First trans-diagnostic experiences with a novel micro-choice based concentrated group rehabilitation for patients with low back pain, long COVID, and type 2 diabetes: a pilot study.

BACKGROUND: The health care is likely to break down unless we are able to increase the level of functioning for the growing number of patients with complex, chronic illnesses. Hence, novel high-capacity and cost-effective treatments with trans-diagnostic effects are warranted. In accordance with the protocol paper, we aimed to examine the acceptability, satisfaction, and effectiveness of an interdisciplinary micro-choice based concentrated group rehabilitation for patients with chronic low back pain, long COVID, and type 2 diabetes. METHODS: Patients with low back pain > 4 months sick-leave, long COVID, or type 2 diabetes were included in this clinical trial with pre-post design and 3-month follow-up. The treatment consisted of three phases: (1) preparing for change, (2) the concentrated intervention for 3-4 days, and (3) integrating change into everyday life. Patients were taught and practiced how to monitor and target seemingly insignificant everyday micro-choices, in order to break the patterns where symptoms or habits contributed to decreased levels of functioning or increased health problems. The treatment was delivered to groups (max 10 people) with similar illnesses. Client Satisfaction Questionnaire (CSQ-8)) (1 week), Work and Social Adjustment Scale (WSAS), Brief Illness Perception Questionnaire (BIPQ), and self-rated health status (EQ-5D-5L) were registered at baseline and 3-month follow-up. RESULTS: Of the 241 included participants (57% women, mean age 48 years, range 19-84), 99% completed the concentrated treatment. Treatment satisfaction was high with a 28.9 (3.2) mean CSQ-8-score. WSAS improved significantly from baseline to follow-up across diagnoses 20.59 (0.56) to 15.76 (0.56). BIPQ improved from: 22.30 (0.43) to 14.88 (0.47) and EQ-5D-5L: 0.715 (0.01) to 0.779 (0.01)), all P<0.001. CONCLUSIONS: Across disorders, the novel approach was associated with high acceptability and clinically important improvements in functional levels, illness perception, and health status. As the concentrated micro-choice based treatment format might have the potential to change the way we deliver rehabilitation across diagnoses, we suggest to proceed with a controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05234281.

Endoluminal treatment for Zenker's diverticulum - a population-based observational study.

BACKGROUND: Zenker's diverticulum is a false diverticulum arising in the oesophago-pharyngeal junction. It may cause symptoms like dysphagia and regurgitation. In Central Norway, treatment is centralized to St. Olavs hospital, either as an endoscopic stapled oesophago-diverticulostomy procedure at the Department of Gastrointestinal Surgery or as laser diverticulostomy at the Department of Ear, Nose and Throat Surgery, depending on diverticulum size. METHODS: Retrospective, population-based, study from 2001-2020 on patients treated for Zenker's diverticulum, at the time with a rigid endoscopic approach. Patients were identified through the in-hospital register for operations. The two treatment groups were compared on relevant pre-, intra-, and postoperative variables by review of the individual patient records. RESULTS: 78 consecutive patients, 36 at Dept. of Ear, Nose and Throat Surgery and 42 at Dept. of Gastrointestinal Surgery, were treated with a total of 104 interventions. Crude incidence for a surgery-demanding Zenker's diverticulum was 0.57 per 100 000 per year. The Dept. of Ear, Nose and Throat Surgery administered significantly less often prophylactic antibiotics than the Dept. of Gastrointestinal Surgery (p < 0.001), administered more frequently intraoperative dexamethasone (p < 0.001), and had significantly more postoperative infections (19.6% vs 3.4%, p = 0.01). No procedure-related mortality was registered. Although no standardized follow-up took place, at a median of 119 months elapsed, observed clinical recurrence was 35% for the endostapler treatment and 51% for the laser treatment procedure. CONCLUSION: Both rigid endoscopic stapled oesophago-diverticulostomy and laser diverticulostomy are safe treatments for Zenker's diverticulum, however with a substantial risk of recurrence.

Concentrated transdiagnostic and cross-disciplinary micro-choice based group treatment for patients with depression and with anxiety leads to lasting improvements after 12 months: a pilot study.

BACKGROUND: A concentrated transdiagnostic and micro choice-based group treatment for patients with depression and anxiety has previously shown to yield significant reduction in symptoms and increased level of functioning from pre to 3-month follow-up. In the present study, we report the results after 12 months follow-up. METHODS: This was a non-randomized clinical intervention pilot study, conducted in line with a published protocol. Sixty-seven consecutively referred patients, aged 19-47 (mean age 32.5, SD = 8.0) were included and completed treatment. All had a severity of their problems that entitled them to care in the specialist public mental health care. Self-reported age at onset of symptoms was 17.6 (SD = 7.9) years. Mean number of prior treatment courses was 3.5 (SD = 3.3; range 0-20). The main objective was to assess the treatment effectiveness by questionnaires measuring relevant symptoms at pre-treatment, 7 days-, 3 months-, 6 months- and at 12-months follow-up. RESULTS: Validated measures of functional impairment (WSAS), depression (PHQ9), anxiety (GAD7), worry (PSWQ), fatigue (CFQ), insomnia (BIS) and illness perception (BIPQ) improved significantly (p < .0005) from before treatment to 12 months follow-up, yielding mostly large to extremely large effect sizes (0.89-3.68), whereas some moderate (0.60-0.76). After 12 months, 74% report an overall improvement in problems related to anxiety and depression. Utilization of specialist, public and private mental health care was reported as nonexistent or had decreased for 70% of the patients at 12-month follow up. CONCLUSIONS: The concentrated, micro-choice based group treatment approach yielded a highly clinically significant reduction in a wide range of symptoms already one week after treatment, and the positive results persisted at 12-month follow-up. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05234281, first posted date 10/02/2022.

Characterisation of HNF1A variants in paediatric diabetes in Norway using functional and clinical investigations to unmask phenotype and monogenic diabetes.

AIMS/HYPOTHESIS: Correctly diagnosing MODY is important, as individuals with this diagnosis can discontinue insulin injections; however, many people are misdiagnosed. We aimed to develop a robust approach for determining the pathogenicity of variants of uncertain significance in hepatocyte nuclear factor-1 alpha (HNF1A)-MODY and to obtain an accurate estimate of the prevalence of HNF1A-MODY in paediatric cases of diabetes. METHODS: We extended our previous screening of the Norwegian Childhood Diabetes Registry by 830 additional samples and comprehensively genotyped HNF1A variants in autoantibody-negative participants using next-generation sequencing. Carriers of pathogenic variants were treated by local healthcare providers, and participants with novel likely pathogenic variants and variants of uncertain significance were enrolled in an investigator-initiated, non-randomised, open-label pilot study (ClinicalTrials.gov registration no. NCT04239586). To identify variants associated with HNF1A-MODY, we functionally characterised their pathogenicity and assessed the carriers' phenotype and treatment response to sulfonylurea. RESULTS: In total, 615 autoantibody-negative participants among 4712 cases of paediatric diabetes underwent genetic sequencing, revealing 19 with HNF1A variants. We identified nine carriers with novel variants classified as variants of uncertain significance or likely to be pathogenic, while the remaining ten participants carried five pathogenic variants previously reported. Of the nine carriers with novel variants, six responded favourably to sulfonylurea. Functional investigations revealed their variants to be dysfunctional and demonstrated a correlation with the resulting phenotype, providing evidence for reclassifying these variants as pathogenic. CONCLUSIONS/INTERPRETATION: Based on this robust classification, we estimate that the prevalence of HNF1A-MODY is 0.3% in paediatric diabetes. Clinical phenotyping is challenging and functional investigations provide a strong complementary line of evidence. We demonstrate here that combining clinical phenotyping with functional protein studies provides a powerful tool to obtain a precise diagnosis of HNF1A-MODY.

High number of hypoglycaemic episodes identified by CGM among home-dwelling older people with diabetes: an observational study in Norway.

BACKGROUND: A scoping review from 2021 identified a lack of studies on the incidence, prevention and management of hypoglycaemia in home-dwelling older people with diabetes. The aim of this study was to investigate the frequency and duration of hypoglycaemic episodes measured by continuous glucose monitoring (CGM) in older people with diabetes who received home care and who were treated with glucose-lowering medications, and to compare the frequency and duration of hypoglycaemic episodes between subgroups of the study population according to demographic and clinical variables. METHODS: This was an observational study investigating the occurrence of hypoglycaemia in people with diabetes aged ≥ 65 years. Data were collected using blinded continuous glucose monitoring (CGM, iPro2) for 5 consecutive days. Frequency and duration of hypoglycaemic episodes were assessed using a sensor glucose cut-off value of 3.9 mmol/L. A blood sample for measurement of HbA1c and creatinine-based eGFR (CKD-EPI) was obtained during the monitoring period. Demographic and clinical data were collected from electronic patient records. RESULTS: Fifty-six individuals were enrolled (median age 82 years and 52% were men). Of the 36 participants who were treated with insulin, 33% had at least one hypoglycaemic episode during the five-day period. Among 18 participants who neither used insulin nor sulfonylurea, but other glucose-lowering medications, 44% had at least one hypoglycaemicepisode. Of those with hypoglycaemic episodes, 86% lived alone. The median duration of the hypoglycaemia was 1 h and 25 min, ranging from 15 min to 8 h and 50 min. CONCLUSION: This study identified an unacceptably high number of unknown hypoglycaemic episodes among older home-dwelling people with diabetes receiving home care, even among those not using insulin or sulfonylurea. The study provides essential knowledge that can serve as a foundation to improve the treatment and care for this vulnerable patient group. The routines for glucose monitoring and other prevention tasks need to be considered more comprehensively, also, among those treated with glucose-lowering medications other than insulin.

A Health Economic Evaluation of the World Health Organization Surgical Safety Checklist: A Single Center Assessment.

OBJECTIVES: To evaluate cost-effectiveness of the WHO Surgical Safety Checklist. BACKGROUND: The clinical effectiveness of surgical checklists is largely understood. Few studies to-date have evaluated the cost-effectiveness of checklist use. METHODS: An economic evaluation was carried out using data from the only available randomized controlled trial of the checklist. Analyses were based on 3702 procedures. Costs considered included checklist implementation costs and length and cost of hospital stay, costs of warming blanket use, blood transfusions and antibiotics used in the operating room, and the cost of clinical time in the operating room - all calculated for each procedure and its associated admission. Nonparametric bootstrapping was used to simulate an empirical distribution of the mean effect of the checklist on total admission costs and the probability of observing a complication-free admission and to quantify sampling uncertainty around mean cost estimates. RESULTS: The overall cost of checklist implementation was calculated to be $900 per 100 admissions. Implementation of the WHO checklist resulted in an additional 5.9 complication-free admissions per 100 admissions and an average of 110 bed-days saved per 100 admissions. Accounting for all costs included in the analysis, for every 100 admissions, use of the WHO checklist was estimated to save $55,899. CONCLUSIONS: Implementation of the WHO checklist was a cost-effective strategy for improving surgical safety.

Sexual dysfunction in women with type 1 diabetes in Norway: A qualitative study of women's experiences.

AIM: The aim of this study was to explore the experiences of sexual health and sexual challenges in women with type 1 diabetes (T1D). METHODS: We used a qualitative study design and conducted semistructured interviews with 15 women (26-57 years) with T1D. The participants were recruited based on their Female Sexual Function Index score that indicated sexual dysfunction. We used thematic analysis to analyse the data. RESULTS: We generated three themes, each with subthemes: (1) Diabetes is present at all times (subthemes: having diabetes is onerous, and diabetes affects the relationship with my partner); (2) various challenges related to sexual health (subthemes: experiencing reduced sexual desire and physical challenges, and challenges related to sexual health affect the relationship with my partner); and (3) diabetes may affect sexual function (subthemes: glucose levels and technical devices may have an impact on sexual function, and sexual health should be addressed in diabetes follow-up). CONCLUSIONS: The women with T1D experienced different challenges related to their sexual health. The most common were reduced sexual desire, vaginal dryness and pain during intercourse. The study emphasizes the importance of addressing sexual health in diabetes follow-up to provide comprehensive health services to people with diabetes.

Sexual dysfunction in women with type 1 diabetes in Norway: A cross-sectional study on the prevalence and associations with physical and psychosocial complications.

AIM: To estimate the prevalence of sexual dysfunction in women with type 1 diabetes (T1D) compared with women without diabetes and to analyse associations between sexual dysfunction and the presence of chronic physical diabetes complications, diabetes distress and depression in women with T1D. METHODS: This cross-sectional study was conducted in Norway, and 171 women with T1D and 60 controls completed the Female Sexual Function Index (FSFI) and the Hospital Anxiety and Depression Scale (HADS). Diabetes distress was assessed with the Problem Areas in Diabetes (PAID) scale. Data on diabetes complications were retrieved from medical records. We performed logistic regression to estimate differences in the prevalence of sexual dysfunction (defined as FSFI ≤26.55) between women with T1D and women without diabetes and to examine associations of sexual dysfunction with chronic diabetes complications, diabetes distress and depression in women with T1D. RESULTS: The prevalence of sexual dysfunction was higher in women with T1D (50.3%) compared with the controls (35.0%; unadjusted odds ratio [OR] 1.89 [95% confidence interval (CI) 1.06-3.37]; adjusted OR 1.93 [1.05-3.56]). In women with T1D, sexual dysfunction was associated with both diabetes distress (adjusted OR 1.03 [1.01-1.05]) and depression (adjusted OR 1.28 [1.12-1.46]), but there were no clear associations with chronic diabetes complications (adjusted OR 1.46 [0.67-3.19]). CONCLUSIONS: This study suggests that sexual dysfunction is more prevalent in women with T1D compared with women without diabetes. The study findings emphasize the importance of including sexual health in relation to diabetes distress and psychological aspects in diabetes care and future research.

Concentrated transdiagnostic and cross-disciplinary group treatment for patients with depression and with anxiety: a pilot study.

BACKGROUND: A number of treatment approaches have shown efficacy for depression and/or anxiety, yet there is a paucity of research on potentially cost-effective concentrated approaches. Based on our previous experience with concentrated treatment in disorders such as Obsessive-Compulsive Disorder and chronic fatigue, we proposed that this novel approach could be useful for other conditions, including depression and/or anxiety. As a pre-requisite for a future randomized controlled trial, the aim of this study was to investigate the acceptability, satisfaction and effectiveness of a transdiagnostic, interdisciplinary group treatment delivered during 5 consecutive days to groups of 6-10 patients with depression and/or anxiety. METHODS: This was a non-randomized clinical intervention pilot study in line with a published protocol. Forty-two consecutively referred patients, aged 19-47 (mean age 31.7, SD = 8.12) were included and completed treatment. All had a severity of their problems that entitled them to care in the specialist public mental health care. Self-reported age when the symptoms became a problem was 20.9 years. Mean number of prior treatment courses was 2.77 (SD = 2.19; range 0-8). Acceptability was defined as the proportion of eligible patients who accepted and completed the treatment. Satisfaction was evaluated by Client Satisfaction Questionnaire-8. Secondary objectives were to assess the treatment effectiveness by questionnaires at pre-treatment, seven days post-treatment and three months follow-up. RESULTS: The treatment was highly acceptable (91.3% accepted, all completed), and patients were highly satisfied with the treatment, including the amount. Functional impairment, as measured by Work and Social Adjustment Scale (WSAS) improved significantly (p < .0005) from "severe" (mean 25.4 SD = 6.59) to "less severe" (mean 13.37, SD = 9.43) at 3 months follow-up. Using the Generalized Anxiety Disorder Scale (GAD-7) and the Patient Health Questionnaire (PHQ-9), the effect sizes at 3 months follow-up were 1.21 for anxiety and 1.3 for depression. More than 80% reported reduced utilization of mental health care, and 67% had not used, or had used the family doctor less, for anxiety or depression. 52% had not used, or had reduced, medication for their disorder. CONCLUSIONS: The concentrated, interdisciplinary treatment approach yielded promising results. Long-term follow up is warranted. TRIAL REGISTRATION: This study is registered in Clinical Trials, identifier NCT05234281 and approval date 09/02/2022.

Development and validation of patients' surgical safety checklist.

BACKGROUND: Poor uptake and understanding of critical perioperative information represent a major safety risk for surgical patients. Implementing a patient-driven surgical safety checklist might enhance the way critical information is given and increase patient involvement in their own safety throughout the surgical pathway. The aim of this study was to develop and validate a Surgical Patient Safety Checklist (PASC) for use by surgical patients. METHOD: This was a prospective study, involving patient representatives, multidisciplinary healthcare professionals and elective surgical patients to develop and validate PASC using consensus-building techniques in two Norwegian hospitals. A set of items intended for PASC were rated by patients and then submitted to Content Validation Index (CVI) analyses. Items of low CVI went through a Healthcare Failure Mode and Effect Analysis (HFMEA) Hazard Scoring process, as well as a consensus process before they were either kept or discarded. Reliability of patients' PASC ratings was assessed using Intraclass Correlation Coefficient analysis. Lastly, the face validity of PASC was investigated through focus group interviews with postoperative patients. RESULTS: Initial development of PASC resulted in a checklist consisting of two parts, one before (32 items) and one after surgery (26 items). After achieving consensus on the PASC content, 215 surgical patients from six surgical wards rated the items for the CVI analysis on a 1-4 scale and mostly agreed on the content. Five items were removed from the checklist, and six items were redesigned to improve PASCs' user-friendliness. The total Scale-level index/Average (S-CVI/Ave) before revision was 0.83 and 0.86 for pre- and post-operative PASC items, respectively. Following revision, these increased to 0.86 and 0.93, respectively. The PASC items reliability score was 0.97 (95% confidence interval 0.96 to 0.98). The qualitative assessment identified that patients who used PASC felt more in control of their situation; this was achieved when PASC was given to them at what they felt was the right time and healthcare professionals took part in its usage. CONCLUSION: Multidisciplinary perioperative care staff and surgical patients agreed upon PASC content, the checklist ratings were reliable, and qualitative assessment suggested good face validity. PASC appears to be a usable and valid checklist for elective surgical patients across specialties.

Diabetic diarrhoea: A study on gastrointestinal motility, pH levels and autonomic function.

BACKGROUND: Chronic diarrhoea is a common, but poorly investigated diabetes complication. Autonomic neuropathy is a leading pathophysiological theory founded on old, small studies. Studies of gastrointestinal motility and pH levels are lacking. OBJECTIVES: Using new diagnostic methods, we aimed to find out if diabetic diarrhoea was associated with alterations in gastrointestinal motility, pH levels and autonomic function. METHODS: Fifty-seven patients (42 women, 46 with type 1 diabetes) were prospectively included. Symptoms were evaluated with the gastrointestinal symptom rating scale, defining ≥4 points as cases with diarrhoea. Patients scoring <4 were used as controls. We used the wireless motility capsule to measure gastrointestinal transit times, pH levels and contractility parameters. Autonomic function was assessed by measuring heart rate variability, baroreflex sensitivity and orthostatic hypotension. RESULTS: Seventeen patients (30%) had diarrhoea. Compared with controls, cases had slower gastric emptying (21:46 vs. 4:14, h:min, p = 0.03) and faster colonic transit (18:37 vs. 54:25, p < 0.001). Cases had increased intraluminal pH in the antrum (2.4 vs. 1.2, p = 0.009), caecum (7.3 vs. 6.4, p = 0.008) and entire colon (7.1 vs. 6.7, p = 0.05). They also had a decreased pH difference across the pylorus (3.3 vs. 4.9, p = 0.004) and ileocaecal junction (0.6 vs 1.0, p = 0.009). The groups did not differ in autonomic function, but diastolic blood pressure drop correlated rs = -0.34 (p = 0.04) with colonic transit time. CONCLUSIONS: Patients with diabetic diarrhoea had altered gastrointestinal transit and intraluminal pH levels, but minimal changes in autonomic function. Our results suggest that tests of gastrointestinal function are clinically useful in diabetic diarrhoea.

Pancreatic exocrine insufficiency in diabetes is associated with autonomic dysfunction.

OBJECTIVES: Pancreatic exocrine insufficiency (PEI) is prevalent in diabetes. Pathophysiological theories imply autoimmune destruction, lack of trophic effects of insulin or impaired neuronal stimulation, but the relationship between PEI and autonomic dysfunction is largely unknown. In a pilot study, we aimed to investigate if patients with diabetes and PEI had impaired autonomic function. METHODS: We measured faecal elastase in 59 patients with type 1 or 2 diabetes, using a cut-off-value <200 µg/g to define PEI. Based on faecal elastase results, patients were stratified into matched case (n = 8) and control groups (n = 13). We used heart rate variability, baroreflex sensitivity and orthostatic hypotension tests to assess autonomic dysfunction. RESULTS: All baroreflex sensitivity parameters were reduced in cases with PEI compared with controls (all p < .05). The heart rate variability parameters root mean square of successive RR interval differences (p = .05) and high frequency (p = .04) were also reduced. We found no difference in orthostatic hypotension between the groups. CONCLUSIONS: In this first-of-its-kind study, we found that diabetes patients with PEI had reduced autonomic function compared with matched controls. Although numbers are small, results support the hypothesis that autonomic dysfunction could be a contributor to PEI in diabetes.

How does the WHO Surgical Safety Checklist fit with existing perioperative risk management strategies? An ethnographic study across surgical specialties.

BACKGROUND: The World Health Organization (WHO) Surgical Safety Checklist (SSC) has demonstrated beneficial impacts on a range of patient- and team outcomes, though variation in SSC implementation and staff's perception of it remain challenging. Precisely how frontline personnel integrate the SSC with pre-existing perioperative clinical risk management remains underexplored - yet likely an impactful factor on how SSC is being used and its potential to improve clinical safety. This study aimed to explore how members of the multidisciplinary perioperative team integrate the SSC within their risk management strategies. METHODS: An ethnographic case study including observations (40 h) in operating theatres and in-depth interviews of 17 perioperative team members was carried out at two hospitals in 2016. Data were analysed using content analysis. RESULTS: We identified three themes reflecting the integration of the SSC in daily surgical practice: 1) Perceived usefullness; implying an intuitive advantage assessment of the SSC's practical utility in relation to relevant work; 2) Modification of implementation; reflecting performance variability of SSC on confirmation of items due to precence of team members; barriers of performance; and definition of SSC as performance indicator, and 3) Communication outside of the checklist; including formal- and informal micro-team formations where detailed, specific risk communication unfolded. CONCLUSION: When the SSC is not integrated within existing risk management strategies, but perceived as an "add on", its fidelity is compromised, hence limiting its potential clinical effectiveness. Implementation strategies for the SSC should thus integrate it as a risk-management tool and include it as part of risk-management education and training. This can improve team learning around risk comunication, foster mutual understanding of safety perspectives and enhance SSC implementation.

Patients' and healthcare workers' recommendations for a surgical patient safety checklist - a qualitative study.

BACKGROUND: Patients' involvement in patient safety has increased in healthcare. Use of checklists may improve patient outcome in surgery, though few have attempted to engage patients' use of surgical checklist. To identify risk elements of complications based on patients' and healthcare workers' experiences is warranted. This study aims to identify what the patients and healthcare workers find to be the risk elements that should be included in a patient-driven surgical patient safety checklist. METHOD: A qualitative study design where post-operative patients, surgeons, ward physicians, ward nurses, and secretaries from five surgical specialties took part in focus group interviews. Eleven focus groups were conducted including 25 post-operative patients and 27 healthcare workers at one tertiary teaching hospital and one community hospital in Norway. Based on their experiences, participants were asked to identify perceived risks before and after surgery. The interviews were analysed using content analysis. RESULTS: Safety risk factors were categorised as pre-operative information: pre-operative preparations, post-operative information, post-operative plans and follow-up. The subcategories under pre-operative information and preparations were: contact information, medication safety, health status, optimising health, dental status, read information, preparation two weeks before surgery, inform your surgical ward, planning your own discharge, preparation on admission and just before surgery. The subcategories under post-operative information, further plans and follow-up were: prevention and complications, restriction and activity, medication safety, pain relief, stomach functions, further care and appointments. Both healthcare workers and patients express the need for a surgical patient safety checklist. CONCLUSION: A broad spectre of risk elements for a patient safety checklist were identified. Developing a surgical safety checklist based on these risk elements might reduce complications and unwanted errors. TRAIL REGISTRATION: The study is registered as part of a clinical trial in ClinicalTrials.gov: NCT03105713.

Causal Analysis of World Health Organization's Surgical Safety Checklist Implementation Quality and Impact on Care Processes and Patient Outcomes: Secondary Analysis From a Large Stepped Wedge Cluster Randomized Controlled Trial in Norway.

OBJECTIVE: We hypothesize that high-quality implementation of the World Health Organization's Surgical Safety Checklist (SSC) will lead to improved care processes and subsequently reduction of peri- and postoperative complications. BACKGROUND: Implementation of the SSC was associated with robust reduction in morbidity and length of in-hospital stay in a stepped wedge cluster randomized controlled trial conducted in 2 Norwegian hospitals. Further investigation of precisely how the SSC improves care processes and subsequently patient outcomes is needed to understand the causal mechanisms of improvement. METHODS: Care process metrics are reported from one of our earlier trial hospitals. Primary outcomes were in-hospital complications and care process metrics, e.g., patient warming and antibiotics. Secondary outcome was quality of SSC implementation. Analyses include Pearson's exact χ test and binary logistic regression. RESULTS: A total of 3702 procedures (1398 control vs. 2304 intervention procedures) were analyzed. High-quality SSC implementation (all 3 checklist parts) improved processes and outcomes of care. Use of forced air warming blankets increased from 35.3% to 42.4% (P < 0.001). Antibiotic administration postincision decreased from 12.5% to 9.8%, antibiotic administration preincision increased from 54.5% to 63.1%, and nonadministration of antibiotics decreased from 33.0% to 27.1%. Surgical infections decreased from 7.4% (104/1398) to 3.6% (P < 0.001). Adjusted SSC effect on surgical infections resulted in an odds ratio (OR) of 0.52 (95% confidence interval (CI): 0.38-0.72) for intervention procedures, 0.54 (95% CI: 0.37-0.79) for antibiotics provided before incision, and 0.24 (95% CI: 0.11-0.52) when using forced air warming blankets. Blood transfusion costs were reduced by 40% with the use of the SSC. CONCLUSIONS: When implemented well, the SSC improved operating room care processes; subsequently, high-quality SSC implementation and improved care processes led to better patient outcomes.

Impact of the World Health Organization Surgical Safety Checklist on Patient Safety.

The incidence of surgical complications has remained largely unchanged over the past two decades. Inherent complexity in surgery, new technology possibilities, increasing age and comorbidity in patients may contribute to this. Surgical safety checklists may be used as some of the tools to prevent such complications. Use of checklists may reduce critical workload by eliminating issues that are already controlled for. The global introduction of the World Health Organization Surgical Safety Checklist aimed to improve safety in both anesthesia and surgery and to reduce complications and mortality by better teamwork, communication, and consistency of care. This review describes a literature synthesis on advantages and disadvantages in use of surgical safety checklists emphasizing checklist development, implementation, and possible clinical effects and using a theoretical framework for quality of provided healthcare (structure-process-outcome) to understand the checklists' possible impact on patient safety.

Correction to: HbA1c versus oral glucose tolerance test as a method to diagnose diabetes mellitus in vascular surgery patients.

The authors found errors in Table 1 after publication of the original article [1].The correct values for medical history of coronary artery disease (CAD) at baseline are 110 (40%) of all patients, 54 (35.5%) of patients categorized as having normoglycaemia, 42 (46.7%) of patients categorized as having intermediate hyperglycaemia, and 14 (42.4%) of patients categorized as having DM.All presented numbers and calculations in Table 1 are checked. No other errors were found. The presented errors did not affect results, scientific content or conclusions.The corrected Table 1 is presented in this erratum.The authors apologize for having presented this error in the original article.

[Gastroparesis - causes, diagnosis and treatment]. / Gastroparese - årsaker, diagnostikk og behandling.

BACKGROUND Gastroparesis is a motility disorder of the stomach. The symptoms are non-specific: nausea and vomiting are most common. Stomach pains, early satiety, postprandial fullness and bloating are also frequent symptoms. Current diagnostic criteria require delayed gastric emptying in the absence of any detectable mechanical obstruction. In this review article we elucidate the causes, assessment and treatment options.MATERIAL AND METHOD Structured article search in Embase and PubMed.RESULTS A number of conditions can lead to gastroparesis. The most frequent somatic cause is diabetes mellitus. Gastroparesis may also be iatrogenically inflicted by means of surgery or drugs. It may be difficult to discriminate between functional dyspepsia and idiopathic gastroparesis. Examination is based on patient history, gastroscopy and measurement of the rate of gastric emptying. Biochemical tests are also relevant for differential diagnosis. The treatment is primarily symptomatic, and consists of dietary measures, fluid therapy, drugs, gastric electrical stimulation, or endoscopic or surgical intervention in the form of insertion of a feeding tube for nutrition and abdominal relief, pyloroplasty or gastrectomy.INTERPRETATION Gastroparesis is a serious motility disorder. The condition may have significant consequences for patients, entailing reduced quality of life, reduced workforce participation and a considerable need for health assistance.

Effect of the World Health Organization checklist on patient outcomes: a stepped wedge cluster randomized controlled trial.

OBJECTIVES: We hypothesized reduction of 30 days' in-hospital morbidity, mortality, and length of stay postimplementation of the World Health Organization's Surgical Safety Checklist (SSC). BACKGROUND: Reductions of morbidity and mortality have been reported after SSC implementation in pre-/postdesigned studies without controls. Here, we report a randomized controlled trial of the SSC. METHODS: A stepped wedge cluster randomized controlled trial was conducted in 2 hospitals. We examined effects on in-hospital complications registered by International Classification of Diseases, Tenth Revision codes, length of stay, and mortality. The SSC intervention was sequentially rolled out in a random order until all 5 clusters-cardiothoracic, neurosurgery, orthopedic, general, and urologic surgery had received the Checklist. Data were prospectively recorded in control and intervention stages during a 10-month period in 2009-2010. RESULTS: A total of 2212 control procedures were compared with 2263 SCC procedures. The complication rates decreased from 19.9% to 11.5% (P < 0.001), with absolute risk reduction 8.4 (95% confidence interval, 6.3-10.5) from the control to the SSC stages. Adjusted for possible confounding factors, the SSC effect on complications remained significant with odds ratio 1.95 (95% confidence interval, 1.59-2.40). Mean length of stay decreased by 0.8 days with SCC utilization (95% confidence interval, 0.11-1.43). In-hospital mortality decreased significantly from 1.9% to 0.2% in 1 of the 2 hospitals post-SSC implementation, but the overall reduction (1.6%-1.0%) across hospitals was not significant. CONCLUSIONS: Implementation of the WHO SSC was associated with robust reduction in morbidity and length of in-hospital stay and some reduction in mortality.

Rectal sensitivity correlated with gastrointestinal-mediated glucose disposal, but not the incretin effect.

OBJECTIVE: The mechanisms behind the diminished incretin effect in type 2 diabetes are uncertain, but impaired vagal transmission has been suggested. We aimed to investigate the association between the incretin effect and autonomic neuropathy, and the degree of dysglycaemia and duration of diabetes. DESIGN AND METHODS: For a cross-sectional study, we included participants with either longstanding type 2 diabetes, recent onset, untreated diabetes and controls without diabetes matched for age, sex and body mass index. Autonomic nerve function was assessed with cardiovascular reflex tests, heart rate variability and sudomotor function. Visceral afferent nerves in the gut were tested performing rapid rectal balloon distention. An oral glucose tolerance test and an intravenous isoglycaemic glucose infusion were performed to calculate the incretin effect and gastrointestinal-mediated glucose disposal (GIGD). RESULTS: Sixty-five participants were recruited. Participants with diabetes had rectal hyposensitivity for earliest sensation (3.7 ± 1.1 kPa in longstanding, 4.0 ± 1.3 in early), compared to controls (3.0 ± 0.9 kPa), p = .005. Rectal hyposensitivity for earliest sensation was not associated with the incretin effect (rho = -0.204, p = .106), but an association was found with GIGD (rho -0.341, p = .005). Incretin effect and GIGD were correlated with all glucose values, HbA1c and duration of diabetes. CONCLUSIONS: Rectal hyposensitivity was uncovered in both longstanding and early type 2 diabetes, and was not associated with the incretin effect, but with GIGD, implying a potential link between visceral neuropathy and gastrointestinal handling of glucose. Both the incretin effect and GIGD were associated with the degree of dysglycaemia and the duration of diabetes. PREVIOUSLY PUBLISHED: Some of the data have previously been published and presented as a poster on the American Diabetes Association 83rd Scientific Sessions: Meling et al; 1658-P: Rectal Hyposensitivity, a Potential Marker of Enteric Autonomic Nerve Dysfunction, Is Significantly Associated with Gastrointestinally Mediated Glucose Disposal in Persons with Type 2 Diabetes. Diabetes 20 June 2023; 72 (Supplement_1): 1658-P. https://doi.org/10.2337/db23-1658-P.