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.

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.

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.

Relationship between exercise capacity and fatigue, dyspnea, and lung function in non-hospitalized patients with long COVID.

Long COVID is a global health problem that impairs patients' functional status. More than 200 reported symptoms have been identified where fatigue, dyspnea, and exercise impairment are most common. This study aimed to describe exercise capacity, fatigue, dyspnea, and lung function in previously non-hospitalized patients with long COVID, and examine the relationship between exercise capacity and fatigue, dyspnea, and lung function. Sixty-five patients, 54 women (83%), mean age of 39 standard deviation (12) years, were included and completed spirometry, cardiopulmonary exercise test, stair climbing test (SCT), 30 second sit-to-stand test (30STST), and questionnaires regarding fatigue and dyspnea. Fatigue was reported by 95% of the participants, whereas 65% reported severe fatigue, and 66% reported dyspnea. Mean exercise capacity measured with peak oxygen uptake (V̇O2peak % pred.) was ≥85% in 65% of the participants. Mean forced expiratory volume in 1 s. and forced vital capacity were 96.6 (10.7)% and 100.8 (10.9)%, respectively, while reduced diffusion capacity for carbon monoxide (DLCO ) was found in eight participants (13%). Reduced V̇O2peak kg-1 and increased time on SCT were significantly associated with increased dyspnea and reduced DLCO but not with fatigue, while 30STST was associated with increased fatigue and dyspnea in previously non-hospitalized patients with long COVID.

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.

The Composite Autonomic Symptom Score 31 Questionnaire: A Sensitive Test to Detect Risk for Autonomic Neuropathy.

Background and Aims: Autonomic neuropathy is a common but often neglected complication of diabetes, prediabetes, and even in individuals with an elevated risk of diabetes. The Composite Autonomic Symptom Score (COMPASS) 31 is a validated and easy-to-use questionnaire regarding autonomic symptoms. We aimed to use a digitally, Norwegian version of the COMPASS 31 in people with different durations of diabetes and healthy controls to consider feasibility and to investigate if scores could discriminate between positive and negative outcomes for established tests for diabetic neuropathy, including cardiovascular autonomic neuropathy (CAN) and a novel method of examining the gastrointestinal visceral sensitivity. Method: We included 21 participants with longstanding type 2 diabetes, 15 with early type 2 diabetes, and 30 matched controls. The mean age for all groups was 69 years. Participants were phenotyped by cardiovascular autonomic reflex tests, electrical skin conductance, sural nerve electrophysiology, and the monofilament test. As a proxy for gastrointestinal visceral and autonomic nerve function, evoked potentials were measured following rapid rectal balloon distention. Results: Participants with longstanding diabetes scored a median (IQR) of 14.9 (10.8-28.7) points, early diabetes of 7.3 (1.6-15.2), and matched controls of 8.6 (4.1-21.6), p = 0.04. Women and men scored 14.4 (5.5-28.7) and 7.8 (3.6-14.6) points, respectively, p = 0.01. Participants with definite or borderline CAN scored 14.3 (10.4-31.9) points, compared to participants with no CAN, 8.3 (3.2-21.5), p = 0.04. Lowering the diagnostic cut-off from 16 to 10 points increased the sensitivity from 0.33 to 0.83, with a decreased specificity from 0.68 to 0.55. Conclusion: We successfully used COMPASS 31 in Norwegian. Thus, following the guidelines, we suggest clinical implementation for the assessment of autonomic neuropathy. Participants with longstanding diabetes had an increased likelihood of symptoms and signs of autonomic neuropathy. For screening purposes, the sensitivity was improved by lowering the cut-off to 10 points, with a lower score nearly excluding the diagnosis.

A safe and effective micro-choice based rehabilitation for patients with long COVID: results from a quasi-experimental study.

At least 65 million people suffer from long COVID. Treatment guidelines are unclear, especially pertaining to recommendations of increased activity. This longitudinal study evaluated safety, changes in functional level and sick leave following a concentrated rehabilitation program for patients with long COVID. Seventy-eight patients (19-67 years) participated in a 3-day micro-choice based rehabilitation program with 7-day and 3-month follow-up. Fatigue, functional levels, sick leave, dyspnea and exercise capacity were assessed. No adverse events were reported and 97.4% completed the rehabilitation. Fatigue measured with Chalder Fatigue Questionnaire decreased at 7-days [mean difference (MD = - 4.5, 95% CI - 5.5 to - 3.4) and 3-month (MD = - 5.5, 95% CI - 6.7 to - 4.3). Sick leave rates and dyspnea were reduced (p < 0.001) and exercise capacity and functional level increased (p < 0.001) at 3-month follow-up regardless of severity of fatigue at baseline. Micro-choice based concentrated rehabilitation for patients with long COVID was safe, highly acceptable and showed rapid improvements in fatigue and functional levels, sustaining over time. Even though this is a quasi-experimental study, the findings are of importance addressing the tremendous challenges of disability due to long COVID. Our results are also highly relevant for patients, as they provide the base for an optimistic outlook and evidence supported reason for hope.

Feasibility of implementing a surgical patient safety checklist: prospective cross-sectional evaluation.

BACKGROUND: The World Health Organization's Global Patient Safety Action Plan 2021-2030 call for attention to patient and family involvement to reduce preventable patient harm. Existing evidence indicates that patients' involvement in their own safety has positive effects on reducing hospitalisation time and readmissions. One intervention reported in the literature is the use of checklists designed for patients' completion. Studies on such checklists are small scale, but they are linked to reduction in length of hospital stay and readmissions. We have previously developed and validated a two-part surgical patient safety checklist (PASC). This study aims to investigate the feasibility of the PASC usage and implementation prior to its use in a large-scale clinical trial. METHODS: This is a prospective cross-sectional feasibility study, set up as part of the design of a larger stepped-wedge cluster randomised controlled trial (SW-CRCT). Descriptive statistics were used to investigate patient demographics, reasons for not completing the PASC and percentage of PASC item usage. Qualitative patient interviews were used to identify barriers and drivers for implementation. Interview was analysed through content analysis. RESULTS: Out of 428 recruited patients, 50.2% (215/428) used both parts of PASC. A total of 24.1% (103/428) of the patients did not use it at all due to surgical or COVID-19-related cancellations. A total of 19.9% (85/428) did not consent to participate, 5.1% (22/428) lost the checklist and 0.7% (3/428) of the patients died during the study. A total of 86.5% (186/215) patients used ≥ 80% of the checklist items. Barriers and drivers for PASC implementation were grouped into the following categories: Time frame for completing the checklist, patient safety checklist design, impetus to communicate with healthcare professionals and support throughout the surgical pathway. CONCLUSIONS: Elective surgical patients were willing and able to use PASC. The study further revealed a set of barriers and drivers to the implementation. A large-scale definitive clinical-implementation hybrid trial is being launched to ascertain the clinical effectiveness and scalability of PASC in improving surgical patient safety. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03105713. Registered 10.04.2017.

The PanGut-study: Evoked potentials following rectal balloon distention, a way of evaluating diabetic autonomic neuropathy in the gut?

AIM: There is a lack of methods for investigating the autonomic nerves of the gastrointestinal tract. Our aim was to explore a novel test measuring visceral sensory evoked potentials (EPs) in response to rapid balloon distention in the rectum and compare it to established tests for diabetic neuropathy. METHOD: Participants with longstanding type 2 diabetes, newly onset, untreated diabetes <1 year, and matched controls, were included. Tests included cardiovascular reflex tests, orthostatic blood pressure, electrical skin conductance assessment, sural nerve testing and monofilament test. The rectal balloon distention pressure at earliest sensation and threshold of unpleasantness were identified and used to elicit mechanical EPs. RESULTS: The pressure at earliest sensation was higher in people with diabetes, 0.038 (0.012) bar vs. controls 0.030 (0.009) bar, p = 0.002, and in people with signs of peripheral neuropathy, 0.045 (0.014) bar, p < 0.01. Clinical correlations between EP amplitude and latency, and other tests were found. CONCLUSIONS: Rectal hyposensitivity was associated with both longstanding and early diabetes, indicating enteric sensory dysfunction already in early stages of diabetes. Correlation analyses may indicate that central afferent processing is affected in parallel with peripheral neuronal function.

A Novel Concentrated, Interdisciplinary Group Rehabilitation Program for Patients With Chronic Obstructive Pulmonary Disease: Protocol for a Nonrandomized Clinical Intervention Study.

BACKGROUND: Pulmonary rehabilitation has been demonstrated to be a highly effective treatment for people with chronic obstructive pulmonary disease (COPD). However, its availability is scarce worldwide, and new and innovative rehabilitation models are highly warranted. Recently, the group behind the present study published a protocol describing a novel concentrated, interdisciplinary group rehabilitation program for patients with chronic illnesses. The current paper describes an extension of this protocol to patients with COPD. OBJECTIVE: The objective of this study is to explore the acceptability of concentrated, interdisciplinary group pulmonary rehabilitation for patients with COPD. The intervention is expected to improve functional status and be highly acceptable to patients. METHODS: This study will include 50 patients aged over 40 years who fulfill the diagnostic criteria for COPD: a forced expiratory volume at the first second (FEV1) <80% of expected and a FEV1/forced vital capacity ratio below the lower limit of normal according to the Global Lung Function Initiative. An interdisciplinary team consisting of physicians, physiotherapists, psychologists, pharmacists, clinical nutritionists, and nurses will deliver the treatment to groups of 6 to 10 patients over 3 to 4 consecutive days with a 12-month follow-up. The intervention is divided into three distinct phases: (1) pretreatment preparation for change, (2) concentrated rehabilitation, where the patient is coached to focus on making health-promoting microchoices, and (3) integration of the changes into everyday living, aided by digital follow-up and 2 on-site clinical examinations. Statistical significance will be set at α=.05. RESULTS: The recruitment period will last from April 2022 until June 2023. CONCLUSIONS: If successful, this highly novel rehabilitation format might change the way we deliver care for patients with COPD, leading to substantial societal and socioeconomic gains. The study will expand knowledge on the concentrated treatment format as a rehabilitation model for people with COPD. TRIAL REGISTRATION: ClinicalTrials.gov NCT05234281; https://clinicaltrials.gov/ct2/show/NCT05234281. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40700.

Physician participation in quality improvement work- interest and opportunity: a cross-sectional survey.

BACKGROUND: Lack of physician involvement in quality improvement threatens the success and sustainability of quality improvement measures. It is therefore important to assess physicians´ interests and opportunities to be involved in quality improvement and their experiences of such participation, both in hospital and general practice. METHODS: A cross-sectional postal survey was conducted on a representative sample of physicians in different job positions in Norway in 2019. RESULTS: The response rate was 72.6% (1513 of 2085). A large proportion (85.7%) of the physicians wanted to participate in quality improvement, and 68.6% had actively done so in the last year. Physicians' interest in quality improvement and their active participation was significantly related to the designated time for quality improvement in their work-hour schedule (p < 0.001). Only 16.7% reported time designated for quality improvement in their own work hours. When time was designated, 86.6% of the physicians reported participation in quality improvement, compared to 63.7% when time was not specially designated. CONCLUSIONS: This study shows that physicians want to participate in quality improvement, but only a few have designated time to allow continuous involvement. Physicians with designated time participate significantly more. Future quality programs should involve physicians more actively by explicitly designating their time to participate in quality improvement work. We need further studies to explore why managers do not facilitate physicians´ participation in quality improvement.

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.

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.

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.

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.

Diabetic Gastroenteropathy: Soothe the Symptoms or Unravel a Cure?

Autonomic neuropathy in patients with diabetes mellitus, and especially complications related to gastrointestinal neuropathy, are often overlooked in the clinic. Diabetic gastroenteropathy affects every segment of the gastrointestinal tract and generates symptoms that may include nausea, early satiety, vomiting, abdominal pain, constipation, and diarrhea. Severe cases can be complicated by weight loss, dehydration, and electrolyte disturbances. The pathophysiology is complex, the diagnostics and treatment options are multidisciplinary, and there is generally a lack of evidence for the treatment options. The aims for this review are first to summarize the pathophysiology and describe possible and expected symptoms and complications.Further, we will try to supply the clinician with a straightforward tool for diagnostics, and then, we shall summarize established treatment options, including diet recommendations, pharmacological and non-pharmacological options. Finally, we will explore the multiple possibilities of novel treatment, looking at medications related to the pathophysiology of neuropathy, other manifestations of autonomic neuropathies, and symptomatic treatment for other gastrointestinal disorders, also including new knowledge of endosurgical and neuromodulatory treatment. The overall goal is to increase awareness and knowledge on this frequent diabetic complication and to provide better tools for diagnosis and treatment. Ultimately, we hope to encourage further research in this field, as there are clear shortcomings in terms of biomarkers, pathophysiology, as well as treatment possibilities. In conclusion, diagnosis and management of diabetic gastroenteropathy are challenging and often require multidisciplinary teams and multimodal therapies. Treatment options are sparse, but new pharmacological, endoscopic, and neuromodulatory techniques have shown promising results in initial studies.

Gastric function in diabetic gastroparesis assessed by ultrasound and scintigraphy.

BACKGROUND: Gastroparesis is a severe diabetes complication characterized by delayed gastric emptying. We examined patients with symptoms of diabetic gastroparesis using gastric emptying scintigraphy and ultrasound drink test. The primary aim was to investigate how ultrasound could provide information about gastric motility features in diabetic gastroparesis. MATERIAL AND METHODS: We prospectively included 58 patients with diabetes (48 type 1) with symptoms of gastroparesis and 30 healthy controls. Patients were examined with ultrasound of the stomach in a seated position after drinking 500 ml low-caloric meat soup, at the same time recording dyspeptic symptoms. The following day, they were examined with gastric emptying scintigraphy, defining gastroparesis as >10% retention after 4 h. KEY RESULTS: We found motility disturbances in the proximal stomach measured by ultrasound in patients with diabetic gastroparesis. A linear mixed effects model including repeated ultrasound measurements revealed a slower decrease of the proximal stomach size in gastroparesis compared to healthy controls (p < 0.01), and the proximal diameter at 20 min was correlated to scintigraphy at 4 h (r = 0.510, p = 0.001). The antrum in patients with diabetic gastroparesis was twice as large compared to healthy controls (p = 0.009), and fasting antral size was correlated to gastric emptying scintigraphy (r = 0.329, p = 0.013). Both diabetes patients with and without gastroparesis had impaired accommodation (p = 0.011). CONCLUSIONS AND INFERENCES: On ultrasound, we found delayed reduction of proximal stomach size and impaired accommodation after a liquid meal in patients with gastroparesis, emphasizing the role of the proximal stomach. Furthermore, we found antral distention in gastroparesis patients.

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.