Patients’ psychological health may influence recovery and functional outcomes after total knee arthroplasty (TKA). Pain catastrophizing, known to be associated with poor function following TKA, encompasses rumination, magnification, and helplessness that patients feel toward their pain. Resilience, however, is an individual's ability to adapt to adversity and may be an important psychological construct that supersedes the relationship between pain catastrophizing and recovery. In this study we sought to identify whether pre-operative resilience is predictive of 3-month postoperative outcomes after adjusting for pain catastrophizing and other covariates.Patients undergoing TKA between January 2019 and November 2019 were included in this longitudinal cohort study. Demographics and questionnaires  were collected preoperatively and 3 months postoperatively. Multivariable regression was used to test associations of preoperative BRS with postoperative outcomes, adjusting for PCS and other patient-level sociodemographic and clinical characteristics.p = 0.019) and better general physical health  but not general mental health .The study cohort included 117 patients with a median age of 67.0 years (Q1–Q3: 59.0–72.0). Fifty-three percent of patients were women and 70.1% were white. Unadjusted analyses identified an association between resilience and post-operative outcomes and the relationship persisted for physical function after adjusting for PCS and other covariates; in multivariable linear regression analyses, higher baseline resilience was positively associated with better postoperative knee function (β = 0.24, Our prospective cohort study suggests that resilience predicts postoperative knee function and general physical health in patients undergoing TKA. Exploring interventions that address preoperative mental health and resilience more specifically may improve self-reported physical function outcomes of patients undergoing TKA.The online version contains supplementary material available at 10.1186/s12955-021-01772-2. Total knee arthroplasty (TKA) is a procedure that is currently performed over 600,000 times annually in the United States . Common Despite pain reduction and mobility improvements from TKA, research has indicated that patients undergoing TKA with higher levels of preoperative pain catastrophizing experience lower levels of function following surgery . SimilarUnlike pain catastrophizing, resilience is a positive psychological construct that has recently gained more attention in orthopedics. This construct encompasses positive environmental and emotional characteristics that allow a person to endure adversity . OptimisTo more clearly define the relationship between resilience and postoperative outcomes, we conducted a prospective cohort study to investigate whether preoperative resilience is predictive of postoperative knee function, general physical health, and general mental health 3 months after TKA, and whether any association identified would persist after adjusting for pain catastrophizing and patient sociodemographic and clinical characteristics. These two psychological constructs are often studied independent of one another and to our knowledge, this is the first study of patients with TKA to examine them together.In this prospective cohort study, patients were recruited from an outpatient orthopedic clinic of a large academic medical center from January 2019 to November 2019. Approval from the Institutional Review Board (IRB) was obtained prior to initiation of this study. Patient information was collected and stored within REDCap, a secure, web-based application platform .Prior to a clinic appointment, the patient's electronic medical record was pre-screened for study eligibility. Following consent for surgery by one of four joint replacement surgeons in the outpatient orthopedic clinic, patients were informed of the opportunity to participate in a study of outcomes for patients undergoing TKA. If interested and study eligible, the study was explained, and the patient consented prior to leaving the clinic. Patients were eligible if they were able to read and write in English, able to provide written informed consent, 35–85 years old, and approved to undergo unilateral TKA by an orthopedic surgeon. We chose not to include patients younger than 35 years in order to select against patients with knee pathology related to congenital, traumatic, and developmental origins . The maxTotal knee arthroplasty management criteria at the study’s institution are fairly standardized. On the day of surgery, patients were treated preoperatively with regional anesthesia to include a spinal block in addition to one or two additional peripheral nerve blocks. Postoperatively, in addition to the regional anesthesia blocks, patients received pain medications  for breakthrough pain. Patients were discharged on a combination of these medications. For postoperative therapy, patients were weight-bearing as tolerated and began therapy on postoperative day zero. Aggressive range of motion was discouraged until at least 2-weeks post-surgery, allowing swelling to dissipate and the wound to heal.Baseline assessments were collected at least 7 days prior to the patient’s surgery date. Following study enrollment, patients completed a demographics survey capturing age, sex, race, ethnicity, marital status, employment status, years of education, and insurance type. The patient’s current overall pain intensity was assessed using a Pain Numeric Rating Scale (NRS). The Pain NRS is a single item response value on a scale of 0–10 with higher scores indicating increased intensity .At baseline, patients were asked to complete four questionnaires. These questionnaires were repeated at 3-months following surgery. At the postoperative visit, a study investigator would systematically attempt to meet patients in person at their scheduled clinic visit with the operating provider (if scheduled). If no appointment was scheduled, study investigators would utilize email, then a phone call, which was followed by a mailed survey packet if no contact was made. All follow-up data were obtained no more than 1 week before or after each scheduled 3-month follow-up time point. When evaluating patient-reported function and pain, studies have shown that clinical services and the majority of change occurs within the 3-month postoperative period , 26.Comorbidities have been shown to influence functional outcomes of following TKA. To account for these factors, baseline clinical information was collected via retrospective chart review of the electronic medical record. These data included a documented history or clinical diagnosis of depression, anxiety, and back pain (with specific category for low back pain). We also evaluated for the presence of diabetes by identifying patients with a history or clinical diagnosis of diabetes, or evidence of any of the following: blood sugar > 7 mmol/L or > 126 mg/dL on two or more fasting plasma glucose tests; blood sugar > 200 mg/dL on two or more oral glucose tolerance tests; blood sugar > 200 mg/dL on random plasma glucose test in the presence of increased urination, increased thirst, or unexplained weight loss; hemoglobin A1c ≥ 6.5%; chronic treatment with anti-diabetic medications, including insulin. Classification for a history or clinical diagnosis of diabetes for this study did not include gestational diabetes, glycemic disorders , or pre-diabetes.Patients were evaluated for hypertension by determining if they had a history or clinical diagnosis of high blood pressure; or evidence of any of the following: hypertension, whether treated or untreated; blood pressure > 140 mm Hg systolic and/or > 90 mm Hg diastolic for patients without diabetes or chronic kidney disease; blood pressure > 130 mm Hg systolic and/or 80 mm Hg diastolic on at least two occasions for patients with diabetes or chronic kidney disease; currently prescribed medication for treatment of hypertension . Finally, patients were considered to have a history of cardiovascular disease if there was documentation of a history or clinical diagnosis of coronary artery disease, myocardial infarction, stroke, arrhythmia, valvular disease, or heart failure . Body maPain Catastrophizing Scale (PCS) [Pain catastrophizing scores were calculated using the le (PCS) , 26. ThiBrief Resilience Scale (BRS) [Patient resilience scores were calculated using the le (BRS) . This 6-The following standardized instruments were utilized to collect patient-reported information regarding health:The KOOS, JR. is a Likert-style questionnaire designed to evaluate patient's stiffness, pain , and functional ability (“rising from sitting” and “bending to the floor”). Patients indicate their level of stiffness and pain/difficulty performing these tasks based on the following options: “none”, “mild” “moderate”, “severe”, or “extreme”. The KOOS Jr. questions capture patient opinions up to 1 week prior to survey administration. Scores are transformed to a scale ranging from 0 to 100, with higher scores representing better knee function. The test has been validated against legacy measures, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and full-length KOOS, which take considerably longer to administer . This meThis instrument utilizes 10 items to provide an assessment of different components of patient quality-of-life. Items are used to provide raw scores for physical and mental health and raw response scores for the patient’s perception of overall health and social health. The physical health raw score (PROMIS PH) is calculated from items that ask patients to “rate” their physical health, fatigue, and pain while also considering the patient’s ability to carry out every day physical activities. Similarly, the mental health raw score (PROMIS MH) can be derived from items based on the patient’s general quality of life, mood and ability to think, social satisfaction, and susceptibility to emotional problems . T-score2) of 0.10 attributable to 1 independent variable using an F-Test with a significance level  of 0.05. The variable tested can be adjusted for up to an additional 15 independent variable(s). An effect size of 0.15 can be detected with 93.4% power under similar assumptions. Cohen's f2 interpretation: 0.02 = small, 0.15 = medium, 0.35 = large. Thus, we were adequately powered to detect a small to medium effect size. Additional patients were recruited assuming that some patients would be lost to follow-up [A sample size of 100 patients, achieves at least 80.9% power to detect an effect size (follow-up .Continuous variables are presented using the mean and standard deviation (SD) or median with 25th and 75th percentiles dependent on data distribution. Normality of continuous data was assessed using the Shapiro–Wilk test. Categorical variables are described using counts and percentages of non-missing data. Certain categorical variables were simplified into common subgroups to reduce categories and increase power. In order to measure internal consistency, Cronbach’s alpha coefficients were calculated for the primary patient-reported outcomes; values ≥ 0.70 generally indicate good reliability , 34.each preoperative variable . Model results are presented as the regression slope estimate with 95% confidence interval (CI).Correlations among continuous preoperative variables were determined by calculating Pearson correlation coefficients to determine the linear relationship. Multivariable linear regression models were constructed for each 3-month postoperative primary outcome, including KOOS and PROMIS (GH and MH). The goal was to describe the independent association between each of resilience and pain catastrophizing and the outcome variable of interest. Based on our predetermined data collection procedures we anticipated the number of missing patients would be low. Therefore, we constructed three multivariable models for knee function, general physical health, and general mental health using only complete cases. Preoperative covariates were chosen for each of three models using univariable linear regression analyses to determine the relationship of p < 0.05 was considered statistically significant unless otherwise indicated. Analyses were conducted using RStudio [Pairwise differences within subject were calculated for baseline versus 3-month measurements for each outcome. The significance of each difference was tested using the Wilcoxon sign rank test for paired comparisons. A  RStudio .A total of 404 patients with upcoming clinic visits for surgery evaluation were screened in clinic based on chart review of eligibility criteria. Of those eligible patients, 276 candidates were excluded from inclusion or declined to participate based on rationale provided in Fig. Overall, 53.0% of patients were women, and 70.1% of patients were white , general physical health , and mental health  in unadjusted models. After adjusting for pain catastrophizing and other covariates, the significant association of resilience persisted with 3-month knee function  and general physical health , but not with mental health at 3 months . The full multiple regression models are displayed in Additional file Simple linear regression and adjusted multiple variable regression models were used to determine whether baseline resilience was associated with knee function and general physical and mental health Table . There wIn the current study, we investigated the association between preoperative resilience and postoperative knee function and general health among patients undergoing TKA. The association has not been widely explored in this patient population and to-date has not accounted for a known negative psychological construct, pain catastrophizing. We found preoperative resilience was positively correlated with preoperative knee function and general health. Importantly, our findings suggest that baseline resilience was predictive of 3-month knee function and general physical health and the significant association persisted after adjusting for pain catastrophizing and other patient covariates. This positive psychological construct may be an important area of focus for future intervention in support of optimizing patient outcomes after TKA.or traumatic hip and knee surgery. Though the study found no relationship between resilience  and funce Scale . This sti et al.  demonstrintentionally pursue physically and mentally challenging tasks [Based on our findings, we also postulate that patients with positive perceptions of their recovery process are able to handle the mental and physical stressors of surgery better than those with negative perceptions. Their opinions of recovery are likely based on previous adverse experiences, daily recovery progress, as well as traits that cumulatively guide the patient toward specific emotional and behavioral responses , 38. Somng tasks . A patieng tasks . Alternang tasks . FurtherThe relationship between pain catastrophizing and postoperative knee function, specifically in persons with TKA has received much attention over the last 2 decades. Three studies have found significant relationships between pain catastrophizing and function as measured by the WOMAC knee function subscale and postoperative function during follow-up as early as 6-weeks , 6-monthconsistently predict postoperative outcomes will allow clinicians to gain insights about their patients’ potential functional trajectory that may not have been considered previously. As suggested in recent literature, the broader understanding of the patient experience beyond negative psychosocial factors may hold the key to eliciting modifiable risk factors for patients undergoing TKA [interventions that address key psychological constructs. Two recent studies sought to improve functional outcomes in pain catastrophizing patients undergoing TKA using pain coping skills training [Considering the evidence to-date regarding psychological health and the relationship with outcomes after TKA, we suggest that further research is warranted in this field to elicit other key factors influencing functional recovery –47. Deteoing TKA . The curoing TKA . In additraining  and cogntraining ; howeverThe current study is limited mostly by factors which were related to the most efficient and practical methods of collecting data from a prospective patient cohort in this academic medical center , 51. PatIn conclusion, our study contributes new information on preoperative resilience and its association with 3-month patient-reported outcomes of knee function and physical health. To our knowledge, this is the first study of patients with TKA that suggests this association persists after accounting for pain catastrophizing, sociodemographic, and clinical factors. The results of this study reinforce the importance of assessing preoperative psychological variables prior to TKA. Additional research is needed to support the development and implementation of resilience-related interventions in patients undergoing TKA to evaluate the potential for improvement in knee function and physical health following surgery.Additional file 1.Supplemental Table 1. Patient-Reported Outcome Measure Scores at 3-Months Postoperative and Change from Baseline in Study Population.Additional file 2.Supplemental Table 2. Unadjusted and Adjusted Models for KOOS IS at 3-Months Postoperative.Additional file 3.Supplemental Table 3. Unadjusted and Adjusted Models for PROMIS PH at 3-Months Postoperative.Additional file 4.Supplemental Table 4. Unadjusted and Adjusted Models for PROMIS MH at 3-Months Postoperative.


The postoperative period is critical in neurosurgical patients, where the incidence of postoperative AEs is significantly high. Most of events occurs during recovery phase and has got relation to anaesthetic management. The objective of study was to determine frequency of early AEs in elective neurosurgical patients.This cross sectional study was conducted at our tertiary care center. The duration of study was one year, from August 2017-July 2018. The data was collected using predesigned proforma. The assessment was done on arrival in recovery room (T1) and then at forty five minutes (T2), twenty-fourth hour (T3) and forty-eighth hour (T4) postoperatively.Total ninety-five patients were included. Overall, five hundred and forty AEs were recorded at T1, T2, T3 and T4. Anaesthesia related events like pain, postoperative sore throat, hoarseness, shivering and hypothermia were the commonest (73%). There was a gradual decline in incidence of these events over period of 48 hours. There was no effect of age, sex, BMI and blood loss on incidence of AEs.Postoperative pain, PONV and shivering were frequently reported AEs. We did not identify the impact of age, sex, BMI, comorbid or type of surgery in terms of having these events. The postoperative period is critical in neurosurgical patients, demands individualized and procedural specific care. The incidence of postoperative adverse events (AEs) in this patient population is higher as compared to other surgical procedures.th January 2017 bearing letter no 4409-Ane-ERC-16, and informed consent was taken from patients fulfilling inclusion criteria. Non-probability consecutive sampling technique was used. All adult patients with age ranges between 18 to 70 years, undergoing elective neurosurgical procedures were included. The procedures were divided into either Cranial or Spinal surgery. Cranial surgeries included were elective tumor craniotomies. While procedures like laminectomy, discectomy, pedicle screw fixation and excision of spinal tumours were included as spinal surgical procedures. Patients already planned for postoperative intensive care unit (ICU) stay, had intraoperative major catastrophic event like cardiac arrest, myocardial infarction, major hypoxia and massive bleeding were excluded from study. Patients required unplanned ICU admission were also excluded from study protocol. The enrollment of patient into the study was started after hospital admission. The intraoperative anaesthetic care, monitoring, induction technique and maintenance of anaesthesia were at the discretion of primary anesthetist. After extubation, patients were shifted to PACU. An independent data collector was responsible for retrieving the data from patient progress notes and recording it on predesigned data collection form. All patients were reviewed immediately at the time of arrival in PACU (T1). The relevant clinical data was recorded from anaesthesia monitoring form. This included details about demographic data, anaesthetic care and surgical procedure. The patient was then reassessed at 45 minutes (T2) for any complications occurred at PACU. The recovery room chart was also reviewed. In ward, all patients were followed up at 24th hour (T3) and then; the final assessment was done at 48th hour (T4) postoperatively. The file notes and daily progress sheets were reviewed for any AEs that occurred during ward stay. However, in case of any ambiguity in documentation, relevant teams were contacted to overcome any bias. For all time intervals that is; T1, T2, T3 and T4, legends were marked for any events, even if it already been marked for previous time interval. Recorded AEs were categorized as:This cross sectional study was conducted at post anaesthesia care unit and neurosurgical ward, at Aga Khan University Hospital Karachi. The duration of study was one year, from August 2017 - July 2018. The study protocol was approved from Ethical review committee of Aga University Hospital on 16Airway trauma, postoperative pain, postoperative nausea/vomiting (PONV), postoperative sore throat (POST), shivering, and hypothermia.Position related injuries, seizures, reoperation, Cerebrospinal fluid (CSF) leak, drop in GCS, new onset of neurological deficit.Hypertension (HTN), hypotension, arrhythmias, myocardial infarction (MI).Desaturation, re-intubation, hypoventilation, pulmonary edema, acute respiratory distress syndrome (ARDS), respiratory failure, pneumonia and pulmonary embolism (PE).Diabetes Insipidis (DI).Following definitions were used to mark and log the AEs.Procedural pain, the assessment of which was done using Numeric Pain Rating scale (NPRS) of 1-10.6As assessed on the PONV impact scale.7Any trauma to Lips, teeth or tongue associated with intubation, it also includes hoarsness of voice/laryngeal edemaPostoperative pain in throat related in intubation, with no preoperative history of such pain before the operation. It was assessed using verbal rating scale of Yes or No.Core body temperature less than 36 degree Celsius.Involuntary movement associated with hypothermia. It was assessed using verbal rating scale of Yes or No.Evident CSF leakage from nose or in the posterior pharynx as complained by patient and confirmed by surgical team.Pressure sores, burns injuries related to positioning during surgery.Any seizure activity occurred during postoperative period. It was using verbal rating scale of Yes or No.Re-exploration required with in a period of 48 hours after procedure.Any cranial nerve, sensory or motor deficit.Sudden drop in GCS level for base line.Absolute or relative deficiency of Antidiuretic hormone postoperatively. This needs to be associated with increased urine volume and rise in serum sodium level. The diagnosis was made on the basis of clinical notes.Symptomatic thromboembolic phenomena after surgery diagnosed after relevant investigations.Systolic BP higher than 140 mmHg and diastolic higher than 90 mmHg.Systolic BP less than 90 mmHg and diastolic less than 60mmHg.Abnormal electrical rhythm of heart.Rise in serum Troponin levels with or without EKG evidence. This needs to be diagnosed by cardiology and documented accordingly.2) less than 92% requiring supplemental oxygen.Persistent drop in oxygen saturation . Frequency and percentage was computed for qualitative observations like gender, comorbid conditions like diabetes mellitus (DM), hypertension (HTN), ischemic heart disease (IHD), Asthma, and perioperative complications. Mean and standard deviation was estimated for age, height, weight, BMI, duration of surgical procedure and estimated blood loss. The frequency and percentages were also calculated for AEs at T1, T2, T3 and T4. Stratification analysis was done to evaluate the relationship between age, gender, BMI, comorbid, type of procedure and blood loos with the frequency of AEs. Chi-square test was used to observe difference. P≤0.05 was considered as significant. The sample size was calculated on the basis of previous reported incidence of Post operative complications in neurosurgical patients; that is 54.5,th hour (T2), pain and POST (30% and 25%) were the most frequent complications. While, POST was the main problem at 24th (T3) and 48th (T4) hour postoperatively (51% and 60%). (Demographic characteristics of patients are shown in nd 60%). . The sevStratification analysis found no difference of age, sex, BMI and blood loss on incidence of AEs. Similarly, we didn’t identify any significant difference of these events in comparison to spinal versus cranial surgeries. However, metabolic events were more common in spinal surgeries (P= 0.073). Secondly, the pain was more in surgeries related to spine (P=0.040).The postoperative period in our study showed significant association with AEs. The anaesthesia related events were at the top of the list. This corresponds to the results of various studies, which showed immedaite postoperative period as the high risk for such events.At T2, pain and POST (40%:35%) were the most common. The same pattern was followed at intervals of T3 and T4, where the incidence of POST was 63% and 74% respectively. Most of our patients had mild to moderate pain as assessed using NPRS. However, we are not following any set protocol for postoperative pain management which could be the reason of this reporting. Studies have shown better pain management with the implementation of standarized protocol using patient controlled analgesia (PCIA).11The overall incidence of PONV is bit low. This must be because of double antiemetic prophylaxis with Dexamethasone and Ondansteron, which we usually follow for our neurosurgical patients. The efficacy of regime is proven through various studiesIn contrast to results of various studies reporting hypotension during recovery phase,In our elective neurosurgical patients, postoperative pain, nausea, vomiting and shivering were the frequently reported AEs. All of anaesthesia related events were peak at immediate recovery phase (T1 and T2) and got setteled with the passage of time (T3 and T4). We did not identify the impact of age, sex, BMI and comorbid conditions in terms of having these complications. Similarly, there was no significant difference in comparision to occurrence of these events in cranial versus spinal procedures.MC conceived, designed and did statistical analysis. Also responsible and accountable for the accuracy and integrity of work.MC, FS did data collection and manuscript writing and editing of manuscript.SA did review and manuscript writing and design of study.


Background: Chronic pain is a complex, multidimensional experience. Spirituality is hypothesized to impact pain experience in various ways. Nevertheless, the role that spirituality plays in multimodal pain therapy remains controversial and, to date, quantitative data on whether and for which patients spiritual aspects should be considered in the treatment of chronic pain is lacking. The aim of this study was thus to investigate the proportion and characteristics of patients with chronic pain who wish spiritual aspects to be integrated in their treatment.Methods: Two hundred nine patients with chronic pain were recruited from five inpatient departments and outpatient clinics in the German-speaking part of Switzerland. Patients filled out validated questionnaires, such as the Hospital Anxiety and Depression Scale (HADS), the Resilience Scale (RS-11), the Spiritual and Religious Attitudes in Dealing with Illness (SpREUK), and the 12-item Spiritual Well-Being Scale (FACIT-Sp-12).Results: More than 60% (CI95%: 55.5–67.9%) of the patients wanted to address spiritual aspects in their treatment. These patients were significantly younger, had higher levels of education, and suffered from more frequent and more severe pain than patients who did not wish to address spiritual aspects. Furthermore, there were high correlations with existing spiritual resources and higher scores of spirituality.Conclusions: These results confirm that the majority of chronic pain patients wish spiritual aspects to be considered in their treatment. Additionally, the finding that these patients had more spiritual resources underlines the importance of integrating spiritual aspects in a resource-oriented, patient-centered care approach for this condition. Chronic pain is a complex, multidimensional experience  and, conSpirituality can be conceptualized as a fundamental dimension of human life. In 1984, the World Health Assembly passed a resolution which, for the first time, included the spiritual dimension as an important aspect of healthcare . DespiteSeveral studies have found significant relationships between spirituality and physical and mental health and well-being [for reviews see –10]. AltA survey involving a large sample of general practitioners in Switzerland showed that physicians often felt insecure in their professional dealings with spiritual issues . DifficuSpirituality—and the ways in which it can be appropriately discussed in relation to medical treatment—not only varies greatly from individual to individual but is also strongly influenced by cultural factors. Research from other countries and cultures or with other patient groups can therefore only be transferred to chronic pain patients in Switzerland to a limited extent. The population of Switzerland is characterized by a denominational diversity that has undergone great changes in recent decades . This deGiven these considerations, this multi-facility, cross-sectional study aimed to examine whether chronic pain patients wish spiritual aspects to be integrated in their treatment. Validated questionnaires of spiritual and mental health indicators were used to further investigate possible differences in patient characteristics between those who wanted and those who did not want to address spiritual aspects in their treatment.This study was part of a larger research project about the validation of a screening instrument which assess spiritual resources and spiritual distress . PatientThe participants were given the following definition of how the term “spiritual” was to be understood: “Spiritual” refers to meaningful experiences, attitudes and practices that connect a person with what sustains and inspires his or her life. They can be religious or non-religious.” In order to accommodate cultural and ideological diversity and in accordance with WHO documents , we usedAll participants completed a sociodemographic questionnaire to obtain data on their age in years, gender, in which country they had grown up, level of education, socioeconomic and marital status, as well as denominational affiliation. The participants were asked about the duration of their illness, pain frequency, intensity and localization, use of analgesics, and whether they had been granted leave from work by their attending physician.The medical diagnoses, which were used to characterize the sample, were obtained from the attending physicians. Based on this information, the main somatic diagnoses were classified according to the subcategories of chronic pain in ICD-11: chronic primary pain , chronic cancer pain, chronic postsurgical and posttraumatic pain, chronic neuropathic pain, chronic headache and orofacial pain, chronic visceral pain, and chronic musculoskeletal pain . The maiTo avoid exclusive definitions prior to any explanation or definition of spirituality, the patients were asked for a self-categorization rating of how “religious” and “spiritual” they considered themselves to be, each on a scale from 0 to 10.To assess the spiritual resources and spiritual and religious attitudes of patients, we used the German version of the Spiritual and Religious Attitudes in Dealing with Illness (SpREUK) questionnaire . This 15The 12-item Spiritual Well-Being Scale (FACIT-Sp-12) is a widely used measure of spiritual well-being among people with cancer and has been demonstrated to have good validity and reliability . Each itThe Distress Thermometer (DT) is recommended as a screening tool for the assessment of psychosocial distress in patients and is measured on a scale from 0 (no distress) to 10 (extreme distress) . The HosIn order to assess resilience, the German version of the Resilience Scale (RS-11) with 11 items was used . Each it95%) for the proportion of patients wishing to address spiritual aspects in their treatment, bootstrapping based on 1,000 bootstrap samples was performed. To assess differences between the two groups of patients , two-tailed t-tests for independent samples were applied to compare continuous variables, while Fisher's exact tests were used to compare the nominal data. A P-value < 0.05 was considered to be statistically significant. For the multivariate analysis, we modeled a backward stepwise logistic regression to determine to what extent socio-demographic, pain-related and spirituality-related variables predict the patients' wish to address spiritual aspects in treatment.Study data were collected and managed using REDCap electronic data capture tools . StatistSociodemographic characteristics of the final sample consisting of 209 patients with chronic pain conditions are displayed in Regarding sample proportion, 67.5% of the patients were recruited from outpatient facilities and 32.5% from inpatient facilities. The mean duration of chronic pain was 11.0 ± 11.3 years. Most of the patients suffered from primary chronic pain, including unspecific back pain and fibromyalgia (46.1%), or from secondary musculoskeletal pain (31.9%). Patients with neuropathic pain (8.8%), chronic headache and orofacial pain (7.8%), chronic postsurgical or posttraumatic pain (4.4%), and chronic secondary visceral pain (1.0%) were less frequently represented. The proportion of patients with a psychiatric diagnosis was 54.1% in total: 26.3% had a depressive disorder, 9.1% a somatoform disorder, 3.8% a personality disorder, 2.4% an anxiety or obsessive-compulsive disorder, and 12.4% other psychiatric diagnoses.While the denominational affiliation in our sample was predominantly Christian , 5.3% were Muslim, and 26.0% of the participants were unaffiliated/non-denominational or defined themselves as atheist . In selfr = −0.56, P < 0.001), and slightly negative with the Distress Thermometer . The SpREUK subscale “Search” correlated slightly with the Distress Thermometer .There were some associations between measures of spirituality and health parameters: Spiritual well-being (FACIT-Sp) correlated strongly negative with higher levels of psychological distress , or 1/6 for “no, not at all” (20.1%), while the options between the extremes were less frequently chosen .95%: 55.5–67.9%) of the study participants preferred spiritual aspects to be addressed in their treatment, while 38.3% preferred spiritual not to aspects be considered in their treatment.Considering the bimodal distribution, for all further analyses the answers were dichotomized into two groups with a cut-off in the middle on the 6-point Likert scale. This new grouping showed that 61.7% (CIP < 0.01). In addition, the former group had grown up more often in Switzerland than in other countries and were more likely to have an academic-level education. There were no significant differences concerning gender or marital status  attributed to the chronic pain condition compared to the other group, there were no significant differences found regarding the Distress Thermometer. There was also no correlation with resilience as measured by the RS-11 scale or the Resilience Scale RS-11 scores between groups. The RS-11 is conceptualizes Resilience as a personal characteristic which correlates with general self-efficacy .P < 0.01, see P = 0.253), nor between the unaffiliated and atheists concerning the wish to include spiritual aspects in the treatment. Significant differences could only be found when comparing the small subgroup of Muslim patients with the subgroup of “other Christian denominations” or when comparing this latter group with the Protestant patients .Regarding denominational affiliation, the wish to incorporate spiritual aspects in treatment was unequally distributed , academic education , pain intensity, pain frequency, and the HADS score. To avoid multicollinearity (r > 0.6).A backward stepwise logistic regression analysis was calculated to analyze the wish to include spiritual issues in chronic pain treatment (dependent variable) in a multivariate model. The planned potential predictors for consideration in this model were all socio-demographic, pain-related, and spirituality-related variables with a bivariate significance level of inearity  of spiriOne of the main aims of this study was to evaluate whether chronic pain patients in Switzerland would be interested in the integration of spiritual aspects in their medical treatment. Of the participating chronic pain patients, 61.7% wanted spiritual aspects to be considered in their medical treatment. This is a remarkably high proportion which is in accordance with the qualitative results of the previous focus group interviews with chronic pain patients in Switzerland .These findings are also in line with the results of quantitative studies of patients with chronic diseases. In the United States, Balboni and Balboni  found thOur finding that a majority of the chronic pain patients in our study wanted spiritual aspects to be taken into account in treatment underlines the need to develop concepts and structures in patient-centered care in order to adequately assess and integrate spiritual aspects in treatment. If the patient's desire for spiritual aspects to be included in treatment is so common, then the question arises as to which profession this task falls to. Further it would also be necessary to clarify how these topics can be adequately addressed and which kind of interventions in the realm of spiritual care would be effective and health-promoting . To furtPatients with an academic-level education and who were younger in age were more likely to want to address spiritual aspects in the treatment. This rather surprising result might be of relevance for the clinical practice, as it shows that those with higher education and who are younger cannot be assumed to be less interested in addressing spiritual aspects. The desire to discuss spiritual topics could depend to some extent on linguistic ability, which may be reflected in the higher education of these patients. The definition of spirituality given to the patients prior to asking them if they wish to address these issues was based on a broad and non-religion-specific concept of spirituality. This could also contribute to the fact that younger and more educated patients felt addressed. This result fits with the observation that especially among young people in Switzerland the practice of spiritual practices such as meditation has increased significantly in recent years .It is surprising to note that, although higher pain intensity and frequency were associated with greater interest in addressing spiritual aspects in treatment, no clear association with higher psychological distress could be found. Taking into account the findings in patients with cancer, it could be assumed that a higher psychological burden is associated with increased spirituality and spiritual practice, and thus also with a greater interest in spiritual topics in treatment , 44. EveSelf-categorization of spirituality showed an interrelation with the wish to address spiritual aspects, but no significant differences could be found between the major groups of denominational affiliation  and the unaffiliated. These results suggest that the lack of a religious affiliation should not be interpreted as indicative of a lack of interest in spiritual aspects. In the small subgroup of Muslims, only one third of respondents wished to integrate spiritual aspects into treatment. This greater reluctance may be due to the fact that Muslims feel less well-understood with their particular spiritual concerns in a secular context.The missing associations with general resilience (RS-11) and psychological distress (HADS and DT) could be an indication that the concept of spirituality differs fundamentally from concepts within the psychological domain, and might therefore need to be considered as a separate dimension of health and disease. However, further studies are needed to elucidate the relationships between these concepts.The integrating logistic regression model of demographic and disease-related variables had a moderate predictive power for an individual patient wanting spiritual aspects to be addressed in the treatment. There was a strong association between the wish to include spiritual aspects in the treatment and existing spiritual resources as they are measured in the SpREUK, especially for the subscale “Search.” This subscale measures the interest in searching for meaning and purpose in life as well as for a transcendental truth . On the It is possible that there was a selection bias of patients who are particularly interested in spiritual aspects. However, our sample was not highly religious or spiritual according to the results of self-categorization , results which reflect those of the general population of Switzerland . While “Because the study was cross-sectional, no causal relationships can be inferred from the findings.A majority (61.7%) of chronic pain patients in Switzerland found it important to consider spiritual aspects in their treatment. Those patients who wished to address spiritual aspects also had more spiritual resources such as a renewed interest in spiritual issues or an intensified search for a spiritual source to cope with illness. The results of this study point to the need to consider the psychiatric and psychotherapeutic recommendations concerning the inclusion of the spiritual dimension , 46 and The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The studies involving human participants were reviewed and approved by Cantonal Ethics Commission, Zurich. The patients/participants provided their written informed consent to participate in this study.SP-K, MR, HM, and KH designed the study and interpreted the data HS, AL, RH, IR, and KH recruited the participants and conducted the survey. KH and HM analyzed the data. KH wrote the manuscript. All authors read and approved the final manuscript.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.


Background: Transcutaneous electrical nerve stimulation (TENS) is presently one of the main methods of treatment for neuropathic pain in type II diabetes mellitus. The discussion about which TENS frequency is more effective in the treatment of neuropathic pain has been ongoing for many years. Despite this, the response of different aspects of neuropathic pain to various TENS modalities has not been sufficiently studied. Aim: To analyze changes in characteristics of neuropathic pain depending on the frequency of TENS. Materials and methods: Seventy-five Russian diabetic patients with painful distal axonal neuropathy were enrolled in the study. Patients were assigned to three groups: in the HF TENS group, 25 patients received standard drug therapy  + high-frequency TENS (HF); in the LF TENS group, 25 patients received standard drug therapy  + low-frequency TENS (LF); in the control group, 25 patients underwent just standard drug therapy . Pain intensity was calculated before and after treatment with visual analogue scale (VAS), McGill pain questionnaire (MPQ), Douleur Neuropathique 4 Questions (DN4) and Pain Drawing. Results: TENS increased the therapeutic effect of standard drug therapy, in the treatment of neuropathic pain, by 65.9% and prolonged its efficacy by 31% for up to 6 months after treatment. HF TENS had a more pronounced analgesic effect than LF TENS based on VAS (34.7%), sensory (57.6%) MPQ dimensions and DN4 (21%). Affective MPQ dimension with the use of LF TENS was lower than HF TENS by 34.7% immediately after treatment, by 47.3% after 2 months and by 34.8% after 6 months of the follow-up period. Conclusion: There are significant differences between HF and LF TENS based on pain assessment using various pain scales. This reflects the distinctive effects of different TENS modalities on different aspects of neuropathic pain.  Regional improvement of blood circulation in nerve and surrounding tissue ,3;Increased axonal transport, contributing to the accumulation of growth factors in peripheral nerves ,5,6;Creation of anastomoses between intact and damaged peripheral nerve fibers ;Reinnervation of muscle fibers ;Regeneration of peripheral nerve fibers ,8,9;Inhibition of pro-inflammatory cytokines .The Transcutaneous Electrical Nerve Stimulation (TENS) of peripheral nerves for treatment of diabetic distal polyneuropathy in Russia was used for the first time in 2015 . . 35]. In our study analgesic effect is prolonged and maintained 6 months after completion of TENS treatment. The maximum analgesic effect in the post-treatment period was recorded 2 months after TENS, with gradual regression over the next 4 months. Warke et al. demonstrated that the long-term analgesic effect of low-frequency TENS could last for about 7 months , while NOur findings, supported by the existing literature, suggest that this prolonged analgesic effect is due to two factors. Firstly, regression of central sensitization, with a delay in its formation while maintaining nociceptive afferentation ,39,40,41Using direct TENS of peroneal and tibial nerves in treatment of neuropathic pain;A combination of HF TENS and LF TENS in treatment of patients with neuropathic pain;Complex application of VAS, MPQ, DN4 and Pain Drawing in neuropathic pain diagnosis in patients with diabetic neuropathies.As a result of this study, we recommend:However, these guidelines can be changed in other countries and other racial groups of patients, depending on the genetic and nongenetic  factors that influence pain perception.It was not possible to study the effectiveness of the combined use of HF TENS and LF TENS in the treatment of diabetic neuropathic pain and to compare these results with the use of separate methods of TENS;There was no comparative analysis of the effectiveness of HF TENS and LF TENS in the treatment of diabetic neuropathic pain between patients with type 1 diabetes mellitus and type 2 diabetes mellitus;We could not investigate the effectiveness of TENS methods in the treatment of patients with myelinopathy type of peripheral nerve disorders, and we could not compare these results with the results of treatment of patients with an axonal disorder;We could not study the effectiveness of TENS compared with the use of sham stimulation in the control group.There are significant differences between HF and LF TENS based on pain assessment using various pain scales, which reflects the distinctive effects of different TENS modalities on different aspects of pain. Sensory aspects of pain respond better to HF TENS therapy and affective aspects to LF TENS.


P = 0.0180) and permanent (P = 0.0002) facial numbness. Ten patients experienced pain recurrence. Thus, 39 patients (67%) sustained complete pain relief at the last follow-up , which was significantly associated with the presence of any (P = 0.0228) and permanent (P = 0.0427) postoperative facial numbness. In conclusion, in cases of TN, small offending veins arising from REZ and/or distal CN V and causing their stretching may be coagulated and cut. In many cases, TPV can be also interrupted safely or considered as collateral way for blood outflow. The main complication of such procedures is facial numbness, which is associated with the venous infarction of middle cerebellar peduncle and long-term complete pain relief.The optimal technique of microvascular decompression (MVD) for trigeminal neuralgia (TN) caused by venous conflict remains unclear. The objectives of this study are to characterize the offending veins identified during MVD for TN and to evaluate intraoperative technique applied for their management. From 2007 till 2019, 308 MVD surgeries were performed in 288 consecutive patients with TN, and in 58 of them, pure venous conflict was identified. In 44 patients, the offending vein was interrupted, as was done for small veins arising from the cisternal trigeminal nerve (CN V) or its root entry zone (REZ) causing their stretching (19 cases), small veins on the surface of REZ (9 cases), transverse pontine vein (TPV) compressing REZ or distal CN V (12 cases), and superior petrosal vein (SPV) using flow conversion technique (4 cases). In 14 other cases, the offending vein was relocated, as was done for the SPV or the vein of cerebellopontine fissure (8 cases), TPV (3 cases), and the vein of middle cerebellar peduncle (3 cases). Complete pain relief after surgery was noted in 49 patients (84%). No one patient experienced major neurological deterioration. Postoperative facial numbness developed in 14 patients (24%), and in 8 of them, it was permanent. In 14 patients, MRI demonstrated venous infarction of the middle cerebellar peduncle, which was associated with the presence of any ( Compression of the cisternal segment of trigeminal nerve (CN V) by the adjacent veins is widely recognized as one of the possible causes of trigeminal neuralgia (TN). However, only few studies highlighted the details of microvascular decompression (MVD) surgery in such cases , 22–24. The program of MVD surgeries for TN has been established in the Department of Neurosurgery, Medical Center East, Tokyo Women’s Medical University more than 10 years ago and presumes consistent collection of all relevant clinical, radiological, surgical, and follow-up information in the prospectively maintained computer database. From the most beginning of this initiative, the particular interest was put on cases with pure venous conflict. Our experience with characterization of veins offending CN V in patients operated on for TN and evaluation of the surgical technique applied for the management of these vessels with regard to both short- and long-term postoperative outcomes are presented herein.From April 2007 till December 2019, 308 MVD surgeries were performed in 288 consecutive patients with TN admitted to our center. During 19 primary or repeat procedures, no neurovascular conflict was identified intraoperatively; in 111 cases, the compressing artery was noted; in 120 cases, the neurovascular conflict was predominantly caused by the compressing artery, but offending veins were presented as well; and in 58 surgeries performed in 58 patients, only offending vein(s) were identified. The latter cases have formed the study cohort of the present retrospective analysis. All evaluated data were extracted from the prospectively maintained computer database, as well as from the surgical records and intraoperative videos. Research protocol was approved by the Institutional Review Board of Tokyo Women’s Medical University (No. 2741).®) administration or associated side effects. In all cases, MRI excluded presence of the structural intracranial lesion or identifiable neurovascular conflict.The study cohort comprised 39 women (67%) and 19 men (33%) aged from 17 to 81 years ; 17 patients (29%) were younger than 50 years. The duration of symptoms varied from 6 months to 30 years , and in 21 cases (36%), it was less than 3 years. Typical clinical presentation of TN with paroxysmal “electric discharge”-like facial pain with certain unilateral topographical distribution within the one or more divisions of CN V triggered by the facial stimulation was noted in 52 patients (90%). In other 6 patients (10%), the clinical symptoms were considered atypical . Pain was located on the right and left side of the face in 36 (62%) and 22 (38%) patients, respectively. It was localized solely within the areas of ophthalmic (V1), maxillary (V2), and mandibular (V3) divisions of CN V in 2 (3%), 19 (33%), and 15 (26%) cases, respectively, whereas in 7 cases (12%), pain included areas of V1 and V2, in 14 (24%) of V2 and V3, and in 1 case (2%) of all three divisions (V1/V2/V3). The indications for surgical treatment included insufficient control of pain at the optimal dose and schedule of carbamazepine (TegretolFifty patients (86%) in the study cohort underwent MVD procedure for newly diagnosed TN, whereas in 8 others (14%), surgery was done for pain recurrence. Informed consent was provided before intervention by each patient and his/her nearest family member.The consistent goal of surgical treatment was the elimination of vascular compression or kinking of REZ and distal CN V. The insertion of the separating prostheses was avoided, and instead the offending vessel was relocated distally and fixed  in new position by fibrin glue with or without use of the small piece of Teflon . AlthougAll surgical procedures were performed under general anesthesia with the use of retrosigmoid approach and auditory brainstem response (ABR) monitoring. The patient was placed in a park-bench position. After straight incision of the soft tissues, craniectomy with diameter of 2.5–3 cm bordering transverse and sigmoid sinuses was created. T-shaped dural incision was made, and cerebrospinal fluid was withdrawn from the subarachnoid cisterns. The great horizontal fissure of the cerebellum was dissected (unless it was adhered too tightly), and superior semilunar lobule was gently retracted with the suction tube, which allowed for access to REZ and distal CN V. By wide opening of the arachnoid and dissection of its membranes, the main trunk of SPV and its tributaries were freed as much as was needed in each individual case. The entire length of CN V from the pons to the porus trigeminus was inspected for the presence of offending vessel(s), which was facilitated in some cases by drilling the suprameatal tubercle off. If arterial compression was revealed, it was managed appropriately. If arterial compression was not apparent, the thorough search for offending veins and their management were done.Head CT next day after surgery was performed routinely in all cases. MRI examination was done in 51 patients (88%), usually 1 month after surgery or earlier, if new neurological symptoms were evident. Subsequent follow-up was carried on in the outpatient clinic. In addition, in April 2020, a survey with standard questionnaire addressed via postal mail or phone calls was accomplished for the evaluation of long-term outcomes. Pain relief and facial numbness were assessed according to the proposal for standardized analysis of the results of MVD surgery for TN  and the P < 0.05. All calculations were performed with the commercially available software JMP® Pro 14 .Two-tailed Fisher exact test and ANOVA were used for data analysis. Proportion of patients with complete pain relief during follow-up was evaluated with the Kaplan-Meier method. The level of statistical significance was defined at P = 0.0206) and more frequently underwent surgery for pain recurrence (P = 0.0089). In addition, in all patients with atypical clinical symptoms, pure venous conflict was identified intraoperatively, and in neither such case, a compressing artery was revealed (P < 0.0001).In comparison with cases with the apparent compressing artery identified during MVD surgery for TN Table , patientIn 44 patients (76%), the offending vein was coagulated and cut Figs. , and 3, In 14 other cases (24%), the offending vein was relocated and fixed in new position with fibrin glue, as was done for the main trunk of SPV or the vein of cerebellopontine fissure (VCPF) in 8 cases, TPV (3 cases), and the vein of middle cerebellar peduncle (3 cases). Nevertheless, even if these major veins have been transposed, their small tributaries arising from the pons, REZ, or distal CN V frequently should be coagulated and cut.Outcomes after MVD surgeries for TN caused by pure venous conflict with regard to type of the offending vein management are summarized in Table Complete pain relief  or permanent (P = 1.000) facial numbness did not differ significantly between subgroups of patients in whom interruption or relocation of the offending vein was done.Postoperative facial numbness was revealed in 14 patients (24%), and in 8 of them, it persisted at the time of the last follow-up examination or response to survey. In cases of permanent facial numbness, it was considered not bothersome (C-1  or BNI FP = 0.0180) and permanent (P = 0.0002) postoperative facial numbness (Table P = 0.2907).In 7 patients with facial numbness, including 6 in whom this complication was permanent, postoperative MRI demonstrated area of mild-to-moderate hyperintensity on T2-weighted, constructive interference in steady state (CISS), fluid attenuation inversion recovery (FLAIR), and diffusion-weighted (DWI) images within the middle cerebellar peduncle, considered as the venous infarction Fig. . There wP = 0.0228) and permanent (P = 0.0427) postoperative facial numbness , which was performed within the first month after surgery in 88% of cases. Overall frequency of the venous infarction of middle cerebellar peduncle was prominent, as corresponding imaging findings were marked in 27% of patients in whom examination was done. Nevertheless, while relatively high probability of this complication should be taken into consideration during planning of surgery and getting an informed consent from the patient, it should be noted that in neither case of our series the venous infarction of middle cerebellar peduncle has resulted in major neurological deterioration, nor cerebellar hemorrhage or swelling were observed. The incidence and clinical course of the venous cerebellar infarctions after MVD surgery for TN certainly require additional analysis in large-scale clinical investigations.Notably, the present study identified a statistically significant association between postoperative facial numbness and long-term pain-free status. Out of 39 patients who sustained complete pain relief, 13 experienced postoperative facial numbness, and in 8 of them, it was permanent. In contrast, among 19 individuals who did not show complete pain relief after surgery or experienced pain recurrence, transient postoperative facial numbness was noted only in one. The association between development of facial numbness and pain relief has been frequently noted after destructive treatment of TN with stereotactic radiosurgery, glycerol or radiofrequency rhizotomy, and percutaneous balloon compression. However, it was not reported after MVD surgery and may represent a specific feature of such procedures directed at the release of pure venous conflict. In such cases, the interruption of small offending veins may result not only in release of the neurovascular conflict and elimination of the nerve stretching or kinking but also in inadvertent lesioning of the REZ and/or distal CN V, which may have an additional favorable impact on the outcome. Moreover, considering statistically significant associations of the postoperative facial numbness both with the venous infarction of middle cerebellar peduncle and with the durable complete pain relief demonstrated in our patients, it may be suggested that such treatment effect has been caused not only by the peripheral decompression itself, but in some part resulted from the central denervation in the brainstem, e.g., due to lesion within the principal sensory nucleus of CN V. The possibility of such pathophysiological mechanism should be taken into consideration and investigated further.Finally, similar to Lee et al. , we haveThe main limitations of the present study are related to its retrospective design, while extraction of all relevant information from the rigorously completed prospectively maintained computer database has significantly reduced the risk of relevant biases. The number of patients was relatively small; thus, statistical analysis may be somewhat underpowered. Finally, postoperative follow-up in some cases was short, and not all patients have responded to survey directed at the evaluation of long-term outcome, but it is most likely that the majority of those individuals who denied postoperative examinations and did not respond to questionnaire had sufficient pain relief after treatment.Surgical management of TN caused by pure venous conflict is challenging. According to our experience, small veins, which converge into SPV group, frequently arise directly from REZ and/or distal CN V and cause their stretching or kinking. These tiny offending vessels may be coagulated and cut. In many cases, TPV, and even SPV, can be also interrupted safely, while it should be done with certain caution and consideration of the individual details of vascular anatomy allowing for adequate collateral venous pathway if flow conversion technique is applied. Utilization of such intraoperative strategies in the present series has resulted in complete pain relief after surgery and on the long-term follow-up in 84% and 67% of patients, respectively. There was no one case of major complications or cerebellar hemorrhage or swelling. The venous infarction of middle cerebellar peduncle was revealed in 27% of patients, in whom postoperative MRI was done, and either manifested with facial numbness or was asymptomatic . Temporary or permanent facial numbness after surgery was encountered rather often (24% of cases) and showed association with the venous infarction of middle cerebellar peduncle and the long-term complete pain relief.


Asthma affects 235 million people worldwide. Supported self-management, including an action plan agreed with clinicians, improves asthma outcomes. Internet-of-things (IoT) systems with artificial intelligence (AI) can provide customized support for a range of self-management functions, but trust is vital to encourage patients’ adoption of such systems. Many models for understanding trust exist, some explicitly designed for eHealth, but no studies have used these models to explore trust in the context of using IoT systems to support asthma self-management.In this study, we aim to use the McKnight model to explore the functionality, helpfulness, and reliability domains of patients’ and clinicians’ trust in IoT systems to deliver the 14 components of self-management support defined by the PRISMS  taxonomy.think-aloud techniques in semistructured interviews to explore the views of patients and clinicians. Patients were recruited from research registers and social media and purposively sampled to include a range of ages, genders, action plan ownership, asthma duration, hospital admissions, and experience with mobile apps. Clinicians  were recruited from professional networks. Interviews were transcribed verbatim, and thematic analysis was used to explore perceptions of the functionality, helpfulness, and reliability of IoT features to support components of supported self-management.We used A total of 12 patients and 12 clinicians were interviewed. Regarding perceived functionality, most patients considered that an IoT system had functionality that could support a broad range of self-management tasks. They wanted a system to provide customized advice involving AI. With regard to perceived helpfulness, they considered that IoT systems could usefully provide integrated support for a number of recognized components of self-management support. In terms of perceived reliability, they believed they could rely on the system to log their asthma condition and provide preset action plan advice triggered by their logs. However, they were less confident that the system could operate continuously and without errors in providing advice. They were not confident that AI could generate new advice or reach diagnostic conclusions without the interpretation of their trusted clinicians. Clinicians wanted clinical evidence before trusting the system.IoT systems including AI were regarded as offering potentially helpful functionality in mediating the action plans developed with a trusted clinician, although our technologically adept participants were not yet ready to trust AI to generate novel advice. Research is needed to ensure that technological capability does not outstrip the trust of individuals using it. Asthma is a variable long-term condition that affects 235 million people worldwide . In evernarrow  or can mimic, equal, or ultimately surpass human intelligence to create new ways to interact with users   on the app where you’re using the app but it gives you a tip each day that you know, “air pollution could be a trigger for your asthma” or “washing can be a trigger for asthma”, then that might give you some additional information.P7, 46-65 years, maleI think kind of mindfulness breathing exercises you can find on, like, YouTube. If it was, like, breathing exercises to assess the asthma, it might be the sort of thing I might try once and see what I thought of it and if I thought it was useful I might try it again.P10, 16-25 years, femaleSome clinicians perceived that the IoT had the functionality to engage patients to look after their asthma and support self-management. They believed (in the future) systems could transfer patients’ manual or auto logs to a health care professional for review or flag up when inhaler medication needed to be replenished. In contrast, others doubted whether technology could change patients’ behavior:There isn’t an app that I’m aware of that can link with the GP systems. So if that is possible from a technology perspective, inputting how much they’re using and there’s a log then of when they have their new prescription, and then that app then talks to the GP system it can flag when they get to a certain level and order a repeat, I think that’s perfectly feasible.HCP2, pharmacist in hospital, femaleI think patients either are physically active or they’re not, and the app’s not going to make them physically active if they’re not.HCP5, consultant chest physician, femaleIn the last few months in my pharmacy we’ve introduced...well, we always had online ordering but there wasn’t huge engagement with it but we’ve introduced an app-based system for ordering. A younger population who is ordering things like asthma inhalers and contraceptive pills and so on have really engaged with that actually quite well.HCP7, pharmacist in practice, maleMost patients had a perception that IoT systems could provide a useful service to provide integrated support for a number of recognized components of self-management support   or automatic data collection from wearable devices or environmental sensors in their living areas. Some specific ways in which they thought an IoT system would be useful if they could help them look after their asthma by providing customized alerts and advice were the following:Identifying unusual asthma symptoms or peak flows and automatically providing customized information about their asthma and advice on medication adjustment and follow-up actions Alerting them if their inhaler technique was incorrectDetecting unusual use of rescue inhalers to help them identify what triggered their asthmaReminding them to comply with their preventer inhalerIn addition, they thought that an IoT system would be helpful in supporting their communication with clinicians. Most participants believed it would be helpful to be able to ask quick questions or arrange follow-up consultations with clinicians via text, WhatsApp, or email and then be able to share their data with clinicians to assess their asthma status. Some patients thought objective evidence from logs would help explain their asthma to their friends or senior colleagues at work:I’ve missed so many events in my life because of my asthma and I think it’s difficult to say to someone. I think if you had this medical evidence behind you, they’d understand without you having to explain it.P6, 16-25 years, femaleI think particularly my parents. I live in a flat on my own and if for whatever reason during the night I was suddenly puffing my blue inhaler multiple times, I’d almost want a warning siren to be sent to my parents just in case I’m really struggling.P12, 26-45 years, femaleA patient who had had a recent hospital admission thought it would be helpful to automatically share their asthma logs with the emergency department and share test reports between different hospitals to prevent treatment delay. Some patients described how they panicked when they were very short of breath and could lose track of how many puffs of their reliever inhaler they had taken in a short period. A system that counted the doses of reliever inhaler they had taken and warned them in real time about overdose would be a helpful safety net. Patients with multimorbidity wanted the system to integrate information from different health care specialists about all their treatments and provide medication advice to reduce the side effects of different drugs.Most clinicians agreed that receiving data about peak flow and symptoms would help them assess asthma status in reviews, but also highlighted the benefits of an IoT system that could transfer objective data on incorrect or correct inhaler technique and medication use to help assess the adherence and suitability of the inhaler device:Because very often patients don’t remember to bring their inhaler with them so it’s difficult to always test when they’re in the clinic. So if you’re being alerted to that, when they’re doing it at home, then that’s perfect, because if you ask a patient are you doing it right, they always say “yes”.HCP1, GP, femaleIf I’ve got some hard data on their peak flow and their symptoms over the last couple of months, and their adherence, that gives me a much better idea of what I need to do with them, so that’s incredibly helpful for me.HCP5, consultant chest physician, femalePatients and clinicians discussed reliability—whether they trusted the IoT system would operate continuously and without error—in two contexts: logging data and providing advice.in the background would reduce missing data. They believed that smart peak flow meters and smart inhalers could reliably capture data, although there were caveats. Some patients did not always carry these devices with them or had more than one reliever inhaler in use , and a reliable system would need to accommodate these behaviors. Some patients suggested that a voice assistant was easier to use, but others raised concerns about its accuracy. Most clinicians agreed that automatic logs are more accurate, as they reduce human error:Some patients observed that a system that logged data  automatically If it can capture most things, like obviously in the air it’s cold or there’s pollen or there’s pollution, I could probably trust it quite a bit, that, because it’s solid data that’s already captured in other places.P1, 46-65 years, femaleI think it (an IoT system) might be more accurate as well than say if I did it (logging) myself.P11, 16-25 years, femaleI know some people say that sometimes they [patients] come in and they sit in the waiting room and they’re filling in the results.HCP4, prescribing support pharmacist in practice, femaleI suppose adding technology in to it might make it more accurate and take out the human error and that.HCP10, GP, malehuman factors  into account when reaching a diagnosis. Clinicians were also comfortable with an IoT-based early warning system to alert patients to seek further assistance when their condition worsened but considered the automatic generation of new advice as an unproven route. They also cited the importance of personal relationships. They accepted that AI may be used to generate new intelligent advice to patients in the future but would need evidence to prove clinical accuracy before trusting in its reliability:Most patients believed that the system could accurately highlight the advice on an agreed action plan when their condition was getting worse but were skeptical that the system could safely generate new advice. They would trust the system to reliably prompt an alarm when their condition worsened or if they took their inhaler incorrectly, identify environmental triggers and recommend avoidance, and remind them of the actions suggested on an agreed action plan. In contrast, all patients preferred their clinician to interpret the data and decide on new advice. Similarly, patients did not believe that the system could take Well, again it goes through two stages, so if I’m really bad, maybe a message to say I’m really bad and...probably notice my wife first (to make decisions) and then the health care professional (to arrange follow up actions)...I wouldn’t want that to trigger an appointment with a health care professional.P4, 26-45 years, maleLike if it was suggesting changes to me, that feels more like the time that I would actually have to have a conversation with the GP or nurse rather than my phone triggering stuff like that.P12, 26-45 years, femaleSo if there’s some sort of really intelligent system that can work out how to do an asthma action plan for somebody based on intelligent peak flow monitoring and intelligent looking at the symptoms and all of that, great, but until we’ve got that we need a human being I think to sit with the patient and make an asthma action plan. Because even as an experienced clinician it can be quite challenging sometimes because you have to know quite a lot about asthma to do them.HCP5, consultant chest physician, femaleI don’t think we’re at a stage where a system can advise patients. I would be a little bit nervous about it. I’d have to have proof that that actually works because I think I would recognize that in my practice I establish a relationship with a patient. A machine advice, automated advice doesn’t necessarily understand that.HCP11, pediatrician, malePrivacy of personal data was a strong overarching theme that emerged in the interviews. Although clearly relevant to trust but not task specific (as in the McKnight trust model), patients were found to accept the health services to implement IoT systems if they knew how their data would be used. Attitudes varied, with a patient suggesting they were not concerned about data security, whereas another explained that they were not happy to use a voice assistant because it was connected to the cloud service. Most patients and clinicians wanted to use SMS text messages or emails for follow-up questions, although both suggested that the General Data Protection Regulation was a barrier to adopting these services in the NHS. Clinicians balanced the data privacy risk and the helpfulness of the services and thought that explaining to patients about the use of their data and having their consent was a pragmatic approach, as opposed to blocking the service completely:That (Email communication) would be useful sometimes, but they  wouldn’t do it, so I don’t really know...(the clinicians) they’d be worried about that (spam in email), same with text messages and WhatsApp...It might work from my side, but I don’t think it would work from their side.P5, >65 years, maleThe NHS contract can be difficult, with regards to GDPR and so on, so nearly everything is done via phone, and if you can’t speak to an actual person, we don’t routinely leave messages and so on.HCP7, pharmacist in practice, maleThis is personal data but it’s only about your health condition. So in one way I wouldn’t be that worried about that so much because actually that’s just about one condition that actually you want to make sure that people know about so that you actually get treated properly.HCP4, prescribing support pharmacist in practice, femalehuman advice before acting on AI-determined actions. Most patients’ beliefs resonated with those of the clinicians. Before trusting and adopting AI-developed advice, clinicians wanted evidence to reassure them about accuracy. Pragmatic approaches are required to deliver services based on the requirements of the General Data Protection Regulation. Our study did not find a diversity of views among different ages and genders, possibly because all participants had experience with technology and were the end users of similar NHS asthma care services in the United Kingdom. Racial biases, sociocultural norms, and an understanding of AI are other potential factors that need to be considered when developing IoT-supported services applicable to diverse communities.Most patients believed IoT systems to be functional and helpful in supporting a broad range of self-management tasks, but they raised some concerns about reliability. They believed IoT systems could collect their data accurately from devices, check for incorrect inhaler techniques, and advise them on treatment options based on the thresholds and actions agreed with clinicians  and customized to their situation. However, they doubted whether the system could interpret their data to generate novel advice or reach diagnostic conclusions. They would want to check with a health care professional for reassurance and We explored perceived trust in IoT systems from the perspective of patients and clinicians; however, there are some limitations. First, patients and clinicians based their opinions on their past experience of existing technologies and arrangements within current health care services. Our clinician participants were interested in technology and asthma, which will have influenced their opinions that were based on their experience, personal interest, age, and gender. The views from these groups of participants may not apply to users with limited access to technology or lack of experience with digital options. Real-life experiences with an IoT system may have generated new themes. However, our findings represent perceived expectations from patients and clinicians and can therefore inform future IoT system design and underpin further investigation. Second, because of time and resource limitations, we did not interview children (patients aged ≤16 years) and their parents, although we included experienced pediatricians to explore some of the issues from their perspective. Third, we could not recruit patients who were newly diagnosed (0-1 year) with asthma who may have had specific requirements, although our experienced asthma patients provided some feedback on their needs or expectations when they were newly diagnosed. Fourth, all of our participants were confident in using technology such as social media, web information, voice assistants, and activity trackers. Hence, participants may be biased in assessing perceived functionality, helpfulness, and reliability because of their past use of technologies. However, their real-life experience enabled them to give examples of IoT features that they considered trustworthy (or not) from personal experience. Finally, the McKnight domains used in this study were limited to perceived functionality, helpfulness, and reliability; other domains such as perceived ease of use, perceived value, and the source of the recommendation  ,46 may aOur findings show that patients and clinicians both recognized the potential of IoT systems to provide a range of customized support for self-management, which they believed would help them look after their asthma. They trusted smart devices to observe their status accurately and had confidence that the system could trigger advice previously agreed with the clinician when they experienced unusual asthma symptoms or reduced peak flows. They found it acceptable for systems to detect errors, correct inhaler techniques, and address noncompliance to medication. These functions imply that IoT systems can be trusted to include AI that can learn about an individual’s asthma throughout time and provide advice based on a set of rules. However, neither patients nor clinicians trusted the IoT system to mimic clinicians’ intelligence and create new self-management advice, preferring a human check to reassure that the AI advice was applicable to the individual before deciding what to do. This resonates with the findings of a recent review on AI clinical interventions in the context of other long-term conditions, such as depression, weight, nutrition, limb pain, and smoking cessation management . People narrow intelligence that follows preset rules  to general  or superintelligence  in which the system initiates rules. Although there are high-level guiding principles [Technically, patients and clinicians are reluctant to move from using inciples ,49 and ginciples  to ensurinciples   transparent. This may be a reason many patients trust that AI-based IoT systems can record their asthma condition better than themselves, but none have shifted their trust from the clinician to the AI in terms of issuing new advice.Patients are not yet ready to transfer their trust from the clinician (a human) they know to an IoT system (a machine) generating self-management advice through AI. In the traditional self-management model, the GP or asthma nurse assesses the patient’s condition and agrees with self-management advice in a face-to-face consultation. In the new IoT self-management model, the app interface, smart devices, or lifelike robots (in the near future) have the responsibility to sense the patients’ condition, which replaces the clinicians’ intelligence in giving self-management advice to patients. The decision process is an impenetrable From e-commerce literature, we know that it is possible to shift people’s trust from a known person, organization, or shop to an electronic service related to the known entity ,52,53 ornarrow intelligence directed by clinician-determined action plans to a future in which advice is generated by the IoT system. Our technologically adept participants were not yet ready for this step; research is needed to ensure that technological capability does not outstrip the trust of the individuals using it.Introducing IoT systems involving advice from AI to support self-management requires more than just functionality that can deliver tasks users regard as helpful. There is a need to increase the trust of users in the reliability of systems as AI moves from the currently acceptable