Development of a patient-reported experience measure for chronic inflammatory skin diseases.

BACKGROUND: Patient involvement and high-quality patient-provider interactions are critical factors for quality of care in chronic inflammatory skin diseases. Also, assessing the patient's perspective contributes to optimizing care delivery and patient's experience. Until today, no user-friendly tools to measure patient experiences exist within immunodermatology. OBJECTIVES: The aim of this study was to identify the relevant items for patient's experience in immunodermatology and develop a concise questionnaire to assess patient's experience in routine clinical care. METHODS: Potential relevant items for measuring patient's perspective of immunodermatology care were identified by a literature search. From this longlist, a shortlist from patient's perspective was distilled by semi-structured interviews with a diverse patient group. This list was reduced to final items using a modified Delphi method in a multi-stakeholder focus group. For each item, one question was formulated to generate the Patient-Reported Experience Measure (PREM) questionnaire. A first internal validation was achieved by an email round. RESULTS: Forty longlist items were categorized into five domains (access to care, patient centeredness, access to information, care process and satisfaction). During interview rounds, 19 shortlist items were selected if mentioned by ≥40% of interviewees. Via the focus group, the most important items were chosen by participant consensus. For each item, a question was formulated. The final PREM covers 11 items (plus 2 in case of a first consult). The first internal validation showed that the tool is clear, understandable and has an ideal length. CONCLUSION: This short user-friendly PREM can be used in scientific and routine settings to improve care for patients who suffer from chronic inflammatory skin diseases.

Optimizing diabetes control in people with Type 2 diabetes through nurse-led telecoaching.

AIMS: To study the effect of a target-driven telecoaching intervention on HbA1c and other modifiable risk factors in people with Type 2 diabetes. METHODS: We conducted a randomized controlled trial in patients receiving hypoglycaemic agents. The primary outcome was HbA1c level at 6 months in the entire sample and in a subgroup with HbA1c levels ≥ 53 mmol/mol (7%) at baseline. Secondary outcomes were HbA1c at 18 months; total cholesterol, LDL, HDL, triglycerides, blood pressure, BMI and proportion of people who had achieved guideline-recommended targets at 6 and 18 months. RESULTS: A total of 287 participants were randomized to telecoaching and 287 to usual care. The mean (sd) baseline HbA1c level was 53 (11) mmol/mol [7.0 (1.0)%] overall and 63 (10) mmol/mol [7.9 (0.9)%] in the elevated HbA1c subgroup. At 6 months, the between-group differences in favour of telecoaching were: HbA1c -2 (95% CI -4; -1) mmol/mol [-0.2 (95% CI -0.3;-0.1)%; P=0.003] overall and -4 (95% CI -7; -2) mmol/mol [-0.4 (95% CI -0.7; -0.2)%; P=0.001] in the elevated HbA1c subgroup; BMI -0.4 kg/m(2) (95% CI -0.6; -0.1; P=0.003); total cholesterol -6 mg/dl (95% CI -11; -1, P=0.012). The proportion of participants on target for the composite of HbA1c , LDL and blood pressure increased by 8.9% in the intervention group and decreased by 1.3% in the control group (P=0.011). At 18 months, the difference in HbA1c was: -2 (95% CI -3;-0) mmol/mol [-0.2 (95% CI -0.3; -0.0)%; P=0.046] overall and -4 (-7; -1) mmol/mol [-0.4 (95% CI -0.7; -0.1)%; P=0.023] in the elevated HbA1c subgroup. CONCLUSION: Nurse-led telecoaching improved glycaemic control, total cholesterol levels and BMI in people with Type 2 diabetes. Twelve months after the intervention completion, there were sustained improvements in glycaemic control.

Hospital- and community-based interventions enhancing (re)employment for people with spinal cord injury: a systematic review.

STUDY DESIGN: Systematic Review. OBJECTIVES: To investigate the effect of interventions enhancing (re)employment following spinal cord injury (SCI). SETTING: Studies from multiple countries were included. METHODS: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, PsycINFO and SPORTDISCUS databases were searched. Randomized controlled trials (RCTs) and non-randomized studies (NRSs) describing a hospital- or a community-based intervention aiming at employment in a SCI population were selected. Quality appraisal was done using the SIGN methodology, and the quality of evidence was graded using the Grade approach. Data extraction was performed according to the Cochrane Handbook. Employment rate and duration were primary outcomes. RESULTS: Only one RCT, including 201 patients describing an intervention over 1 and 2 years, was of sufficient quality. In this study, the employment rate was 26% after 1 and 31% after 2 years for competitive work, compared with 10% in the treatment as usual-intervention site (TAU-IS) control group and 2% in the treatment as usual observational site (TAU-OS) after 1 and 2 years. Other studies were of low quality and describe higher employment rates from 36 to 100%. CONCLUSIONS: Only one RCT was of sufficient quality and showed evidence that a vocational rehabilitation programme based on the principles of supported employment integrated in a multidisciplinary team enhances employment for SCI people. As the vast majority of studies included in this review are of low methodological quality, further research is needed.

Patient and provider acceptance of telecoaching in type 2 diabetes: a mixed-method study embedded in a randomised clinical trial.

BACKGROUND: Despite advances in diagnosis and treatment of type 2 diabetes, suboptimal metabolic control persists. Patient education in diabetes has been proved to enhance self-efficacy and guideline-driven treatment, however many people with type 2 diabetes do not have access to or do not participate in self-management support programmes. Tele-education and telecoaching have the potential to improve accessibility and efficiency of care, but there is a slow uptake in Europe. Patient and provider acceptance in a local context is an important pre-condition for implementation. The aim of the study was to explore the perceptions of patients, nurses and general practitioners (GPs) regarding telecoaching in type 2 diabetes. METHODS: Mixed-method study embedded in a clinical trial, in which a nurse-led target-driven telecoaching programme consisting of 5 monthly telephone sessions of +/- 30 min was offered to 287 people with type 2 diabetes in Belgian primary care. Intervention attendance and satisfaction about the programme were analysed along with qualitative data obtained during post-trial semi-structured interviews with a purposive sample of patients, general practitioners (GPs) and nurses. The perceptions of patients and care providers about the intervention were coded and the themes interpreted as barriers or facilitators for adoption. RESULTS: Of 252 patients available for a follow-up analysis, 97.5 % reported being satisfied. Interviews were held with 16 patients, 17 general practitioners (GPs) and all nurses involved (n = 6). Themes associated with adoption facilitation were: 1) improved diabetes control; 2) need for more tailored patient education programmes offered from the moment of diagnosis; 3) comfort and flexibility; 4) evidence-based nature of the programme; 5) established cooperation between GPs and diabetes educators; and 6) efficiency gains. Most potential barriers were derived from the provider views: 1) poor patient motivation and suboptimal compliance with "faceless" advice; 2) GPs' reluctance in the area of patient referral and information sharing; 3) lack of legal, organisational and financial framework for telecare. CONCLUSIONS: Nurse-led telecoaching of people with type 2 diabetes was well-accepted by patients and providers, with providers being in general more critical in their reflections. With increasing patient demand for mobile and remote services in healthcare, the findings of this study should support professionals involved in healthcare policy and innovation. TRIAL REGISTRATION: NCT01612520 , registered prior to recruitment on 4th June 2012.

Medication review by a clinical pharmacist at the transfer point from ICU to ward: a randomized controlled trial.

WHAT IS KNOWN AND OBJECTIVE: Drug-related problems (DRPs) occur frequently in hospitalized patients. Patient discharge from the intensive care unit (ICU) to a non-ICU ward is one of the most challenging and high-risk transitions of care due to the number of medications, and the complexity and acuity of the medical conditions that characterize this patient group. Pharmacists could play an important role in preventing DRPs. This study was undertaken to evaluate the impact on the number and severity of drug-related problems by assigning a clinical pharmacist to the transfer process from ICU to wards. METHODS: The study was a randomized controlled multicentre trial conducted at the Hospital Network of Antwerp between December 2010 and January 2012. The clinical pharmacist performed a medical review in both the intervention and control group. Recommendations for drug therapy changes were immediately communicated in the intervention group but were kept blinded in the control group. The primary outcome was expressed as the number of implemented recommendations for drug therapy changes. Differences between groups were calculated using mixed effects binary logistic regression. RESULTS: Drug-related problems were found in the medical records of 360 of the 600 participants (60%). A total of 743 recommendations could be made, 375 in the intervention group and 368 in the control group. 54·1% of these problems were adjusted on time in the intervention group vs. 12·8% in the control group. Of 743 recommendations, 24·8% were judged by the expert group as major, 13·1% as moderate, 53.4% as minor and 8·9% as having no clinical impact. The odds of implementing recommendations of drug therapy changes in the intervention group were 10 times the odds of implementing recommendations of drug therapy changes in the control group (odds ratio = 10·1; 95%CI [6·3-16·1]; P < 0·001), even after accounting for differences in types of DRP between the groups (odds ratio = 15·6; 95%CI [9·4-25·9]; P < 0·001). WHAT IS NEW AND CONCLUSION: The integration of a clinical pharmacist at the transfer point from ICU to ward led to a significant reduction in DRPs.

Care for adult non-ICU Covid-19 patients: early experiences from a Belgian tertiary care centre.

The current Covid-19 outbreak poses many challenges on hospital organisation and patient care. Our hospital lies at the epicentre of the Belgian epidemic. On April 1st, a total of 235 Covid-19 patients had been admitted to our hospital. This demanded an unprecedented adaptation of our hospital organisation, and we have met many clinical issues in the care for Covid-19 patients. In this article, we share our experience in the handling of some of the practical and organisational issues in the care for Covid-19 patients.

The evaluation of diagnostic tests: evidence on technical and diagnostic accuracy, impact on patient outcome and cost-effectiveness is needed.

OBJECTIVE: Before introducing a test in clinical practice, its characteristics and added value should be assessed. Diagnostic accuracy studies only are not sufficient; the test's impact on patient outcome ought to be assessed as well. To do this, we propose a stepwise evaluation of diagnostic tests. STUDY DESIGN AND SETTING: Theoretical-conceptual approach. RESULTS: First, the test's technical accuracy refers to the ability to produce usable information under standardized conditions. In a second step, the place of the new test in the clinical pathway is determined. Thirdly, the test's diagnostic accuracy is assessed, depending on its intended goal. The fourth step assesses the test's impact on the patient outcome. Depending on the place of the test in the clinical pathway, existing evidence can be used, or new evidence will be needed. At the final step, a cost-effectiveness analysis assesses the test's financial and societal consequences. CONCLUSION: Diagnostic tests evaluation should consider the technical accuracy, the test's place in the clinical pathway, its diagnostic accuracy, and its impact on patient outcome.

[The gap between evidence-based medicine (EBM) and practice: how is the "evidence" brought together?]. / De kloof tussen EBM en de praktijk: hoe de "evidence" samenbrengen?

The implementation of the growing body of evidence in health care is a major matter of concern. Health care professionals and policy makers often only had a limited if any training in searching for relevant and objective information efficiently. Furthermore, information sources of high quality are not readily available in the health care system or are often not accessible in daily practice. Health care workers depend on other sources for information about newest developments: marketing from the industry, media, opinion leaders, CPD, etc. In this lecture, three possible ways to summarize the available evidence and to forward pre-appraised sources of information to health care professionals are discussed: systematic reviews, practice guidelines and health care technology assessment reports. Finally, the recently founded Belgian health care knowledge centre is presented. This government agency has the mission to diminish the gap between the scientific community and health care policy makers.

Protected carotid artery stenting (PCAS): a short medical technology assessment.

After a period of experimenting with angioplasty and stenting, carotid artery stenting under embolic protection (PCAS) is becoming a viable alternative for carotid endarterectomy (CEA). A standard literature review showed that, at January 2005, there was no evidence that PCAS is more effective than CEA. The high costs of stent and protection device makes PCAS then inferior to CEA. PCAS may be the sole possible option in patients with symptomatic carotid artery stenosis unfit for surgery, where the high risk of stroke overrides uncertainty about health effects and overrides cost-effectiveness. These are a few patients per year in Belgium. Several randomised controlled trials comparing PCAS and CEA are now recruiting patients. To have answers on key questions of cost-effectiveness, it is of paramount importance that these trials recruit and publish rapidly. The KCE (Belgian HealthCare Knowledge Center/Centre Fédéral d'Expertise des Soins de Santé/Federaal Kenniscentrum voor de Gezondheidszorg) therefore advises cooperation with these trials. Outside these trials and compassionate use in the few symptomatic patients unfit for CEA, the use of PCAS raises serious ethical questions.

[Systemic validation of clinical practice guidelines: the AGREE network]. / La validation systématique de guides de pratique clinique: l'instrument AGREE, elaboration et diffusion d'une liste internationale de critères.

INTRODUCTION: Over recent decades, the number of available clinical practice guidelines has enormously grown. Guidelines should meet specific quality criteria to ensure good quality. There is a growing need for the developement of a set of criteria to ensure that potential biases inherent in guideline development have been properly addressed and that the recommendations for practice are valid and reliable. AIM: The AGREE-collaboration is an international network that developed an instrument to critically appraise the methodological quality of guidelines. AGREE promotes a clear strategy to produce, disseminate and evaluate guidelines of high quality. METHOD: In the first phase of the international project the AGREE-instrument was tested in 11 different countries. Based on this experience the instrument was refined and optimised. In the second phase it was disseminated, promoted and evaluated in 18 participating countries. Belgium was one of them. RESULTS: The Belgian partner in the AGREE-project developed 3 workshops and established 13 validation committees to validate guidelines from Belgian developer groups. We collected 33 questionnaires from participants of the workshops and the validation committees, in which we asked for primary experiences and information on the usefulness and applicability of the instrument. We were also interested in the shortcomings of the instrument and potential strategies to bridge them. DISCUSSION: More efforts should be made to train methodological experts to gain certain skills for a critical appraisal of clinical practice guidelines. Promoting the AGREE-instrument will lead to a broader knowledge and use of quality criteria in guideline development and appraisal. CONCLUSION: The development and dissemination of an international list of criteria to appraise the quality of guidelines will stimulate the development of methodologically sound guidelines. International comparisons between existing guidelines will lead to a better collaboration between guideline developers throughout the world.

Effect of POMC(1-76), its C-terminal fragment gamma3-MSH and anti-POMC(1-76) antibodies on DNA replication in lactotrophs in aggregate cell cultures of immature rat pituitary.

Treatment of aggregate cell cultures of 14-day-old rat pituitary for 40 h with purified human (h) POMC(1-76) dose-dependently augmented the number of DNA replicating lactotrophs as estimated by autoradiography of [3H]-thymidine (3H-T) incorporation in cells immunostained for prolactin (PRL). No such effect was seen on the total number of 3H-T labelled cells (the majority of which did not contain any pituitary hormone in a detectable amount) or on the total number of lactotrophs. The effect of hPOMC(1-76) on 3H-T incorporation in lactotrophs was blocked by concomitant treatment with anti-hPOMC(1-76) monoclonal and polyclonal antibodies cross-reactive with rat POMC(1-74). The latter anti-hPOMC(1-76) antibodies also decreased the number of 3H-T incorporating lactotrophs in the absence of hPOMC(1-76). Gamma3-MSH, which is the C-terminal domain of hPOMC(1-76), mimicked the effect of hPOMC(1-76) on 3H-T incorporation in lactotrophs but its potency was lower than that of hPOMC(1-76). Other melanocortin (MC) peptides such as alpha- and beta-MSH were also effective but were less potent than gamma3-MSH. The difference in potency was not due to partial degradation of the peptides. hPOMC(1-76) did not affect 3H-T incorporation in other pituitary cell types. In contrast gamma3-MSH also augmented the number of 3H-T labelled somatotrophs and thyrotrophs. In the embryonic kidney 293 cell line stably transfected with the MC-3 receptor, gamma3-MSH (10 nM) augmented cAMP formation up to 30 times. In contrast, hPOMC(1-76) (100 nM) was inactive in this test system, indicating this peptide is not an agonist at the MC-3 receptor. The present investigation further supports the role of rat POMC(1-74) as a paracrine growth factor in the development of lactotrophs. The active core of POMC(1-76) does not seem to be restricted to its C-terminal domain gamma3-MSH as the latter peptide displays a growth promoting effect that is different from that of POMC(1-76): it is less potent, it is not specific for lactotrophs and whereas the effect of gamma3-MSH may be mediated by the MC-3 receptor that of POMC(1-76) is not.

Detection of melanocortin-3 receptor mRNA in immature rat pituitary: functional relation to gamma3-MSH-induced changes in intracellular Ca2+ concentration?

We have previously shown that gamma3-MSH stimulates DNA replication in lactotrophs, somatotrophs and thyrotrophs of early postnatal rat pituitary in culture. Since the melanocortin-3 (MC-3) receptor is the only known receptor displaying high affinity for gamma3-MSH, the present study explored whether mRNA of the latter receptor is present in the pituitary and whether the receptor is functional. RT-PCR of RNA extracts from 14-day-old rat pituitary revealed the presence of MC-3 receptor mRNA in both the anterior and the neurointermediate lobe. The identity of the amplified products was confirmed by sequence analysis. Dispersed cells of 14-day-old female rats (24 h in culture) were exposed to gamma3-MSH, and changes in intracellular free calcium levels ([Ca2+]i) were assessed by means of fluo-3 video imaging. Gamma3-MSH evoked a rapid and maintained oscillating [Ca2+]i increase in 5%, 10% and 15% of the cells at a dose of 0.1, 1 and 10 nM, respectively. The MC-3/MC-4 receptor antagonist Ac-Nle4-c[Asp5,(D-Nal(2)7,Lys10]alpha-MSH-(4-10)-NH2 (SHU 9119) blocked the effect of gamma3-MSH in about 50% of the responsive cells. The present data suggest that the MC-3 receptor is expressed in the rat pituitary but that this receptor mediates only half of the effects of its putative ligand, gamma3-MSH, on [Ca2+]i. Part of the effect of gamma3-MSH may be mediated by a MC-3 receptor in a functional state different from the one studied previously in transfected cell lines or by a hitherto unidentified MC receptor.

Wavelet decomposition analysis of heart rate variability in aerobic athletes.

Heart rate variability (HRV) can be quantified, among others, in the frequency domain using digital signal processing (DSP) techniques. The wavelet transform is an alternative tool for the analysis of non-stationary signals. The implementation of perfect reconstruction digital filter banks leads to multi resolution wavelet analysis. Software was developed in LabVIEW. In this study, the average power was compared at each decomposition level of a tachogram, containing the consecutive RR-intervals of two groups of subjects: aerobic athletes and a control group. Compared to the controls, the aerobic athletes showed an increased power in all frequency bands. These results are in accordance with values obtained by spectral analysis using the Fourier transform, suggesting that wavelet analysis could be an appropriate tool to evaluate oscillating components in HRV, but in addition to classic methods, it also gives a time resolution.

Analysis of heart rate variability with correlation dimension method in a normal population and in heart transplant patients.

INTRODUCTION: The correlation dimension (CD) method is related to chaos theory and is used to quantify heart rate variability (HRV). The CD is a measure for the amount of correlations present in the signal. METHODS: The algorithm used to calculate the CD is based on the method of Grassberger and Proccacia. The method was first validated on signals with known CD and then applied to HRV-signals of heart transplants and an age-matched control group of healthy subjects. The CD of the corresponding surrogate time series was calculated to investigate non-linear correlations in the HRV-signal. Circadian variations of the CD were studied in 20 healthy subjects, including men and women. RESULTS: The value of the CD for healthy subjects ranged from 2.12 to 5.53 with a mean value of 4.32. For heart transplants, only a few time series showed a finite value of the CD that varied between 2.10 and 5.60. Also, a significant difference was found between the CD of the original and the surrogate time series in healthy subjects. The CD of women is higher than the CD of men, and this difference was more pronounced during the night than during the day. CONCLUSIONS: This limited study shows that the CD alone cannot be used to make a distinction between HRV-signals of healthy subjects and of heart transplants. However, there is evidence that there are non-linear correlations present in the HRV-signal and that there are significant gender and circadian differences in the CD.

Neurocardiology: the benefits of irregularity. The basics of methodology, physiology and current clinical applications.

Cardiovascular variability in heart rate and blood pressure can be used to quantify the autonomic modulation of cardiovascular function. Although the first studies were only published 10 to 20 years ago, there is presently a vast amount of knowledge from numerous publications that allows a better insight into the neural control mechanisms of the heart. The development of methods such as heart rate variability and baroreflex sensitivity prompted a multidisciplinary approach since many aspects were involved: mathematics, signal processing, physiology and cardiology. Therefore, it is obvious that an adequate understanding of certain basic principles is necessary before its clinical potential can be fully exploited. This current review outlines the physiological background and the fundamental methodology used in the field of neurocardiology by presenting the newer insights and developments from both fundamental and clinical sides. Recent publications indicate that neurocardiological applications in (risk stratification of) myocardial infarction, congestive heart failure and heart transplant patients can be expected to enter daily clinical practice in the next millennium.

The analysis of heart rate variability in unrestrained rats. Validation of method and results.

An experimental setting and software were developed to evaluate cardiac autonomic function in unrestrained rats. Subcutaneously implanted ECG electrodes and an indwelling venous catheter were tunneled to a tail cuff in five rats. The ECG was A/D converted at 1000 Hz. After peak detection, a time series of RR intervals was obtained. Programs for the analysis of heart rate variability (HRV) were implemented in LabVIEW. Statistical properties were determined in the time domain. After cubic spline function curve fitting, resampling at 0.1 s and test for stationarity, power spectral analysis was performed on sampled records of 30 min duration after applying a sliding Hanning window (Welch method: 256 points (duration 25.6 s), 50% overlap and 0.039 Hz resolution). Algorithms were tested with simulated signals consisting of isolated frequency components, which were retrieved at their exact locations. Physiological validation of the system was performed by, beta-adrenergic and cholinergic blockade and by forced breathing at a fixed rate. Measurements were performed on five unrestrained rats under basal conditions. Mean RR was 174.2 +/- 3.6 ms; S.D., 13.3 +/- 4.6 ms; rMSSD, 5.2 + /- 1.2 ms; pNN10, 3.5 +/- 1.9% and pNN5, 18.7 +/- 6.4%. Low (0.19-0.74 Hz) and high frequency (0.78-2.5 Hz) power were determined (and also percent of low to total and high to total): 18.42 +/- 10.74 ms2 (22.9 +/- 6.5%) and 15.66 +/- 5.56 ms2 (19.9 +/- 2.7%), and the ratio low/high: 1.16 +/- 0.39. In conclusion, HRV analysis programs were developed and thoroughly tested through simulations and in vivo, under basal conditions and after pharmacological blockades. Using this software, HRV data from unrestrained rats were obtained.

Rigour of development does not AGREE with recommendations in practice guidelines on the use of ice for acute ankle sprains.

OBJECTIVE This study evaluated whether the Appraisal of Guidelines Research and Evaluation (AGREE) rigour of development score of practice guidelines on ice for acute ankle sprains is related to the convergence between recommendations. DESIGN The authors systematically reviewed guidelines on ice for acute ankle sprains. Four appraisers independently used the AGREE instrument to evaluate the rigour of development of selected guidelines. For each guideline, one reviewer listed the cited evidence on ice and calculated a cited evidence score. The authors plotted the recommended durations and numbers of ice applications over the standardised rigour of development score to explore the relationships. DATA SOURCES Three reviewers searched for guidelines in Medline, Embase, Sportdiscus, PEDro, G-I-N Guideline Library, Trip Database, SumSearch, National Guideline Clearinghouse and the Health Technology Assessment database, and conducted a web-based search for guideline development organisations. ELIGIBILITY CRITERIA Eligible guidelines had a development methodology that included a process to search or use results from scientific studies and the participation of an expert group to formulate recommendations. RESULTS The authors identified 21 guidelines, containing clinically significant variations in recommended durations and numbers of ice applications. The median standardised rigour of development score was 57% (IQR 18 to 77). Variations occurred evenly among guidelines with low moderate or high rigour scores. The median evidence citation score in the guidelines was 7% (IQR 0 to 61). CONCLUSIONS There is no relationship between the rigour of development score and the recommendations in guidelines on ice for acute ankle sprains. The guidelines suffered from methodological problems which were not captured by the AGREE instrument.