A model for programmatic assessment in action is proposed that optimizes assessment for learning as well as decision making on learner progress. It is based on a set of assessment principles that are interpreted from empirical research. The model specifies cycles of training, assessment and learner support activities that are completed by intermediate and final moments of evaluation on aggregated data-points. Essential is that individual data-points are maximized for their learning and feedback value, whereas high stake decisions are based on the aggregation of many data-points. Expert judgment plays an important role in the program. Fundamental is the notion of sampling and bias reduction for dealing with subjectivity. Bias reduction is sought in procedural assessment strategies that are derived from qualitative research criteria. A number of challenges and opportunities are discussed around the proposed model. One of the virtues would be to move beyond the dominating psychometric discourse around individual instruments towards a systems approach of assessment design based on empirically grounded theory.
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Study goal: This study was carried out to answer the following research question: which motivation do healthy volunteers have to participate in phase I clinical trials? - Methods: A literature search was done through Google Scholar and Academic Search Premier, followed by three interviews with volunteers who had recently concluded their participation in a (non-commercial) phase I trial. - Results: Our literature search revealed mainly commercial motives for volunteers to participate in phase I clinical trials. The interviews (with volunteers in a non-commercial trial) showed that other factors may also play a decisive role, such as: (1) wish to support the investigator (2) wish to contribute to science, (3) access to more/better health care (4) sociability: possibility to relax and to communicate with other participants (5) general curiosity. Precondition is that risks and burden are deemed acceptable. - Conclusions: financial remuneration appears to be the predominant motive to participate voluntarily in a clinical trial. Other reasons were also mentioned however, such as general curiosity, the drive to contribute to science and the willingness to help the investigator. In addition, social reasons were given such as possibility to relax and to meet other people. Potential subjects state that they adequately assess the (safety) risks of participating in a trial as part of their decision process.
Aim Many long-term ostomates are ‘out-of-sight’ of healthcare, and it is unknown how ostomates deal with ostomy- related problems and how these problems affect their quality of life (QOL). The aim is to examine patient-related studies describing ostomy-related problems and their impact on the perceived QOL of long-term colostomates. Methods The electronic databases PubMed (MEDLINE), CINAHL, Cochrane Library and PsycINFO were systematically searched. All studies were included in which ostomy- specific QOL was measured using validated multidimensional instruments. Results Of the 6447 citations identified, 14 prevailingly descriptive cross-sectional studies were included. Three different validated multidimensional instruments for measuring QOL in ostomates were used (EORTC C30/CR38, MCOHQOLQO, Stoma QOL Questionnaire). All studies demonstrated that living with a colostomy influences the overall QOL negatively. The ostomy-related problems described included sexual problems, depressive feelings, gas, constipation, dissatisfaction with appearance, change in clothing, travel difficulties, feeling tired and worry about noises. Conclusion In conclusion, all 14 studies gave an indication of the impact of ostomy-related problems on the perceived QOL and demonstrated that a colostomy influences the QOL negatively. There is a wide range of ostomyspecific QOL scores, and there seem to be higher QOL scores in the studies where the MCOHQOLQO instrument was used. The MCOHQOLQO and the Stoma QOL Questionnaire gave the most detailed information about which ostomy-related problems were experienced. This review adds knowledge about the impact of stoma-related problems on QOL of long-term ostomates, but more research has to be conducted, to detect ostomy-related problems and especially possible care needs.