As inadequate pain communication contributes to difficulties in optimizing outcomes of outpatients, we investigated the effect of reinforced education using WeChat App to the opioid titration treatment of cancer-related pain in the outpatient setting.We conducted a prospective study to compare reinforced education using Wechat with care as usual from February to December 2019. Patients in the reinforced education group received reinforced education via Wechat, while those in the control group received care as usual. Effect measurements for both groups are carried out with questionnaires at the baseline and 3 days later. Questionnaires include pain intensity (NRS), treatment-related adverse events, cancer-related quality of life (QOL), sleep (PSQI), satisfaction, anxiety (GAD-7) and depression (PHQ-9). Number of patients whose NRS reduced to less than three points in 24 h was the primary outcomes. Secondary outcomes included treatment-related adverse events, cancer-related quality of life, sleep, satisfaction, anxiety and depression.Although there was no significant difference regarding pain intensity (NRS) between the two groups at 72 h, the rate of NRS that reduced to less than three points in 24 h was significantly higher in the Wechat group than in the control group. Patients’ satisfaction was significantly higher in the Wechat group than in the control group. There was no significant difference between the two groups regarding the other findings at 72 h, including pain intensity (NRS), cancer-related quality of life (QOL), anxiety (GAD-7), depression (PHQ-9), and sleep (PSQI). However, no significant difference was found between the two groups for constipation, nausea, vomiting, dizziness, somnolence, pruritus, loss of consciousness, and death.Our results indicated that receiving instructions delivered by Wechat resulted an increased number of patients with good pain control and better satisfaction. The study provided insight into the effectiveness of the reinforced education using a Wechat app delivered by a doctor to outpatients in the titration treatment of cancer-related pain.ChiCTR1900021150, Date of Registration: January 30, 2019).This study was registered at chictr.org (Registration number:  Pain is the most significant concerns of many patients secondary to their disease and significantly impacting upon their quality of life. It is a considerable challenge to management of this pain successfully, especially for outpatients. Following the World Health Organization (WHO) analgesic ladder, treatment with strong opioids can be considered the mainstay of cancer pain therapy , 2. HoweAdequate knowledge and understanding of pain and analgesic medications is critical for managing cancer pain, and influences on the quality of pain management for patients at home . DistingIn recent years, Wechat provided an easily accessible and interactive channel of communication between patients and medical providers, playing an important role in optimizing clinical work , 12. As chictr.org (ChiCTR1900021150). Written informed consent was obtained from all patients and our study adhered to CONSORT guidelines. According to the WHO’s three-step principle, individuals over the age of 18 years of age and not older than 75 years who needs to start opiate titration in outpatient clinics were enrolled in the study, which took place from February to December 2019.A prospective, randomized, controlled study was conducted at the First Affiliated Hospital, Zhejiang University School of Medicine. The study was approved by the institutional review board of the first affiliated hospital, Zhejiang University School of Medicine, and was registered at Patients meeting the following inclusion criteria were eligible to participate: subjects voluntarily signed the informed consent for the clinical observation; Subject had a digital score of persistent pain (≥4) and (or) number of breakthrough cancer pain (≥3 times per day) originated from cancer, regardless of distant metastasis; pain is mainly caused by physical factors, not mental and psychological factors; subjects or caregivers can use Wechat skillfully. We defined breakthrough cancer pain as “a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain” . PatientAccording to the order of the patients enrolled, the patients were assigned to the Wechat group or the control group according to the computer-generated random numbers plan.The National Comprehensive Cancer Network’s (NCCN) clinical practice guidelines in adult cancer pain, this protocol defines the dose of oral morphine, the interval, absence of limitation of the total dose, numerical rating scale (NRS) threshold required to administer morphine, criteria to stop titration, and how to convert immediate-release morphine into sustained-release oxycodone. Figure Any questions were answered at the initial appointment. Reinforced education was provided by one experienced doctor through Wechat. Based on the standardized management of cancer pain in the control group, Wechat was used to provide reinforced education. Wechat Subscription Platform was used to publish information including the pain score, knowledge related to opioid analgesics, role of such drugs, common errors when taking tablets, possible adverse reactions, and prevention and treatment methods. Doctors actively and timeously answered patients’ concerns regarding the treatment, and marked the department contact telephone on the subscription plat information column. Members of the pain control group used Wechat to communicate using either voice or text depending on the patient’s needs in the micro-letter. We tried to enable all participants to achieve satisfactory pain control and handle risk factors related to opioid use.Other than answering questions at the initial appointment, patients in the control group received no further active education from doctors. Afterward, patients were seen again at the outpatient clinic for further education or contacted by phone for a follow-up consultation. The timing and frequency of the follow-up consultation differed according to patients’ general conditions.Patients in the reinforced education group received reinforced education via Wechat, while those in the control group received care as usual. Wechat Subscription Plat is used to publish information, which includes pain score and opioid analgesics related knowledge. Doctors actively answered patients’ doubts in the treatment in time. We strived to let all participants be able to achieve satisfactory pain control and how to handle risk factors related to opioid using. The intervention period and the control period before study assessments were conducted was 72 h the initial appointment.Number of patients whose NRS reduced to less than three points in 24 h was the primary outcomes. Secondary outcomes included pain intensity (NRS), satisfaction with pain management and pain intensity, sleep , anxiety , depression , and cancer-related quality of life (QOL) at 72 h after the initionation of treatment. In addition, treatment-related adverse events including nausea, vomiting, dizziness, somnolence, pruritus, loss of consciousness and death were also recorded.We used the GAD-7 and PHQ-9 to measure the anxiety and depression. The reliability and validity of GAD-7 and PHQ-9 are well established and they are commonly used as self-report tools to evaluate the severity of anxiety and depression. Patients whose scores are greater than 4 on the GAD-7 or the PHQ-9 are considered as suffering from anxiety or depression, respectively , 17.The PSQI was used to evaluate patients’ sleep quality of patients. This scale consists of 18 self-report items that are divided into 7 dimensions, namely subjective sleep quality, time to fall asleep, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The score on each dimension ranges from 0 to 3 and higher total scores indicate lower sleep quality [The QOL was used for evaluating the quality of life of cancer patients. This scale consists of 12 self-report items, including appetite, spirit, sleep, fatigue, pain, family coordination, colleagues coordination, oneself understanding of cancer, attitude to treatment, daily life, side effects of treatment, facial expressions. The score on each dimension ranges from 1 to 5 with the total scores as 60 and higher total scores indicate better quality of life.Patients in the Wechat and control groups were expected to show a 15% improvement (from 75 to 90%) in the rate of NRS ≤ 3 within 24 h. Thus, a sample size of 130 patients in each group was required for a statistical power of 80% at a two-tailed significance level of 0.05. Assuming a 10% dropout rate, it was deemed that 145 patients per group would be required to obtain statistically significant results for the primary outcome.p value, and p < 0.05 indicated statistical significance. All analyses were performed using the SPSS software .Continuous variables were presented as means ± standard deviation, and categorical data were shown as numbers and percentages. For different variable types, we employ different approaches to evaluate their differences. For categorical variables, we employ Chi-squared tests to evaluate the variable differences. While for continuous variables, we adopt Student’s T test to assess their differences. The statistical significance is measured by Between February and December 2019, 380 outpatients were considered for the purposes of this study. Figure p > 0.05) (refer to Table Although there was no significant difference regarding pain intensity (NRS) between the two groups at 72 h, the rate of NRS that reduced to less than three points in 24 h was significantly higher in the Wechat group than in the control group. Patients’ satisfaction was significantly higher in the Wechat group than in the control group. There was no significant difference between the two groups regarding the other findings at 72 h, including cancer-related quality of life (QOL), anxiety (GAD-7), depression (PHQ-9), and sleep (PSQI)  between the two groups at 72 h; however, the rate of NRS that reduced to less than 3 points in 24 h was significantly higher in the Wechat group than in the control group. Patients’ satisfaction with pain management and pain intensity was significantly higher in the Wechat group than in the control group. There were no significant differences between the two groups regarding the other findings at 72 h, including cancer related quality of life (QOL), anxiety (GAD-7), depression (PHQ-9) and sleep (PSQI).The frequent occurrence of unwanted side effects may be a barrier to optimal dosing and patients’ compliance, especially for patients at home. It has been suggested that the goal of the opioid titration treatment of cancer-related pain in outpatients is to find a favorable balance between pain control and side effects , 23. HowCompared to care as usual, reinforced education using Wechat result in better pain control and better patients’ satisfaction, contributing to improve cancer pain in outpatients. The intervention could be used for other cancer-related health problems or pain problems in other chronic disease populations , 21, 24.This study has some limitations. As this study mainly evaluated the effect of Wechat-based reinforced education on opioid titration, the follow-up time was only 3 days. In the future, evaluating the long-term help of Wechat for cancer pain management should be considered. In addition, although we try to obtain patient’s information through data acquisition and analysis in order to obtain better clinical protocols, it is impossible to do big data analysis due to the limitation of the number of patients. However, this may be a good research direction in the future. Better programs should be developed to apply to a larger number of people, so as to do big data analysis and artificial intelligence analysis to obtain the optimal diagnosis and treatment automatically in the future, which will better serve for public health.Our results indicated that patients receiving instructions delivered by Wechat had a relatively higher quality of opioid titration treatment and better satisfaction. To provide long-term support for a wider population of cancer patients with pain, clinicians should integrate evidence-based activities to support reinforced education in routine clinical practice.


Background: Efficient maternal pain relief after cesarean delivery remains challenging, but it is important to improve outcomes for the mother and the newborn during the puerperium. We compared the analgesic effect of nalbuphine (a κ receptor agonist/μ receptor antagonistic) with that of sufentanil (a µ-receptor agonist) in patient-controlled intravenous analgesia (PCIA) after cesarean section.Methods: We enrolled 84 patients scheduled for elective cesarean sections with spinal anesthesia and randomized them into either nalbuphine or sufentanil groups (42 patients each). Pain scores, PCIA drug consumptions, degree of satisfaction, and adverse events were recorded as outcome measures.Results: The pain scores at rest and uterine cramping pain scores in the nalbuphine group were lower than those in the sufentanil group at 6, 12, and 24 h after the operation. Also, the pain scores while switching to a seated position were lower in the nalbuphine group than in the sufentanil group at 6 and 12 h after the operation (p < 0.05). We found no significant differences in the PCIA drug consumption between the two groups. The degree of satisfaction in patients in the nalbuphine group was higher than that of patients in the sufentanil group (p = 0.01). Adverse events did not differ in the two groups.Conclusion: PCIA with nalbuphine provides better analgesia and higher patient satisfaction than sufentanil after cesarean section. It is well-known that surgical procedures are a common cause of acute pain , and cesInadequate pain control can have several adverse effects in patients undergoing surgery. Acute postoperative pain is considered a risk factor for chronic pain  and may Despite several clinical trials evaluating different analgesic modalities, no clear guidelines exist for the management of pain after cesarean section . Multimoµ-receptor agonist is known to provide better analgesia and reduced respiratory depression as compared to an equivalent dose of fentanyl. The drug has a rapid peak and short half-life which makes it ideal for PCIA . The study protocol was pre-registered on μg) and ramosetron (0.3 mg). Both groups of patients were managed with a continuous dose of 1 ml h−1 and a bolus dose of 1 ml, with a lock-out of 10 min, and a maximum PCIA dose per hour of 10 ml. The number of bolus doses per patient was controlled by the maximum PCIA dose per hour and the lock-out time. The test drugs diluted in 10 ml of saline were randomly selected by the computer half an hour before the intervention. A researcher handed the drug over to the operator for connecting it to the analgesic pump at the end of the operation. This researcher was not involved in any other part of the trial or the data collection process.Patients were randomized into two groups, stratified based on age and body weight, using two sets of randomized medication codes generated by the computer. The sealed codes were preserved by the medication staff and follow-up manager. The women in the nalbuphine group received nalbuphine (100 mg) and ramosetron (0.3 mg) while those in the sufentanil group received sufentanil (100 2) using an S/5 Anesthesia Monitor . A 500 ml hydroxyethyl starch solution was infused at 0.2 ml kg−1·min−1 followed by Lactated Ringer's solution at the same rate till the end of every operation. A combined spinal-epidural anesthesia procedure was performed at the L3-4 intervertebral space. Briefly, 10 mg (2 ml) of isobaric bupivacaine 0.5% was diluted into 2.5 ml with cerebrospinal fluid and injected into the subarachnoid space over 15–30 s. The sensory block level to cold was inspected every 3 min  with alcohol swabs, and was recorded at the time point of 10 min. Hypotension was defined as SBP lower than 80% of the baseline value and was managed with intravenous phenylephrine 100 µg as necessary. Severe sinus bradycardia (HR <50 beats/min) was treated with intravenous administration of 0.3 mg atropine. The surgery commenced when the sensory block reached the T6 level. Patients unable to achieve this level were excluded from the study. The anesthesiologist provided 1.5% lidocaine through the epidural catheter for women with inadequate sensory block. During the operation, a uterine contraction agent was administered as needed.None of the patients were premedicated. The temperature of the operation room was maintained at 22°C. An anesthesiologist commenced monitoring including electrocardiography, heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure, and pulse oxygen saturation (SpOFlurbiprofen axetil (50 mg) was intravenously administered to all patients at 0 and 6 h postoperatively. We instructed patients on the use of the PCIA pump  in the postoperative acute care unit . PatientThe primary outcome of this study was pain determined by the VAS, total PCIA drug consumption, and the patient’s degree of satisfaction. The secondary outcomes included the sedation scores, lochia volume, time to initiation of lactation, and adverse events.The same blinded physician (SS) explained the VAS to all patients to minimize subjective variations. A score of 0 indicated no pain and 10 indicated the worst possible pain. At each follow-up time-interval, detailed instructions explaining how to assess the VAS were read aloud and the patients then informed the same physician of the VAS score that best reflected their pain status. Patients were asked to report VAS of incision pain at rest (VAS-R) while shifting into a seated position (VAS-S), and of uterine cramping (VAS-U). VAS scores and total PCIA drug consumption were recorded at 6, 12, and 24 h after the operation.2 <90%), bradycardia (HR <60 bpm), respiratory depression (respiratory rate <10 breaths per minute for more than 10 min) and nausea and vomiting from the end of surgery until the termination of the PCIA. Hypotension or bradycardia was managed with phenylephrine or atropine, respectively, and respiratory depression was dealt with naloxone and oxygen.The patient’s degree of satisfaction was assessed at 24 h on a scale of 0–3 . We used the Ramsay sedation scores  to assess sedation levels . The amoα of 0.05 and power of 90%, to gain a difference of no less than 1.5 in VAS after cesarean section between two equal groups, a total of 38 patients in each group were required. To account for potential exclusions, a total of 84 patients (42 in each group) were enrolled in the study.Under the supervision of the ethical committee a preliminary trial with 30 patients under combined spinal-epidural anesthesia was performed, in which the SD of VAS-U after the cesarean section was found to be 2. With a one-tailed t-test. Ranked data were compared using the Cochrane-Mantel-Haenszel test. p < 0.05 was considered statistically significant.Graphpad Prism 5  and Stata 9.0  were used for the statistical analysis. Data were presented as means ± SD and medians (interquartile ranges). The normalcy of data distribution was evaluated with normality plots and the Kolmogorov-Smirnov test. Numerical variables of normal distribution were compared using the student’s independent samples µg respectively.Eighty four patients were enrolled in the trial (42 in each group). Data of two patients (one from each group), who did not reach adequate levels of spinal anesthesia were excluded from the study . The chap = 0.03, 0.001, 0.001, respectively; p = 0.04, 0.04, respectively; p = 0.01, 0.02, 0.01, respectively; p = 0.01; The mean VAS-R in the nalbuphine group at 6, 12, and 24 h  were significantly lower than those in the sufentanil group  and sufentanil (100 μg) were evaluated and compared in our study  used in that study of Jacqz-Aigrain et al. have reported that the relative infant dose of nalbuphine via intake of breast milk of the mother is 0.59 ± 0.27% of the weight-adjusted maternal daily dose . Thus, bWe are aware of the limitations of our study. First, our results may only apply to women undergoing elective cesarean section after an otherwise uneventful pregnancy. Second, the study was not powered to assess the safety of the patients and neonates.In conclusion, our study indicates that the administration of nalbuphine for PCIA after cesarean sections can provide improved analgesic effects with a higher degree of patient satisfaction as compared with sufentanil. The incidence of adverse events is not increased with the use of nalbuphine as compared to sufentanil. Further studies with a larger sample size are needed to confirm the results of our trials and to further evaluate maternal and neonatal safety of nalbuphine.The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The ethics committee of Obstetrics and Gynecology Hospital of Fudan University approved this study with the approval number: 2017-22.SS and TW: Data analysis, drafting of the paper. YG: Patient enrollment, data collection. SH: Study design.Youth Foundation from Shanghai Municipal Health Bureau (201344196).The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


Of particular note is the effectiveness on manifestations that are difficult to treat such as neuropathic pain features and on negative psychological perceptions such as pain catastrophizing. It can be stated that acupuncture can be proposed also in phases of high severity of disease. Intervention with multimodal strategies, including acupuncture, could be of great benefit to patients.The treatment of fibromyalgia syndrome (FMS) is still far from being optimally coded, and pharmacological strategies are often unsatisfactory. Acupuncture plays a role among nonpharmacological intervention approaches; however, there is still no clarity as to when to integrate it into therapy. The objective of this study is to explore the role of acupuncture, in terms of efficacy on main disease severity measures and pain features, in patients with nonresponsive disease, defining nonresponsive FMS characterized by a revised Fibromyalgia Impact Questionnaire (FIQ-R) ≥39 and a Patient Health Questionnaire 15-item (PHQ15) ≥5 despite optimal drug therapy. Patients were treated with weekly sessions, for a total of eight acupuncture sessions. At the baseline and at the end of the treatment cycle, a comprehensive clinical evaluation was carried out to evaluate improvements in terms of disease severity and impact on neuropathic pain features (measured with the painDETECT questionnaire (PDQ)) and pain catastrophizing ). At the end of the eight-week treatment, patients experienced a significant improvement in all evaluated parameters (for FIQ-R, PDQ, and PHQ15  Fibromyalgia syndrome (FMS) still represents an “hard to treat” disease, and current treatment strategies leave a large number of unmet needs in patients. The pharmacological approach is still unsatisfactory considering that drugs currently available provide only modest benefits on pain, often with significant side effects, without having substantial efficacy on fatigue and quality of life compared to placebo .In 2016, the European League against Rheumatism (EULAR) experts updated the recommendations on the management of FMS, addressing a “weak for” agreement for the use of acupuncture in FMS. On the other hand, nonpharmacological approaches are recommended as first-line therapy in patients with FMS [To date, several studies have explored the effects of acupuncture, all showing good effects on pain and health in general in FMS patients –8.Some authors have also demonstrated its effectiveness through randomized double-blind studies , 8. EvidHowever, there is no clarity on when to recommend a course of treatment with acupuncture, as it is unlikely to be adopted as a continuous treatment. In particular, it is not clear to which kind of patients  and in which phase of disease severity should be proposed. To the best of our knowledge, to date, there have been no studies that have precisely identified these two standards. Among the various studies carried out, there are no well-defined inclusion criteria based on indices of severity of disease and unresponsiveness to drug therapy. In the available studies, inclusion criteria have been mainly based on the visual analogue scale (VAS) of pain , on the The symptoms of FMS are increasingly considered as a continuum, and the importance of continuity of distress caused by symptoms is also important for diagnostic-classification purposes . PatientToday, there are widely validated clinical instruments available, and categories of disease severity have also been proposed for FMS, with cutoff points easily applicable to disease severity indices such as the revised Fibromyalgia Impact Questionnaire (FIQ-R). These categories can be used to classify patients in remission, mild, moderate, and high disease severity .In the light of the aforementioned background, the aims of the present study were to explore the role of acupuncture, in terms of efficacy on main disease severity measures and pain features, in patients with nonresponsive disease, defining the latter on the basis of precise criteria listed below.From January 2018 to June 2019, patients with FMS were enrolled in the outpatient clinic of a third-level rheumatology centre that represents the regional referral for this condition. Patients were enrolled consecutively, compatibly with their possibility of reaching the centre weekly for acupuncture sessions.The diagnosis of FMS was made in all patients in accordance with the 2010 American College of Rheumatology criteria .To define nonresponsive FMS, reference was made to the FIQ-R and to Patient Health Questionnaire 15-item (PHQ15) cutoffs proposed by Häuser and colleagues in 2017 . These cAll patients who had previously undergone acupuncture (even for indications other than FMS) were excluded from the scope of the study. Patients with concomitant life-threatening illnesses  or with widespread skin diseases that contraindicated acupuncture were excluded. Patients with conditions that could mimic the symptoms of FMS or invalidate the disease assessment  were also excluded .All the procedures carried out in this study have been conducted in accordance with the 1964 Declaration of Helsinki. Patients signed informed consent to participate in the study, and the local ethics committee approved the protocol.The procedures carried out in this study are described according to the STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) checklist . In partAll treatment sessions were conducted with needles with a guide tube, with the size of 0.25 × 25 mm (Huanqiu®), handled until the de Qi achievement. The following acupoints were used in all the patients for all the sessions: LV3, LI4, SP6, ST36, CV6, CV12, Ex-HN-3 (Yintang), and GV20 . Paired Qi (LV3 + LI4), tonifying Qi and Blood (ST36 + SP6 + CV6 + CV12), raising Qi (GV20), and calming Shen (Ex-HN-3) [The acupoints were chosen in accordance with the principles of Traditional Cinese Medicine with the intention of moving Ex-HN-3) .All acupuncture sessions were performed by a physician (MDC) with nine years' experience in the field, with the certificate of acupuncture obtained at the end of a four-year course in 2014.During the treatment sessions, the acupuncturist was not allowed to ask questions about the health status of the patients, and only minimal interaction with the patients was allowed. The acupuncturist was also blinded in relation to the precise number of sessions that were performed, and interaction with the patient was also prohibited in this sense. Throughout the study, the acupuncturist did not have access to the database and was blinded to the patients' clinimetric data.No control group was used in this study, in particular, no control group based on sham acupuncture. An explanation of this choice is provided in the The clinical evaluation was carried out at the beginning of the acupuncture treatment and at the end of the treatment, for each patient one week after the end of the treatment. The clinimetric assessment based on patient-reported outcomes (PROs) was conducted by a single physician  in all patients and for all scheduled visits, while the tender point count (TPC), in the established visits, was conducted by a rheumatologist (FS) with more than thirty years of experience in the field of FMS, blind to the results of PROs.For each patient, the severity of the disease was assessed through the FIQ-R, the severity of the somatic symptoms through the PHQ15. Other characteristics of painful symptoms were also investigated by assessing the neuropathic pain features, through the painDETECT questionnaire (PDQ), and the pain catastrophizing, through the Pain Catastrophizing Scale (PCS). The main characteristics of each instrument are briefly described below.The FIQ-R consists of 21 numerical rating scales (NRS) , and investigates function, overall impact and symptoms, three fundamental domains of health status in patients with FMS. The questions refer to the previous seven days, the final score goes from 0 to 100 and is the sum of the scores of the three domains: the algebraic sum of the 9 NRS in the function domain is divided by three, that of the 2 NRS in the overall impact domain is considered as it is, and that of the 10 NRS of the symptoms domain is divided by two . DiseaseThe PHQ15 is an easy-to-administer questionnaire focused mainly on somatic symptoms. The cutoffs distinguish low (below 5), medium (between 5 and 10), and high (above 15) severity of symptoms. The questionnaire proved to be a good predictor of the general state of health and healthcare use in somatic symptom disorders. It also demonstrated its validity in FMS .The PDQ is a questionnaire completely self-administered, based solely on symptoms (no objective examination is required), which investigates the neuropathic features of painful symptoms. It has been available for over 10 years and has been studied for different conditions, including FMS , 20. PDQTo investigate the psychological aspects of painful symptoms, patients completed the PCS . The PCSFinally, TPC, although no longer necessary in recent diagnostic criteria, is still the only objective measure of FMS, and it is still a common rheumatological clinical practice to perform it. The degree of tenderness represents a measure of the distress caused by FMS, and some authors consider TPC as the “sedimentation rate” of distress .p were considered significant, and analyses were performed with SPSS for Mac, version 17.0.The results are described as mean and standard deviation, with 95% confidence interval for the mean. The expected improvement at the end of the acupuncture treatment course, for all the parameters under study, was analyzed through the one-way analysis of variance (ANOVA), corrected for age and disease duration, with the adjustment of Holms-Bonferroni. For values <0.05,  The treatment course was started in 102 patients. Of these 102 patients, six did not complete the planned number of acupuncture sessions for two reasons. In detail, the reasons for the suspension were in two patients  a poor tolerance to needle insertion, so it was decided to discontinue treatment at the second session, while in four patients , the sessions were stopped due to the impossibility of reaching the hospital weekly.The treatment course and clinical evaluation was completed in 96 patients (94.1% of patients who started treatment), who tolerated the treatment well in the absence of significant adverse events (in eight patients was registered the presence of mild ecchymosis).2.Of these 96 patients, 85 (88.5%) were female and 11 (11.5%) male. In this cohort of patients, the mean age (standard deviation (SD)) was 50.6 (12.3) years, with a duration of disease (SD) of 5.6 (6.2) years and body mass index of 26.2 (5.8) kg/mThirty-two (33.3%) of them were on duloxetine + pregabalin combination treatment, 22 (22.9%) were taking pregabalin in monotherapy, 13 (13.5%) were taking duloxetine in monotherapy, while 29 (30.2%) patients were not taking either of the two reference molecules.Although the ambitious goal of reaching the target of a FIQ-R <39 and a PHQ15 <5 was achieved only in a minority of patients (4.2%), the course of eight weekly sessions of treatment with acupuncture resulted in a significant improvement of health status in many respects. p < 0.0001) both in the overall score of the index and in its subscale symptoms, function, and overall impact.Starting from the key clinimetric index in assessing the severity of the FMS, i.e., the FIQ-R, there has been a significant improvement , and in 39 patients (40.6%), the improvement was clinically significant (>30%) according to the definition proposed by Bennett et al. . In 14 pAccording to the definition of disease severity proposed by Salaffi and colleagues , a totalp < 0.0001). There was also a marked improvement in neuropatic-like features estimated by PDQ (p < 0.0001). If the pretreatment median values of PDQ started from 20, the median values of 15.5 were reached, below the cutoff threshold for the presence of neuropathic pain. The TPC also revealed a significant reduction in the number of tender points that could be detected on objective examination at the end of treatment (p < 0.0001).An important and significant improvement was also recorded for somatic symptoms, measured with the PHQ15 (p=0.001), as did helplessness (p=0.001) and rumination (p=0.003). For the magnification was recorded a smaller improvement (p=0.129).Finally, at the end of the acupuncture treatment cycle, significant changes in the catastrophic attitude to pain in patients with FMS have been documented. In particular, the overall score of PCS improved significantly . We believe that this approach can be a great help mainly for patients, but also for clinicians, providing them with a proposal on the modalities of prescription of acupuncture.The effectiveness of acupuncture in FMS is well known –8. An inOther more recent research has also used pain VAS  as the only criterion for inclusion. In our opinion, the only assessment of pain remains a limit in assessing the severity of FMS. However, this study also confirms the effectiveness of 20 acupuncture sessions conducted in accordance with the diagnosis in TCM .In a recent randomized trail conducted in the setting of primary care, it was shown that true personalized acupuncture on TCM diagnosis, compared to sham acupuncture, leads to a marked improvement in painful symptoms, also improving functional capacity and quality of life. In our opinion, again, a limit is represented by generic inclusion criteria and covering a wide range of symptoms, so it was enough to be affected by FMS in accordance with the criteria ACR 1990 .In our work, we considered it appropriate to use stringent inclusion criteria to define a severe and refractory disease, based on the reference clinimetry. FMS is a symptomatological continuum, of which pain is a substantial part but which may not be the major part of the problems , 27.In this study, we also demonstrated the positive effect of acupuncture on pain catastrophizing. Acupuncture, therefore, allows patients to distract themselves, at least temporarily, from the pervasiveness of the symptoms. In FMS, PCS has been shown to correlate with kinesiophobia . InterveHigh PDQ scores are frequent in patients with FMS, and in these patients, high PDQ is probably a measure of pain centralization rather than an expression of injury to the somatosensory system –32.In any case, neuropathic pain features are classically difficult manifestations to treat, both pharmacologically and with acupuncture . This stTo date, there was no data in the literature to provide the efficacy of acupuncture on pain castrophizing and neuropathic pain features in patients with FMS.The potential limitations of the study should also be mentioned. First of all, this research can be criticized for the fact that no control group was conducted for sham acupuncture to distinguish the placebo components from the verum ones of the treatment. However, on the basis of what has already been observed by some researchers, the use of a sham acupuncture , especially in the field of painful diseases, instead of reducing the bias probably introduces others since it is a sensory stimulation not inert , 35.A second and a third limit are represented by the single centre recruitment and that all acupuncture sessions were performed by a single practitioner, so our study methods (inclusion criteria and treatment scheme) need to be evaluated on a larger scale. A fourth potential limit was to use a “prescription” acupuncture scheme that was the same for all patients. However, this allowed us to use the same “dose” of acupuncture in all participants, ensuring uniformity of treatment.In this study, we demonstrated the short-term efficacy of an eight-week course of acupuncture, added to the ongoing drug therapy, in patients affected by severe FMS. Based on strict inclusion criteria, acupuncture may also be proposed in phases of high severity of disease. For the first time, acupuncture has been shown to be effective on disease features such as pain catastrophizing and neuropathic pain features.Earlier intervention with multimodal strategies, including acupuncture, could be of great benefit to patients. Future research should be directed at revealing predictors of the response to acupuncture treatment.


Higher CCI scoring was associated with lower complete response rate (p = 0.020). Both advanced CCI and HCT-CI were significantly associated with shortened overall survival . Both comorbidity scores remained independent risk factors in the multivariate analysis . Conclusion: This study demonstrates the prognostic relevance of comorbidities classified by CCI and HCT-CI in patients with DLBCL undergoing curative treatment with R-CHOP. A structured evaluation of comorbidities might refine prognostication alongside currently used prognostic parameters, namely age, and should be evaluated in prospective trials.Background: Patient-related factors, namely comorbidities, impact the clinical outcome of patients with diffuse large B-cell lymphoma (DLBCL). Methods: The prevalence and prognostic impact of comorbidities were examined using the validated scores Charlson Comorbidity Index (CCI) and Hematopoietic Cell Transplantation-specific Comorbidity Index (HCT-CI) in 181 patients with DLBCL at initial diagnosis before treatment with rituximab, cyclophosphamide, vincristine, doxorubicin and prednisone (R-CHOP). Results: Pronounced comorbidities as defined by CCI and HCT-CI scoring of ≥2 were detected in 9.9% and 28.2% of patients, respectively, and occurred more frequently at advanced age ( Diffuse large B cell lymphoma (DLBCL) accounts for approximately 25–30% of all types of non-Hodgkin lymphomas (NHL), thus representing the most common histological subtype . The cliThe prognostic parameters of the IPI consider the biology and the stage of the malignant disorder, as well as the age and the performance status of patients. Recently, the relevance of patient-related factors, namely comorbidities, were recognized as important parameters for prognostication and decision-making. Therefore, the integration of comorbidity scores into clinical practice has been suggested . ComorbiThe goal of this study was to analyze the prognostic impact of the comorbidity burden as defined by the CCI and the HCT-CI in real-life in a homogeneous cohort of consecutive DLBCL patients treated at a single institution.Between October 2000 and November 2012, 181 consecutive patients newly diagnosed with DLBCL and treated in first line in curative intent with full dose R-CHOP at the Medical University of Innsbruck were included in this study. Parameters included were baseline characteristics, treatment-related variables and clinical outcome. While the clinical data and the outcome of this cohort of patients have already been published ,28, the p-value of < 0.05 was considered statistically significant. All statistical analyses were performed with the Statistical Package for the Social Sciences (SPSS) software, version 20.0 . The study was approved by the Ethics Committee of the Medical University of Innsbruck.The Chi-square test was performed to assess the significance of differences between categorical variables. Response was assessed with CT or PET-CT applying the international response criteria for NHL ,30. OverAltogether, 181 consecutive patients with newly diagnosed DLBCL were included in this analysis. Median age at diagnosis was 60 (SD 16.4) years. Median time between diagnosis and start of treatment with R-CHOP was 16 days (interquartile range 9–28). Of the 181 included patients 85 (47.0%) were female. An IPI ≥ 3 was recorded in 63 (42.6%) of 148 evaluable patients. In total, 96.1% of patients received at least four cycles of R-CHOP. Complete response (CR) on first-line R-CHOP was achieved in 135 (74.6%) patients. A relapse was observed in 53 (30.5%) of 174 patients .n = 139) did not reveal any comorbidities. 13.3% had one index point and 9.9% had an index ≥ 2. The most prevalent comorbid conditions were chronic obstructive pulmonary disease, diabetes without complications and a secondary non-metastatic tumor (Based on CCI criteria 76.8% of the patients (ic tumor .n = 116) of the patients presented without comorbidities, whereas in 7.7% (n = 14) one index point was observed. The remaining 28.2% (n = 51) of the patients had at least two HCT-CI points. The most prevalent comorbidities were a history of a previous solid tumor and cardiovascular comorbidities  (p = 0.006) and a HCT-CI ≥ 2 (p = 0.001).Advanced age was significantly associated with an increased burden of comorbidities: in patients <50 years a CCI ≥ 2 and a HCT-CI ≥ 2 were recorded in 1.9% and 7.5% of patients, whereas in individuals ≥70 years the prevalence was 22.6% and 47.2%, respectively (< 0.001) . In a bip = 0.403; CCI: 96.6% vs. 88.9%, p = 0.150). Likewise, time between diagnosis and treatment start was comparable between the two comorbidity groups . Duration of R-CHOP treatment, which might be considered a surrogate for dose-density, was similar in patients with CCI < 2 and CCI ≥ 2 (p = 0.359). When patients were broken down according to HCT-CI, a trend towards prolonged treatment duration was observed for the HCT-CI ≥ 2 group (p = 0.092). The complete remission (CR) rate was 77.3% in patients with CCI < 2, whereas the CR rate was 50.0% in patients with CCI ≥ 2 (p = 0.020). The CR rate in the HCT-CI groups was 78.5% and 64.7% in HCT-CI < 2 and HCT-CI ≥ 2 patients, respectively (p = 0.061) . At final analysis median OS had not been reached: 3-year and 5-year OS rates were 76.6% and 74.0%, respectively. All parameters of IPI, the number of administered treatment cycles as well as the response to R-CHOP were significantly associated with OS in univariate analysis (p < 0.001) (p < 0.001) .The number of administered R-CHOP cycles was comparable between groups with low vs. high comorbidities:  . With reanalysis . Most im< 0.001) . Likewis< 0.001) . In an en = 136). In both multivariate models, advanced stage at diagnosis (≥III), performance status ≥ 2 and either HCT-CI or CCI ≥ 2 remained independent prognostic factors. Thus, HCT-CI ≥ 2 and CCI ≥ 2 were associated with a 2.6 (95% CI 1.4–5.0) and a 3.6 (95% CI 1.7–7.4) -fold increased risk for death (As can be seen in or death .To date, the IPI has represented the gold standard for prognostication in DLBCL. As a means of refining prognostic scoring the integration of comorbidities has been suggested . This reOur cohort of patients was characterized by a relevant comorbidity burden, as highlighted by CCI scoring ≥ 2 in 9.9%. This proportion is within the range of 5.8–26% reported in retrospective series in the literature ,20,21,31The HCT-CI was developed to better define and assess pre-existing comorbidities in hematological malignancies . The betMost importantly, an increased comorbidity burden as defined by both scores was an independent predictor of clinical outcome. The prognostic relevance of CCI in this study is in line with results from previous studies conducted in patients with DLBCL ,31,33,34Remarkably, advanced age as dichotomized variable in accordance of the IPI definition, was a significant predictor in univariate analyses, but this association was no longer present when comorbidities were included in multivariate analyses. Additionally, the age cut-off set at 70 years failed to be an independent prognostic factor in another multivariate model. However, it has to be mentioned that age remained a significant independent prognostic factor when a model was performed with age as continuous variable. In general, age is a commonly used prognostic parameter in hematological malignancies ,12,35. HClinical outcome in R-CHOP-treated patients with DLBCL is associated with the administered dose intensity ,38. WherImproved life expectancy will result in an increasing number of cancer patients at advanced age ,41. ThusIn patients with DLBCL undergoing treatment with R-CHOP the burden of comorbidities, evaluated by the CCI and HCT-CI, represents an independent adverse prognosticator. Structured evaluations of comorbidities by validated scores might add important information on the prognosis of DLBCL patients aside of currently used prognostic items and should be evaluated in prospective trials.


Chronic musculoskeletal pain (CMP) affects daily life function and is the most prevalent disorder in primary health care. The primary objective was to examine demographic factors and pain characteristics associated with reduced health-related quality of life (HRQoL) among patients in primary care reporting CMP. Our secondary objective was to compare HRQoL in patients with and without CMP.This cross-sectional study was conducted in Trondheim, Norway. Twenty randomly selected GPs, and their listed patients aged 21–58 were invited to participate. Self-reported CMP data was collected using online questionnaires. HRQoL was measured by the 15D questionnaire, total score of 0.9 was used as cut-off for clinical reduced HRQoL.A total of 969 patients  were recruited from six GPs’ patient lists, mean age 45.6 (SD 10.1). CMP was reported by 517 (53%). Factors significantly associated with reduced HRQoL were gender , disability pension , mood , relations with other people , sleep  and enjoyment . CMP patients had significantly lower total HRQoL score compared to patients without CMP . Half of the CMP patients reported a HRQoL score < 0.9 compared to 14% in the no CMP group.Being female, receiving disability pension, and several psychosocial factors were found highly associated with reduced HRQoL in CMP patients, whereas pain characteristics were not. Patients with CMP reported statistically and clinically significant lower HRQoL than patients without CMP. Due to low response rate the conclusions must be handled with caution.Clinicaltrials.gov (NCT02020772) Chronic musculoskeletal pain (CMP) is characterized by prolonged pain affecting muscles, joints or bones. CMP may be single- or multi sited, and may be present in absence of any disease . CMP is Chronic pain is found to be associated with reduced health-related quality of life (HRQoL) in general , 26, andThe primary aim of this study was to examine demographic and pain characteristics associated with reduced HRQoL among patients with CMP in primary health care. Our secondary aim was to compare HRQoL among patients with and without CMP.This is a cross-sectional study based on data collected from patients of general practitioners (GPs) in Trondheim municipality, Norway, during the period November 2013 to July 2015.Among 162 GPs in Trondheim, 20 GPs were randomly identified by using a computer random number generator, developed and administrated at the Unit for Applied Clinical Research, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. The randomization of GPs was stratified by gender, to prevent gender influencing our patient selection and results. The 20 randomly selected GPs were invited to participate in the study by postal mail and telephone. To balance urbane patient populations, we included two additional GPs  from more rural areas.The common age for pension in Norway is 67 years. All patients registered in the GPs’ patient lists, aged 21 and 58 years were invited to participate in the study. The age range 21 to 58 years was selected in order to ensure that the included patients would be from a working population throughout the three-year study period. There were no medical exclusion criteria. All eligible patients received information about the study and an invitation to participate by postal mail. Eligible patients accepted the invitation by replying to the invitational letter in writing, by phone, or by completing the web-based questionnaire . Informed consent was provided by logging into the web-based questionnaire.All data were collected by self-reported online questionnaires (CheckWare). The participants completed the questionnaires within one month after consenting. An automatic reminder was sent to non-responders after three weeks.Patients responding “yes” to the question “Have you experienced pain and/or disabilities related to the muscular or the skeletal system, with continuous duration of at least 3 months during the last year?” were categorized as experiencing CMP.www.15d-instrument.net) [Measures developed for assessing HRQoL in patients with chronic musculoskeletal pain include the Short Form (SF)-36 Health Survey , the Eurent.net) , 38. Theent.net) . A 15D Hent.net) .Questions assessing pain related characteristics were designed for this study based on questions from the “SF-36 Health Survey ” , 41, theThe patients who reported CMP were asked to indicate pain sites, pain intensity and how musculoskeletal pain influence general daily life function. Pain and duration of pain was assessed by the questions; 1.) “Do you have current pain which has lasted for more than 6 months?” Yes/No. 2.) “How would you rate your current pain?” 1. None, 2. Very mild, 3. Mild, 4. Moderate, 5. Severe, 6. Very severe. Patients indicated pain location(s) and number of pain sites on the NMQ digital pain map. The response alternatives for pain sites were: head, neck/shoulder, shoulder, upper back, chest, elbow, abdomen, lower back, hand, hip/thighs, knee, ankle/foot. For the statistical analyses, pain sites were grouped into six pain areas; head/neck/shoulder, chest/abdomen, elbow/hand, upper back, lower back, hip/thigh/knee/ankle/foot. Intensity of pain was assessed by patients rating the intensity of their current perceived pain on an 11-point numerical rating scale ranging from “0” (No pain), to “10” (Worst pain imaginable). For the statistical analyses current pain intensity was categorized as no to little pain (0–2), as low to moderate pain (3–5), as severe pain (6–8), and very severe pain (9–10). How pain influenced various daily life functions during the last 24 hours was evaluated by participants rating functions such as general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment on a 11-point numerical rating scale from no influence (0) to large influence (10). A mean score was calculated for each variable. Current self-reported health was reported as either excellent, very good, good, fair or poor, and self-assessed economic status was reported as either good, fair, poor , 50.The Regional Committee for Medical and Health Research Ethics in Central Norway (2012/1232) approved the study and study procedures followed the Helsinki Declaration. The participants signed digital informed consent prior to participation. The participants who attended the study were part of a prize draw for a gift card worth 500 NOK.Participant characteristics and demographic variables are presented as mean and standard deviation (SD), or number (n) and percentage (%), as appropriate. When comparing participants with and without CMP the independent samples t-test was used for continuous variables (age), the Chi-square test was used for dichotomous variables, and the Mann-Whitney U-test for ordinal variables.P-values less than 0.05 were considered statistically significant. The statistical analyses were conducted using IBM SPSS Statistics version 25 and R version 2.13.1.Due to a skewed distribution of 15D scores, HRQoL was dichotomized using a threshold of 0.9 in order to analyze factors associated with HRQoL using univariable and multivariable logistic regression analyses. An odds ratio (OR) above 1 represents an increased risk of reporting reduced HRQoL . Statistically significant variables in the univariable analyses were included in multivariable analysis. Six GPs  agreed to participate. Among the eligible patients aged 21–58 in the GPs’ lists, 972 (23.3%) agreed to participate  reported CMP. CMP patients were significantly older, had lower education and more worked part-time compared to patients without CMP (Table 7/969 repp = 0.13) and “Vision” (p = 0.06). The highest between-groups difference in the 15D sub scores were found in the dimensions “Discomfort/Symptoms”  and “Sleeping”   for the two groups are presented in Fig. The univariable logistic regression analyses showed that being female, receiving disability pension, and having no occupational activity were factors significantly associated with reduced HRQoL . Patients who had completed higher education and/or in full time employment had a significantly lower risk of reporting reductions in HRQoL. In the multivariable regression analyses, being female and receiving disability pension were the only demographic factors that remained significantly associated with reduced HRQoL , although the confidence interval for receiving disability pension was very wide Table .The majority of CMP patients reported three pain sites or more, and the most common pain site was the lower back. Most patients graded their current pain intensity as “low” to “moderate”, and among daily life activities, sleep and general daily activity were most affected by pain. In the univariable logistic regression analyses, almost all the pain-related variables were significantly associated with reduced HRQoL . Factors that remained significantly associated with reduced HRQoL in the multivariable analyses were everyday life functions affected by pain such as mood, relations to other people, sleep and enjoyment Table .In this cross-sectional observational study among 969 patients in primary health care practice, 53% reported CMP. Among the CMP patients, nearly half experienced lower back pain, most had low to moderate pain intensity, and more than half reported three or more pain sites. CMP patients had significantly lower total HRQoL score compared to patients without CMP, and “Discomfort/Symptoms” and “Sleeping” were the HRQoL dimensions most influenced by CMP. Half of the group of CMP patients reported a HRQoL score representing a clinically impaired quality of life. In the multivariable analyses, only gender and receiving disability pension remained significantly associated with reduced HRQoL among the demographic variables. Among the pain-related variables, the multivariable analyses showed that psychosocial factors such as impaired mood, sleep and enjoyment were significantly associated with increased risk of reporting reduced HRQoL, whereas the risk of impaired HRQoL was lower for patients who had relations with other people. Interestingly, current pain and pain sites were not associated with HRQoL in the multivariable analyses.Our study is unique as it included an unselected group of patients in primary health care. Considering that, most CMP patients suffer from multisite pain, and most studies on CMP pain include single-site pain patients, the findings of our study may be highly relevant for daily clinical practice in primary health care and provide important information about the general burden of CMP. Further, the current study included a high number of participants and comprehensive information regarding pain characteristics and daily life function, which in turn gives us a valuable basis for exploring factors associated with HRQoL in this population. Assessing multiple aspects involved in the complex mechanism of CMP is vital in order to develop effective strategies to prevent and limit negative consequences of CMP at both individual and societal level. The 15-D questionnaire is a valid and reliable tool for measuring pain among primary care patients as it uses both a profile system to describe 15 dimensions important for quality of life, and an index system using population-based preferences.n = 517) of all invited list patients of the GP’s met the eligibility criteria for CMP, it is likely that we recruited a high proportion of patients who experienced or had experienced long-lasting musculoskeletal pain during the past 12 months. However, for background variables such as occupational activity, sick leave, prevalence of musculoskeletal disorders, disability pension/benefits the our study population is similar to the general Norwegian population in the report about work and health by the Norwegian Institute of Public Health [There are some limitations to this study. Our study design was cross-sectional, thus we cannot imply causality or directional relationship between the different factors and HRQoL. Further, the patients themselves reported whether they fulfilled the criteria for CMP, thus the CMP categorization was mostly based on the patients’ subjective evaluation and understanding of CMP. Only one in four patients invited to the study (23%), agreed to participate and the response rate from both GPs and patients was relatively low. However, considering that approximately one in four patient in Norwegian general practice presents with musculoskeletal disorders , and thaApproximately half of the study population reported CMP. This is similar to a previous Danish study among 390 patients in general practice . SorenseSimilar to previous findings, HRQoL was significantly lower among CMP patients compared to patients without CMP , 54–56. n = 1893) [The primary aim of our study was to examine demographic factors and pain characteristics associated with HRQoL among CMP patients in primary health care practice. A limited number of studies have assessed important factors for HRQoL in this particular population. However, similar to our findings, a Norwegian cross-sectional study including a general population of chronic pain patients aged 19–81  = 1893) , found n = 1893) . Jones a = 1893)  addresse = 1893) . Moreove = 1893) . In a pr = 1893) . In the  = 1893) , 61. A h = 1893) , which i , found  = 1893) , 63. In  = 1893) , which i = 1893) . Studies = 1893) .Among the demographic characteristics, we found that female CMP patients had lower HRQoL compared to male CMP patients. This is in concurrence with the study by Wahl et al. (2009), who found that female chronic pain patients had lower global quality of life than male chronic pain patients . PossiblEven though multisite pain is common among patients with CMP, most research on CMP and HRQoL have focused on populations with single-site specific musculoskeletal pain disorders. Therefore, our study on characteristics and associations with HRQoL in an unspecified group of CMP patients in primary health care practice may provide important knowledge about the state of health and potential variables associated with quality of life. Discrepancies between reported study findings may be due to differences in pain duration and prevalence of co-existing musculoskeletal disorders. In the present study, few participants reported current sick leave due to CMP, which may indicate that our study population consisted of many patients with a relatively low symptom burden or that they were able to manage work despite pain. Inclusion criteria for CMP in this study was self-reported pain and/or disabilities related to the musculoskeletal system for 3 months or longer during the last year, indicating the patients were suffering or had suffered a recent chronic pain condition. Enhancing the knowledge base on CMP is of major importance in order to develop more precisely targeted prevention and treatment strategies in the primary health care system for this group of patients. Our findings may be useful for primary health care personnel, especially GPs and physiotherapists in clinical practice, by increasing their awareness of pain rarely being a single important factor for quality of life in this population.All participants included in our study were informed of the main focus; musculoskeletal pain. We included a high number of patients in primary health care with previous and present symptoms related to the musculoskeletal system, also among patients in the group without CMP. Our population consisted of patients receiving ongoing treatment in primary health care, and patients on the GPs’ patient lists currently receiving no active treatment. There were more females in the CMP group, and participants were slightly older, had lower education and more worked part-time compared to the group without CMP. In addition, receiving disability pension was more frequent, and self-assessed economic status and health status tended to be lower among CMP patients. These characteristics of CMP patients, in addition to multisite pain and low back pain being the most prevalent pain site, are in concurrence with findings in previous studies, and indicate that our study population may be representative of CMP patients in general , 60, 66.Just over half of the recruited primary health care patients reported CMP. Being female, receiving disability pension and psychosocial factors such as mood, sleep, enjoyment and relation to other people were identified as factors strongly associated with reduced HRQoL in CMP patients. Pain intensity, pain sites and type of pain sites were not significantly associated with reduced HRQoL. CMP patients reported significantly lower HRQoL than patients without CMP, and the total score indicate reduced quality of life of clinical importance for everyday living among the majority of CMP patients. Because of the relatively low response rate in our study, the conclusions must be handled with caution.In primary health care practice, it may be important to establish strategies aiming to improve psychological well-being among CMP patients and to be aware of how possible gender differences may affect quality of life in CMP patients.


Despite rapid advancements in laparoscopic surgical devices and techniques, pain remains a significant issue. We examined the efficacy of preemptive transversus abdominis plane (TAP) block for acute postoperative pain in patients undergoing laparoscopic colorectal cancer surgery. We retrospectively analyzed 153 patients who underwent laparoscopic colorectal cancer surgery with or without TAP block; among them, 142 were allocated to the TAP or non-TAP group. We performed between-group comparisons of demographic, clinical, and anesthetic data and pain scores at a postoperative anesthesia care unit (PACU) and at postoperative days 1, 3, and 5. There were no significant between-group differences in demographic and clinical characteristics. The mean arterial pressure, heart rate, and minimum alveolar concentration (MAC) were significantly lower in the TAP group at the start and end of surgery. The post-extubation bispectral index was significantly higher in the TAP group. There were no significant between-group differences in the pain scores and opioid consumption at the PACU or at postoperative days 1, 3, and 5, or in the time to pass flatus, the hospital stay length, and postoperative complications. Preemptive TAP block showed an intraoperative, but not postoperative, analgesic effect, characterized by a low mean arterial pressure, heart rate, and MAC. Despite rapid advancements in laparoscopic surgical devices and techniques, postoperative pain remains a significant clinical issue ,2,3. Poshttp://cris.nih.go.kr/cris/index.jsp, ref: KCT0004920).We retrospectively reviewed the electronic medical records of patients who underwent elective laparoscopic colorectal surgery between October 2019 and February 2020 at a single center. The age of the patients ranged from 28 to 86 years. All patients had colon or rectum tumors and had undergone laparoscopic colectomy or anterior resection . We used®, Ace Medical, Seoul, Korea), which delivered 20 µg/kg of fentanyl in normal saline (100 mL) at a basal infusion rate of 0.5 mL/h and a 1 mL bolus. The lockout interval was 15 min. At the end of surgery, the patients received an intravenous injection of 0.4 mg/kg of sugammadex. After extubation, the patients were moved to the postoperative anesthesia care unit (PACU). Furthermore, they received an intravenous bolus of 0.5 µg/kg of fentanyl when the numeric rating scale  scores were >3. Postoperative opioids at the general ward included intravenous fentanyl, pethidine, or hydromorphone, as well as oral medications, including oxycodone and tapentadol. Opioid consumption was recorded by conversion to fentanyl units throughout the postoperative days (PODs) 1, 3, and 5 [There was no preoperative premedication. Upon admission to the operating room, standard monitoring  was performed, including oxygen saturation determination, electrocardiography, end-tidal carbon dioxide determination, pulse oximetry, bispectral index (BIS) determination, and non-invasive blood pressure determination. The patients were placed in the supine position, exposing the costal margin and iliac crest. After aseptic preparation, a 12 MHz linear transducer was placed above the iliac crest. Subsequently, 2 mL of 1% lidocaine was infiltrated at the location of the rectus abdominis muscle tapering in an anterior axillary line with clear visualization of the three abdominal wall muscle layers. Subsequently, a 23-gauge needle  was inserted in the plane between the internal oblique and transversus abdominis muscles. After confirming an appropriate needle position, a 20 mL mixture of 0.15% ropivacaine and 0.5 mg of hydromorphone was injected. The horizontal spread of injectate was visualized with ultrasound. TAP block was performed on the bilateral side. All blocks were performed by the same experienced anesthesiologist (J.Y.L.). After TAP block completion, anesthesia was induced using an intravenous injection of 40 mg of 2% lidocaine, 2 mg/kg of 2% propofol, 0.5–1 µg/kg of fentanyl, 0.05 mg/kg of midazolam, and 0.6–0.8 mg/kg of rocuronium. Endotracheal intubation was performed using a Macintosh laryngoscope after mask ventilation for approximately 3–5 min and the loss of all four twitches elicited by train-of-four ulnar nerve stimulation. After tracheal intubation, anesthesia was maintained with 1.5–3.0 vol% sevoflurane and a bolus injection of 0.5–1 µg/kg of fentanyl for maintaining hemodynamic parameters within 20% of the baseline values and the BIS at 40–60. The lungs were ventilated using 50% oxygen with air with adjustment for maintaining an end-tidal carbon dioxide level of 30–40 mmHg. All surgeries were performed by one of six specialized colorectal surgeons following techniques similar to those for colorectal cancer [p < 0.05.All statistical analyses were performed using SAS 9.4 . Data were expressed as the mean ± standard deviation (SD) or number (proportion), as appropriate. Between-group comparisons of demographic, clinical, and anesthetic characteristics were performed using a chi-square test, t-test, or Fisher’s exact test. We extracted the mean arterial pressure, heart rate, and BIS before intubation (T1), at the start of surgery (T2), at the end of surgery (T3), and after extubation (T4). The minimum alveolar concentration (MAC) of sevoflurane was determined at T2 and T3 and compared using the t-test or Wilcoxon rank-sum test. We compared pain scores at PACU arrival and discharge, as well as PODs 1, 3, and 5, with rest and movement. Moreover, we compared opioid consumption at anesthesia, the PACU, and at PODs 1, 3, and 5 using the Wilcoxon rank sum test. The postoperative complications were compared using the chi-square test. The statistical significance level was set at n = 70) or not . p = 0.004) and T3 (p = 0.003), and heart rate at T2 (p < 0.000) and T3 (p = 0.002). The TAP group had a significantly lower MAC of sevoflurane at T2 (p = 0.002) and T3 (p = 0.020), and a significantly higher BIS at T4 (p = 0.038)  . There w= 0.038) . Postope= 0.038) . Moreove= 0.038) .This study aimed to evaluate whether preemptive TAP block with ropivacaine and hydromorphone exerts an analgesic effect on acute postoperative pain in patients undergoing laparoscopic colorectal cancer surgery. We observed an intraoperative analgesic effect characterized by a decreased mean arterial pressure, heart rate, and MAC of sevoflurane. TAP block did not reduce postoperative pain scores or opioid consumption; accordingly, there was no between-group difference in the incidence of postoperative nausea/vomiting and itching. We suspect that laparoscopic colorectal surgical pain may be predominantly visceral or neuropathic pain rather than somatic pain. Recent colorectal surgery has seen technical improvement for invasiveness reduction via smaller incisions, which could be associated with reduced somatic pain . HoweverERAS protocols in colorectal cancer resection are designed to reduce the hospital stay length, readmission rate, and postoperative complications, thereby improving patient outcomes ,27. ERASThis study had several limitations. First, we could not exclude the systemic analgesic effect of ropivacaine and hydromorphone in TAP block since we did not determine their plasma concentrations. Second, we did not individually assess somatic  and visceral  pain characteristics; therefore, we could not exactly determine the analgesic effect of TAP block on each pain type. Third, we did not include a sham group for comparing the efficacy of TAP block without hydromorphone. Fourth, we excluded patients who intraoperatively received non-opioid analgesics, including acetaminophen, a non-steroidal anti-inflammatory agent, tramadol, or a glucocorticoid, since it is difficult to compare different forms and combinations of analgesics that may affect postoperative pain. A previous study reported that multi-model pain concepts of ERAS could not decrease morphine consumption because of the unstandardized opioid-sparing strategies in colorectal surgery . Fifth, In conclusion, preemptive lateral TAP block with ropivacaine and hydromorphone showed an intraoperative, but not postoperative, analgesic effect characterized by a low mean arterial pressure, heart rate, and MAC. There is a need for further prospective randomized studies including sham blocks with larger sample sizes to evaluate analgesic prolongation through differing concentrations of local anesthetics as part of the TAP block, as well as combined approaches that use different regional anesthesia techniques and other adjuvants.


In conclusion dysautonomia and chronic pain showed a severe impact on sleep quality and disability with a consequent worsening of depressive symptom in our cohort of SSc patients.Chronic pain and dysautonomic symptoms deteriorate Systemic sclerosis (SSc) patients’ health-related quality of life with serious repercussions on social life and even on sleep. Heart Rate Variability (HRV) analysis can identify cardiovascular autonomic control impairment in subclinical condition. The aim of the present observational cross-sectional study was to assess the relationship between dysautonomic symptoms, quality of life status and cardiovascular autonomic profile. ECG and respiration were recorded at rest in 20 SSc patients. HRV analysis was performed using two different approaches: Linear spectral analysis and non-linear symbolic analysis. Pain was evaluated using the Numeric Rating Scale (NRS) and 3 questionnaires were administered for the evaluation of sleep quality (PSQI), mood tone (PHQ-9) and disability (HAQ). We found that sleep impairment was related to sympathetic predominance at rest measured as low-frequency/high-frequency ratio (LF/HF) (r = 0.48 and  Systemic sclerosis (SSc) is a systemic autoimmune disease that affects both skin and internal organs characterized by microvascular involvement, autoantibody production, extracellular matrix remodeling and collagen deposition leading to fibrosis. From the most recent epidemiological data, dating back to 2016, SSc prevalence in Italy is estimated to be 306.1 per million, with an overall female to male (F/M) ratio of 7.8:1 ,5. MoreoChronic pain is known to be strictly interrelated with autonomous nervous system (ANS) dysfunction being both its trigger and its consequence . TherefoHeart rate variability (HRV) is a non-invasive measure of ANS modulation on the cardiovascular system and investigations show its association at rest with cardiovascular risk and mortality in SSc ,14,15. IOn these premises, the present study was undertaken to test the hypothesis that, in a cohort of SSc patients, HRV indexes are associated with SSc HR-QoL assessed by validated scales and questionnaires.For the present monocentric cross-sectional study, we enrolled all SSc patients (N = 20) who were experiencing pain and who consented to participate in the study from the Day Hospital of Internal Medicine, Immunology and Allergology Department, . All the patients fulfilled the 2013 American College of Rheumatology/European league against rheumatism classification criteria for SSc . PatientThe enrollment and recording period elapsed between March 2019 and January 2020. Every patient underwent a single assessment: Each experimental session consisted of a resting ECG and respiratory recording, pain assessment and the administration of 3 questionnaires. All experimental sessions took place between 8 a.m. and 12 noon. The protocol was approved by the local Ethics Committee (Comitato Etico Milano Area 2: 158_2019bis) and it was developed in accordance with the Declaration of Helsinki. All the subjects signed informed written consent before participation to the study.Cardiovascular recordings were performed at rest, in the supine position and with spontaneous breathing for 10 min. All participants were informed to avoid taking food and caffeine in the 2 h preceding the recording session and physical exercise the day before. ECG (lead II) and respiration through a thoracic piezoelectric belt were recorded with a sampling frequency of 250 Hz, using an ad hoc telemetric system device. All measurements were performed in a quiet and temperature-controlled room (between 22 °C and 24 °C), and all patients had a normal body temperature during the recordings (between 35.5 °C and 36.5 °C).Subjects were asked to report the pain perceived in the week preceding the recording session on NRS with numbers from 0 to 10 (‘no pain’ to ‘worst pain imaginable’). NRS cut-offs are ≤4, 5–7, and ≥8 for mild, moderate, and severe pain, respectively . Functio2) and normalized units (LFnu and HFnu) to represent the relative amount of each component compared to the total power of the HRV spectrum. The algorithm also calculates the LF/HF ratio, which is considered an index of the sympatho-vagal balance [Segments around 300 consecutive beats were selected from the ECG signal for the analysis of HRV. Two different approaches, linear spectral analysis and non-linear symbolic analysis, were applied through a specific software . The autoregressive model was performed to identify the spectral power in the low-frequency band , an index of sympathetic modulation and baroceptive activity, and in the high-frequency band , an index of parasympathetic modulation and synchronous with respiration. The LF and HF components were expressed in absolute values  0V, patterns with no variation, all 3 symbols are equal; (b) 1V, patterns with 1 variation, 2 consecutive symbols are equal forming a 2-beat plateau, while the remaining one is different; (c) 2LV, patterns with 2 like variations, all symbols are different from the previous one and they are in ascending or descending order; (d) 2UV, patterns with 2 unlike variations, all symbols are different from the previous one but not in a consequent order. The percentage of the patterns 0V is a marker of cardiac sympathetic modulation and 2UV or 2LV are markers of cardiac vagal modulation . With rep < 0.05 was considered statistically significant.Data were analyzed using SigmaStat software . Results were expressed as the median and interquartile range (25°–75° IQR). The Shapiro-Wilk test was used to evaluate the normality of data. The Pearson Product Moment Correlation was applied to explore the association between cardiovascular autonomic control variables and HR-QoL scores and among the results of questionnaires. A total of 20 SSc patients were included in the study. Demographic and clinical characteristics are described in Nine SSc patients experienced severe pain, 8 SSc patients had moderate pain and 3 patients reported mild pain. Fifteen out of 20 subjects reported a significant disability in daily activities (HAQ disability index ≥1) and 9 out of 20 passed the cut-off score of PHQ-9. Finally, 18 out of 20 patients had sleep disturbances.r and the significance values p resulting from the comparisons between the study indices are shown in The correlation coefficients The correlation analysis highlighted a significant negative association between the global score of PSQI and LF band power expressed by absolute values A. MoreovA positive association between the score of Sleep Disturbances category (item 5 of PSQI) and the LF/HF index was found, as reported in Surprisingly, a significant positive correlation was found between NRS pain values and 2UV%, which is an index of cardiovascular vagal modulation D.Positive associations were also found between questionnaires scores. Assessment of pain through NRS positively correlated with the PSQI E and thep value = 0.032; r = −0.49, p value = 0.029)  see p = 0.021)  was observed with diffuse cutaneous subset and with anti Scl-70 antibodies positivity  A,B. The = 0.021) E.The aim of the present study was to assess the quality of life and the association with the cardiovascular autonomic control in SSc patients with chronic pain. The major findings of this study, include that, in this population of SSc patients: (i) Sleep impairment is related to lower spectral power of LF and HF band and to a sympathetic predominance in the cardiovascular autonomic control at rest; (ii) poorer sleep quality is related to higher pain values and depressive symptoms; (iii) higher pain scores are related to higher cardiovascular vagal modulation; (iv) higher pain values are related to higher disability indexes; (v) a sympathetic predominance is correlated with the diffuse cutaneous subset and with anti Scl-70 autoantibodies positivity while the presence of digital ulcers correlates with a parasympathetic modulation.Our results showed that alterations of the cardiovascular autonomic control in SSc are related to sleep disturbances as highlighted by the two inverse correlations between the spectral power of LF and HF band and PSQI scores. Moreover, the moderate direct correlation between LF/HF and PSQI Item 5 scores highlighted a relationship between sympathetic predominance and sleep impairment. Consistently with our observation, it is known that the autonomic nervous system modulates the cardiovascular functions during sleep onset and the transition into different sleep stages . In turnIn our study, 18 out of 20 patients reported sleep disturbances  and we observed a positive association between sleep impairment and depressive symptoms. Sleep impairment is common in SSc, with 76% of patients reporting difficulty in sleeping and 59% reporting a moderate to severe impact of sleep lack on their daily functions ,5. MoreoWe investigated on cardiovascular parameters correlation with SSc clinical features showing how the diffuse cutaneous subset and the anti-Scl-70 positivity are related with a sympathetic predominance. This data confirms our previous study in which we observed that these alterations are detectable mostly in the advanced and fibrotic forms of SSc.p < 0.05) between NRS value at rest and the power of high frequency band (HF nu) of HRV spectrum, a vagal index [Surprisingly, we also observed that patients who reported higher pain values showed a higher parasympathetic modulation than patients who have lower pain levels, still maintaining an overall sympathetic predominance. The literature evidence suggests that the experience of pain is inversely associated with vagally mediated heart rate variability ,35,36. Hal index . Additioal index . Based oThere is a threefold connection between the autonomic nervous system, nociception and inflammation. Nociception and autonomic nervous system share many structures of the central nervous system for reception of stimuli, integration and processing of responses ,40. As dOur study has some limitations. We investigated a numerically limited cohort of 20 SSc patients with a prevalence of females, although this reflects the natural higher prevalence of Systemic sclerosis in female population. To conduct our study, we focused on a selected group of SSc with chronic pain features and mild to high pain as inclusion criteria to guarantee the homogeneity of the study population. Further studies are needed to enlarge the sample size and to investigate also patients in the early stages of the disease and with shorter disease duration.Despite limitations, our study elucidated the interconnection between autonomic dysfunction and quality of life in Systemic sclerosis patients, investigating sleep, depressive symptoms, pain and disability with validated scales. An intriguing observation emerged from our analysis, suggesting that pain, when chronic, is related to vagal responses. Further studies will be needed to enlarge the analysis and investigate this phenomenon as a possible time-dependent adaptive response in SSc patients, as well as in other conditions characterised by chronic pain.In conclusion, sleep impairment, pain and depressive symptoms are present and interrelated in patients with Systemic sclerosis, and lead to poor quality of life. In particular, sleep disturbances are correlated with a sympathetic cardiovascular predominance at rest, while chronic pain seems to lead to vagal responses as a possible adaptive mechanism in patients with higher pain values. In a chronic disease, such as SSc, sleep impairment and chronic pain should get the adequate attention from health care providers during the clinical assessment with an early recognition in order to improve patient’s quality of life.


Poor disease control and Pain management adversely affects the well-being and mental health of affected children. Questionnaires have been utilized in other regions to report the quality of life (QOL) in children with SCD, but assessments from Africa are lacking.children age 2-14 years with SCD presenting for routine outpatient consultations at Hospital Central de Maputo from June-August 2017 were offered participation. After informed consent, the Pediatric QOL Inventory (PedsQL) SCD Module was administered to all caregivers and children > 5 years. Responses were scored from 0-100, with higher scores representing better QOL.a total of 14 children were included, with six (43%), four (29%), two (14%), and two (14%) from the age groups of 2-4, 5-7, 8-12, and 13-14 years, respectively. Mean overall patient QOL was 65.3 and 56.0 in child and caregiver respondents. In patients > 5 years, the difference in mean overall QOL for those on/not on hydroxyurea was 0.6 (66.5-64.9) in child respondents and 15.8 (68.4-52.6) in caregiver respondents. Domains related to worry/emotions and communication scored lower in QOL than Pain-related domains for both patient and caregiver respondents.SCD has a negative impact on QOL as reported by this cohort of Mozambican pediatric patients and caregivers, with Pain being less of a concern than emotional and interpersonal issues. A comprehensive, child-focused care approach with robust psychosocial support is needed. Sickle cell disease (SCD) is a group of inherited hematological disorders characterized by vaso-occlusive Pain crises, multiorgan infarction, chronic anemia, and reduced life expectancy . It is eThe hallmark of SCD is the reoccurrence of vaso-occlusive episodes that contributes to acute and chronic Pain . HydroxyDespite the growth of research on the methods of screening, prophylaxis, and treatment of children with SCD, less emphasis has been placed on the psychosocial impact of this condition . CurrentVarious quality of life measures exist to assess the psychosocial consequences of SCD . The PedSetting: this study took place at Hospital Central de Maputo (HCM), Mozambique´s largest and highest-level referral hospital. HCM is also the principal academic hospital in the country. The Pediatrics Department has a Hematology Oncology division with inpatient and outpatient services, led by a pediatric subspecialist. Routine hematology labs are available in addition to hemoglobin electrophoresis for SCD diagnosis. Child-friendly 200mg hydroxyurea tablets only became available in 2019. Parenteral narcotics are available in the inpatient setting for the treatment of Pain, but there is no patient - controlled analgesia. Oral opioids are not used for the ambulatory management of Pain.Patients: patients with SCD who presented to the pediatric hematology outpatient service at HCM for regularly scheduled follow up appointments during the time period of June 1 - Aug 31, 2017 were recruited. Inclusion criteria were: confirmed SCD diagnosis per hemoglobin electrophoresis, > 2 and < 15 years of age, and clinic enrollment between January 1, 2011 and July 1, 2016 with at least one year of follow-up time.Data collection: after informed consent and assent, when applicable, quality of life (QOL) was assessed via the PedsQL SCD Module, which is available with an official Portuguese language translation [nslation . A trainThe questionnaire includes QOL domains that pertain to Pain and hurt, Pain impact, Pain management and control, worrying (two domains), emotions, treatment, and communication (two domains). The scoring of the questionnaire utilizes a 5-point Likert scale , with exception of the young child report that utilizes a “not at all,” “sometimes,” and “a lot” grading schematic represented by face scales that correspond to scores of 0, 2, and 4 respectively. Scoring procedures were executed in accordance to the scoring protocol supplied by PedsQL .Questionnaire responses were transcribed into a Microsoft Excel® database. Clinical and demographic data including laboratory results and treatment regimens were extracted from medical charts and also entered into the same database.Analysis: following standard PedsQL methodology, scores were averaged per domain, and then reverse scored and linearly transformed to a 0-100 scale with higher scores representing higher QOL. For each patient and caregiver respondent, scores were then averaged across all domains to establish a single composite total score. Means were calculated for caregiver and patient responses. Questionnaire domains were grouped into three categories for sub-analysis; 1) Pain and Treatment , 2) Worry and Emotion , and 3) Communication (includes Communication 1 and Communication 2). Due to a relatively small sample size, purely descriptive statistics (differences between means) were used to compare mean scores according to demographic and clinical predictive variables.Ethical considerations: this study was approved by the Scientific Directorate of HCM and received final bioethical approval from the Mozambique National Bioethics Committee (53/CNBS/2017). Informed consent was obtained from all caregivers and informed assent from all patients 13-14 years of age. Caregivers served as the consenting parties for all children. Since potential hazards from completing the study questionnaire included emotional distress and potential disagreements between patients and their caregivers on certain issues, the surveys were administered by trained clinical psychologists and child and caregiver questionnaires were administered separately.Patient characteristics: this study includes 14 patients with SCD . However, caregivers reported a much larger perceived benefit of hydroxyurea treatment .Domain sub-analysis: mean scores per grouped domain categories were also compared by respondent  and 13-14 year  age groups, but higher for children in the 8-12 year  age group.Mean scores per grouped domain categories were also compared between respondents according to hydroxyurea treatment . In chilTo our knowledge, this is the first reported study to utilize the PedsQL SCD Module to assess the impact of SCD on QOL from the African continent. Our results show that SCD has a significant negative impact on QOL from the patients´ perspective, with a mean total score of 65.3 out of a maximum of 100. These findings are similar to published reports from other global pediatric cohorts that used the PedsQL SCD tool in Jamaica (73.6 in adolescents) and Brazil (60.7 in children and adolescents) , 23. Of Our cohort had relatively similar QOL compared with two studies from the United States that reported total scores of 65.8 and 73.6 for child respondents , 22. GivAnother surprising finding from this study was that the highest QOL scores were observed in the Pain and Treatment category for both patients and caregivers. It is well established that Pain is undertreated and inadequately evaluated in most sub-Saharan African settings , 26, 27.While analgesics are important for SCD Pain management, hydroxyurea is the only drug that effectively reduces the frequency of Painful vaso-occlusive episodes and prolongs survival in patients with SCD -30. FurtThe lack of agreement between caregiver and patient responses to the PedsQL SCD Module was also noteworthy in our cohort, and has been noted in other studies using the tool . CaregivThis study is not without limitations. We had a small sample size and were unable to extend recruitment beyond the mentioned study period to include more patients. As such, we used purely descriptive statistics and did not have the power needed to determine if differences had statistical significance. The level of care available at HCM is far beyond what is available in most other parts of Mozambique, which may limit the generalizability of our findings. In addition, as with any questionnaire, there was a possibility of responder bias, but we tried to mitigate this possibility by having psychologists who did not regularly participate in the SCD clinic administer the PedsQL SCD Module as opposed to regular clinical staff. And, as mentioned previously, there was likely some selection bias in that patients on hydroxyurea therapy were more likely to have advanced disease.Despite these limitations, this study helps fill an important knowledge gap in the literature regarding the psychosocial impact of SCD in African children. These results can be used to advocate for comprehensive medical and psychosocial care of children with SCD and have already had a general stimulatory effect in terms of quality improvement at HCM, with an additional three patients from the cohort initiated on hydroxyurea in the year following completion of the PedsQL SCD questionnaire. We plan to conduct a similar evaluation in the future with children admitted to the wards with SCD to better understand the patient and caregiver experience, especially in regards to Pain and Pain management.SCD has a negative impact on quality of life as reported in this cohort of Mozambican pediatric patients and their caregivers, with Pain being less of a concern than emotional and interpersonal issues. A comprehensive, child-focused care approach with robust psychosocial support, in addition to evidence-based medical therapies that include hydroxyurea and opioids for Pain crises, is needed to improve overall mental and physical health outcomes.Sickle cell disease can have a significant impact on the physical health and psychosocial wellbeing of affected children and adolescents;Validated questionnaires such as the PedsQL Sickle Cell Disease tool have been used in other parts of the world to assess quality of life in affected children.Using the PedsQL tool, Mozambican pediatric patient and caregiver respondents generally reported lower quality of life in emotional and communication domains, than in Pain-related domains;Quality of life assessments often differ between children and their caregivers;A child-focused, comprehensive care approach with psychosocial support is needed for children and adolescents in care for sickle cell disease.