Assessing the effect of hyperbaric oxygen therapy in breast cancer patients with late radiation toxicity (HONEY trial): a trial protocol using a trial within a cohort design

BACKGROUND: Breast cancer treatment with radiotherapy can induce late radiation toxicity, characterized by pain, fibrosis, edema, impaired arm mobility, and poor cosmetic outcome. Hyperbaric oxygen therapy (HBOT) has been proposed as treatment for late radiation toxicity; however, high-level evidence of effectiveness is lacking. As HBOT is standard treatment and reimbursed by insurers, performing classic randomized controlled trials is difficult. The "Hyperbaric OxygeN therapy on brEast cancer patients with late radiation toxicity" (HONEY) trial aims to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the trial within cohorts (TwiCs) design. METHODS: The HONEY trial will be conducted within the Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaluation (UMBRELLA). Within UMBRELLA, breast cancer patients referred for radiotherapy to the University Medical Centre Utrecht are eligible for inclusion. Patients consent to collection of clinical data and patient-reported outcomes and provide broad consent for randomization into future intervention studies. Patients who meet the HONEY in- and exclusion criteria (participation ≥ 12 months in UMBRELLA, moderate/severe breast or chest wall pain, completed primary breast cancer treatment except hormonal treatment, no prior treatment with HBOT, no contraindications for HBOT, no clinical signs of metastatic or recurrent disease) will be randomized to HBOT or control group on a 2:1 ratio (n = 120). Patients in the control group will not be informed about participation in the trial. Patients in the intervention arm will undergo 30-40 HBOT treatment sessions in a high pressure chamber (2.4 atmospheres absolute) where they inhale 100% oxygen through a mask. Cohort outcome measures (i.e., physical outcomes, quality of life, fatigue, and cosmetic satisfaction) of the HBOT group will be compared to the control group at 3 months follow-up. DISCUSSION: This pragmatic trial within the UMBELLA cohort was designed to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the TwiCs design. Use of the TwiCs design is expected to address issues encountered in classic randomized controlled trials, such as contamination (i.e., HBOT in the control group) and disappointment bias, and generate information about acceptability of HBOT. TRIAL REGISTRATION: ClinicalTrials.gov. NCT04193722 . Registered on 10 December 2019

The change in capacity and service delivery at public and private hospitals in Turkey: A closer look at regional differences

<p>Abstract</p> <p>Background</p> <p>Substantial regional health inequalities have been shown to exist in Turkey for major health indicators. Turkish data on hospitals deserves a closer examination with a special emphasis on the regional differences in the context of the rapid privatization of the secondary or tertiary level health services.</p> <p>This study aims to evaluate the change in capacity and service delivery at public and private hospitals in Turkey between 2001-2006 and to determine the regional differences.</p> <p>Methods</p> <p>Data for this retrospective study was provided from Statistical Almanacs of Inpatient Services (2001-2006). Hospitals in each of the 81 provinces were grouped into two categories: public and private. Provinces were grouped into six regions according to a development index composed by the State Planning Organisation. The number of facilities, hospital beds, outpatient admissions, inpatient admissions (per 100 000), number of deliveries and surgical operations (per 10 000) were calculated for public and private hospitals in each province and region. Regional comparisons were based on calculation of ratios for Region 1(R1) to Region 6(R6).</p> <p>Results</p> <p>Public facilities had a fundamental role in service delivery. However, private sector grew rapidly in Turkey between 2001-2006 in capacity and service delivery. In public sector, there were 2.3 fold increase in the number of beds in R1 to R6 in 2001. This ratio was 69.9 fold for private sector. The substantial regional inequalities in public and private sector decreased for the private sector enormously while a little decrease was observed for the public sector. In 2001 in R1, big surgical operations were performed six times more than R6 at the public sector whereas the difference was 117.7 fold for the same operations in the same regions for the private sector. These ratios decreased to 3.6 for the public sector and 13.9 for the private sector in 2006.</p> <p>Conclusions</p> <p>The private health sector has grown enormously between 2001-2006 in Turkey including the less developed regions of the country. Given the fact that majority of people living in these underdeveloped regions are uninsured, the expansion of the private sector may not contribute in reducing the inequalities in access to health care. In fact, it may widen the existing gap for access to health between high and low income earners in these underdeveloped regions.</p

Different patient subgroup, different ranking? Which quality indicators do patients find important when choosing a hospital for hip- or knee arthroplasty?

<p>Abstract</p> <p>Background</p> <p>Patients are increasingly expected to become active, critical consumers in healthcare. They can use comparative healthcare information presented on websites to make informed choices for healthcare providers. However, the use of this information has been limited so far. An obstacle can be that the information is not perceived as relevant by patients. Presenting only the most important quality indicators might improve the usefulness of this information. The aim of this study was to explore which quality indicators different subgroups of patients find important when choosing a hospital for total hip arthroplasty (THA) or total knee arthroplasty (TKA).</p> <p>Methods</p> <p>In this explorative, cross-sectional study, questionnaires were distributed to 265 patients who underwent or had to undergo THA/TKA. Participants were asked to rank the importance of three types of quality indicators: patient experience indicators, clinical performance indicators, and indicators about hospital services. We used random effects regression analyses to assess the relative importance of the indicators in different subgroups of patients.</p> <p>Results</p> <p>110 patients (response rate 41.5%) who underwent or had to undergo THA/TKA participated. Conduct of doctors, the presence of procedures to prevent adverse effects of thrombosis and information about the specialist area of orthopaedists were the most important patient experience indicator, clinical performance indicator and indicator about hospital services, respectively. We found a few differences between patient subgroups in the importance attached to the quality indicators.</p> <p>Conclusions</p> <p>This study provides a first insight into which quality indicators patients find important when choosing a hospital for THA/TKA, and shows that subgroups of patients differ in the value they attach to these indicators. More extended research is needed to establish the indicators that should at least be presented in succinct overviews of comparative healthcare information for patients choosing a hospital for THA/TKA.</p

Physicochemical characterization of must and wine Moscato Giallo from grapevines grown under plastic overhead cover

O objetivo deste trabalho foi avaliar a influência da cobertura de plástico sobre as características físico-químicas do mosto e do vinho da cultivar Moscato Giallo. Na safra 2006, um experimento em delineamento completamente casualizado foi realizado em vinhedo com cobertura de plástico impermeável, e sem cobertura como controle. De cada vinhedo, três microvinificações (20 L) foram elaboradas. Foram realizadas avaliações físico-químicas quanto ao: mosto – oBrix, açúcares redutores, densidade, acidez total, ácido tartárico, ácido málico e pH; e vinho – densidade, graduação alcoólica, acidez total, acidez volátil, pH, extrato seco, açúcares redutores, cinzas, I 420, compostos voláteis e minerais. O mosto das videiras cobertas apresentou maior rendimento, porém, menor concentração de açúcares pelo fato de a maturação das uvas ter-se atrasado. Como conseqüência, os vinhos do cultivo protegido tiveram menor graduação alcoólica, embora tenham sido beneficiados pela sanidade das uvas, com a redução de acetato de etila e acidez volátil. O microclima da cobertura também restringiu a concentração de alguns minerais no vinho, principalmente P e K. A cobertura beneficiou a qualidade enológica, porém requer atraso na data de colheita, para as uvas atingirem adequada maturação fisiológica e tecnológica.The objective of this work was to evaluate the plastic overhead cover (POC) effect on must and wine composition of the cultivar Moscato Giallo. In 2006 vintage, it was performed a completely randomly designed experiment, in a vineyard covered with an impermeable plastic cloth, and without covering as control. From each vineyard, three microvinification (20 L) were elaborated. Physico-chemical analysis were performed for: musts – oBrix, reducer sugar contents, density, total acidity, tartaric acid, malic acid and pH; and wines – density, alcohol degree, acidity, volatile acidity, pH, dry extract, reducer sugar contents, ashes, I 420, volatile compounds and minerals. The must of the covered vineyard presented higher yield, but lower sugar content, due to delay on ripening. As consequence, the POC wines showed lower alcohol degree, but with the benefit of a lower ethyl-acetate and volatile acidity levels. The POC microclimate also caused a decrease of some minerals (mainly P and K) in the wines. POC improved the enological quality, however, this demands delay in the harvest date to achieve the adequate physiological and technological maturation of grapes