Background Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions. Methods and findings We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator.
Background People’s social and economic circumstances are important determinants of their health, health experiences, healthcare access, and healthcare outcomes. However, patients’ socioeconomic circumstances are rarely asked about or documented in healthcare settings. We conducted a systematic review of published reasons for why patients’ socioeconomic contexts (including education, employment, occupation, housing, income, or wealth) should, or should not , be enquired about. Methods Systematic review of literature published up to and including 2016. A structured literature search using databases of medicine and nursing (pubmed, embase, global health), ethics (Ethicsweb), social sciences (Web of Science), and psychology (PsychINFO) was followed by a ‘snowball’ search. Eligible publications contained one or more reasons for: asking patients about socioeconomic circumstances; collecting patients’ socioeconomic information; ‘screening’ patients for adverse socioeconomic circumstances; or linking other sources of individual socioeconomic data to patients’ healthcare records. Two authors conducted the screening: the first screened all references, the second author screened a 20% sample with inter-rater reliability statistically confirmed. ‘Reason data’ was extracted from eligible publications by two authors, then analysed and organised. Results We identified 138 eligible publications. Most offered reasons for why patients’ should be asked about their socioeconomic circumstances. Reasons included potential improvements in: individual healthcare outcomes; healthcare service monitoring and provision; population health research and policies. Many authors also expressed concerns for improving equity in health. Eight publications suggested patients should not be asked about their socioeconomic circumstances, due to: potential harms; professional boundaries; and the information obtained being inaccurate or unnecessary. Conclusions This first summary of literature on the subject found many published reasons for why patients’ social and economic circumstances should be enquired about in healthcare settings. These reasons include potential benefits at the levels of individuals, health service provision, and population, as well as the potential to improve healthcare equity. Cautions and caveats include concerns about the clinician’s role in responding to patients’ social problems; the perceived importance of social health determinants compared with biomedical factors; the use of average population data from geographic areas to infer the socioeconomic experience of individuals. Actual evidence of outcomes is lacking: our review suggests hypotheses that can be tested in future research.
In the past decade, the teaching of surgery in the undergraduate curriculum has undergone considerable changes in quantity, mode and method of delivery. This is a result of the radical reforms of higher education, the health service and the undergraduate medical curriculum. The changes are complex and require us to ask the questions: how important is the teaching of surgery in the modern medical undergraduate curriculum and is there a need for change? We aim to tackle these questions and propose practical action which medical schools can take to ensure that they deliver effective surgical teaching within the modern medical curriculum and health service.
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