Adoption of a Postoperative Pain Self-Report Tool: Qualitative Study.

BACKGROUND: With electronic technologies, patients are provided with tools to easily acquire information and to manage and record their own health status. eHealth interventions are already broadly applied to perioperative care. In a similar way, we aimed to utilize a smartphone application to enable postoperative patients to partially self-manage their postoperative pain. The results of a previously performed proof-of-concept study regarding the application were promising, and nurses as well as patients were optimistic regarding this innovative mobile application. Nevertheless, in reality, it appears that the usage and overall implementation of this application have stagnated since its introduction. Problems with innovation adoption are not novel; various studies have been conducted to explore the reasons for low implementation success of eHealth applications and indicated that adoption is influenced by multiple organizational factors. This study investigated the influence of these organizational factors on the adoption process, aiming to provide more insight in the dos and don'ts for implementing eHealth in the working processes of hospital care. OBJECTIVE: This study aimed to provide insight in how to successfully implement a technological eHealth innovation in a general nonacademic hospital. METHODS: A qualitative study was conducted to explore organizational factors affecting the innovation adoption process. Data were collected by conducting semistructured one-on-one interviews with 11 stakeholders. The data were analyzed using thematic analysis identifying overarching themes. RESULTS: Absorptive capacity, referred to as an organization's dynamic capability pertaining to knowledge creation and utilization that enhances an organization's ability to gain and sustain a competitive advantage, was regarded as the most influential factor on the application's adoption. Accordingly, it appeared that innovation adoption is mainly determined by the capability and willingness to assimilate and transform new information into productive use and the ability to absorb a novel innovation. Absorptive capacity was found to be influenced by the innovation's benefit and the sense of ownership and responsibility. Organizational readiness and management support were also regarded as essential since absorptive capacity seemed to be mediated by these factors. The size of the hospital influenced eHealth adoption by the amount of resources available and by its organizational structure. CONCLUSIONS: In conclusion, absorptive capacity is essential for eHealth adoption, and it is mediated by management support and organizational readiness. It is recommended to increase the degree of willingness and ability to adopt an eHealth innovation by enhancing the relevance, engaging stakeholders, and assigning appropriate leaders to offer guidance.

Patient reported postoperative pain with a smartphone application: A proof of concept.

MAIN OUTCOME: Thirty patients (60%) found it satisfying or very satisfying to communicate their pain with the app. Pain experienced after surgery was scored by patients as 'no': 3 (6%), 'little': 5 (10%), 'bearable': 25 (50%), 'considerable': 13 (26%) and 'severe': 1 (2%). Forty-five patients (90%) were positive about the ease of recording. Forty-five patients (90%) could correctly record their pain with the app. Thirty-eight patients (76%) agreed that in-app notifications to record pain were useful. Two patients (4%) were too ill to use the application. Based on usability feedback, we will redesign the pain intensity wheel and the in-app pain chart to improve clarity for patients to understand the course of their pain. SECONDARY OUTCOMES: The median patient recorded pain app score 4.0 (range 0 to 10) and nurse recorded numerical rating scale (NRS) for pain NRS 4.0 (range 0 to 9) were not statistically different (p = 0.06). Forty-two percent from a total of 307 patient pain app scores were ≥ 5 (on a scale from 0 no pain at all to 10 worst imaginable pain). Of these, 83% were recorded as 'bearable' while only in 18% of the recordings patients asked for additional analgesia. The results suggest that self-recording the severity of postoperative pain by patients with a smartphone application could be useful for postoperative pain management. The application was perceived as user-friendly and had high satisfaction rates from both patients and stakeholders. Further research is needed to validate the 11-point numeric and faces pain scale with the current gold standards visual analogue scale (VAS) and NRS for pain.

Effects of Liraglutide on Myocardial Function After Cardiac Surgery: A Secondary Analysis of the Randomised Controlled GLOBE Trial.

INTRODUCTION: Previous studies demonstrated the cardioprotective properties of glucagon-like peptide-1 receptor agonists in patients with diabetes or cardiac disease. We investigated whether preoperative subcutaneous liraglutide improves myocardial function after cardiac surgery. METHODS: We performed a pre-planned secondary analysis of adult patients undergoing cardiac surgery included in the GLOBE trial. Patients were randomised to receive 0.6 mg subcutaneous liraglutide on the evening before surgery and 1.2 mg after induction of anaesthesia, or matching placebo. Perioperative echocardiographic assessments, haemodynamic parameters, doses of vasoactive inotropic support and postoperative measurements of troponin, Creatine Kinase-MB , creatinine and lactate were compared between groups. RESULTS: The study population consisted of the entire intention-to-treat cohort of the GLOBE trial. In this study, 129 patients received liraglutide and 132 patients placebo. Baseline characteristics were comparable between groups. Postoperatively, 170 (65%) patients underwent echocardiography. In the liraglutide group, more patients had a normal left ventricular systolic function (68%, 59 patients) compared to placebo (53%, 44 patients), difference = 15%, 95%CI = 0-30, p = 0.049. Assessment of the right ventricle revealed no difference in function. CONCLUSIONS: Patients receiving short-term preoperative liraglutide treatment better maintained normal myocardial function after cardiac surgery. This study warrants further evaluation of the potential beneficial effects of GLP-1 receptor agonists in cardiac surgery patients.

Liraglutide for perioperative management of hyperglycaemia in cardiac surgery patients: a multicentre randomized superiority trial.

AIMS: Most cardiac surgery patients, with or without diabetes, develop perioperative hyperglycaemia, for which intravenous insulin is the only therapeutic option. This is labour-intensive and carries a risk of hypoglycaemia. We hypothesized that preoperative administration of the glucagon-like peptide-1 receptor agonist liraglutide reduces the number of patients requiring insulin for glycaemic control during cardiac surgery. MATERIALS AND METHODS: In this randomized, blinded, placebo-controlled, parallel-group, balanced (1:1), multicentre randomized, superiority trial, adult patients undergoing cardiac surgery in four Dutch tertiary hospitals were randomized to receive 0.6 mg subcutaneous liraglutide on the evening before surgery and 1.2 mg after induction of anaesthesia or matching placebo. Blood glucose was measured hourly and controlled using an insulin-bolus algorithm. The primary outcome was insulin administration for blood glucose >8.0 mmol/L in the operating theatre. Research pharmacists used centralized, stratified, variable-block, randomization software. Patients, care providers and study personnel were blinded to treatment allocation. RESULTS: Between June 2017 and August 2018, 278 patients were randomized to liraglutide (139) or placebo (139). All patients receiving at least one study drug injection were included in the intention-to-treat analyses (129 in the liraglutide group, 132 in the placebo group). In the liraglutide group, 55 (43%) patients required additional insulin compared with 80 (61%) in the placebo group and absolute difference 18% (95% confidence interval 5.9-30.0, P = 0.003). Dose and number of insulin injections and mean blood glucose were all significantly lower in the liraglutide group. We observed no difference in the incidence of hypoglycaemia, nausea and vomiting, mortality or postoperative complications. CONCLUSIONS: Preoperative liraglutide, compared with placebo, reduces insulin requirements while improving perioperative glycaemic control during cardiac surgery.

Study protocol of the randomised placebo-controlled GLOBE trial: GLP-1 for bridging of hyperglycaemia during cardiac surgery.

INTRODUCTION: Perioperative hyperglycaemia is common during cardiac surgery and associated with postoperative complications. Although intensive insulin therapy for glycaemic control can reduce complications, it carries the risk of hypoglycaemia. GLP-1 therapy has the potential to lower glucose without causing hypoglycaemia. We hypothesise that preoperative liraglutide (a synthetic GLP-1 analogue) will reduce the number of patients requiring insulin to achieve glucose values<8 mmol l-1 in the intraoperative period. METHODS AND ANALYSIS: We designed a multi-centre randomised parallel placebo-controlled trial and aim to include 274 patients undergoing cardiac surgery, aged 18-80 years, with or without diabetes mellitus. Patients will receive 0.6 mg liraglutide or placebo on the evening before, and 1.2 mg liraglutide or placebo just prior to surgery. Blood glucose is measured hourly and controlled with an insulin bolus algorithm, with a glycaemic target between 4-8 mmol l-1. The primary outcome is the percentage of patients requiring insulin intraoperatively. ETHICS AND DISSEMINATION: This study protocol has been approved by the medical ethics committee of the Academic Medical Centre (AMC) in Amsterdam and by the Dutch competent authority. The study is investigator-initiated and the AMC, as sponsor, will remain owner of all data and have all publication rights. Results will be submitted for publication in a peer-reviewed international medical journal. TRIAL REGISTRATION NUMBER: NTR6323; Pre-results.

Examining the effects of enhanced provider-patient communication on postoperative tonsillectomy pain: protocol of a randomised controlled trial performed by nurses in daily clinical care.

INTRODUCTION: Placebo effects (true biopsychological effects not attributable to the active ingredients of medical technical interventions) can be attributed to several mechanisms, such as expectancy manipulation and empathy manipulation elicited by a provider's communication. So far, effects have primarily been shown in laboratory settings. The aim of this study is to determine the separate and combined effects of expectancy manipulation and empathy manipulation during preoperative and postoperative tonsillectomy analgesia care on clinical adult patients' outcomes. METHODS AND ANALYSIS: Using a two-by-two randomised controlled trial, 128 adult tonsillectomy patients will be randomly assigned to one out of four conditions differing in the level of expectancy manipulation (standard vs enhanced) and empathy manipulation (standard vs enhanced). Day care ward nurses are trained to deliver the intervention, while patients are treated via the standard analgesia protocol and hospital routines. The primary outcome, perceived pain, is measured via hospital routine by a Numeric Rating Scale, and additional prehospitalisation, perihospitalisation and posthospitalisation questionnaires are completed (until day 3, ie, 2 days after the operation). The manipulation is checked using audio recordings of nurse-patient interactions. ETHICS AND DISSEMINATION: Although communication is manipulated, the manipulations do not cross norms or values of acceptable behaviour. Standard medical care is provided. The ethical committee of the UMC Utrecht and the local OLVG hospital committee approved the study. Results will be published via (inter)national peer-reviewed journals and a lay publication. TRIAL REGISTRATION NUMBER: NTR5994; Pre-results.

Continuous wound infiltration versus epidural analgesia after hepato-pancreato-biliary surgery (POP-UP): a randomised controlled, open-label, non-inferiority trial.

BACKGROUND: Epidural analgesia is the international standard for pain treatment in abdominal surgery. Although some studies have advocated continuous wound infiltration with local anaesthetics, robust evidence is lacking, especially on patient-reported outcome measures. We aimed to determine the effectiveness of continuous wound infiltration in hepato-pancreato-biliary surgery. METHODS: In this randomised controlled, open label, non-inferiority trial (POP-UP), we enrolled adult patients undergoing hepato-pancreato-biliary surgery by subcostal or midline laparotomy in two Dutch hospitals. Patients were centrally randomised (1:1) to receive either pain treatment with continuous wound infiltration using bupivacaine plus patient-controlled analgesia with morphine or to receive (patient-controlled) epidural analgesia with bupivacaine and sufentanil. All patients were treated within an enhanced recovery setting. Randomisation was stratified by centre and type of incision. The primary outcome was the mean Overall Benefit of Analgesic Score (OBAS) from day 1-5, a validated composite endpoint of pain scores, opioid side-effects, and patient satisfaction (range 0 [best] to 28 [worst]). Analysis was per-protocol. The non-inferiority limit of the mean difference was + 3·0. This trial is registered with the Netherlands Trial Registry, number NTR4948. FINDINGS: Between Jan 20, 2015, and Sept 16, 2015, we randomly assigned 105 eligible patients: 53 to receive continuous wound infiltration and 52 to receive epidural analgesia. One patient in the continuous wound infiltration group discontinued treatment, as did five in the epidural analgesia group; of these five patients, preoperative placement failed in three (these patients were treated with continuous wound infiltration instead), one patient refused an epidural, and data for the primary endpoint was lost for one. Thus, 55 patients were included in the continuous wound infiltration group and 47 in the epidural analgesia group for the per-protocol analyses. Mean OBAS was 3·8 (SD 2·4) in the continuous wound infiltration group versus 4·4 (2·2) in the epidural group (mean difference -0·62, 95% CI -1·54 to 0·30). Because the upper bound of the one-sided 95% CI did not exceed +3·0, non-inferiority was shown. Four (7%) patients in the continuous wound infiltration group and five (11%) of those in the epidural group had an adverse event. One patient in the continuous wound infiltration group had a serious adverse event (temporary hypotension and arrhythmia after bolus injection); no serious adverse events were noted in the epidural group. INTERPRETATION: These data suggest that continuous wound infiltration is non-inferior to epidural analgesia in hepato-pancreato-biliary surgery within an enhanced recovery setting. Further large-scale trials are required to make a definitive assessment of non-inferiority. FUNDING: Academic Medical Centre, Amsterdam, Netherlands.

Continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (POP-UP trial): study protocol for a randomized controlled trial.

BACKGROUND: Postoperative pain prevention is essential for the recovery of surgical patients. Continuous (thoracic) epidural analgesia (CEA) is routinely practiced for major abdominal surgery, but evidence is conflicting on its benefits in this setting. Potential disadvantages of epidural analgesia are a) perioperative hypotension, frequently requiring additional intravenous fluid boluses or prolonged use of vasopressors; b) relatively high failure rates, with periods of inadequate analgesia; and c) the risk of rare but serious, at times persistent, neurologic complications (hematoma and abscess). In recent years, continuous (subfascial) wound infiltration (CWI) plus patient-controlled analgesia (PCA) has been suggested as a safe and reliable alternative, which does not have the previously mentioned disadvantages, but evidence from multicenter trials targeting a specific surgical population is lacking. We hypothesize that CWI+PCA is equally as effective as CEA, without the mentioned disadvantages. METHODS/DESIGN: POP-UP is a randomized controlled noninferiority multicenter trial, recruiting adult patients scheduled for elective hepato-pancreato-biliary surgery via laparotomy in an enhanced recovery setting. A total of 102 patients are being randomly allocated to CWI+PCA or (P)CEA. Our primary endpoint is the Overall Benefit of Analgesic Score (OBAS), a composite endpoint of pain intensity, opioid-related adverse effects and patient satisfaction, during postoperative days 1 to 5. Secondary endpoints include length of the hospital stay, number of patients with severe pain, and the use of rescue medication. DISCUSSION: POP-UP is a pragmatic trial that will provide evidence of whether CWI+PCA is noninferior as compared to (P)CEA after elective hepato-pancreato-biliary surgery via laparotomy in an enhanced recovery setting. If this hypothesis is confirmed, this finding could contribute to more widespread implementation of this technique, especially when the described disadvantages of epidural analgesia are less often observed with CWI+PCA. TRIAL REGISTRATION: Netherlands Trial Register NTR4948 (registry date 2 January 2015).