Essential variables for reporting research studies on fetal growth restriction: a Delphi consensus.

OBJECTIVE: To determine, by expert consensus using a Delphi procedure, a minimum reporting set of study variables for fetal growth restriction (FGR) research studies. METHODS: A panel of experts, identified based on their publication record as lead or senior author of studies on FGR, was asked to select a set of essential reporting study parameters from a literature-based list of variables, utilizing the Delphi consensus methodology. Responses were collected in four consecutive rounds by online questionnaires presented to the panelists through a unique token-secured link for each round. The experts were asked to rate the importance of each parameter on a five-point Likert scale. Variables were selected in the three first rounds based on a 70% threshold for agreement on the Likert-scale scoring. In the final round, retained parameters were categorized as essential (to be reported in all FGR studies) or recommended (important but not mandatory). RESULTS: Of the 100 invited experts, 87 agreed to participate and of these 62 (71%) completed all four rounds. Agreement was reached for 16 essential and 30 recommended parameters including maternal characteristics, prenatal investigations, prenatal management and pregnancy/neonatal outcomes. Essential parameters included hypertensive complication in the current pregnancy, smoking, parity, maternal age, fetal abdominal circumference, estimated fetal weight, umbilical artery Doppler (pulsatility index and end-diastolic flow), fetal middle cerebral artery Doppler, indications for intervention, pregnancy outcome (live birth, stillbirth or neonatal death), gestational age at delivery, birth weight, birth-weight centile, mode of delivery and 5-min Apgar score. CONCLUSIONS: We present a list of essential and recommended parameters that characterize FGR independent of study hypotheses. Uniform reporting of these variables in prospective clinical research is expected to improve data quality, study consistency and ultimately our understanding of FGR. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

Health-related problems in adult cancer survivors: development and validation of the Cancer Survivor Core Set.

PURPOSE: Improved survival rates from cancer have increased the need to understand the health-related problems of cancer treatment. We aimed to develop and validate the "Cancer Survivor Core Set" representing the most relevant health-related problems in adult cancer survivors using the International Classification of Functioning, Disability, and Health (ICF). METHODS: First, a Delphi study was conducted to select ICF categories representing the most relevant health-related problems. There were three Dutch expert panels, one each for lung, colorectal, and breast cancer. Each panel comprised lay experts and professionals. The experts reached within- and between-panel consensus in two rounds (≥70 % agreement). Second, a validation study was performed. Generic cancer survivorship questionnaires assessing health-related problems or quality of life among cancer survivors were selected. Items of selected questionnaires were linked to the best-fitting ICF category and to the selected ICF categories from the Delphi study, respectively. RESULTS: In total, 101 experts were included, of which 76 participated in both rounds, reaching consensus on 18 ICF categories. The Distress Thermometer and Problem List, the Impact of Cancer (v2), and the Quality of Life in Adult Cancer Survivors questionnaires were selected for the validation study, which led to the inclusion of one additional ICF category. CONCLUSIONS: The developed Cancer Survivor Core Set consisted of 19 ICF categories representing the most relevant health-related problems in adult cancer survivors: five from the "body functions and structures" component, eight from the "activities and participation" component, and six from the "environmental factors" component. HIGHLIGHTS: • Many adult cancer survivors have persistent health-related problems. • The Cancer Survivor Core Set was developed using the Delphi method. • The patients' perspectives were prioritized in this Delphi study • Content validity was confirmed by validated cancer survivorship questionnaires. • The Cancer Survivor Core Set may help optimize care for cancer survivors.

Impact of integration of clinical and outpatient units on cancer patient satisfaction.

OBJECTIVE: There is an ongoing drive to measure and improve quality of care. Donabedians' quality framework with structure, process and outcome domains provides a useful hold to examine quality of care. The aim of this study was to address the effect of an intervention in hospital structure (integration of three units into one) with the purpose of improving processes (increase meeting, cooperation and communication between professionals and patients) and its effect on the outcome (cancer patient satisfaction). DESIGN: Pre-test-post-test. SETTING: University Medical Center Utrecht, The Netherlands, Department of Medical Oncology. PARTICIPANTS: Cancer patients (n = 174, n = 97). INTERVENTIONS: Physical integration by bringing separately located units (outpatient clinic, day-care clinic, clinical ward) together in one wing of the hospital and adjustments in communication and coordination structures. MAIN OUTCOME MEASURE: Patient satisfaction questionnaire. RESULTS: Satisfaction with care improved for six scales (27%) after integration. Effect sizes (ESs) ranged from 0.36 to 0.80, indicating a small to moderate effect. The most important improvement was found at the day-care clinic on aspects like 'the degree in which the nurses were informed about a patients situation', 'privacy', 'interior design', 'quality of hospital equipment', 'sanitary supplies' and 'waiting periods'. With regard to continuity and coordination of care, satisfaction increased for five items (28% of items concerning continuity and coordination of care). ESs ranged from 0.42 to 0.75. CONCLUSIONS: Integration of three oncology units into one unit had a positive impact on care delivery processes and resulted in improved patient satisfaction concerning care and treatment.

Medical oncology patients' preferences with regard to health care: development of a patient-driven questionnaire.

BACKGROUND: To improve quality of care for cancer patients, it is important to have an insight on the patient's view on health care and on their specific wishes, needs and preferences, without restriction and without influence of researchers and health care providers. The aim of this study was to develop a questionnaire assessing medical oncology patients' preferences for health care based on their own input. PATIENTS AND METHODS: Items were generated using 10 focus group interviews with 51 cancer patients. A preliminary questionnaire was handed out to 681 patients of seven Dutch departments of medical oncology. Explorative factor analysis was carried out on the 386 returned questionnaires (response 57%). RESULTS: Focus group interviews resulted in a preliminary questionnaire containing 136 items. Explorative factor analysis resulted in a definitive questionnaire containing 123 items (21 scales and eight single items). Patients rated expertise, safety, performance and attitude of physicians and nurses as the most important issues in cancer care. CONCLUSION: This questionnaire may be used to assess preferences of cancer patients and to come to a tailored approach of health care that meets patients' wishes and needs.