One-month recovery profile and prevalence and predictors of quality of recovery after painful day case surgery: Secondary analysis of a randomized controlled trial.

BACKGROUND/OBJECTIVES: This study aimed to study one-month recovery profile and to identify predictors of Quality of Recovery (QOR) after painful day surgery and investigate the influence of pain therapy on QOR. METHODS/DESIGN: This is a secondary analysis of a single-centre, randomised controlled trial of 200 patients undergoing ambulatory haemorrhoid surgery, arthroscopic shoulder or knee surgery, or inguinal hernia repair between January 2016 and March 2017. Primary endpoints were one-month recovery profile and prevalence of poor/good QOR measured by the Functional Recovery Index (FRI), the Global Surgical Recovery index and the EuroQol questionnaire at postoperative day (POD) 1 to 4, 7, 14 and 28. Multiple logistic regression analysis was performed to determine predictors of QOR at POD 7, 14, and 28. Differences in QOR between pain treatment groups were analysed using the Mann-Whitney U test. RESULTS: Four weeks after haemorrhoid surgery, inguinal hernia repair, arthroscopic knee and arthroscopic shoulder surgery, good QOR was present in 71%, 76%, 57% and 24% respectively. Poor QOR was present in 5%, 0%, 7% and 29%, respectively. At POD 7 and POD 28, predictors for poor/intermediate QOR were type of surgery and a high postoperative pain level at POD 4. Male gender was another predictor at POD 7. Female gender and having a paid job were also predictors at POD 28. Type of surgery and long term fear of surgery were predictors at POD 14. No significant differences in total FRI scores were found between the two different pain treatment groups. CONCLUSIONS: The present study shows a procedure-specific variation in recovery profile in the 4-week period after painful day surgery. The best predictors for short-term (POD 7) and long-term (POD 28) poor/intermediate QOR were a high postoperative pain level at POD 4 and type of surgery. Different pain treatment regimens did not result in differences in recovery profile. TRIAL REGISTRATION: European Union Clinical Trials Register 2015-003987-35.

Neurological outcome after minimally invasive coronary artery bypass surgery (NOMICS): An observational prospective cohort study.

BACKGROUND/OBJECTIVES: Endoscopic coronary artery bypass grafting (Endo-CABG) is a minimally invasive CABG procedure with retrograde arterial perfusion. The main objective of this study is to assess neurocognitive outcome after Endo-CABG. METHODS/DESIGN: In this prospective observational cohort study, patients were categorised into: Endo-CABG (n = 60), a comparative Percutaneous Coronary Intervention (PCI) group (n = 60) and a healthy volunteer group (n = 60). A clinical neurological examination was performed both pre- and postoperatively, delirium was assessed postoperatively. A battery of 6 neurocognitive tests, Quality of life (QoL) and the level of depressive feelings were measured at baseline and after 3 months. Patient Satisfaction after Endo-CABG was assessed at 3-month follow-up. Primary endpoints were incidence of postoperative cognitive dysfunction (POCD), stroke and delirium after Endo-CABG. Secondary endpoints were QOL, patient satisfaction and the incidence of depressive feelings after Endo-CABG. RESULTS: In total, 1 patient after Endo-CABG (1.72%) and 1 patient after PCI (1.67%) suffered from stroke during the 3-month follow-up. POCD in a patient is defined as a Reliable Change Index ≤-1.645 or Z-score ≤-1.645 in at least two tests, and was found in respectively 5 and 6 patients 3 months after Endo-CABG and PCI. Total incidence of POCD/stroke was not different (PCI: n= 7 [15.9%]; Endo-CABG: n= 6 [13.0%], p = 0.732). ICU delirium after Endo-CABG was found in 5 (8.6%) patients. QoL increased significantly three months after Endo-CABG and was comparable with QoL level after PCI and in the control group. Patient satisfaction after Endo-CABG and PCI was comparable. At follow-up, the level of depressive feelings was decreased in all groups. CONCLUSIONS: The incidence of poor neurocognitive outcome, including stroke, POCD and postoperative ICU delirium until three months after Endo-CABG is low and comparable with PCI. TRIAL REGISTRATION: Registered on ClinicalTrials.gov (NCT02979782).

Four-Week Pain Profile and Patient Non-Adherence to Pharmacological Pain Therapy After Day Surgery.

BACKGROUND: Nowadays, complicated and painful surgical procedures are encouraged to be carried out in an ambulatory setting. OBJECTIVES: The current study aimed to assess 4-week postoperative pain profiles of 4 painful ambulatory surgical procedures. We analyzed the prevalence of and reasons for non-adherence and partial adherence of patients to a predefined treatment schedule after the ambulant surgery. METHODS: The current study analyzed data from a large randomized trial by evaluating the effect of postoperative pain medication on acute postoperative pain at home during the first 4 postoperative days (POD) in patients scheduled for ambulatory hemorrhoid surgery, shoulder or knee arthroscopy, and inguinal hernia repair. Postoperative pain intensity was assessed at POD 0, 1, 2, 3, 4, 7, 14, and 28 via the Numeric Rating Scale (NRS). Adherence was assessed on POD 1, 2, 3, and 4. RESULTS: Median average pain scores were above an NRS of 3 during the first postoperative week after shoulder arthroscopy and even above 4 during the first postoperative week after hemorrhoid surgery. 26% of patients undergoing shoulder arthroscopy and hemorrhoid surgery still had moderate pain 1 week after surgery. Median average pain scores were below an NRS of 3 during the whole study period after inguinal hernia repair and knee arthroscopy. 24.61% of patients did not use the study medication as prescribed, 5.76% of whom were non-adherent, and 18.85% were partially adherent. CONCLUSIONS: Each type of ambulant surgery has its unique postoperative pain profile. New strategies should be developed for pain therapy at home, particularly after the ambulatory arthroscopic shoulder surgery and hemorrhoid surgery. Non-adherence is uncommon if they are provided with a multimodal analgesic home kit together with clear verbal, written instructions, and intensive follow-up.

Metamizole vs. ibuprofen at home after day case surgery: A double-blind randomised controlled noninferiority trial.

BACKGROUND: NSAIDs and paracetamol are the cornerstones of pain treatment after day case surgery. However, NSAIDs have numerous contraindications and consequently are not suitable in up to 25% of patients. Metamizole is a non-opioid compound with a favourable gastro-intestinal and cardiovascular profile compared with NSAIDs. OBJECTIVES: The study aimed to assess if a combination of metamizole and paracetamol is noninferior to a combination of ibuprofen and paracetamol in treating pain at home after painful day case surgery. DESIGN: A double-blind randomised controlled trial. SETTING: Single centre. PATIENTS: Two hundred patients undergoing elective ambulatory haemorrhoid surgery, arthroscopic shoulder or knee surgery, or inguinal hernia repair. INTERVENTION: Patients were randomly allocated to receive either metamizole and paracetamol (n = 100) or ibuprofen and paracetamol (n = 100) orally for four days. MAIN OUTCOME MEASURES: Average postoperative pain intensity using a numerical rating scale and use of rescue medication were measured in the postanaesthesia care unit (PACU) and on postoperative days (POD) 1 to 3. A difference in mean numerical rating scale score of 1 point or less was considered noninferior. Adverse effects of study medication and satisfaction with study medication were measured on PODs 1 to 3 by telephone follow-up. RESULTS: In the PACU, the difference in mean ±â€ŠSD pain score between metamizole and paracetamol and ibuprofen and paracetamol was 0.85 ±â€Š0.78. From POD 1 to 3, this difference was lower than 1, resulting in noninferiority. Rescue opioid consumption in the PACU and on PODs 1 and 3 was not significantly different between treatment groups. Rescue opioid consumption on POD2 was significantly higher in the ibuprofen and paracetamol group (P = 0.042). Adverse effects of study medication and overall patient satisfaction were similar in both groups. CONCLUSION: Paracetamol/metamizole and paracetamol/ibuprofen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction levels. TRIAL REGISTRATION: European Union Clinical Trials Register 2015-003987-35.

Metadata Correction: Clinical Validation of Heart Rate Apps: Mixed-Methods Evaluation Study.

[This corrects the article DOI: 10.2196/mhealth.7254.].

Clinical Validation of Heart Rate Apps: Mixed-Methods Evaluation Study.

BACKGROUND: Photoplethysmography (PPG) is a proven way to measure heart rate (HR). This technology is already available in smartphones, which allows measuring HR only by using the smartphone. Given the widespread availability of smartphones, this creates a scalable way to enable mobile HR monitoring. An essential precondition is that these technologies are as reliable and accurate as the current clinical (gold) standards. At this moment, there is no consensus on a gold standard method for the validation of HR apps. This results in different validation processes that do not always reflect the veracious outcome of comparison. OBJECTIVE: The aim of this paper was to investigate and describe the necessary elements in validating and comparing HR apps versus standard technology. METHODS: The FibriCheck (Qompium) app was used in two separate prospective nonrandomized studies. In the first study, the HR of the FibriCheck app was consecutively compared with 2 different Food and Drug Administration (FDA)-cleared HR devices: the Nonin oximeter and the AliveCor Mobile ECG. In the second study, a next step in validation was performed by comparing the beat-to-beat intervals of the FibriCheck app to a synchronized ECG recording. RESULTS: In the first study, the HR (BPM, beats per minute) of 88 random subjects consecutively measured with the 3 devices showed a correlation coefficient of .834 between FibriCheck and Nonin, .88 between FibriCheck and AliveCor, and .897 between Nonin and AliveCor. A single way analysis of variance (ANOVA; P=.61 was executed to test the hypothesis that there were no significant differences between the HRs as measured by the 3 devices. In the second study, 20,298 (ms) R-R intervals (RRI)-peak-to-peak intervals (PPI) from 229 subjects were analyzed. This resulted in a positive correlation (rs=.993, root mean square deviation [RMSE]=23.04 ms, and normalized root mean square error [NRMSE]=0.012) between the PPI from FibriCheck and the RRI from the wearable ECG. There was no significant difference (P=.92) between these intervals. CONCLUSIONS: Our findings suggest that the most suitable method for the validation of an HR app is a simultaneous measurement of the HR by the smartphone app and an ECG system, compared on the basis of beat-to-beat analysis. This approach could lead to more correct assessments of the accuracy of HR apps.