Rehabilitation care for patients with chronic musculoskeletal pain (CMP) is not optimally organized. The Network Pain Rehabilitation Limburg 2.0 (NPRL2.0) provides integrated care with a biopsychosocial approach and strives to improve the Quadruple Aim outcomes: pain-related disability of patients with CMP; experiences of care of patients with CMP; meaning in the work of healthcare professionals; and healthcare costs. Firstly, in this study, the effectiveness (with regard to the functioning and participation of patients) of primary care for patients with CMP will be assessed, comparing care organized following the NPRL2.0 procedure with usual care. Secondly, the cost-effectiveness and cost-utility with regard to health-related quality of life and healthcare costs will be assessed. And thirdly, the effect of duration of participation in a local network in primary care will be studied.In this pragmatic study, it is expected that two local networks with 105 patients will participate in the prospective cohort study and six local networks with 184 patients in the stepped-wedge based design. Healthcare professionals in the local networks will recruit patients. Inclusion criteria: age ≥ 18 years; having CMP; willing to improve functioning despite pain; and adequate Dutch literacy. Exclusion criteria: pregnancy; and having a treatable medical or psychiatric disease. Patients will complete questionnaires at baseline (T1), 3 months (T2), 6 months (T3), and 9 months (T4). Questionnaires at T1 and T4 will include the Pain Disability Index and Short Form Health Survey. Questionnaires at T1, T2, T3, and T4 will include the EQ-5D-5L, and iMTA Medical Consumption and Productivity Cost Questionnaires. Outcomes will be compared using linear mixed-model analysis and costs will be compared using bootstrapping methods.NPRL2.0 is a multidimensional, complex intervention, executed in daily practice, and therefore needing a pragmatic study design. The current study will assess NPRL2.0 with respect to the Quadruple Aim outcomes: patient health and costs. This will provide more information on the (cost-) effectiveness of the organization of care in a network structure regarding patients with CMP. The other two Quadruple Aim outcomes will be examined alongside this study.Trial registration Netherlands Trial Register: NL7643. https://www.trialregister.nl/trial/7643. In Western society, the prevalence of chronic musculoskeletal pain (CMP) is up to 20% in the adult population , 2. CMP,Due to high healthcare costs and high work absenteeism, CMP is one of the most expensive health conditions worldwide. In the Netherlands, CMP costs approximately 20 billion euros per year (direct and indirect costs) . Of peopMultidisciplinary and interdisciplinary treatments, with a biopsychosocial focus in primary, secondary, and tertiary care, have been shown to be both clinically- and cost-effective for people with CMP –26. In oAs an elaboration of the NCSCP, the Network Pain Rehabilitation Limburg 1.0 (NPRL1.0) was developed to provide integrated care with a biopsychosocial approach for people with CMP in order to improve their level of functioning. Its main aim is to deliver the right care, at the right place, by the right person, for the right price, thus accomplishing the Quadruple Aim: improving the functioning and participation of people with CMP; improving the experiences of care of people with CMP; improving the meaning of the work of healthcare professionals; and reducing the healthcare costs of people with CMP , 30. As To evaluate whether primary care organized according to NPRL2.0 leads to a lower level of pain-related disability in patients with CMP than in patients receiving usual care (effectiveness).To evaluate whether primary care organized according to NPRL2.0 is more cost-effective for the health-related quality of life in patients with CMP than in patients receiving usual care (cost-effectiveness).To evaluate whether primary care organized according to NPRL2.0 leads to higher Quality Adjusted Life Years (QALYs) than in patients receiving usual care .To study the effect of duration of participation and the experience of using biopsychosocial principles in treatment of local networks on (cost)-effectiveness (learning curve).In this phase, the Quadruple Aim outcomes from NPRL2.0 will be evaluated. This study will focus on the (long-term) effectiveness, cost-effectiveness, and cost-utility part of the Quadruple Aim for primary care of patients with CMP organized according to NPRL2.0 compared to usual care. The research aims of this study are:In this pragmatic study, the recruiting period will be from April 2019 till March 2020, with follow-ups till December 2020. This study comprises two designs; a prospective cohort study and a stepped-wedge based design.Two local networks of NPRL1.0 will be enrolled in NPRL2.0. They will receive additional education and information based on the results of the feasibility study of NPRL1.0. In NPRL2.0, they will invite patients to participate in a prospective cohort study.In the stepped-wedge based design working according to NPRL2.0 will be introduced in three steps in two local primary care networks at the same step . Local networks that intensively collaborate, due to their geographical location, will be placed together in one step . An independent research assistant will randomly allocate the local networks over the steps. In one local network, at least one therapist, general practitioner (GP), and mental health nurse will participate. Each local network will first recruit patients as controls during a period of care as usual, followed by a 3-month ‘wash-out’ period in which education is given see Fig. . After tNPRL2.0 is an integrated, transmural healthcare network for patients with CMP, focusing on improving the level of functioning of patients, despite pain. In the primary care of NPRL2.0, the GP is the gatekeeper for assessing the level of complexity of pain complaints, referral, and treatment selection. In the Netherlands, therapists  in primary care can be visited by people with CMP directly, without referral. Therefore, therapists will also be able to assess the level of complexity of the pain complaints and to advise these patients to visit a GP if necessary. Depending on the level of complexity involved, the follow-up policy will either include advice without further treatment, monodisciplinary treatment in primary care, interdisciplinary treatment in primary care  or interdisciplinary treatment in secondary or tertiary care  are organized by the project team in each local network after the wash-out period. During these meetings, healthcare professionals apply the theories and treatment protocols learned during the education program in daily practice, with room for extra education by the teachers if necessary. After these three peer-review meetings, the local networks are encouraged to organize further such meetings in order to align the working procedures and treatment plans of the patients.All networks start with a control period, in which local networks will invite patients who are attending consultations for CMP complaints to participate in the study. The healthcare professionals will refer and treat the patients, following the usual way of working in pain rehabilitation care in the Netherlands. In usual care, patients can receive treatments from a variety of approaches: from a more biomedical to a psychological or biopsychosocial approach. This results in a wide range of treatments that can vary in duration, content, and intensity, like medication prescription, a few sessions of physiotherapy in primary care or a complex multidisciplinary treatment in tertiary care. In usual care, the goal of the treatment does not have to be on daily functioning of the patient.Primary healthcare professionals  working in the Parkstad region  who have no prior experience with NPRL1.0 will be recruited for participation in the study. Social media and the network of healthcare professionals of NPRL1.0 will be used to recruit new healthcare professionals. Healthcare professionals must be willing to recruit patients for the control and intervention periods, to attend the education days, and to make use of the assessment tool and treatment protocol of NPRL2.0.Patients with CMP complaints, who visit the participating GPs and therapists via direct access, will be informed about the study and asked for consent to transfer their contact details to the research team. The research team will contact these patients by phone to inform them about the study and ask for oral consent for participation. Subsequently, the patients will receive the first questionnaire (T1) electronically or by post, in which they can give electronic/written informed consent for participation in the study.Patients will be eligible if they are ≥ 18 years at the start of the study, have CMP or musculoskeletal pain with a high risk of becoming chronic, are willing to improve their functioning despite the pain, and have adequate Dutch literacy to complete the questionnaires. Exclusion criteria are pregnancy or any medical  or psychiatric disease which could be treated by a more appropriate therapy, according to the expert opinion of the GP. The data will be handled based on intention-to-treat.In the prospective cohort, all patients with CMP who visit the two local networks of NPRL1.0 will be invited to participate in the study. Based on the recruitment results of the feasibility study of NPRL1.0, and the number of patients visiting a GP practice, we expect that each local network will also recruit about six patients per month. Therefore, the two local networks from NPRL1.0 together should recruit approximately 132 patients in 11 months. Assuming a dropout rate of 20%, we expect to include approximately 105 patients in this study.To calculate the desired sample size for the stepped-wedge based design, we used the method described by Woertman et al. . The calAn overview of the content of the different data collection methods can be found in Fig. Patients participating in NPRL2.0 are asked to fill in four questionnaires electronically or on paper: T1 after initial contact with healthcare professionals about their CMP complaints (50 min completion time); T2 3 months after T1 (30 min completion time); T3 6 months after T1 (30 min completion time); and T4 9 months after T1 (50 min completion time).Additionally, assessment tool 1 will be used for research purposes, as well as for decision-making in primary care. Therefore, patients in the control group will complete assessment tool 1 as part of the questionnaire at T1. Patients in the intervention group will complete it during their consultations in primary care. Assessment tool 1 will assess the level of complexity of the pain complaints and consists of one Visual Analogue Scale (VAS) for pain intensity and nine dichotomous questions on biopsychosocial factors.At the end of the study, records of the treatment characteristics of each patient will be collected from the participating practices and rehabilitation centers.In order to encourage completion of the questionnaires, patients will be reminded up to three times by phone if they have not responded within one week. If incomplete questionnaires are returned, patients will be contacted by phone to answer the remaining questions. The researcher who performs the analyses will be blinded as to patient allocation.Baseline characteristics will be collected at T1 and they will include questions about: birth date, gender, nationality, marital status, family composition, level of education, and co-morbidities.The Pain Disability Index (PDI) will be used as the primary outcome for pain-related disability. It measures the influence of pain on a patient’s life and on the performance of daily activities. The questionnaire consists of seven items that measure the complexity of the disabilities experienced in different situations such as work, leisure time, activities in daily life, and sport. Each item is scored on a scale from 0 (no disability) to 10 (severe disability). Scores from the individual items are summed to a total (0–70). The minimal important change is 13 points for patients with CMP . The DutThe Dutch language version of the Short Form Health Survey (SF-12) will be used as the primary outcome for cost-effectiveness, measuring quality of life on specific domains. The SF-12 has proven to be a practical, reliable, and valid instrument for use in both general population surveys and in studies of chronic disease populations in the Netherlands , 44. TheThe EQ-5D-5L will be used for the cost-utility analysis: it provides a single health index based on self-reported mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with a minimal clinically important change of 0.04 . There aThe Numeric Rating Scale (NRS) will be used to measure pain intensity on an 11-point scale varying from 0 (no pain) to 10 (worst pain imaginable). At each measurement point (T1-4), the patient will complete the NRS three times: current pain intensity; lowest pain intensity in the last week; highest pain intensity in the last week. The NRS has shown high test–retest reliability and validity . A reducThe Hospital Anxiety and Depression Scale (HADS) consists of 14 items of which seven are related to anxiety and seven to depression. The patient is asked to rate the items on a 4-point scale ranging from 0  to 3 (most of the time). Total scores range from 0 to 21 on each subscale: a higher score reflects higher distress. The HADS has a sensitivity and specificity of about 80% and a predictive validity for identification of about 70% . The relThe six-item short form Pain Catastrophizing Scale (PCS-6) comprises six definitions of thoughts and feelings when experiencing pain . The patThe Pain Self-Efficacy Questionnaire (PSEQ) is used to measure pain self-efficacy . In patiTo evaluate the economic consequences of NPRL2.0 from a societal perspective, as recommended by the Dutch guidelines for costing studies in healthcare, the intervention costs, other healthcare costs, patient and family costs, and productivity losses will be assessed .The intervention costs include costs of education meetings for healthcare professionals and peer review meetings for the intervention group, and consulting and/or treatment hours for the intervention and control groups. The education costs are for 2 × 3 h of education and 1 × 3 h of additional education for therapists. For each education session, the costs of two teachers and one meeting room will be taken into account. These costs will be charged at 10% per patient as it is assumed that healthcare professionals need education only once. Multidisciplinary consultations are organized with all healthcare professionals of the local networks in the absence of patients. For the multidisciplinary consultations per patient, the costs of the healthcare professionals will be divided by six, assuming that during one hour the status of six patients will be discussed. Moreover, it will be assumed that on average each patient is discussed during three multidisciplinary consultations. The number of consultations and/or treatment hours will be collected by the research team from the records of the patients in both the intervention and control groups. To calculate costs for healthcare professionals, standardized cost-prices as prescribed in the Dutch manual for cost-analysis in healthcare research will be used .www.imta.nl). The iMCQ will be combined with the iMTA Productivity Cost Questionnaire (iPCQ), a standardized instrument suitable for self-completion by patients for measuring and valuing all relevant productivity losses of paid and unpaid work for use in economic evaluations [https://www.medicijnkosten.nl; the pharmacist costs will also be included. For over-the-counter medication, the lowest prices of Dutch drugstores and pharmacies will be used. All costs will be given in euros and, when necessary, indexed using the general Dutch Consumer Price Index rates [Healthcare usage will be measured with the iMTA Medical Consumption Questionnaire (iMCQ). It contains questions about healthcare consumption related to frequently-occurring contacts with healthcare professionals  will be used to measure clinicians’ biomedical and biopsychosocial treatment orientations with respect to back pain . It const-test for continuous variables and the chi-squared test for categorical variables. If variables differ between the two groups, with p ≤ 0.10, they are considered to be potential confounders in further analyses.Demographic data  will be described overall and separately for the intervention and control groups. Frequencies are to be presented for categorical variables, means and standard deviations (SDs) for normally-distributed continuous variables, and medians and ranges for non-normally-distributed continuous data. The two groups will be tested on differences between characteristics, using the p ≤ 0.10) will be added to the model. An unstructured covariance structure will be used for repeated measures. Missing values for items in the questionnaires will be handled according to the scoring algorithms of the questionnaires. Missing variables in the follow-up data will not be imputed because linear mixed-model analysis is a flexible method for handling missing data for stepped-wedge and repeated-measures designs (likelihood-based approach). Linear mixed-model analyses will be performed using IBM SPSS Statistics for Windows  according to the intention-to-treat principle. Other missing values for non-repeated measures will be handled by multiple imputation, which means that missing values will be predicted using existing values for other variables [Outcomes on questionnaires will be compared using linear mixed-model analysis, to take into account repeated measurements in patients as well as the effects of the clustering of patients within local networks. The fixed part of the model contains treatment group (intervention/control), time, treatment group*time, and cluster . To assess the learning effect in local practices, the time (months) that a local network participates in NPRL2.0 will also be taken into account as a fixed variable. Variables known to be related to the outcome and differing between treatment groups at T1 (ariables .Costs will be compared using bootstraps (1000 replications) with Microsoft Excel 2016 with mean differences and 95% confidence intervals. Subsequently, sample uncertainties around the incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) will be explored using bootstrapping with a minimum of 5,000 replications. The ICER and ICUR will be defined by the difference in costs between NPRL2.0 and the control group, divided by the difference in incremental effects of the SF-12 and incremental QALYs respectively. Cost-effectiveness analyses will be performed with the mean total costs and the mean SF-12 scores. The cost-utility analysis will be performed by relating the mean total costs to the mean QALY scores of both groups, and the bootstrapped ICURs will be plotted in cost-effectiveness planes. Moreover, uncertainties of the ICERs and ICURs will be graphically presented in cost-effectiveness planes (CE plane), as well as cost-effectiveness acceptability curves (CEAC). A CEAC will be calculated to describe the probability of NPRL2.0 being a cost-effective alternative to the control group . This CEFour sets of sensitivity analyses will be performed to measure the robustness of the economic evaluation. These analyses will explore the impact of an assumption on the results when changing one value of one parameter while keeping all the other parameter values unchanged . One senThe Network Pain Rehabilitation Limburg 2.0 (NPRL2.0) has been developed in order to provide integrated care with a biopsychosocial approach for people with CMP with the goal of improving their level of functioning. Moreover, it is intended to accomplish the Quadruple Aim: improvement of pain-related disability of people with CMP; improvement of experiences of care of people with CMP; improvement in the meaning of work for healthcare professionals; and the reduction of healthcare costs of people with CMP. In this quantitative study, the effectiveness of NPRL2.0 in reducing the pain-related disability of people with CMP will be assessed. In addition, the influence of NPRL2.0 on healthcare costs will be examined with a cost-effectiveness and cost-utility analysis. Moreover, the learning curve of healthcare professionals working in NPRL2.0 will also be studied.NPRL2.0 is a multidimensional, complex intervention, executed in daily practice . BecauseAs NPRL2.0 is a complex intervention, it takes time for healthcare professionals to fully adopt the guidelines and treatments in their daily practice. Also, the internalization of the biopsychosocial perspective by healthcare professionals takes time and so no beneficial change in pain-related disability or healthcare costs is expected in the short term, as shown in other studies of complex interventions , 72. Ins


Severe postoperative pain affects most patients after thoracotomy and is a risk factor for post-thoracotomy pain syndrome (PTPS). This randomized controlled trial compared preemptively administered ketamine versus continuous paravertebral block (PVB) versus control in patients undergoing posterolateral thoracotomy. The primary outcome was acute pain intensity on the visual analog scale (VAS) on the first postoperative day. Secondary outcomes included morphine consumption, patient satisfaction, and PTPS assessment with Neuropathic Pain Syndrome Inventory (NPSI). Acute pain intensity was significantly lower with PVB compared to other groups at four out of six time points. Patients in the PVB group used significantly less morphine via a patient-controlled analgesia pump than participants in other groups. Moreover, patients were more satisfied with postoperative pain management after PVB. PVB, but not ketamine, decreased PTPS intensity at 1, 3, and 6 months after posterolateral thoracotomy. Acute pain intensity at hour 8 and PTPS intensity at month 3 correlated positively with PTPS at month 6. Bodyweight was negatively associated with chronic pain at month 6. Thus, PVB but not preemptively administered ketamine decreases both acute and chronic pain intensity following posterolateral thoracotomies. Even with recent advances in pain management, moderate to severe postoperative pain still affects many patients after open-chest surgeries or thoracotomies . FactorsThe combination of systemic analgesics with regional anesthesia techniques is the most preferred pain management approach in patients undergoing thoracotomies . Among tKetamine is a general anesthetic with analgesic properties. Its action is mediated via N-methyl-D-aspartate (NMDA)-receptors . Many reThis study aimed to compare pain intensity in patients after preemptive ketamine versus PVB during scheduled posterolateral thoracotomy, with further analysis of morphine consumption, patient satisfaction, and chronic pain evaluation.The randomized, controlled trial was conducted in a thoracic surgery department of a teaching hospital. The study protocol was approved by the Institutional Review Board of the Medical University of Lublin, Lublin, Poland  before patient recruitment. Written informed consent was obtained from each patient, and the study was conducted in accordance with the tenets of the Declaration of Helsinki for medical research involving human subjects.The inclusion criteria identified patients scheduled for posterolateral thoracotomy and those whose age was >18 and <75 years. Patients with known coagulopathy, poorly controlled diabetes mellitus, depression or other psychiatric disorders that required antidepressant drugs, alcohol or recreational drug addiction, or an allergy to the studied drugs were excluded. Before study inclusion, each patient was tested for the capability to understand the visual analog scale (VAS), operate a patient-controlled analgesia (PCA) pump, answer a phone call, and comprehend the Neuropathic Pain Syndrome Inventory (NPSI). Patients who did not fulfill these criteria were excluded from the study. Individuals older than 75 years were presumed to have difficulties with answering phone calls and describing chronic pain on the NPSI.The patients were randomly allocated to one of three groups (detailed below) by computer-generated randomization conducted by a team member who was not involved in patient assessment or surgery. The same team member prepared opaque envelopes in which the intervention type was concealed. These envelopes were opened when the patient was present in the operating theater.Each patient was anesthetized in the same manner. The drugs used for induction of general anesthesia were propofol , fentanyl , and rocuronium . Suxamethonium was used  if required. A double-lumen endotracheal tube was inserted, and the ipsilateral lung was deflated during the procedure. Maintenance was provided with continuous infusion of propofol (4–8 mg/kg/h) and additional boluses of fentanyl and rocuronium.In the PVB group, an ipsilateral block was performed by the same anesthesiologist before the induction of general anesthesia. The loss of resistance technique was used for identifying the PVB space and catheter  placement. The solution of bupivacaine  with fentanyl (2 µg/mL) was deposited after proper identification of the PVB space.In the ketamine group (KET), after the induction of general anesthesia but before the first incision, patients received a bolus of ketamine  intravenously. Patients in the control group (CON) did not receive any additional intervention.Approximately 30 min before the end of the surgery, each patient received morphine  and metamizole  intravenously.Each patient was admitted to the postoperative care unit where vital signs—respiratory rate, plethysmography, oxygen saturation, heart rate, and blood pressure—were monitored. Postoperative pain was treated with morphine and metamizole. Morphine was administered via the PCA pump . In case of severe pain or ≥40 mm on the VAS, up to two doses of morphine (5 mg) were administered based on the nurse’s discretion. In the PVB group, the local anesthetic (5–8 mL/h) solution was continued in the postoperative period.The primary outcome of the study was to evaluate pain severity on the VAS scale (0–100 mm) in patients after three types of analgesic approaches. Pain severity was assessed after patient transfer to the postoperative care unit and at hours 2, 4, 8, 12, and 24 after the surgery completion by nurses not directly involved in the study (blinded). The secondary outcomes included total morphine consumption via PCA pump during the first postoperative day, and patient satisfaction with pain management was assessed at the time of discharge from the hospital. Patients could describe their satisfaction with pain management as perfect (5), good (4), moderate (3), poor (2), or very poor (1). Moreover, PTPS was evaluated via a telephone interview after 1, 3 and 6 months from patients’ discharge. For chronic pain analysis, the NPSI by Bouhassira et al. was utilized . This inNormal distribution was checked for all continuous variables with the Shapiro–Wilk test. The analysis of variance (ANOVA) was used for normally distributed parameters. Normally distributed variables were presented as means . The Kruskal–Wallis test by ranks was used to compare parameters with non-normal distribution. If the results of the Kruskal–Wallis test showed statistical significance, a pairwise comparison was performed with the Mann–Whitney U test and Bonferroni correction was applied. Medians (interquartile ranges) were used to present these data. Qualitative variables were compared with Fisher’s exact test. Logistic regression was applied to detect parameters affecting chronic pain presentation, and the odds ratio (OR) was used to describe PTPS predictors included in the model. The receiver operating characteristic (ROC) curve was calculated for the best model. All measurements were performed using Statistica 13.1 software .The sample size analysis was calculated for the primary outcome of the current study. A preliminary study was performed to assess the sample size. Twenty patients  were included. Mean VAS results for the CON and PVB groups were 59 and 40, respectively. Thus, 40 patients were to be recruited, 20 in each group, for significance level (α) = 0.05 and power = 0.8. Because three groups were used in the study, we decided to randomize 120 patients. This single-center study was conducted in a thoracic surgery department of a teaching hospital between July 2016 and November 2018. Patient demographics are presented in The pain intensity measured by VAS was significantly different between the PVB group and other groups at four out of six time points, while no difference was found between the KET and CON groups. The detailed description of VAS measurements is presented in p = 0.004) and CON (25 (24–39), p = 0.0001) groups. Moreover, patients required significantly less rescue doses of morphine in the postoperative period after continuous PVB (0 (0–0)) compared to participants in the KET (5 (0–5), p = 0.0004) or CON (0 (0–8), p = 0.001) groups. No difference in postoperative morphine consumption was noticed between the KET and CON groups either via PCA or rescue boluses.Morphine consumption: Patients in the PVB group (13 (7–21)) had significantly less morphine consumption via PCA than individuals in the KET (34.5 (15–49), p < 0.001) and 4 (3–4) (p < 0.001), subsequently.Patient satisfaction: Patients in the PVB group were more satisfied with their pain management than individuals in other groups. The results of satisfaction presented as medians (interquartile ranges) for patients in PVB, KET, and CON groups were 4 (4–5), 4 (4–4) , lobectomy (28), decortication (20), pneumonectomy (7), segmentectomy (6), tumor resection, and exploratory thoracotomy (2). Because only four patients had tumor resections and exploratory thoracotomies, they were excluded from statistical analysis. Only a single pairwise comparison showed a significant result. Pain intensity was significantly higher after lung decortication than segmentectomy after patients’ admission to the postoperative unit (0 h) and after two postoperative hours (2 h). The median pain severity was 73.5 (58–86) and 46.5 (42–56) after decortication, and 44 (22–51) and 23.5 (16–28) after segmentectomy. Bonferroni correction was applied for multiple pairwise comparisons and probability was set at 0.0051 to present significant results. No difference was found between the surgery type for postoperative morphine consumption. Moreover, the surgery type did not affect PTPS intensity in our study.Post-thoracotomy pain syndrome prediction: Logistic regression analysis detected three variables to predict PTPS occurrence during the sixth month after hospital discharge. Acute pain intensity at hour 8 and chronic pain intensity at month 3 had a positive correlation with PTPS presence during month 6. The OR and 95% CI for acute pain at hour 8 and PTPS intensity at month 3 were 1.085 (1.025–1.148) and 1.182 (1.064–1.312), respectively. In contrast, patients’ weight had a negative association with PTPS occurrence with OR = 0.962 (0.939–0.986). The area under the ROC curve was 0.889 for this predictive model including three variables.The results of this study confirm the effectiveness of PVB in alleviating acute postoperative pain in patients undergoing posterolateral thoracotomy. Preoperative PVB lowers pain intensity on VAS and hence the patients used less morphine via PCA and were more satisfied with their pain management during the perioperative period. However, acute postoperative pain results were not different between patients treated with ketamine or no ketamine. The surgery type following thoracotomy had some impact on acute but not chronic pain severity. Patients experienced higher pain severity on VAS during the first two postsurgical hours after decortication procedures compared to lung segmentectomies.In this study, most patients perceived PTPS at months 1, 3 and 6 after hospital discharge. Patients who received PVB experienced less PTPS intensity compared to controls and ketamine administration. Thus, preemptive ketamine did not alleviate PTPS severity and was comparable to the control group. Furthermore, the surgery type did not affect PTPS intensity. Acute pain intensity at hour 8, PTPS intensity at month 3, and low body weight of the patient influenced chronic pain occurrence during month 6.In a meta-analysis of 14 studies, Yeung et al. reported equal efficacy of PVB and TEA in postoperative pain alleviation . MoreoveIn a systematic review of ketamine effect on acute and chronic postsurgical pain after thoracotomies by Moyse et al. , most stNone of the seven studies showed a beneficial effect of preemptive ketamine administration on PTPS, even though some studies used NPSI to evaluate chronic pain intensity similar to this study ,22,27. DIn the current study, PVB decreased PTPS intensity more significantly than ketamine. Weinstein et al. compared regional anesthesia with conventional treatment to study the incidence of persistent pain in a meta-analysis . InteresOur study has some limitations. Although statistical significance was reached, the number of participants was limited. Ketamine was administered as a single dose only and this might be a reason for ketamine’s lack of effectiveness on acute pain intensity. Only a single anesthesiologist performed each PVB in our study. Pain intensity was evaluated at rest but not during coughing. The lower pain severity and decreased morphine consumption in the PVB group could be also associated with fentanyl added to the local anesthetic solution. Thus, patients in the PVB group also received from 240 to 384 mcg of fentanyl which is approximately 18 to 29 mg of morphine. Pulmonary function tests were not performed in this study. Only ward nurses were blinded in our study. To conclude, PVB as a pain treatment strategy reduces acute and chronic pain intensity in patients after thoracotomy. A single dose of ketamine does not decrease pain intensity after thoracic surgery.


This included 9.8% (n = 19 183) with angina and 11.1% (n = 21 714) with non‐specific chest pain. The unplanned readmission group were younger , more likely to be females , from the lowest quartile of household income , have higher prevalence of cardiovascular risk factors or have index PCI performed for non‐acute coronary syndromes (ACS) . Factors associated with angina readmissions included female sex , history of ischemic heart disease (IHD) , coronary artery bypass grafts , anaemia , hypertension , and dyslipidemia . Non‐specific chest pain compared with angina readmissions were younger , more likely to be females  and have undergone PCI for non‐ACS . Indications for PCI other than ACS have a greater likelihood of readmission with angina or non‐specific chest pain at 30‐days. Readmissions are more common in patients with modifiable risk factors, previous history of IHD and anaemia.Percutaneous coronary intervention (PCI) improves anginal chest pain in most, but not all, treated patients. PCI is associated with unplanned readmission for angina and non‐specific chest pain within 30‐days of index PCI. Patients with an index hospitalization for PCI between January–November in each of the years 2010–2014 were included from the United States Nationwide Readmissions Database. Of 2 723 455 included patients, the 30‐day unplanned readmission rate was 7.2% (  Around 3 million procedures are performed worldwide every year. The results of recent randomized, controlled trials of clinical strategies involving invasive management of CAD have not provided evidence of clear benefits for coronary revascularization over medical therapy in patients with chronic coronary syndromes (CCS).In the ABSORB‐4 trial, which compared clinical outcomes in patients treated with either a bioresorbable scaffold or a 3rd generation drug eluting stent, the occurrence and time‐course of angina post‐PCI was similar in both groups, occurring in 11% of subjects by 30 days and 22% of patients by 1‐year.In this study, we accessed a large, national readmissions database to investigate the proportion of patients re‐admitted to hospital with chest pain attributed to angina or non‐specific chest pain within 30 days after PCI for ACS or CCS and the associated clinical characteristics. In addition, we evaluated the cost burden of chest pain readmissions compared with readmissions due to other causes.2In the United States, the Healthcare Cost and Utilization Project (HCUP) Nationwide Readmissions Database (NRD) records, hospitalization and readmission data for all hospitalized patients within 21 States and is produced by the Agency for Healthcare Research and Quality. This study utilized deidentified data collected and distributed by HCUP and does not require consent from individual patients or an institutional board review (IRB) approval. The distribution of included municipalities is geographically diverse and represents 49.1% of all hospital inpatients, including patients with and without insurance. Admissions are linked by an individual identification number, which enables linkage between admissions independent of readmission location.Angina – ICD‐9: 413.0, 413.1, 413.9; non‐specific chest pain [NSCP] – ICD‐9: 786.5, 786.51) and clinic classification software codes  with discharge data from 2010 to 2014. Only the first admission with PCI within a calendar year was considered. Cases were excluded if they died during index admission, had duplicate data, were missing demographic or readmission data, or readmitted electively. Additionally, patients admitted in December are excluded as they lack 30 days of follow‐up. Patients who were readmitted with a primary chest pain diagnosis are defined by ICD‐9 codes . Weighting is performed using sample discharge weights. Dichotomization of patients based on the presence or absence of readmission within 30 days and subsequent descriptive statistics are presented. Chi‐square or Independent Student‐T testing with 95% two‐tailed significance was utilized for comparing patient demographics. Multiple logistic regression analyses were performed to evaluate the association between these variables and readmission within 30‐days with angina, non‐specific chest pain and the combined population readmitted with angina or non‐specific chest pain. Furthermore, the relative risk (RR) of association with variables and readmission within 30‐days of angina versus non‐specific chest pain is also evaluated.3Of 3 700 737 identified as undergoing PCI in the United States in the years 2010–2014, 2 723 455 were included in the analysis. The reasons for exclusion are described in Figure 3.1n = 2 723 455), 196 581 (7.2%) had an unplanned hospital readmission for any cause within 30‐days. Of these, 40 897 (20.8%) patients (1.5% of the whole post‐PCI cohort) were readmitted with a primary diagnosis of chest pain at 30 days, including 19 183 patients with angina and 21 714 with non‐specific chest pain. The demographics and medical history of the patients who were or were not readmitted during a 30‐day period are provided within Table Within this post‐PCI cohort n =  723 455,P < 0.001), more likely to be females  and within the lowest quartile of household income . The readmission group also had a higher prevalence of previous ischemic heart disease (IHD), coronary artery bypass grafts (CABG), hypertension and dyslipidemia. Furthermore, they were more likely to have index PCI performed for non‐ACS   .3.2Patients readmitted with angina within 30‐days were more likely to be female , younger , associate with the 0–25% of median household income , have history of IHD including previous myocardial infarction  or coronary artery bypass grafting , hypertension  and anaemia . These patients were also more likely to have undergone index PCI for indications other than ACS . Smoking status at index admission, obesity, association with 76–100% of median household income, history of heart failure, valvular heart disease, peripheral vascular disease, and acute coronary syndrome on index PCI  were less likely to be observed compared with those who were not readmitted within 30‐days , younger age , association with 51–75% of household income , previous history of coronary artery bypass grafting , myocardial infarction , hypertension , dyslipidemia , and history of cerebrovascular events  are more likely characteristics compared with patients who were not readmitted. Patients who underwent PCI for indications other than ACS at index admission were observed to have a greater likelihood of readmission at 30‐days . Reduced likelihood is observed in those with a history of smoking, obesity, chronic kidney disease (stage 1–3), family or personal history of IHD, diabetes mellitus, atrial fibrillation, anaemia, peripheral vascular disease and valvular heart disease or history of heart failure prior to index PCI .3.4Compared with patients readmitted within 30 days for nonspecific chest pain, patients who were readmitted with a diagnosis of angina within 30 days were older, more likely to be male, to associate with the 0–25% of household income, have a smoking history, family or personal history of IHD, chronic kidney disease (stage 1–3), dyslipidemia, history of heart failure or valvular heart disease, peripheral vascular disease, anaemia, atrial fibrillation, previous CABG and acute coronary syndrome on admission for index PCI . Patient3.5P < 0.005). Angina or non‐specific chest pain readmissions were also associated with lower hospitalization costs ($7083) compared with other causes of readmission ($11 642) (P < 0.005)  compared with those readmitted for other causes within a 30‐day period  (< 0.005) .4We have assessed unplanned readmission with a primary diagnosis of angina or non‐specific chest pain within 30‐days of PCI in a large, national database. We have found that early readmission with angina or non‐specific chest pain after PCI is uncommon. Only 1.5% of patients treated with PCI were readmitted with angina or non‐specific chest pain and affected patients had more cardiovascular risk factors and history of previous IHD. Nonetheless, since many patients undergo PCI, a readmission rate of 1–2% within 30 days equates to a considerable number of patients. Readmission after PCI was associated with an appreciable cost. Mortality during readmission is low in keeping with the coded diagnoses.4.1PCI is indicated for patients with anginal symptoms despite guideline‐directed medical therapy to relieve symptoms of angina and may improve prognosis.Chest pain after PCI may be experienced in 36% to 42% of patients undergoing both elective and emergent PCI.A further entity may include the psychological burden associated with a diagnosis of non‐specific chest pain and it is estimated that anxiety disorders are prevalent in 30–50% of these patients.4.2Readmissions are a significant source of burden both on the patient and the healthcare system, which is often used as a proxy‐marker for quality of care and penalty systems are implemented for providers with greater proportions of readmission.Patients with chest pain constitute between 0.6 to 2.4% of unplanned presentations to emergency departments and up to one in four admissions to medical and cardiology wards.Our study involved a large sample that is likely to be reasonably representative of the US population undergoing PCI. The NRD has been utilized previously in patients with chest pain, which provides precedent for selection in this study.4.3Demographic factors associated with higher likelihood of unplanned readmission in this sample are in keeping with known cardiovascular risk factors. However, smoking in this sample was not associated with increased readmission at 30 days. This is based on index smoking status and it is plausible that this may be subject to the smoking modification and cessation programmes, which are commonplace in the management of patients with coronary disease. Patients with heart failure, valvular heart disease and non‐cardiac vascular disease were observed to be less likely to be re‐admitted at 30‐days. This is in part due to the proportion undergoing PCI for ACS in whom ventricular dysfunction if present will be identified following PCI rather than as a co‐morbidity on index admission and may also be secondary to increased involvement of secondary care outpatient services in their management and treatment planning.Optimization of modifiable risk factors prior to intervention is performed in surgical patients and the pre‐operative assessment is commonplace in order to improve surgical morbidity and mortality.One evidence‐based example of an intervention to reduce readmissions following PCI is a multimodal strategy as described by Tanguturi et al (2016).4.4Limitations included the composition of the database from separate yearly data, which prevents multi‐year follow‐up of these patients and excludes those admitted in December from 30‐day follow‐up. On the other hand, a longer follow‐up period for example at 6 months would necessitate the exclusion of the inverse proportion for that year and would have reduced the external validity of the analysis. The database is comprised of inpatient admissions and does not include discharges from emergency care, community data or patients managed in observation areas following PCI. In the United States approximately 7.6 million patients present with chest pain per annum, four out of five will not require admission. A further limitation is the lack of information on completeness of revascularization for included patients or their prescribed medications at the time of discharge. This would be of value in this cohort, particularly where subsequent angina diagnoses are coded on readmission in patients who have undergone PCI for indications other than ACS.5Our study provides insights into the prevalence, risk factors and health burden of readmission with angina or non‐specific chest pain following PCI. Secondary prevention measures to reduce cardiovascular risk such as correction of anaemia may help to optimize the clinical status of patients prior to undergoing PCI. PCI performed for an indication other than ACS is associated with a greater likelihood of readmission with angina or non‐specific chest pain at 30‐days within this cohort and further investigation of the etiology within these patients is required.Professor Colin Berry is employed by the University of Glasgow, which holds consultancy and research agreements for his work with companies that have commercial interests in the diagnosis and treatment of angina. The companies include Abbott Vascular, Astra Zeneca, Boehringer Ingelheim, GSK, HeartFlow, Menarini, Novartis, and Siemens Healthcare. None of the other authors have any potential conflicts of interest.AppendixS1: Supporting informationClick here for additional data file.


To find out the mesh fixation technique that minimises chronic pain in Lichtenstein hernioplasty.Mesh fixation may affect chronic pain and recurrence after inguinal hernia surgery, but long-term results of comparative trials are lacking.n = 216), self-gripping mesh (n = 202) or non-absorbable 3–0 polypropylene sutures (n = 216) for the fixation of mesh. A standardised telephone interview or postal questionnaire was conducted 5 years after the index operation. The patients with complaints suggesting recurrence or chronic pain  were examined clinically. The rate of occasional pain, chronic severe pain, recurrence, re-operations, daily use of analgesics, overall patient satisfaction and sensation of a foreign object were recorded.Lichtenstein hernioplasty was performed under local anaesthesia on 625 patients in day care units. The patients were randomised to receive either a cyanoacrylate glue (n = 514) completed the 5-year audit including 177, 167 and 170 patients in the glue, self-fixation and suture groups, respectively. There were no significant differences in the incidence of pain (7–8%), operated recurrences (2–4%), overall re-operations (4–5%), need for analgesics (1–2%), patient’s satisfaction (93–97%) or in the feeling of a foreign object (11–18%) between the study groups.A total of 82% of patients  is a safe option for the fixation of mesh in Lichtenstein hernia repair. During the pre-mesh era, a great number of patients suffered from prolonged pain reaction due to tension caused by sutures and they had more recurrences when compared to the Lichtenstein method , 2. The In the original Lichtenstein method, the mesh was fixed using non-absorbable 3-0 sutures . Later tThe chronic pain after inguinal hernia surgery may also be due to the penetrating fixation of the mesh causing possible nerve damage or tension caused by the non-absorbable sutures. Therefore, many studies have tried to demonstrate the benefit of non-penetrating fixation such as self-gripping mesh, fibrin sealant or cyanoacrylate glue [5–7, 9, 11). The short-term results of our randomised trial failed to show any benefit of non-penetrating fixation over traditional non-absorbable sutures . The aimThis was a randomised, parallel, prospective, multicentre trial in day care units of seven Finnish hospitals. Recruiting and interventions took place from January 2012 to December 2013. The enrolled patients were consecutive from the waiting list. A more detailed description of the methodology has been published previously .n = 650) were over 18 years old, males and females, with uni- or bilateral primary or recurrent inguinal hernias. The exclusion criteria were femoral hernia, large scrotal hernia, strangulated hernia or patient refusal. The study flow chart is presented in Fig. The subjects (Randomisation was performed separately (block randomisation) in every participating centre as described earlier . EnrolleThis was a single blinded study: The patients were unaware of the fixation method used.n = 4), each side was treated individually; the second operation began when the first was finished.The procedures were performed under local anaesthesia as ambulatory surgery. In cases of bilateral hernias , partly absorbable self-gripping polyester/polylactic mesh  or partly absorbable poliglecaprone-25/polypropylene mesh . The fixation of the mesh was done either by a 0.5 ml of butyl-2-cyanoacrylate tissue glue , with a self-fixing mesh  or non-absorbable suture fixation , as described earlier (8).The tension-free hernioplasty was performed by using a 9 × 13 cm trimmed lightweight polypropylene mesh . Chronic pain was defined as pain rated VAS ≥ 3 limiting normal activity. Patients were also asked whether they had a recurrent hernia or re-operation. All patients complaining of symptoms (pain or bulge) that could be related to a possible recurrence were examined clinically and further with imaging (US or MRI), if necessary. The need for analgesics and for inguinal pain and sensation of a foreign object were also recorded. The primary outcome of this trial was the sensation of pain (VAS ≥ 3) after the 5-year follow-up. Secondary outcomes were recurrences, re-operations for a recurrent hernia or intractable pain, the need for analgesics or a sensation of a foreign object.t-test or Mann–Whitney U test.Statistical analysis was carried out using Statistical Package for the Social Sciences (SPSS) version 22.0 for Windows . For categorical variables, we used Pearson’s Chi-squared test or Fisher’s exact test, for numerical variables independent samples P < 0.05 was considered statistically significant. Multiple dependent variables (VAS) measured at multiple time periods  were modelled using the GLM repeated measures procedure. An assessment of the normality of data was performed using SPSS statistic (explore command).A All randomised patients received the intended treatment with 216, 202 and 207 patients in each group . Ultrasound examination was usually necessary if no obvious recurrence was found during clinical examination . In cases of severe inguinal pain without a clinical recurrence, magnetic resonance imaging was performed in six patients with negative results.Altogether 16 patients 2.9%) had a recurrent hernia operated during 5-year follow-up with no difference between the study groups , but only five patients needed analgesics temporarily. Figure Our hypothesis was that the non-penetrating fixation of mesh would cause less chronic pain than fixation with sutures during 5 years of follow-up, but we found no statistically significant difference in any of the measured parameters. Operation times were shorter when using glue or self-gripping mesh compared to a conventional suture fixation . Also, oIn line with our results, a previous well-made randomised study by Kim-Fucs et al.  comparinIn this trial, a total of 19 patients were re-operated on. Fifteen patients had a re-operation due to a recurrent hernia, and four patients had a re-operation due to difficult chronic pain. An open anterior approach was used for patients re-operated on due to pain; two neurectomies and two mesh removals were done. All the re-operated patients had an uneventful recovery from the second surgery. Mesh removal has been proved to be an effective treatment for chronic inguinodynia after Lichtenstein repair . The lowThe strength of our study was a long-term follow-up and a prospective randomised design. Furthermore, we reached 82% of patients to follow-up the groin symptoms. The most obvious weakness of our study was that all the patients were not examined clinically, thus affecting the number of total recurrences detected . Also, the use of different meshes may have influenced the results although our previous studies have not demonstrated any difference between different meshes in terms of pain or recurrences .Less fixation does not mean less pain in the long-term follow-up. There was no statistically significant difference in pain scores, recurrence rate of hernias or in the satisfaction for the operation after 5 years between glue fixation, self-gripping mesh or suture fixation. This may give both the surgeon and the patient the option to choose a variety of operating methods to perform open inguinal hernioplasty.


Methodology. An institutional based cross-sectional study was conducted from March to May 2020. A total of 215 participants were enrolled in this study. A convenience sampling technique was used to get the study participants. Both univariable and multivariable logistic regression were used to identify factors associated with postspinal back pain. Variables with a p value less than <0.2 in the bivariable analysis were fitted into the multivariable analysis. In the multivariable analysis, a variable with a p value of <0.05 was considered statistically significant.  Back pain is often reported as a common complaint after surgery. Many studies showed that the prevalence of back pain after spinal anesthesia is high and its magnitude is considerable in developing countries. It is highly related to reduced quality of life, loss of work productivity, burden of health care costs, and satisfaction regarding health care service; therefore, measures should be taken to reduce or prevented postspinal back. The aim of this cross-sectional study was to assess the prevalence and factors associated with back pain among patients undergoing spinal anesthesia at the University of Gondar Comprehensive and Specialized Hospital, Northwest Ethiopia. Conclusion and Recommendation. The overall incidence of back pain is high. Body mass index, size of spinal needle, number of attempts, and number of bone contacts are significantly associated with the incidence of back pain following spinal anesthesia. Thus, it is better to minimize the number of lumbar puncture attempts and bone contacts during spinal anesthesia to reduce postspinal back pain. In addition, using smaller size spinal needle is a good choice. The overall prevalence of postspinal back pain was 40.5% . Being overweight  and obese , using big spinal needles , two attempts of lumbar puncture , more than three attempts of lumbar puncture , and the number of bone contacts during spinal anesthesia procedure  were positively associated with postspinal back pain.  Spinal anesthesia (SA) is the most commonly preferred and widely used anesthesia technique in surgeries like lower extremity surgery, anorectal, urologic, obstetric, and gynecologic interventions and lower abdominal procedures. , 2 Even Back pain is a worldwide health problem affecting 50% and 80% of people at some time in their lives and it is a major physical and economical burden for the individual and the society –10. The Regardless of the anesthetic technique, postoperative low back pain is often reported as a common complaint after SA but the association between anesthetic technique and back pain is still unclear . Postspist, 2nd, and 3rd postoperative days after SA, respectively . Similarly, obese patients were 5 times more likely to develop PSBP than patients with a BMI of <25 kg/m2 [AOR 4.9 ]. Patients who underwent surgery with big spinal needle gauges were 6 times more likely to develop PSBP than small gauge needles [AOR = 5.9 ].Accordingly, overweight patients were fourfold more likely to develop PSBP than patients with a BMI of <25 kg/mThe number of attempts of lumbar puncture was also significantly associated with PSBP. Patients who had 2-time attempt were 4 times more likely to develop PSBP than patients who had only a single attempt [AOR = 3.6 ] and patients who had more than 3-time attempt also were 5 times more likely to develop PSBP than patients who had only a single attempt [AOR = 4.9 ].Finally, patients who had a single bone contact were 3 times more likely to develop PSBP than patients who had no bone contact [AOR = 3.1 ]. Likewise, patients who had greater than a two-time number of bone contacts during the procedure were 8 times more likely to develop PSBP than patients who had no bone contact [AOR = 7.6 ] .One of the common complications of spinal anesthesia in clinical practice is postoperative back pain. The reduction of this pain is mandatory to increase the quality of life, expand anesthesia outcomes, and improve patient satisfaction , 6.In the current study, the overall prevalence of postspinal back pain was 40.5% (95% CI: 34.0–48.4). This result was consistent with the study done in Germany (40%) . Howevernd day, and 17.9%  on the 3rd day. This finding was in consistence with the study conducted in Iran on the 1st postoperative day (16.7%) [st postoperative day. The reason for this difference might be due to the fact that patients who had preexisting back pain were excluded from our study.In this study, the distributions of the prevalence of PSBP across postoperative days were analysed. The prevalence of PSBP was 18.1%  on the first day, 11.3%  on the 2 (16.7%) . However (16.7%)  and Turkst, 2nd, and 3rd postoperative days, respectively [A study conducted in Asella, Ethiopia, showed an incidence of 38, 29.9, and 31.6% of patients developed back pain on the 1ectively . This miDifferent studies showed that PSBP mostly occurred during the use of bigger size spinal needles than smaller ones , 17, 18.Soft tissue damage during spinal anesthesia intervention had been studied in previous studies and found to be one of the risk factors to develop back pain following spinal anesthesia , 12, 18.The likelihood to developed PSBP in patients who had single and ≥2-time bone contact during the procedure of spinal anesthesia wes 3 times  and 7.6 times , respectively, more than patients who had no bone contact. This might be also due to soft tissue damage, bone scratch, and nerve injuries during bone contacts. This association is in line with the studies done in Turkey .Body mass index was associated with PSBP and supported by other studies , 41. TheFinally, as a limitation, even though this study investigates the unseen problem after spinal anesthesia at the University of Gondar Comprehensive Specialized Hospital, it includes a smaller sample size due to the small number of patient flow due to the pandemic of Covid-19. In addition, patients were followed up for only three postoperative days but they may develop postspinal back pain after they discharge from the hospital. On the other hand, the visual analogue scale score was difficult to understand for most of the study subjects to evaluate the severity of pain since most of them were illiterate.This study confirms that the overall incidence of back pain is high as compared to most studies. Body mass index, the size of spinal needle, the number of attempts, and the number of bone contacts are significantly associated with the incidence of back pain following spinal anesthesia. Hence, health professionals should minimize the number of attempts and bone contacts during lumbar puncture and choose smaller spinal needles to reduce the prevalence of postspinal back pain. Finally, conducting a similar study to assess the long-term occurrence of postspinal back pain is recommended.


This quality improvement study used an automated test messaging system to assess the number of opioid tablets prescribed vs the self-reported number of tablets taken as well as self-reported pain intensity and ability to manage pain after orthopedic and urologic procedures. Are the quantities of short-term opioid prescriptions after common orthopedic and urologic surgical procedures adequate or excessive as measured using automated text messaging?In this quality improvement study of 919 patients who underwent an orthopedic or urologic surgical procedure, most (61%) of the prescribed opioid tablets were reported as unused, and 28% of patients reported not using any opioids.The findings suggest that opportunities exist to tailor opioid prescriptions and reduce excess quantities of opioids prescribed. Surgeons must balance management of acute postoperative pain with opioid stewardship. Patient-centered methods that immediately evaluate pain and opioid consumption can be used to guide prescribing and shared decision-making.To assess the difference between the number of opioid tablets prescribed and the self-reported number of tablets taken as well as self-reported pain intensity and ability to manage pain after orthopedic and urologic procedures with use of an automated text messaging system.This quality improvement study was conducted at a large, urban academic health care system in Pennsylvania. Adult patients (aged ≥18 years) who underwent orthopedic and urologic procedures and received postoperative prescriptions for opioids were included. Data were collected prospectively using automated text messaging until postoperative day 28, from May 1 to December 31, 2019.The primary outcome was the difference between the number of opioid tablets prescribed and the patient-reported number of tablets taken . Secondary outcomes were self-reported pain intensity  and ability to manage pain  after orthopedic and urologic procedures.Of the 919 study participants, 742 (80.7%) underwent orthopedic procedures and 177 (19.2%) underwent urologic procedures. Among those who underwent orthopedic procedures, 384 (51.8%) were women, 491 (66.7%) were White, and the median age was 48 years ; 514 (69.8%) had an outpatient procedure. Among those who underwent urologic procedures, 145 (84.8%) were men, 138 (80.7%) were White, and the median age was 56 years ; 106 (62%) had an outpatient procedure. The mean (SD) pain score on day 4 after orthopedic procedures was 4.72 (2.54), with a mean (SD) change by day 21 of −0.40 (1.91). The mean (SD) ability to manage pain score on day 4 was 7.32 (2.59), with a mean (SD) change of −0.80 (2.72) by day 21. The mean (SD) pain score on day 4 after urologic procedures was 3.48 (2.43), with a mean (SD) change by day 21 of −1.50 (2.12). The mean (SD) ability to manage pain score on day 4 was 7.34 (2.81), with a mean (SD) change of 0.80 (1.75) by day 14. The median quantity of opioids prescribed for patients who underwent orthopedic procedures was high compared with self-reported consumption , similar to findings for patients who underwent urologic procedures . Over the study period, 9452 of 15 581 total tablets prescribed (60.7%) were unused. A total of 589 patients (64.1%) used less than half of the amount prescribed, and 256 patients (27.8%) did not use any opioids (179 [24.1%] who underwent orthopedic procedures and 77 [43.5%] who underwent urologic procedures).In this quality improvement study of adult patients reporting use of opioids after common orthopedic and urologic surgical procedures through a text messaging system, the quantities of opioids prescribed and the quantity consumed differed. Patient-reported data collected through text messaging may support clinicians in tailoring prescriptions and guide shared decision-making to limit excess quantities of prescribed opioids. The rapid adoption of digital media  has created scalable means of engaging patients and collecting real-time health data.25 Use of this approach for patient-reported pain and opioid use remains understudied.A knowledge gap that has inhibited progress toward matching opioid prescriptions with anticipated patient needs is limited procedure-specific data to guide practitioners. Phone-based survey studies have started to fill this gap but have primarily focused on general surgical procedures and are labor intensive to replicate across the entire spectrum of surgical procedures.In this study, we used an automated text messaging system to prospectively collect patient-reported data on pain intensity, ability to manage pain, and use of opioid prescriptions for acute pain after orthopedic and urologic surgical procedures as part of routine care within an academic health system. We also assessed the variations in opioid tablets prescribed and taken and patient pain outcomes over time after the procedures. The text messaging system was designed to develop a scalable system-level method of engaging patients to understand observable outcomes including pain intensity and opioid use in the postoperative period to improve future opioid prescribing.SQUIRE) reporting guideline.26All patients undergoing orthopedic and urologic surgical procedures at the Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center were invited to participate in this quality improvement study. Recruitment of patients undergoing orthopedic procedures started on May 1, 2019, and recruitment of patients undergoing urologic procedures started in August 2019; patients who provided written informed consent through December 31, 2019, were included in this analysis. Patients were considered eligible if they were 18 years or older, were prescribed an opioid for postoperative control of acute pain, and had a verified mobile telephone number listed in the electronic health record. This study was approved by the institutional review board of the University of Pennsylvania. The study followed the Standards for Quality Improvement Reporting Excellence , which was programmed to prospectively collect data from patients on patient-reported outcomes and opioid consumption in the initial 28 days after an orthopedic or urologic procedure .The primary outcome of interest was the difference between the number of opioid tablets prescribed and the number of tablets taken. R, version 3.60  was used for statistical analysis. A 2-sided α of .025 was considered statistically significant. All opioids were converted to equivalent doses of 5-mg oxycodone tablets.P < .001), were more likely to be White , were more likely to have had an outpatient procedure , had fewer comorbidities , and were more likely to be opioid naive, as defined by no record of an opioid prescription in the electronic health record over the past year . Among the 177 patients who underwent urologic procedures, the median age was 56 years , 138 (80.7%) were White, and 106 (62%) had an outpatient procedure. No statistically significant differences in age, sex, comorbidities, or mental health illnesses were observed between consenting and nonconsenting patients who underwent a urologic procedure  provided written, electronic, informed consent through the automated system; 742 (80.7%) patients underwent orthopedic procedures (384 women [51.8%]), and 177 (19.2%) underwent urologic procedures (145 men [84.8%])  pain intensity on postoperative day 4 was 4.72 (2.54), with a mean (SD) change by 21 days after surgery of −0.40 (1.91) . Mean S. A similConsenting patients who underwent orthopedic procedures were prescribed a median number of 20 opioid tablets , and 155 (21.1%) of these patients received an opioid refill within 30 days of surgery. Consenting patients who underwent urologic procedures were prescribed a median of 7 tablets , and 19 (11.1%) received an opioid refill within 30 days of surgery. Prescription of nonsteroidal anti-inflammatory medication was similar for consenting patients and nonrespondents who underwent both types of procedures . VariatiDuring the study period, 15 581 tablets were prescribed, and 9452 tablets (60.7%) were left unused. Of the total patient cohort, 589 (64.1%) used less than half of their prescribed tablets (464 [62.6%] who underwent orthopedic procedures and 125 [70.4%] who underwent urologic procedures). In total, 256 patients (27.8%) did not use any of the prescribed opioids (179 [24.1%] who underwent orthopedic procedures and 77 [43.5%] who underwent urologic procedures).28 we found that for the entire spectrum of orthopedic and urologic procedures, 60.7% of opioid tablets were not taken after surgery, even in a health care system with relatively low baseline prescribing amounts. Third, the difference between short-term prescribing and patient-reported use emerged early and may provide additional context for prescribers in the development of patient-centered strategies to reduce excess quantities of prescription opioids while addressing acute, severe pain.Promoting opioid stewardship for management of acute postoperative pain requires a nuanced and coordinated effort. In this study, we implemented a scalable automated text messaging system designed to immediately engage patients prescribed a short-term opioid treatment for relief of postoperative pain after orthopedic and urologic surgical procedures as part of routine care. Through this automated system, we sought to prospectively investigate opioid use and self-reported patient outcomes . This study had 3 main findings. First, patient-centered data on acute pain and acute pain management could be observed and rapidly collected remotely through automated text messaging as part of routine care. Second, as in previous studies in which patient data were gathered after general surgical procedures,12 has described methods to query patients on their use of opioid prescriptions after surgery. These methods are time- and labor-intensive efforts requiring either telephone calls or paper surveys delivered to participants and returned via mail and may be limited by selection and recall bias as individuals attempt to remember their recovery experiences. Health care professionals have begun using digital methods to connect with patients.25 In prior studies, text messaging has been investigated as a means to monitor opioid use.8 This approach builds on prior research and incorporates the key concepts of a learning health system to serve as a continuous feedback mechanism to support clinical decision-making. This strategy has demonstrated the ability to rapidly capture patient-centered data on postoperative pain and pain management. This approach can be adapted for varying clinical settings and procedures and can gather patient-centered data prospectively and then use the data to inform clinical practices.Previous retrospective researchThis study revealed that discordance among pain intensity, ability to manage pain, and opioid use emerged early in the postoperative recovery period. The mean (SD) pain score within the first week after an orthopedic procedure remained at 4.72 (2.54), with ability to manage pain being high. Low pain intensity was reported early after urologic procedures and improved quickly over a short period. Most opioid tablets were taken within the first 4 days after procedures, and patient reports of their ability to manage pain remained high during these times and subsequently as individuals took fewer or no opioid medications. Prior research has demonstrated similar discordance among pain intensity, ability to manage pain, and opioid use, but often, these data were collected 30 to 60 days after surgery and the analyses were retrospective in design and limited by recall. The approach described in this study provides a real-time and continuous method for clinicians to gain understanding of postoperative pain and opioid use and to build patient-informed and procedure-specific guidelines for future patients.20 In the study of orthopedic procedures, clinicians could proceed to develop procedure-specific and patient-informed prescribing guidelines to match use and need. As described in previous studies,30 aiming to meet the needs of the majority of patients remains a priority and challenge, whereby the 75th percentile of patient needs offers a beginning point for surgeons to tailor prescribing and reduce excess. For example, we found that a prescription for 7 tablets after simple knee arthroscopy would accommodate up to the 75th percentile of consenting patients’ reported use, as compared to the results, which showed a median of 15 tablets  being prescribed . An additional approach could be used to guide broader specialty-level prescribing. In urology, with the exception of major open surgeries, we found that opioid prescriptions of 5 or fewer would address the 75th percentile of patient-reported use. Future research efforts should include study of the factors associated with the heterogeneity in patient-reported opioid use and how to ensure equity in meeting patient needs. Furthermore, these patient-reported data can be used to guide discussions between patients and prescribers toward development of shared decision models for prescribing opioids before surgery as they plan for postoperative pain management.These results suggest key opportunities to address persistent gaps between opioid use for acute pain and prescribing, as 60.7% of tablets were left unused. Of patients who underwent orthopedic and urologic procedures, 24.1% and 43.5%, respectively, did not use any of the opioids prescribed to them. These patient-reported data may be used to guide prescribing. Median patient-reported use after all orthopedic procedures was 15 or fewer tablets (10 or fewer tablets used for 80% of procedures). For the patients who underwent urologic procedures, median reported used was 5 or fewer tablets. The potential to tailor prescribing of opioids to meet patients’ needs according to procedure and reduce excess prescribing remains high; national data reveal median prescribing to be 40 tablets for knee arthroscopy and 20 tablets for transurethral prostate or bladder tumor resections.31The study has strengths. It applied a novel, low-tech method to engage patients and collect patient-reported data to inform clinical practice in a meaningful way. The study did not burden clinical staff with consenting and collecting data from patients. The approach was patient centered and could provide health care systems with a method of expanding the core concepts of a learning health system and continuous quality improvement.This study also has limitations. It was conducted within a single academic health care system with relatively low baseline prescribing compared with national prescribing patterns. Although incorporation of data collection via text messaging into routine care allowed us to solicit responses from all eligible patients, selection and nonresponder bias remained present because individuals had to opt in to the text messaging survey. Response rates were higher than those for standard patient experience surveys collected as part of routine care. Furthermore, participants needed to have regular access to a text message–capable device. Nonresponding patients were older and were more likely to be Black and to have comorbid conditions. Future efforts to develop guidelines using patient-reported data would benefit from assessment of heterogeneity in patient-reported pain needs in consideration of these characteristics to account for the degree of nonresponse in these populations. Nonetheless, to our knowledge, this study is among the first to prospectively engage and begin to investigate patient-reported outcomes in a remote and automated method immediately after high-volume, common surgical procedures when short-term opioids are prescribed. In addition, because we relied on self-reporting, patients might have altered their responses; however, no clinical changes were made to an individual’s care because participants were notified that data collection was only for research. The Hawthorne effect might have also contributed to the limitations because we asked patients about their pain and use of opioid medication early in the postoperative period during a period of increased media coverage and public awareness about the opioid crisis in the US.In this quality improvement study of adult patients reporting use of opioids after common orthopedic and urologic surgical procedures through a text messaging system, the quantities of opioids prescribed and the quantity consumed differed. Patient-reported data collected through text messaging may support clinicians in tailoring prescriptions and guide shared decision-making to limit excess quantities of prescribed opioids.


Chronic pain after breast surgery (CPBS) has a disabling impact on postoperative health status. Mainly because of the lack of a clear definition, inconsistency does exist in the literature concerning both the actual incidence and the risk factors associated to CPBS. The aim of this prospective, observational study is to describe the incidence of and risk factors for CPBS, according to the definition provided by the IASP taskforce. The impact of CPBS on patients’ function and quality of life is also described.Women aged 18+ undergoing oncological or reconstructive breast surgery from Jan until Apr 2018 at the Breast Unit of Careggi Hospital  were prospectively observed. Postoperative pain was measured at 0 h, 3 h, 6 h, 12 h, 24 h, 48 h, and 3 months (CPBS) after surgery. Preoperative, intraoperative, and postoperative factors were compared in CPBS and No-CPBS groups through multivariate logistic regression analysis.p = 0.03), preoperative use of pain medications , and higher dynamic NRS values at 6 h postoperatively  were all independent predictors for CPBS.Among the 307 patients considered in this study, the incidence of CPBS was 28% [95% CI 23.1–33.4%]. Results from the logistic regression analysis suggest that axillary surgery (OR [95% CI], 2.99 [1.13–7.87], Chronic pain after breast surgery is a frequent complication. In our cohort, long-term use of analgesics for pre-existing chronic pain, axillary surgery, and higher dynamic NRS values at 6 h postoperatively were all factors associated with increased risk of developing CPBS. The possibility to early detect persistent pain, particularly in those patients at high risk for CPBS, might help physicians to more effectively prevent pain chronicisation.NCT04309929.ClinicalTrials.gov registration The online version contains supplementary material available at 10.1186/s13741-021-00176-6. Chronic pain after breast surgery (CPBS) is a frequent condition associated with significant morbidity and/or debilitating complications Odle . CPBS caThe pathophysiology of CPBS is extremely complex and not completely understood . Each patient gave her consent for participation in this study and publication of the results. Participants were not compensated for their participation in the study.All adult (age ≥ 18 years) female patients scheduled for breast surgery from Jan to Apr 2018 at the Breast Unit of Careggi Hospital, a large tertiary care teaching hospital in Florence, Italy, were prospectively observed. The study was approved by the Ethical Committee of Area Vasta Toscana Centro before enrolment of the first patient , and the use of patient-controlled analgesia (PCA) and rescue analgesia were explained to all breast surgery candidates.Each patient was prospectively observed during the entire perioperative period . Demographic characteristics and comorbidities were recorded before surgery, as well as the presence of chronic pain and chronic use of analgesics. Intraoperative surgical and anaesthesiologic variables were prospectively recorded right after the surgical procedure. Finally, use of analgesic drugs was recorded at 0 h, 3 h, 6 h, 12 h, 24 h, and 48 h after surgery. Acute postoperative pain was assessed at the same time points using the numerical rating scale (NRS)—ranging from 0 (no pain) to 10 (worst pain)—both in resting conditions (static pain) and during active ipsilateral arm abduction or cough (dynamic pain). Each patient was re-evaluated at 3 months postoperatively for the presence of signs and symptoms of pain that develops or worsens in the breast area. Using a yes/no question, patients were asked to self-report the presence of pain, and, if possible, evaluate its severity through a scale ranging from zero (no pain) to 10 (worst pain imaginable). According to the IASP definition  questionnaire . A backward selection procedure based on the AIC was used to select the variables in the final model. Results are expressed in terms of p-value, odds ratio (OR), and 95% confidence interval (95% CI). The capability of the final model to predict CPBS at 3 months was assessed with a ROC Analysis and expressed as a ROC-AUC. Statistical analysis was performed using the R© software version 3.5.1.Continuous variables are expressed as means ± standard deviation or medians and interquartile range, according to data distribution . The CPBS and No-CPBS groups of patients were compared for statistical differences using the unpaired Student’s Three hundred and fifty-three patients underwent breast surgery in the study period and were prospectively observed during the perioperative period. Of these, 46 13%) dropped out of the study because they were not contactable for assessment at 3 months follow-up; 307 patients were thus considered for the analysis . Table Drugs used for postoperative analgesia are shown in Table p-value < 0.2 in the univariate analysis were considered for multivariate logistic regression analysis. In the final model, variables independently associated with CPBS were axillary surgery (sentinel node biopsy and/or axillary lymph node dissection) ; preoperative use of pain medications ; and higher dynamic NRS values at 6 h postoperatively . This model was able to identify the development of CPBS at 3 months postoperatively with a ROC-AUC of 0.67 (95% CI [0.61–0.74]).All variables statistically associated with CPBS with All pain intensity and interference scores measured through the BPI questionnaire are presented in Fig. In this prospective, single centre, observational study performed in a large tertiary care teaching hospital, we have observed a 28% [95% CI 23.1–33.4%] incidence of CPBS in a cohort of female patients undergoing surgery for breast cancer. Axillary surgery, preoperative use of pain medications, and higher dynamic NRS values at 6 h postoperatively have been identified as independent predictors of CPBS.Chronic pain is a very well-known complication of breast surgery (Alves Nogueira Fabro et al. There is, however, no clear consensus about the definition of “high risk patients” for CPBS, thus making it difficult to identify those subjects who might benefit the most from careful, early pain assessment. A complex multidisciplinary, multiparametric approach involving also psychosocial and genetic factors has been suggested to perioperatively stratify patients and identify those at high risk of developing CPBS (Bortsov et al. In contrast with previous studies, we have not observed an association between CPBS and patient age (Gartner et al. Independently associated factors predicting CPBS in our cohort of patients were long-term use of analgesics for pre-existing chronic pain, axillary surgery, and higher values of dynamic NRS at 6 h postoperatively.Preoperative breast pain and/or pre-existing chronic pain before surgery are well-known risk factors for chronic postoperative pain, particularly for CPBS (Gartner et al. The association between axillary surgery and CPBS has already been reported in the literature. In particular, conclusions produced from a meta-analysis study including more than 19,000 patients have highlighted a 21% increased risk of developing CPBS in those subjects who underwent axillary surgery (Wang et al. Higher dynamic NRS values at 6 h postoperatively play a role as independent factors to predict CPBS in our cohort of patients. Several studies have recognised presence and severity of acute postoperative pain as risk factors for postoperative chronic pain (Palotie et al. Pain intensity and pain interference with daily functions were assessed through the Italian validated version of the BPI questionnaire. This is a reliable, multidimensional tool for evaluating also non-oncological chronic pain and has already been used for CPBS (Bonezzi et al. It is plausible that a number of limitations may have influenced the results of this study. First, this is a single-centre study carried out in a single teaching hospital. Second, our cohort of patients was quite small and therefore our findings need to be validated in a larger population. Also, the numbers of PECS blocks and local anaesthetics infiltration performed in our cohort of patients were too small to adequately address the impact of these procedures on CPBS. Third, we were not able to evaluate other factors such as psychological or genetic features as potential predictors of CPBS. A further limitation is that neither the numbers and levels of sentinel node biopsy nor the preservation vs cut of the intercostobrachial nerve were recorded. Also, we did not explore the effects of the combination of different surgical procedures in determining CPBS. Finally, we were not able to evaluate the effects of locoregional anaesthesia and adjuvant analgesics as well as the role of acupuncture and other non-pharmacologic analgesic therapies or interventional procedures in modulating CPBS.Chronic pain after breast surgery is a frequent complication that interferes with patients’ daily activities. In this study, evaluation of CPBS according to the IASP definition resulted in a 28% incidence at 3 months postoperatively. The possibility to early detect persistent pain, particularly in those patients at high-risk for CPBS, might help physicians to more effectively prevent pain chronicisation. In our cohort of adult surgical female patients, long-term use of analgesics for pre-existing chronic pain, axillary surgery, and higher dynamic NRS values at 6 h postoperatively were statistically associated with a higher risk of developing CPBS. A timely identification of high-risk patients might allow the implementation of proactive pharmacologic and non-pharmacologic approaches to prevent CPBS.Additional file 1: Table S1. BPI score in patients with pain at 3 months.


This study aimed to clarify whether ossification predisposition influences clinical symptoms including pain, restriction of activities of daily living, and quality of life in patients with cervical ossification of the posterior longitudinal ligament (OPLL). Cervical ossification predisposition potentially causes neurologic dysfunction, but the relationship between clinical symptoms and radiologic severity of OPLL has not yet been investigated. Data were prospectively collected from 16 institutions across Japan. We enrolled 239 patients with cervical OPLL. The primary outcomes were patient-reported outcomes, including visual analog scale (VAS) pain scores and other questionnaires. Whole-spine computed tomography images were obtained, and correlations were investigated between clinical symptoms and radiologic findings, including the distribution of OPLL, the sum of the levels where OPLL was present (OP-index), and the canal narrowing ratio (CNR) grade. The cervical OP-index was Grade 1 in 113 patients, Grade 2 in 90, and Grade 3 in 36. No significant correlations were found between radiologic outcomes and VAS pain scores. The cervical OP-index was associated with lower extremity function, social dysfunction, and locomotive function. The CNR grade was not correlated with clinical symptoms, but Grade 4 was associated with lower extremity dysfunction. Thickness and extension of ossified lesions may be associated with lower extremity dysfunction in cervical OPLL. Ossification of spinal ligaments is recognized as a musculoskeletal disorder that often leads to neurological dysfunction. Ossification of the posterior longitudinal ligament (OPLL) has been widely investigated worldwide because of its high prevalence. This heterotopic ossification occurs particularly in the cervical and thoracic spine, where the spinal cord lies inside the canal space, and can result in spinal disorders, even in asymptomatic cases following minor head trauma. Generally, in patients with OPLL, once the onset of myelopathic symptoms has started, neurologic dysfunction gradually deteriorates, and the patient will then require decompressive surgery . TherefoVarious studies on OPLL have described numerous issues, such as the efficacy of surgical treatments ,4,5,6,7,This multicenter prospective cross-sectional study included 16 institutions of the Japanese Multicenter Research Organization for Ossification of the Spinal Ligament established by the Japan Ministry of Health, Labour and Welfare. To be eligible for the study, patients had to meet all the following criteria: ≥20 years of age; a cervical OPLL diagnosis based on X-ray findings; symptoms such as neck pain, upper and/or lower extremity numbness (regardless of whether surgery was required), clumsiness, and gait disturbance; had visited a participating hospital for symptoms between September 2015 and December 2017; and had undergone whole-spine computed tomography (CT) scan to determine the location of ossified lesions in the whole spine. We excluded patients who had undergone anterior decompression surgery or posterior OPLL surgery.The study protocol was approved by the institutional review board of each participating institution and the study was conducted in accordance with relevant guidelines and regulations. Informed consent was obtained from all patients before enrollment in the study.Basic demographic and clinical data, including age and sex, diabetes mellitus (DM), body mass index (BMI), and the presence of neck pain, back pain, and low back pain (LBP), were collected for each patient . ClinicaCT images of the whole spine—including the cervical, thoracic, and lumbosacral spine from the occipital bone to the sacrum—were obtained for each patient. OPLL incidence in the cervical spine, from the clivus to C7 and in other spinal regions from T1 to S1, was evaluated on mid-sagittal CT images. The analysis was performed independently by 6 senior spine surgeons  who were blinded to clinical outcomes. Before the review, all testers read the same images of 20 patients to check the inter-observer agreement. The mean Kappa coefficient of the inter-observer agreement was 0.83 (0.79–0.85), indicating substantial agreement and consistency with previous results . Observe2 test was used for the statistical analysis of the difference in sex, DM, and prevalence of each pain. Kruskal–Wallis analysis was applied to compare three groups in the Cervical OP-index classification and four groups in the CNR grade using SPSS for Windows version 22.0 . All data are expressed as the mean ± standard deviation (SD). A p value less than 0.05 was considered statistically significant.The χIn total, 239 patients were included in this study. Patient demographics are shown in With regards to CNR grading , 71 patiTo clarify associations between ossification predisposition and body pain, we investigated the VAS scores for neck pain, upper extremity numbness, and LBP. The mean VAS in Grades 1, 2, and 3 was 39.4, 38.4, and 37.4 for neck pain a; 44.8, JOA-CMEQ and JOA-BPEQ were used to evaluate ADL in OPLL patients and to investigate whether radiologic findings correlated with the restriction of ADL.For JOA-CMEQ, there were no significant correlations except for lower extremity function a–e. CervFor JOA-BPEQ a–e, therTo clarify the clinical symptoms and OPLL thickness in the cervical spine, we investigated for a relationship between CNR and each item of the patient-reported evaluation. However, there was no significant correlation between the CNR grade and the pain score for each item a–c. SimiThe cervical OP-index grade was also closely related to OPLL in the thoracic and lumbar spine a,b. The Various studies have examined surgical techniques,  postoperThe findings of this surveillance study confirmed an association of the cervical OP-index with the thoracic and lumbar OP-index, which was in agreement with previous retrospective studies ,17, and This study demonstrated that the degree of body pain based on a VAS score was not associated with the OP-index or CNR in OPLL patients. Similarly, there was no significant correlation between upper extremity function on the JOA-CMEQ and cervical OP-index grade or CNR grade. However, with regards to the prevalence of pain symptoms, neck pain and LBP tended to be more frequent in patients with a higher CNR grade, although this was not statistically significant. We did not find this tendency in the cervical OP-index grade. These results indicate the following two points: the bias that most OPLL patients in this study had neck pain and/or upper extremity numbness, which might have masked associations between the severity of these symptoms and the radiologic severity of ossification; and pain symptoms in patients with OPLL that might be influenced by the thickness of ossified lesions compressing the spinal cord rather than extending ossified lesions. In addition, our findings demonstrated that the CNR grade appeared to negatively correlate with the JOA score, which reflected neurologic status. Various studies have reported that massive OPLL can compress the spinal cord and induce myelopathic symptoms. Therefore, it is vital to pay attention to patients with a high CNR grade in order to prevent neurologic deterioration.In this survey, the cervical OP-index grade significantly correlated with lower extremity function, social dysfunction, and locomotive function. Similarly, our findings revealed that patients categorized as Grade 4 CNR were likely to deteriorate in terms of lower extremity function and locomotive function. Ito et al.  reviewedThis study had several limitations. First, it was not population-based and was conducted prospectively. Second, it was not a longitudinal study. Third, we only investigated the severity of symptoms but not detailed characteristics of symptoms in OPLL patients. Therefore, there could be pathological heterogeneity in the patients overall. Fourth, we could not evaluate ossified lesions on the axial CT imaging to clarify whether OPLL develops laterally. In addition, we could not determine whether the mobility of the segment affected by OPLL affects the pain and severity of myelopathy. Nevertheless, we believe that our findings provide important information concerning the diagnostic features of patients with OPLL.