep and superficial LM could not be discerned. We were only able to identify five separate bands between every lumbar spinous processes and the dorsal part of the sacrum in the caudal anatomical cross-sections, but not in the standard US images.Conclusion: The detailed cross-sectional LM-sonoanatomy and reconstructions facilitate the interpretations of standard LM US-imaging, the position of the separate LM-bands, the details of deep interspinal muscles, and demarcation of the LM versus the ES. Guidelines for electrode positioning in EMG studies should be refined to establish reliable and verifiable findings. For clinical practice, this study can serve as a guide for a better characterisation of LM compared to ES and for a more reliable placement of US-probe in biofeedback. [ABSTRACT FROM AUTHOR]

The article presents a follow-up study which investigates whether the practice of continuous palliative sedation has changed after the introduction of a national guideline in Netherlands. It discusses the results of the study including the reported last case of continuous sedation in both the baseline and follow-up studies and the significant increase in patient involvement. It concludes that physicians reported changes in palliative sedation practice comply with the recommendations of the released guidance, in which the use of benzodiazepines for sedation increased.

Background: National Dutch guidelines have been introduced to improve suboptimal perioperative care. A multifaceted implementation programme (IMPlementatie Richtlijnen Operatieve VEiligheid [IMPROVE]) has been developed to support hospitals in applying these guidelines. This study evaluated the effectiveness of IMPROVE on guideline adherence and the association between guideline adherence and patient safety.Methods: Nine hospitals participated in this unblinded, superiority, stepped-wedge, cluster RCT in patients with major noncardiac surgery (mortality risk ≥1%). IMPROVE consisted of educational activities, audit and feedback, reminders, organisational, team-directed, and patient-mediated activities. The primary outcome of the study was guideline adherence measured by nine patient safety indicators on the process (stop moments from the composite STOP bundle, and timely administration of antibiotics) and on the structure of perioperative care. Secondary safety outcomes included in-hospital complications, postoperative wound infections, mortality, length of hospital stay, and unplanned care.Results: Data were analysed for 1934 patients. The IMPROVE programme improved one stop moment: 'discharge from recovery room' (+16%; 95% confidence interval [CI], 9-23%). This stop moment was related to decreased mortality (-3%; 95% CI, -4% to -1%), fewer complications (-8%; 95% CI, -13% to -3%), and fewer unscheduled transfers to the ICU (-6%; 95% CI, -9% to -3%). IMPROVE negatively affected one other stop moment - 'discharge from the hospital' - possibly because of the limited resources of hospitals to improve all stop moments together.Conclusions: Mixed implementation effects of IMPROVE were found. We found some positive associations between guideline adherence and patient safety (i.e. mortality, complications, and unscheduled transfers to the ICU) except for the timely administration of antibiotics.Clinical Trial Registration: NTR3568 (Dutch Trial Registry). [ABSTRACT FROM AUTHOR]

Background: Epidermolysis bullosa (EB) patient anecdotes and case reports indicate that cannabinoid-based medicines (CBMs) may alleviate pain and pruritus and improve wound healing. CBM use has not been characterized in the EB patient population.Objectives: To evaluate CBM use among EB patients, including CBM types, effects on symptoms (e.g., pain and pruritus), disease process (e.g., blistering, wounds, and inflammation), well-being (e.g., sleep, appetite) and concomitant medications.Methods: English-speaking EB patients or caregivers completed an online international, anonymous, cross-sectional survey regarding CBM use. Respondents reported the types of CBMs, subsequent effects including perceived EB symptom alteration, changes in medication use, and side effects.Results: Seventy-one EB patients from five continents reported using or having used CBMs to treat their EB. Missing question responses ranged between 0 (0%) and 33 (46%). Most used more than one CBM preparation (mean: 2.4 ± 1.5) and route of administration (mean: 2.1 ± 1.1). Topical and ingested were the most common routes. Pain and pruritus were reported retrospectively to decrease by 3 points (scale: 0-10; p < 0.001 for both) after CBM use. Most reported that CBM use improved their overall EB symptoms (95%), pain (94%), pruritus (91%) and wound healing (81%). Most participants (79%) reported decreased use of pain medications. The most common side-effect was dry mouth (44%).Conclusions: CBMs improve the perception of pain, pruritus, wound healing, and well-being in EB patients and reduced concomitant medication use. Nevertheless, a direct relation between the use of CBMs and reduction of the above-mentioned symptoms cannot be proven by these data. Therefore, future controlled studies using pharmaceutically standardised CBM preparations in EB are warranted to delineate the risks and benefits of CBMs. [ABSTRACT FROM AUTHOR]

Study Design: Prospective cohort study.Objective: The aim of this study was to identify treatment response trajectories in patients with low back pain (LBP) during and after multidisciplinary care in a tertiary spine center, and to examine baseline patient characteristics that can distinguish trajectories.Summary Of Background Data: Treatment response is often heterogeneous between patients with LBP. Knowledge on key characteristics that are associated with courses of disability could identify patients at risk for less favorable outcome. This knowledge will help improve shared decision-making.Methods: Adult patients with LBP completed questionnaires on disability (Pain Disability Index) and LBP impact (Impact Stratification of the National Institutes of Health minimal dataset) at baseline, 6, 12, 18, and 24 months' follow-up. Latent class analyses were applied to identify trajectories of disability and LBP impact. Baseline sociodemographic and clinical patient characteristics were compared between trajectory subgroups.Results: Follow-up was available for 996 patients on disability and 707 patients on LBP impact. Six trajectories were identified for both outcome measures. Three disability trajectories remained stable at distinct levels of severity (68% of patients) and three trajectories showed patterns of recovery (32%). For LBP impact there was one stable trajectory (17%), two slightly improving (59%), two recovering (15%), and one with a pattern of recovery and relapse (15%). Significant differences between trajectories were observed for almost all baseline patient characteristics.Conclusion: On average, patients show moderate improvements in disability and LBP impact 2 years after visiting a multidisciplinary tertiary spine center. However, latent class analyses revealed that most patients belong to subgroups experiencing stable levels of disability and LBP impact. Differences in baseline patient characteristics were mostly associated with baseline levels of functioning, instead of (un)favorable outcome during follow-up.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]

Study Design: A before and after study cohort study.Objectives: The aim of this study was to examine changes in health care costs after multidisciplinary spine care in patients with complex chronic back pain (CBP), to analyze the predictive value of patient and disease characteristics on health care costs, and to study the potential impact of biases concerning the use of real world data.Summary Of Background Data: Due to high direct and indirect societal costs of back pain there is a need for interventions that can assist in reducing the economic burden on patients and society.Methods: All patients referred to a university-based spine center insured at a major health care insurer in the Netherlands were invited. Personal and disease-related data were collected at baseline. Health care costs were retrieved from the health care insurer from 2 years before to 2 years after intervention. Repeated measures analysis of variances were calculated to study changes in health care costs after intervention. Multivariable regression analyses and cluster robust fixed effect models were applied to predict characteristics on health care costs. To study regression to the mean, a fixed effect model was calculated comparing 2 years before and 2 years post-intervention.Results: In total 428,158 declarations during 4.6 years were filed by 997 participants (128,666 considered CBP-related). CBP-related costs significantly increased during the intervention period and reduced 2 years after the intervention. Total health care costs kept rising. The intervention was associated with a 21% to 34% (P < 0.01) reduction in costs depending on the model used. Reduction in costs was related to being male and lower body mass index.Conclusion: This study suggests that reduction in CBP-related health care utilization in patients with complex CBP can be achieved after a multidisciplinary spine intervention. The results are robust to controlling for background characteristics and are unlikely to be fully driven by regression to the mean.Level Of Evidence: 4. [ABSTRACT FROM AUTHOR]

Background: Lumbar multifidus (LM) is regarded as the major stabilizing muscle of the spine. The effects of exercise therapy in low back pain (LBP) are attributed to this muscle. A current literature review is warranted, however, given the complexity of LM morphology and the inconsistency of anatomical descriptions in the literature.Methods: Scoping review of studies on LM morphology including major anatomy atlases. All relevant studies were searched in PubMed (Medline) and EMBASE until June 2019. Anatomy atlases were retrieved from multiple university libraries and online. All studies and atlases were screened for the following LM parameters: location, imaging methods, spine levels, muscle trajectory, muscle thickness, cross-sectional area, and diameter. The quality of the studies and atlases was also assessed using a five-item evaluation system.Results: In all, 303 studies and 19 anatomy atlases were included in this review. In most studies, LM morphology was determined by MRI, ultrasound imaging, or drawings - particularly for levels L4-S1. In 153 studies, LM is described as a superficial muscle only, in 72 studies as a deep muscle only, and in 35 studies as both superficial and deep. Anatomy atlases predominantly depict LM as a deep muscle covered by the erector spinae and thoracolumbar fascia. About 42% of the studies had high quality scores, with 39% having moderate scores and 19% having low scores. The quality of figures in anatomy atlases was ranked as high in one atlas, moderate in 15 atlases, and low in 3 atlases.Discussion: Anatomical studies of LM exhibit inconsistent findings, describing its location as superficial (50%), deep (25%), or both (12%). This is in sharp contrast to anatomy atlases, which depict LM predominantly as deep muscle. Within the limitations of the self-developed quality-assessment tool, high-quality scores were identified in a majority of studies (42%), but in only one anatomy atlas.Conclusions: We identified a lack of standardization in the depiction and description of LM morphology. This could affect the precise understanding of its role in background and therapy in LBP patients. Standardization of research methodology on LM morphology is recommended. Anatomy atlases should be updated on LM morphology. [ABSTRACT FROM AUTHOR]

Study Design: Cross-sectional study.Objective: The aim of this study was to study the personal and societal impact of low back pain (LBP) in patients admitted to a multidisciplinary spine center.Summary Of Background Data: The socioeconomic burden of LBP is very high. A minority of patients visit secondary or tertiary care because of severe and long-lasting complaints. This subgroup may account for a major part of disability and costs, yet could potentially gain most from treatment. Currently, little is known about the personal and societal burden in patients with chronic complex LBP visiting secondary/tertiary care.Methods: Baseline data were acquired through patient-reported questionnaires and health insurance claims. Primary outcomes were LBP impact (Impact Stratification, range 8-50), functioning (Pain Disability Index, PDI; 0-70), quality of life (EuroQol-5D, EQ5D; -0.33 to 1.00), work ability (Work Ability Score, WAS; 0-10), work participation, productivity costs (Productivity Cost Questionnaire), and healthcare costs 1 year before baseline. Healthcare costs were compared with matched primary and secondary care LBP samples. Descriptive and inferential statistics were applied.Results: In total, 1502 patients (age 46.3 ± 12.8 years, 57% female) were included. Impact Stratification was 35.2 ± 7.5 with severe impact (≥35) for 58% of patients. PDI was 38.2 ± 14.1, EQ5D 0.39 (interquartile range, IQR: 0.17-0.72); WAS 4.0 (IQR: 1.0-6.0) and 17% were permanently work-disabled. Mean total health care costs (&OV0556;4875, 95% confidence interval [CI]: 4309-5498) were higher compared to the matched primary care sample (n = 4995) (&OV0556;2365, 95% CI: 2219-2526, P < 0.001), and similar to the matched secondary care sample (n = 4993) (&OV0556;4379, 95% CI: 4180-4590). Productivity loss was estimated at &OV0556;4315 per patient (95% CI: 3898-4688) during 6 months.Conclusion: In patients seeking multidisciplinary spine care, the personal and societal impact of LBP is very high. Specifically, quality of life and work ability are poor and health care costs are twice as high compared to patients seeking primary LBP care.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

Neuropathic pain is clinically described as pain caused by a lesion or disease of the somatosensory nervous system. The aim of this study was to assess the validity of the Dutch version of the DN4, in a cross-sectional multicentre design, as a screening tool for detecting a neuropathic pain component in a large consecutive, not pre-stratified on basis of the target outcome, population of patients with chronic pain. Patients’ pain was classified by two independent (pain-)physicians as the gold standard. The analysis was initially performed on the outcomes of those patients (n = 228 out of 291) in whom both physicians agreed in their pain classification. Compared to the gold standard the DN4 had a sensitivity of 75% and specificity of 76%. The DN4-symptoms (seven interview items) solely resulted in a sensitivity of 70% and a specificity of 67%. For the DN4-signs (three examination items) it was respectively 75% and 75%. In conclusion, because it seems that the DN4 helps to identify a neuropathic pain component in a consecutive population of patients with chronic pain in a moderate way, a comprehensive (physical-) examination by the physician is still obligate. [ABSTRACT FROM AUTHOR]

The Definition, Assessment, and Prevalence of (Human Assumed) Central Sensitisation in Patients with Chronic Low Back Pain: A Systematic Review. 23444448 7 Jensen O.K., Nielsen C.V., Stengaard-Pedersen K. Low back pain may be caused by disturbed pain regulation: A cross-sectional study in low back pain patients using tender point examination. The Definition, Assessment, and Prevalence of (Human Assumed) Central Sensitisation in Patients with Chronic Low Back Pain: A Systematic Review. Reply to Jensen, O.K. On the Use of Quantitative Sensory Testing to Estimate Central Sensitization in Humans. [Extracted from the article]

Background This study is initiated to evaluate the effects, costs, and feasibility at the hospital and patient level of an evidence-based strategy to improve the use of Dutch perioperative safety guidelines. Based on current knowledge, expert opinions and expertise of the project team, a multifaceted implementation strategy has been developed. Methods/design This is a stepped wedge cluster randomized trial including nine representative hospitals across The Netherlands. Hospitals are stratified into three groups according to hospital type and geographical location and randomized in terms of the period for receipt of the intervention. All adult surgical patients meeting the inclusion criteria are assessed for patient outcomes. The implementation strategy includes education, audit and feedback, organizational interventions (e.g., local embedding of the guidelines), team-directed interventions (e.g., multi-professional team training), reminders, as well as patient-mediated interventions (e.g., patient safety cards). To tailor the implementation activities, we developed a questionnaire to identify barriers for effective guideline adherence, based on (a) a theoretical framework for classifying barriers and facilitators, (b) an instrument for measuring determinants of innovations, and (c) 19 semi-structured interviews with perioperative key professionals. Primary outcome is guideline adherence measured at the hospital (i.e., cluster) and patient levels by a set of perioperative Patient Safety Indicators (PSIs), which was developed parallel to the perioperative guidelines. Secondary outcomes at the patient level are in-hospital complications, postoperative wound infections and mortality, length of hospital stay, and unscheduled transfer to the intensive care unit, non-elective readmission to the hospital and unplanned reoperation, all within 30 days after the initial surgery. Also, patient safety culture and team climate will be studied as potential determinants. Finally, a process evaluation is conducted to identify the compliance with the implementation strategy, as well as an economic evaluation to assess the costs. Data sources are registered clinical data and surveys. There is no form of blinding. Discussion The perioperative setting is an unexplored area with respect to implementation issues. This study is expected to yield important new evidence about the effects of a multifaceted approach on guideline adherence in the perioperative care setting. [ABSTRACT FROM AUTHOR]

Background The reduction of perioperative harm is a major priority of in-hospital health care and the reporting of incidents and their causes is an important source of information to improve perioperative patient safety. We explored the number, nature and causes of voluntarily reported perioperative incidents in order to highlight the areas where further efforts are required to improve patient safety. Methods Data from the Hospital Incident Management System (HIMS), entered in the period from July 2009 to July 2012, were analyzed in a Dutch university hospital. Employees in the perioperatve field filled out a semi-structured digital form of the reporting system. The risk classification of the reported adverse events and 'near misses' was based on the estimated patient consequences and the risk of recurrence, according to national guidelines. Predefined reported incident causes were categorized as human, organizational, technical and patient related. Results In total, 2,563 incidents (1,300 adverse events and 1,263 'near-miss' events) were reported during 67,360 operations. Reporters were anesthesia, operating room and recovery nurses (37%), ward nurses (31%), physicians (17%), administrative personnel (5%), others (6%) and unmentioned (3%). A total of 414 (16%) adverse events had patient consequences (which affected 0,6% of all surgery patients), estimated as catastrophic in 2, very serious in 34, serious in 105, and marginally serious in 273 cases. Shortcomings in communication was the most frequent reported type of incidents. Non-compliance with Standard Operating Procedures (SOPs: instructions, regulations, protocols and guidelines) was reported with 877 (34%) of incident reports. In total, 1,194 (27%) voluntarily reported causes were SOP-related, mainly human-based (79%) and partially organization-based (21%). SOP-related incidents were not associated with more patient consequences than other voluntarily reported incidents. Furthermore 'mistake or forgotten' (15%) and 'communication problems' (11%) were frequently reported causes of incidents. Conclusions The analysis of voluntarily reported perioperative incidents identified an association between perioperative patient safety problems and human failure, such as SOP non-compliance, mistakes, forgetting, and shortcomings in communication. The data suggest that professionals themselves indicate that SOP compliance in combination with other human failures provide room for improvement. [ABSTRACT FROM AUTHOR]

Central sensitisation is assumed to be one of the underlying mechanisms for chronic low back pain. Because central sensitisation is not directly assessable in humans, the term 'human assumed central sensitisation' (HACS) is suggested. The objectives were to investigate what definitions for HACS have been used, to evaluate the methods to assess HACS, to assess the validity of those methods, and to estimate the prevalence of HACS. Database search resulted in 34 included studies. Forty different definition references were used to define HACS. This review uncovered twenty quantitative methods to assess HACS, including four questionnaires and sixteen quantitative sensory testing measures. The prevalence of HACS in patients with chronic low back pain was estimated in three studies. The current systematic review highlights that multiple definitions, assessment methods, and prevalence estimates are stated in the literature regarding HACS in patients with chronic low back pain. Most of the assessment methods of HACS are not validated but have been tested for reliability and repeatability. Given the lack of a gold standard to assess HACS, an initial grading system is proposed to standardize clinical and research assessments of HACS in patients with a chronic low back. [ABSTRACT FROM AUTHOR]

Epidermolysis bullosa (EB) is a genetic blistering skin condition for which no cure exists. Symptom alleviation and quality of life are therefore central to EB care. This study aimed to gain insight into EB patient needs and benefits from current clinical care. Two questionnaires were administered cross-sectionally to adult EB patients at the Dutch expertise centre for blistering diseases. Patient needs and benefits were analyzed using the patient benefit index survey (PBI-S). Ancillary data were compiled pertaining to self-reported EB severity, pain and pruritus, as well as current and previous treatments. In total, 104 participants were included (response rate 69.8%). Sixty-eight participants comprised the analyzed cohort (n = 36 omitted from analysis). The needs given the highest importance were to get better skin quickly (64.7%) and to be healed of all skin alterations (61.8%). A positive correlation between pain and EB severity and the importance of most needs was observed. Minimal clinically important differences within the PBI-S, relating to reported benefits from clinical care, were reported by 60.3% of the cohort. This study highlights a discrepancy between patient needs and feasible treatment outcomes. Utilizing the PBI-S in conjunction with well-established multidisciplinary care may catalyze the process of tailoring treatments to the needs of individual patients. [ABSTRACT FROM AUTHOR]