Assessing Preferences Regarding Healthcare Interventions that Involve Non-Health Outcomes: An Overview of Clinical Studies

Decision making in healthcare often involves decision alternatives that vary on different dimensions in conflicting ways, such as health benefits and costs. In such cases, it is not always easy to identify the best option, as a trade-off has to be made. In preference studies, patients evaluate health states or healthcare strategies reflecting this trade-off. A focus that is restricted to only health outcomes in decision making may be too narrow. Patients also derive utility, or experience disutility, from healthcare processes themselves. A range of techniques is available for eliciting valuations of patients for these processes and other non-health outcomes. At present, it is unclear to what extent, and how, clinical evaluation studies have taken into account non-health outcomes. We performed a systematic review of trade-off and valuation studies to assess the extent to which valuations of process and non-health outcomes have actually been elicited from patients, in what specialty areas, and what techniques were used. We identified 567 articles that addressed patients' preferences involving non-health outcomes. The main therapeutic fields were oncology (17%), gynecology/obstetrics (11%), pulmonology (11%), cardiology (7%), gastroenterology (6%), and infectious diseases (6%). There was an absolute increase from the early 1980s (a handful of studies published each year) to recent years (almost 100 publications per year). We noticed a strong increase in elicitation techniques aimed at identification of determinants of patients' preferences. The number of studies addressing preferences for medical dilemmas involving non-health outcomes is steadily increasing and covers the whole spectrum of health-related interventions across all medical fields. A diversification in application fields as well as in research methods was observed, reflecting a lack of standardization. There is a need for methodological standards and evidence-based criteria to evaluate the methodological quality and clinical validity of studies that address preferences for dilemmas involving non-health outcomes.Conjoint-analysis, Decision-making, Outcome-assessment-(health-care), Patient-preference, Utility-measurement

Continuous Postoperative Pericardial Flushing: A Pilot Study on Safety, Feasibility, and Effect on Blood Loss

Background: Prolonged or excessive blood loss is a common complication after cardiac surgery. Blood remnants and clots, remaining in the pericardial space in spite of chest tube drainage, induce high fibrinolytic activity that may contribute to bleeding complications. Continuous postoperative pericardial flushing (CPPF) with an irrigation solution may reduce blood loss by preventing the accumulation of clots. In this pilot study, the safety and feasibility of CPPF were evaluated and the effect on blood loss and other related complications was investigated. Methods: Between November 2011 and April 2012 twenty-one adult patients undergoing surgery for congenital heart disease (CHD) received CPPF from sternal closure up to 12 h postoperative. With an inflow Redivac drain that was inserted through one of the chest tube incision holes, an irrigation solution (NaCl 0.9% at 38 °C) was delivered to the pericardial cavity using a volume controlled flushing system. Safety aspects, feasibility issues and complications were registered. The mean actual blood loss in the CPPF group was compared to the mean of a retrospective group (n = 126). Results: CPPF was successfully completed in 20 (95.2%) patients, and no method related complications were observed. Feasibility was good in this experimental setting. Patients receiving CPPF showed a 30% (P = 0.038) decrease in mean actual blood loss 12 h postoperatively. Conclusions: CPPF after cardiac surgery was found to be safe and feasible in this experimental setting. The clinically relevant effect on blood loss needs to be confirmed in a randomized clinical trial

Validation of a clinical screening instrument for tumour predisposition syndromes in patients with childhood cancer (TuPS): Protocol for a prospective, observational, multicentre study

Introduction: Recognising a tumour predisposition syndrome (TPS) in patients with childhood cancer is of significant clinical relevance, as it affects treatment, prognosis and facilitates genetic counselling. Previous studies revealed that only half of the known TPSs are recognised during standard paediatric cancer care. In current medical practice it is impossible to refer every patient with childhood cancer to a clinical geneticist, due to limited capacity for routine genetic consultation. Therefore, we have developed a screening instrument to identify patients with childhood cancer with a high probability of having a TPS. The aim of this study is to validate the clinical screening instrument for TPS in patients with childhood cancer. Methods and analysis: This study is a prospective nationwide cohort study including all newly diagnosed patients with childhood cancer in the Netherlands. The screening instrument consists of a checklist, two- and three-dimensional photographic series of the patient. 2 independent clinical geneticists will assess the content of the screening instrument. If a TPS is suspected based on the instrument data and thus further evaluation is indicated, the patient will be invited for full genetic consultation. A negative control group consists of 20% of the patients in whom a TPS is not suspected based on the instrument; they will be randomly invited for full genetic consultation. Primary outcome measurement will be sensitivity of the instrument. Ethics and dissemination: The Medical Ethical Committee of the Academic Medical Centre stated that the Medical Research Involving Human Subjects Act does not apply to this study and that official approval of this study by the Committee was not required. The results will be offered for publication in peer-reviewed journals and presented at International Conferences on Oncology and Clinical Genetics. The clinical data gathered in this study will be available for all participating centres

Clinical value of a screening tool for tumor predisposition syndromes in childhood cancer patients (TuPS)

Recognizing a tumor predisposition syndrome (TPS) in a child with cancer is of clinical relevance. Earlier we developed a screening tool to increase diagnostic accuracy and clinical efficiency of identifying TPSs in children with cancer. Here we report on the value of this tool in clinical practice. TuPS is a prospective, observational, multi-center study including children newly diagnosed with cancer from 2016 to 2019 in the Netherlands. Children in whom a TPS had been diagnosed before the cancer diagnosis were excluded. The screening tool consists of a checklist, 2D and 3D photographic series and digital assessment of these by a clinical geneticist. If a TPS was suspected, the patient was assessed positive and referred for routine genetic consultation. Primary aim was to assess the clinical value of this new screening tool. Of the 363 included patients, 57% (208/363) were assessed positive. In 15% of patients (32/208), the 2D photographic series with (n = 12) or without (n = 20) 3D photographs were decisive in the positive assessment. In 2% (4/208) of positive assessed patients, a TPS was diagnosed, and in an additional 2% (4/208) a germline variant of uncertain significance was found. Thirty-five negatively assessed patients were evaluated through routine genetic consultation as controls, in none a TPS was detected. Using the screening tool, 57% of the patients were assessed as suspected for having a TPS. No false negative results were identified in the negative control group in the clinical care setting. The observed prevalence of TPS was lower than expected, due to selection bias in the cohort.</p