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.

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: Reasons for preference were requested along with votes and those reasons are interesting (Table 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.
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 (http://www.ispor.org > Meetings > Past > Other Meetings onferences) Data to evaluate the efficacy or effectiveness of treatment can come from a variety of sources, including laboratory tests, clinician evaluation, and the patients themselves. In the outcomes research community, the term "patient-reported outcomes (PRO)" is used to refer to a host of outcomes that can be provided only by the patient. Examples of these outcomes include symptom severity, perception of daily functioning, feelings of well being, global impressions of the impact of treatment on daily life, satisfaction with treatment, and health-related quality of life. The role that PROs can and should play in evaluating the efficacy of pharmaceuticals and medical devices and the means by which these outcomes are communicated to clinicians and consumers are subjects of much discussion and debate. Over the past 2 years, representatives from ERIQA 1 , ISOQOL 2 , ISPOR 3 , and PhRMA HOC 4  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, wellbeing 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. Unfortunately, I have to say that I do not like any of the two titles. I do not like the first, because it is too much focused on qol, and you know that in respiratory medicine we prefer the term Health Status Assessment. I do not like the second, as it is too cryptic. However, considering the messages you forwarded to me, I agree that probably choosing PRO (or something similar and less cryptic) could probably represent a good strategy.
Mauro Carone, MD "Salvatore Maugeri" Foundation Institute for Care and Research Division of Respiratory Disease Veruno (NO), Italy The title will depend to some extent on the type of papers you are looking for. One way of thinking about it is that 'health' provides the most narrow account, 'quality of life' a broader account, and 'patient reported outcomes' the broadest. I actually have a preference for the latter because it: a. includes positive consequences of illness -something that is missed from the QOL literature b. includes symptom reporting which is sometimes in and sometimes out of QOL reporting though often in health reporting. However, I do not have strong feelings on this. There is a theoretical rationale which could be built up that goes beyond Clare Bradley's paper -the words reflect an underlying reality that may be important. But that is another story. Patient reported outcomes is wider and may be more relevant to today's needs. The second title (Patient Reported Outcomes) is very trendy, mostly in USA where the acronym PRO is very common. I agree with you that the inclusion of the word "patient" is certainly an advancement in respect to the old concepts (and words). In addition, it may enable us to enlarge the concepts from health-related to non health-related measures, as in the field of PRO measures we are supposed to include also "out of skin measures". Do we want that? Another cons may be the fact that very soon we ought move from "patients" to "consumers" or "citizens" as preferential point-of-view, thus making non-politically correct and obsolete the title... On the other hand, I am not fully satisfied with the first Title "Health and Quality of Life Outcomes", but to be honest with you and with the other authoritative members of the Editorial Board(s), I was not able to come out with an alternative. Giovanni Apolone, MD Istituto Mario Negri, Milan, Italy I think "Patient Reported Outcomes" is much stronger, and am surprised that no one has taken it yet. I think it allows for some evolution in how we think about subjective report, epidemiology and clinical trials. A strength of both titles is that they include "Outcomes," although I am often asked what are outcomes and outcomes of what? Patient reported outcomes has the advantage of being broader than health and opening the possibility of patient satisfaction and other outcomes. A disadvantage of "patient reported outcomes" is that there is great interest, at least in the US, in "consumers" regardless of whether or not they are "patients" in the traditional sense. Another disadvantage of PRO is that "reported" implies a distinction from "evaluated," which are sometimes intended to convey more objective and more subjective, respectively. That is one reason some of us use "assessed" to include both. For me, "patient reported" is much too specific to a particular methodology to be the title of a journal. A noteworthy strength of "Health and Quality of Life Outcomes" is that it recognizes the crucial distinction between health and QOL and, again, it has the word "Outcomes." I believe that QOL in the broadest sense will become increasingly important in health care and as the field moves more and more in the QOL direction as it focuses on the entire economy and not just the health care segment. Hence, I like seeing it in the title, although the journal would have a major task in defining it and setting a good example with regard to the proper use of the term. We already have "Quality of Life Research." What would be different in this new "QOL" journal? Will the new journal be more applications oriented? The answer may have implications for the title. 1. It may be a bit long BUT 2. It address your feelings about "patients"; 3. It includes "health outcomes" [i.e., health status, patient satisfaction, and others]; 4. It includes "quality of life" which a number of respondents felt was appropriate and necessary; 5. While "patient reported outcomes" may be becoming better recognised, in addition to being considered relevant from a policy point of view, the term is also probably somewhat obscure to many potential readers, subscribers, and even authors. If adding "patient" to "Health and Quality of Life Outcomes" makes the title too long, my preference would be for "Health and Quality of Life Outcomes" because I think it is both more self-explanatory and descriptive than "Patient Reported Outcomes" and it broadens the title focus to include many different kinds of measures.
Neil The reason I like 4 is that I think the focus should be on patient reported outcomes and that allows a little more breadth. Some quality of life studies still include instruments that are really physician completed symptom checklists, that are not patient reported. However, if you wish quality of life in the title, then I think the health and quality of life does still allow more breadth and deals with some of the concerns addressed in the attachment you forwarded. I do think that many patient based outcome studies do focus more on health status, but that does not limit their value to our community of researchers. I am inclined to agree that 1 is going to be more familiar to potential readers. I also think it is broad enough to encompass patient reported outcomes. I vote for #1! Deborah P. Lubeck, PhD Adjunct Professor, Department of Urology Director Urology Outcomes Research Group UCSF Comprehensive Cancer Center University of California San Francisco I also liked seeing the word "patient," but I would go with the other title (#1) because it is more accurate. QL studies typically have a clinical status parameter; it seems essential.
Barrie Cassileth, Ph.D. Director Integrative Medicine Service Memorial Sloan-Kettering Cancer Center New York, USA I believe that this is a difficult decision for you -Health and Quality of life Outcomes is a clear and obvious title for the journal but increasingly the cognoscenti talk of patient reported outcomes. Trouble is -will clinicians who have only just come to terms with QoL understand that patient reported outcomes is essentially the same thing ? Another problem is that My preference for the journal title would be "Health and Quality of Life Outcomes". My concern with "Patient Reported Outcomes" is that it may be too narrow in scope, for two reasons. First, as one of the board members pointed out, papers might be published that include clinician-reported measures, chart audit data, and so forth. Second, health status measures are used to survey people who might not be considered "patients" in a traditional sense (e.g., general community surveys, studies of people exposed to environment toxins, etc.). Thus, I prefer what I would consider to be a broader title. Barbara Gandek Health Assessment Lab Boston, Massachusetts, USA I prefer the Health and Quality of Life Outcomes over patient reported outcomes. I don't believe that patient reported outcomes will be understood outside of the circle researchers who follow ISPOR and the FDA. It does not seem to be a term accepted in Europe and I believe it is a very broad term which may include many patient reported outcomes which will not be covered in your journal. (I could be wrong -are you also going to publish articles on utilization and economic data?) Dorothy L Keininger, MS, BS Pharm Mapi Values, Boston, MA, USA I prefer "Health and Quality of Life Outcomes" for two reasons: a) It joins the concept of health with the concept of quality of life, giving the possibility of new developments; b) it is very important that "quality of life" is in the title of the journal. Quality of life is both a technical concept (measurement, symptoms and so on) and a philosophical one. That is a noble "double sense", that, in my opinion, should be preserved. Amedeo Santosuosso Judge, Court of Milan, Italy "Patient Reported Outcomes" will appeal to the FDA-attention seekers, if that's what they want. The term has a funny little story behind it, but it's actually a good one that covers more than QoL (satisfaction, preference, etc). Either choice is a good one. remember that after you finally make it. I can make a case either way, but in the end my sense is that those who articulated their reasons for the title: "Health and Quality of Life Outcomes" were more persuasive (especially Ruth McCorkle). In the end, I think the term "patient reported outcomes" will feel more limiting than it feels today, as it is still new. "Health and Quality of Life Outcomes" is a more-established title that has obvious meaning and recognition to many.
David  My preference is Health and Quality of Life Outcomes, for 3 reasons: (1) "patient" is a limiting word -there are many health issues which concern people who are not patients; (2) you may not wish to limit the journal to only patient reported outcomes; (3) not everyone will readily understand the meaning of the term "patient reported outcomes," but you will have no such problem with "health and quality of life outcomes. Although it seems a little out of the ordinary, that is one of the reasons I support it. 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 Burckhardt, PhD Professor of Nursing Asst. Professor of Medicine (Research) Oregon Health Sciences University Portland, OR, USA I prefer Patient Reported Outcomes Journal because seems to me more appropriate to describe the large interests of the issues related with the subjective evaluation made by patients. In the future probably patients will be substitute with consumers. My preference would be #2 since it covers both health outcomes (non qol) and qol outcomes. Paola Mosconi, Istituto Mario Negri, Milan, Italy A. Consider for the title of the publication something like: 1. Health and Quality of Life Outcomes 2. Health-Related Quality of Life Outcomes [Justification: You might want more of an emphasis on health as the focus of the journal as opposed to other indicators of QOL e.g., social, economic, environmental, etc. Not that those aren't equally important, but perhaps just not the focus of your journal.] Clare Bradley raises important points about the fine distinction between health status measures and quality of life measures. I also understand your dilemma in terms of the title. I believe that Patient Reported Outcomes, although perhaps timely, is more suggestive of a clinical orientation that includes measuring the effects of medical interventions on health. If the intent of the journal is to provide a forum for exactly that, then PRO is probably appropriate. I'm not sure, however, that a section on population health assessment would necessarily be appropriate for a publication that focuses on patient-reported outcomes. Nonetheless, if the focus will be on clinical care outcomes, then the focus on PRO is probably both timely and appropriate. If, on the other hand, you want to broaden the scope beyond patients (i.e., the general population), something other than Patient Reported Outcomes would probably be better. I believe it comes down to what you foresee as the focus of the journal -will it be a forum for the clinical community, a forum for public health researchers and social scientists; or for both. If the first, PRO as a title would probably work; if the second or third, better yet, Health & QOL Outcomes.