Not-only-a-title.

In the course of eliciting feedback on possible titles for this new journal the comments revealed a fascinating range of views on the terminology commonly used and abused in the literature. We describe here some highlights of the exploration on the meaning and the implication of the words that led to the title chosen after much deliberation. The working title used by the Editor, Marcello Tamburini, during the early planing stages of this journal was 'Quality of Life Outcomes'. When he issued invitations to join the Editorial Board, Clare Bradley replied that there was indeed scope for the kind of journal described and welcomed the initiative but expressed concern about the title as follows: I think the use of the term 'quality of life' in the title of the journal Quality of Life Research' has contributed to the confusion about the measures described within the journal. Health status measures are often referred to as quality of life measures when they are actually measuring quality of health not quality of life. There are very important differences between the two and when those differences are not recognised it can lead to erroneous conclusions. I attach a commentary that was published last year in The Lancet where I discuss these issues 1. I hope you will understand why I would not want to have a journal called 'Quality of Life Outcomes' that then included papers on health status measures, patient satisfaction etc. Having said that, I think that health status and satisfaction measures are important too and I would like to see more outlets for publishing such material. Thus, rather than narrow down the content to fit the title of 'Quality of Life Outcomes', I would prefer to broaden the title to include all such measures. 'Patient Reported Outcomes' is becoming the new well-recognised phrase in this field and this might make a good title for a journal. What do you think? The Lancet commentary attached gave the example of the UK Prospective Diabetes Study 2 as one of many that has erroneously used a health status measure, in this case the EQ-5D (also known as the EuroQoL), as if it were a measure of quality of life. When no differences were found between EQ-5D scores of participants with Type 2 diabetes who were more intensively treated on insulin and scores of those treated less intensively with oral hypoglycaemic agents or diet alone, the UKPDS researchers concluded that the therapies were neutral in their effect on quality of life 3. Clare Bradley pointed out that given the nature of the EQ-5D health status measure, in fact what had been shown was that the therapies had no differential effect on perceived health which is a very different matter. Perhaps surprisingly, more intensive treatment didn't make these patients feel any healthier. We don't know what it did to their quality of life because it wasn't measured. The problem of misinterpreting health status measures as if they were measuring quality of life continues and is not restricted to the EQ-5D. Speight has recently critiqued one of the many papers that wrongly describes the SF-36 as a measure of quality of life 4. Marcello Tamburini circulated Clare Bradley's letter and attachment to 21 Editorial Board members when asking which of four possible titles they preferred and why. The four options offered were: 1. Quality of Life Outcomes 2. Health and Quality of Life Outcomes 3. Health-related Quality of Life Outcomes 4. Patient Reported Outcomes The 16 immediate replies narrowed down the choice to options 2 and 4. A ballot was then taken among 63 experts in the field (most of them editorial board members of the new Journal). They were sent an extract from information presented as background to a symposium (May 19 2002) on Patient-Reported Outcomes to be held by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) (Table ​(Table1).1). The results of the ballot were as follows: Table 1 Background – PATIENT-REPORTED OUTCOMES 'PRO' SYMPOSIUM CONCEPTUAL AND METHODOLOGICAL ISSUES – International Society for Pharmacoeconomics and Outcomes Research Preferences and Number of Votes • Missing 10 • No preference 2 • Preferred 'Health and Quality of Life Outcomes' 33 • Preferred 'Patient Reported Outcomes' 18 Reasons for preference were requested along with votes and those reasons are interesting (Table ​(Table2).2). It appeared to be accepted that 'patient reported outcomes' would cover the intended subject matter of the journal fairly well. However, there was one notable exception – we may not wish to restrict coverage to the reports of patients but may also wish to publish work that includes reports of family members and carers, and reports of people at risk of health problems who are not currently patients. However, as Deborah Lubeck pointed out 'Some quality of life studies still include instruments that are really physician completed symptom checklists that are not patient reported'. It would be an advantage to have a title that encouraged use of patient reports. Health and Quality of Life Outcomes had its own limitations concerning coverage. It would cover health status, symptoms, and, perhaps, well being under the 'health' label as well as quality of life measures under their own banner, and these could include reports by non-patients as well as by patients. However, it seemed that certain outcomes were excluded, in particular measures of satisfaction, and this was not intended. Patient Reported Outcomes was a broader term in this respect and could include patient satisfaction. Dorothy Keininger suggested that Patient Reported Outcomes might embrace articles on utilisation and economic data and asked if the journal intended to publish such articles (it does) and she was not alone in raising this question. Thus there was concern that Patient Reported Outcomes might be too narrow in excluding non-patient community surveys, carer's reports and chart audits. Table 2 Comments on the title of the new journal It was widely recognised that 'patient reported outcomes' was a new term and would be unfamiliar to many potential readers of this new journal. The novelty was greeted with caution by some and enthusiasm by others. There was concern that the term was 'somewhat obscure' although 'becoming better recognised' and that it was 'too cryptic' while Health and Quality of Life Outcomes was more 'self-explanatory and descriptive'. Dorothy Keininger suggested that patient reported outcomes may not be understood 'outside of the circle of researchers who follow ISPOR and the FDA' (Federal Drugs Administration). In contrast there was some suggestion that 'Maybe Patient Reported Outcomes will become the new buzz word that quality of life was...' (Anne Coscarelli), and that 'Here is a chance to be on the cutting edge of a new way of thinking about outcomes that puts the patient's view first' (Carol Buckhardt). Franco Toscani expressed a clear preference for Patient Reported Outcomes, commenting 'do you remember the term palliative care? When we started using it, it looked a strange, unusual, peculiar term, and many colleagues suggested rather continuing care. History always prizes the new and difficult, not the old and comfortable. If you need work and application for making Patient Reported Outcomes understandable, clear and accepted, well, this is part of the fun!' Catherine Acquadro was equally confident of her preference for Patient Reported Outcomes (PRO) Journal. 'As Clare tells so aptly, PRO has a broader scope, and will include HRQL (Health Related Quality of Life) as well as satisfaction with treatment, health status measures, global impression, well-being etc. Moreover the term PRO is widely accepted by regulators especially by the FDA'. Marcello Tamburini declared himself to be 'lacerate' between the two titles, welcoming the familiarity of Health and Quality of Life and the word 'patient' in Patient Reported Outcomes. He observed that 'patient' occurs in the titles of only 17 of 4,600 biomedical journals included in Medline. A downside of Patient Reported Outcomes is that the term 'patient' has unfortunate and inappropriate connotations of passivity that Clare Bradley would rather avoid although others have restricted their concern to the fact that a focus on patients excludes other groups of interest. The term does, however, have advantages over the old chestnut 'subjective outcomes', the reverse of which was the much-prized 'objective outcomes' (also known as 'hard outcomes') against which 'subjective outcomes' (or 'soft outcomes') came a poor second in the typical medical mind if not the psychological one. Finally, as pointed out by John Ware in his response to the ballot, 'A noteworthy strength of 'Health and Quality of Life Outcomes' is that it recognises the crucial distinction between health and quality of life'. The majority of the Editorial Board members expressed a preference for Health and Quality of Life Outcomes. The outcomes referred to here are more specific than those encompassed by 'patient reported outcomes' and the title does not specify some outcomes that we may go on to include in the journal, such as patient satisfaction. This title has the advantage of familiarity but also makes the crucial distinction between two of the most important goals attainable – health and quality of life.