ObjectiveThis study assesses the effectiveness of different interventions of knowledge transfer and behaviour modification to improve type 2 diabetes mellitus patients’ (T2DM) reported outcomes ...measures (PROMs) in the long-term. Design: open, community-based pragmatic, multicentre, controlled trial with random allocation by clusters to usual care (UC) or to one of the three interventions.ParticipantsA total of 2334 patients with uncomplicated T2DM and 211 healthcare professionals were included of 32 primary care centres.SettingPrimary Care Centers in Canary Islands (Spain).InterventionThe intervention for patients (PTI) included an educational group programme, logs and a web-based platform for monitoring and automated short message service (SMS). The intervention for professionals (PFI) included an educational programme, a decision support tool embedded into the electronic clinical record and periodic feedback about patients’ results. A third group received both PTI and PFI (combined intervention, CBI).Outcome measureCognitive-attitudinal, behavioural, affective and health-related quality of life (HQoL) variables.ResultsCompared with UC at 24 months, the PTI group significantly improved knowledge (p=0.005), self-empowerment (p=0.002), adherence to dietary recommendations (p<0.001) and distress (p=0.01). The PFI group improved at 24 months in distress (p=0.03) and at 12 months there were improvements in depression (p=0.003), anxiety (p=0.05), HQoL (p=0.005) and self-empowerment (p<0.001). The CBI group improved at 24 months in self-empowerment (p=0.008) and adherence to dietary recommendations (p=0.004) and at 12 months in knowledge (p=0.008), depression (p=0.006), anxiety (p=0.003), distress (p=0.01), HQoL (p<0.001) and neuropathic symptoms (p=0.02). Statistically significant improvements were also observed at 24 months in the proportion of patients who quit smoking for PTI and CBI (41.5% in PTI and 42.3% in CBI vs 21.2% in the UC group).ConclusionsAssessed interventions to improve PROMs in T2DM attain effectiveness for knowledge, self-empowerment, distress, diet adherence and tobacco cessation. PTI produced the most lasting benefits.Trial registration numberClinicalTrials.gov NCT01657227 (6 August 2012) https://clinicaltrials.gov/ct2/show/NCT01657227.
Type 2 diabetes mellitus is a chronic disease whose health outcomes are related to patients and healthcare professionals' decision-making. The Diabetes Intervention study in the Canary Islands ...(INDICA study) aims to evaluate the effectiveness and cost-effectiveness of educational interventions supported by new technology decision tools for type 2 diabetes patients and primary care professionals in the Canary Islands.
The INDICA study is an open, community-based, multicenter, clinical controlled trial with random allocation by clusters to one of three interventions or to usual care. The setting is primary care where physicians and nurses are invited to participate. Patients with diabetes diagnosis, 18-65 years of age, and regular users of mobile phone were randomly selected. Patients with severe comorbidities were excluded. The clusters are primary healthcare practices with enough professionals and available places to provide the intervention. The calculated sample size was 2,300 patients. Patients in group 1 are receiving an educational group program of eight sessions every 3 months led by trained nurses and monitored by means of logs and a web-based platform and tailored semi-automated SMS for continuous support. Primary care professionals in group 2 are receiving a short educational program to update their diabetes knowledge, which includes a decision support tool embedded into the electronic clinical record and a monthly feedback report of patients' results. Group 3 is receiving a combination of the interventions for patients and professionals. The primary endpoint is the change in HbA1c in 2 years. Secondary endpoints are cardiovascular risk factors, macrovascular and microvascular diabetes complications, quality of life, psychological outcomes, diabetes knowledge, and healthcare utilization. Data is being collected from interviews, questionnaires, clinical examinations, and records. Generalized linear mixed models with repeated time measurements will be used to analyze changes in outcomes. The cost-effectiveness analysis, from the healthcare services perspective, involves direct medical costs per quality-adjusted life year gained and two periods, a 'within-trial' period and a lifetime Markov model. Deterministic and probabilistic sensitivity analyses are planned.
This ongoing trial aims to set up the implementation of evidence-based programs in the clinical setting for chronic patients.
Clinical Trial.gov NCT01657227.
Malnutrition is highly prevalent in hospitalized patients and results in a worsened clinical course as well as an increased length of stay, mortality, and costs. Therefore, simple nutrition screening ...systems, such as CIPA (control of food intake, protein, anthropometry), may be implemented to facilitate the patient's recovery process. The aim of this study is to evaluate the effectiveness and cost-effectiveness of implementing such screening tool in a tertiary hospital, consistent with the lack of similar, published studies on any hospital nutrition screening system.
The present study is carried out as an open, controlled, randomized study on patients that were admitted to the Internal Medicine and the General and Digestive Surgery ward; the patients were randomized to either a control or an intervention group (n = 824, thereof 412 patients in each of the two study arms). The control group underwent usual inpatient clinical care, while the intervention group was evaluated with the CIPA screening tool for early detection of malnutrition and treated accordingly. CIPA nutrition screening was performed upon hospital admission and classified positive when at least one of the following parameters was met: 72 h food intake control < 50%, serum albumin < 3 g/dL, body mass index < 18.5 kg/m
(or mid-upper arm circumference ≤ 22.5 cm). In this case, the doctor decided on whether or not providing nutrition support. The following variables will be evaluated: hospital length of stay (primary endpoint), mortality, 3-month readmission, and in-hospital complications. Likewise, the quality of life questionnaires EQ-5D-5 L are being collected for all patients at hospital admission, discharge, and 3 months post-discharge. Analysis of cost-effectiveness will be performed by measuring effectiveness in terms of quality-adjusted life years (QALYs). The cost per patient will be established by identifying health care resource utilization; cost-effectiveness will be determined through the incremental cost-effectiveness ratio (ICER). We will calculate the incremental cost per QALY gained with respect to the intervention.
This ongoing trial aims to evaluate the cost-effectiveness of implementing the malnutrition screening tool CIPA in a tertiary hospital.
Clinical Trial.gov ( NCT02721706 ). First receivevd: March 1, 2016 Last updated: April 8, 2017 Last verified: April 2017.
News about suicide may have either a contagion effect or a protective effect. For this reason, interventions aimed to the media are a priority. However, the effectiveness of the interventions has not ...yet been elucidated. The objective of the study was to evaluate comparatively the characteristics and adequacy of suicide news articles between geographical areas in which interventions aimed at media either exist or not.
We evaluated suicide news articles in the four main digital media of Spain (without interventions) and Victoria, Australia (with interventions), according to Alexa (a website traffic statistics). We assessed adherence to World Health Organization (WHO) recommendations, avoidability, frequency, and typology of suicide news articles. The evaluation period was 6 months. Bivariate analysis was performed comparing the samples using t-test, Chi-Squared test and Fisher's exact test according to the type of variable.
We identified 378 suicide news articles: 141 in Spain and 237 in Victoria. Suicide news articles in Spain showed a lower degree of adherence to the WHO recommendations than those from Victoria (2.97 vs. 11.8; p<0.001). Mean daily number of suicide news articles was lower in Spain (0.78 vs. 1.31; p<0.001). Typology according to contents was different between both regions (p=0.045), with greater prevalence of "suicide after murder" in Spain. However, there were no differences either in avoidability, or in typology according to behaviour.
Suicide news articles are more adequate in the geographic area in which interventions aimed at media are performed. These better characteristics imply lower risk of contagion effect, greater likelihood of protective effect and, therefore, a potential beneficial effect on the suicidal behaviour in the reference population.
Alopecia is one of the most common adverse effects of chemotherapy, having a significant impact on the quality of life of patients who suffer from it. Among the interventions available for its ...prevention, scalp cooling (SC) is the most widely used. The aim of this study was to assess the efficacy and safety of the use of SC systems during chemotherapy sessions for the prevention or the reduction of the extent of chemotherapy-induced alopecia.
A systematic review of the literature published up to November 2021 was carried out. Randomized clinical trials were selected. The main outcome measure was alopecia (hair loss>50%) during and after chemotherapy treatment. When possible, a quantitative synthesis of the results was performed through meta-analysis using the Stata v.15.0 software. The risk ratio (RR) of the variable alopecia, was estimated using a random effects model following the Mantel-Haenszel method. Statistical heterogeneity of the results was evaluated graphically and through the test of heterogeneity χ
and the Higgins I
statistic. Sensitivity analyses and subgroup analyses were performed.
13 studies were included, with a total of 832 participants (97.7% women). In most studies, the main chemotherapy treatment applied was anthracyclines or the combination of anthracyclines and taxanes. The results obtained indicate that SC prevents alopecia (loss>50%) by 43% compared to the control group (RR=0.57; 95% CI=0.46 to 0.69; k=9; n=494; I
=63.8%). No statistically significant difference was found between the efficacy of automated and non-automated cooling systems (P=0.967). No serious short- or medium-term adverse events related to SC were recorded.
The results suggest that scalp cooling contributes to the prevention of chemotherapy-induced alopecia.
To assess the relationship between mental health and health-related quality of life (HRQL) in the general population, and to map GHQ-12 as a screening test for population psychological distress to a ...generic health state measure (EQ-5D) in order to estimate health state values and allow deriving quality-adjusted life years.
Relationship between mental health and HRQL was examined from the 2004 Canary Islands' Health Survey. Participants were classified as probable psychiatric cases according to GHQ-12. HRQL was measured by the EQ-5D index. Multivariate lineal regression analysis was used to examine the association between mental health and HRQL adjusting by socio-demographic variables and comorbidities. A multivariate regression model was built from EQ-5D to estimate health states values using GHQ-12 as exposure.
EQ-5D index scores decreased as the GHQ-12 scores increased. Clinical and socio-demographic factors influenced HRQL without changing the overall trend for this negative relationship. The regression equation explained 43% of the variance. For estimation of utility scores, the model showed a high predictive capacity, with a mean forecast errors of 16%.
HRQL progressively decreased when the probability of being a psychiatric case increased. Findings enable health state values to be derived from GHQ-12 scores for populations where utilities has not or cannot be measured directly.
In this article, we describe the eq5dds command, which presents the results of a descriptive system using individuals’ responses for mobility, self care, usual activities, pain or discomfort, anxiety ...or depression, and visual analog scale from the EQ-5D health-related quality-of-life instrument (in its 3L and 5L versions). The command presents each of the tables and the figures recommended in the official user guide of the instrument (developed by the EuroQol Group).
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