Telehealth system (e-CUIDATE) to improve quality of life in breast cancer survivors: rationale and study protocol for a randomized clinical trial.

BACKGROUND Breast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increase the prevalence of handicaps associated to unhealthy lifestyle (for example, decreased aerobic capacity and strength, weight gain, and fatigue). Recent work has shown that exercise adapted to individual characteristics of patients is related to improved overall and disease-free survival. Nowadays, technological support using telerehabilitation systems is a promising strategy with great advantage of a quick and efficient contact with the health professional. It is not known the role of telerehabilitation through therapeutic exercise as a support tool to implement an active lifestyle which has been shown as an effective resource to improve fitness and reduce musculoskeletal disorders of these women. METHODS / DESIGN This study will use a two-arm, assessor blinded, parallel randomized controlled trial design. People will be eligible if: their diagnosis is of stages I, II, or IIIA breast cancer; they are without chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program; they had access to the Internet and basic knowledge of computer use or living with a relative who has this knowledge; they had completed adjuvant therapy except for hormone therapy and not have a history of cancer recurrence; and they have an interest in improving lifestyle. Participants will be randomized into e-CUIDATE or usual care groups. E-CUIDATE give participants access to a range of contents: planning exercise arranged in series with breathing exercises, mobility, strength, and stretching. All of these exercises will be assigned to women in the telerehabilitation group according to perceived needs. The control group will be asked to maintain their usual routine. Study endpoints will be assessed after 8 weeks (immediate effects) and after 6 months. The primary outcome will be QoL measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version 3.0 and breast module called The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire. The secondary outcomes: pain (algometry, Visual Analogue Scale, Brief Pain Inventory short form); body composition; physical measurement (abdominal test, handgrip strength, back muscle strength, and multiple sit-to-stand test); cardiorespiratory fitness (International Fitness Scale, 6-minute walk test, International Physical Activity Questionnaire-Short Form); fatigue (Piper Fatigue Scale and Borg Fatigue Scale); anxiety and depression (Hospital Anxiety and Depression Scale); cognitive function (Trail Making Test and Auditory Consonant Trigram); accelerometry; lymphedema; and anthropometric perimeters. DISCUSSION This study investigates the feasibility and effectiveness of a telerehabilitation system during adjuvant treatment of patients with breast cancer. If this treatment option is effective, telehealth systems could offer a choice of supportive care to cancer patients during the survivorship phase. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01801527.

Expert study: A bolus calculator improves glycemic control and quality of life of type 1 diabetic patients (T1DM) (preliminary results)

Aims: To evaluate the impact on glycemic control and quality of life of a bolus calculator. Methods: Multicentre randomized prospective crosssectional study. Patients were randomized to control phase (3 months; calculation of prandial insulin according to insulinto-carbohydrate ratio and insulin sensitivity factor using a single strip meter) or intervention phase (3 months; calculation of prandial insulin with a bolus advisor), with a washout period (3 months). Patients wore a continuous glucosensor (7 days) and answered a quality of life questionnaire at the beginning and at the end of each phase. A questionnaire of satisfaction was obtained at the end of both phases. Inclusion criteria: Adults; T1DM> 1 year, HbA1c > 7.5%, basal-bolus therapy with insulin analogs, experience with carbohydrate Results: Data from the first 32 subjects with at least 1 ended phase (27 females, age 38 – 11 years, diabetes duration 16.8 – 7.5 years). Basal characteristics were comparable independently of the starting phase. No differences were found between phases in terms of mean blood glucose, standard deviation (from meter neither from sensor) and satisfaction. Conclusions: The use of a bolus calculator improves glycemic control and quality of life of T1DM subjects.

Evaluation of quality improvement for cesarean sections caesarean section programmes through mixed methods.

BACKGROUND The rate of avoidable caesarean sections (CS) could be reduced through multifaceted strategies focusing on the involvement of health professionals and compliance with clinical practice guidelines (CPGs). Quality improvements for CS (QICS) programmes (QICS) based on this approach, have been implemented in Canada and Spain. OBJECTIVES Their objectives are as follows: 1) Toto identify clusters in each setting with similar results in terms of cost-consequences, 2) Toto investigate whether demographic, clinical or context characteristics can distinguish these clusters, and 3) Toto explore the implementation of QICS in the 2 regions, in order to identify factors that have been facilitators in changing practices and reducing the use of obstetric intervention, as well as the challenges faced by hospitals in implementing the recommendations. METHODS Descriptive study with a quantitative and qualitative approach. 1) Cluster analysis at patient level with data from 16 hospitals in Quebec (Canada) (n = 105,348) and 15 hospitals in Andalusia (Spain) (n = 64,760). The outcome measures are CS and costs. For the cost, we will consider the intervention, delivery and complications in mother and baby, from the hospital perspective. Cluster analysis will be used to identify participants with similar patterns of CS and costs based, and t tests will be used to evaluate if the clusters differed in terms of characteristics: Hospital level (academic status of hospital, level of care, supply and demand factors), patient level (mother age, parity, gestational age, previous CS, previous pathology, presentation of the baby, baby birth weight). 2) Analysis of in-depth interviews with obstetricians and midwives in hospitals where the QICS were implemented, to explore the differences in delivery-related practices, and the importance of the different constructs for positive or negative adherence to CPGs. Dimensions: political/management level, hospital level, health professionals, mothers and their birth partner. DISCUSSION This work sets out a new approach for programme evaluation, using different techniques to make it possible to take into account the specific context where the programmes were implemented.

Transcultural adaptation and validation of the "Hip and Knee" questionnaire into Spanish.

BACKGROUND The purpose of the present study is to translate and validate the "Hip and Knee Outcomes Questionnaire", developed in English, into Spanish. The 'Hip and Knee Outcomes Questionnaire is a questionnaire planned to evaluate the impact in quality of life of any problem related to the human musculoskeletal system. 10 scientific associations developed it. METHODS The questionnaire underwent a validated translation/retro-translation process. Patients undergoing primary knee arthroplasty, before and six months postoperative, tested the final version in Spanish. Psychometric properties of feasibility, reliability, validity and sensitivity to change were assessed. Convergent validity with SF-36 and WOMAC questionnaires was evaluated. RESULTS 316 patients were included. Feasibility: a high number of missing items in questions 3, 4 and 5 were observed. The number of patients with a missing item was 171 (51.35%) in the preoperative visit and 139 (44.0%) at the postoperative. Internal validity: revision of coefficients in the item-rest correlation recommended removing question 6 during the preoperative visit (coefficient <0.20). Convergent validity: coefficients of correlation with WOMAC and SF-36 scales confirm the questionnaire's validity. Sensitivity to change: statistically significant differences were found between the mean scores of the first visit compared to the postoperative. CONCLUSION The proposed translation to Spanish of the 'Hip and Knee Questionnaire' is found to be reliable, valid and sensible to changes produced at the clinical practice of patients undergoing primary knee arthroplasty. However, some changes at the completion instructions are recommended. LEVEL OF EVIDENCE Level I. Prognostic study.

Use of Hy's law and a new composite algorithm to predict acute liver failure in patients with drug-induced liver injury.

BACKGROUND & AIMS Hy's Law, which states that hepatocellular drug-induced liver injury (DILI) with jaundice indicates a serious reaction, is used widely to determine risk for acute liver failure (ALF). We aimed to optimize the definition of Hy's Law and to develop a model for predicting ALF in patients with DILI. METHODS We collected data from 771 patients with DILI (805 episodes) from the Spanish DILI registry, from April 1994 through August 2012. We analyzed data collected at DILI recognition and at the time of peak levels of alanine aminotransferase (ALT) and total bilirubin (TBL). RESULTS Of the 771 patients with DILI, 32 developed ALF. Hepatocellular injury, female sex, high levels of TBL, and a high ratio of aspartate aminotransferase (AST):ALT were independent risk factors for ALF. We compared 3 ways to use Hy's Law to predict which patients would develop ALF; all included TBL greater than 2-fold the upper limit of normal (×ULN) and either ALT level greater than 3 × ULN, a ratio (R) value (ALT × ULN/alkaline phosphatase × ULN) of 5 or greater, or a new ratio (nR) value (ALT or AST, whichever produced the highest ×ULN/ alkaline phosphatase × ULN value) of 5 or greater. At recognition of DILI, the R- and nR-based models identified patients who developed ALF with 67% and 63% specificity, respectively, whereas use of only ALT level identified them with 44% specificity. However, the level of ALT and the nR model each identified patients who developed ALF with 90% sensitivity, whereas the R criteria identified them with 83% sensitivity. An equal number of patients who did and did not develop ALF had alkaline phosphatase levels greater than 2 × ULN. An algorithm based on AST level greater than 17.3 × ULN, TBL greater than 6.6 × ULN, and AST:ALT greater than 1.5 identified patients who developed ALF with 82% specificity and 80% sensitivity. CONCLUSIONS When applied at DILI recognition, the nR criteria for Hy's Law provides the best balance of sensitivity and specificity whereas our new composite algorithm provides additional specificity in predicting the ultimate development of ALF.

Oral and general health-related quality of life in patients treated for oral cancer compared to control group.

BACKGROUND Health-related quality of life (HRQoL) is gaining importance as a valuable outcome measure in oral cancer area. The aim of this study was to assess the general and oral HRQoL of oral and oropharyngeal cancer patients 6 or more months after treatment and compare them with a population free from this disease. METHODS A cross-sectional study was carried out with patients treated for oral cancer at least 6 months post-treatment and a gender and age group matched control group. HRQoL was measured with the 12-Item Short Form Health Survey (SF-12); oral HRQoL (OHRQoL) was evaluated using the Oral Health Impact Profile (OHIP-14) and the Oral Impacts on Daily Performances (OIDP). Multivariable regression models assessed the association between the outcomes (SF-12, OHIP-14 and OIDP) and the exposure (patients versus controls), adjusting for sex, age, social class, functional tooth units and presence of illness. RESULTS For patients (n = 142) and controls (n = 142), 64.1% were males. The mean age was 65.2 (standard deviation (sd): 12.9) years in patients and 67.5 (sd: 13.7) years in controls. Patients had worse SF-12 Physical Component Summary scores than controls even in fully the adjusted model [β-coefficient = -0.11 (95% CI: -5.12-(-0.16)]. The differences in SF-12 Mental Component Summary were not statistically significant. Regarding OHRQoL patients had 11.63 (95% CI: 6.77-20.01) higher odds for the OHIP-14 and 21.26 (95% CI: 11.54-39.13) higher odds for OIDP of being in a worse category of OHRQoL compared to controls in the fully adjusted model. CONCLUSION At least 6 months after treatment, oral cancer patients had worse OHRQoL, worse physical HRQoL and similar psychological HRQoL than the general population.

Quality of life in patients with respiratory allergy is influenced by the causative allergen.

OBJECTIVE We aimed to analyze health-related quality of life (HRQOL) in adults with newly diagnosed respiratory allergy according to the sensitization profile for relevant aeroallergens in their usual area of residence. METHODS We performed a cross-sectional, epidemiological, observational, descriptive, multicenter study in allergy clinics in Spain. The sample comprised adults diagnosed with rhinitis, asthma, or both caused by significant allergens in their residential area (olive and/or grass pollen or house dust mite). Allergic rhinitis was classified according to the Allergic Rhinitis and its Impact on Asthma guidelines; asthma was classified according to the Guía Españiola para el Manejo del Asma (Spanish Guideline on the Management of Asthma). HRQOL was studied according to the ESPRINT-15 questionnaire and Mini Asthma Quality of Life Questionnaire. Control of asthma was measured using the Asthma Control Questionnaire 5. RESULTS We studied 1437 patients. Rhinitis was the most common respiratory disease. The HRQOL of rhinitis patients was lower in those sensitized to olive pollen only and in those with combined sensitization to olive and grass pollens. HRQOL associated with rhinitis was worse in patients diagnosed with both rhinitis and asthma than in patients diagnosed with rhinitis only. Asthma patients sensitized to olive pollen or olive and grass pollens had worse HRQOL. CONCLUSIONS In our study population, the HRQOL of patients with respiratory allergies varied with the allergen responsible for symptoms. In patients with rhinitis, the presence of asthma significantly worsened rhinitis-associated HRQOL.