Palliative care was a priority issue in the Cancer Control Act enacted in 2007 in Japan, and this has resulted in efforts being made toward educational goals in clinical settings. An investigation of how descriptions of palliative care for the treatment of cancer have changed in clinical practice guidelines (CPGs) could be expected to provide a better understanding of palliative care-related decision-making. This study aimed to identify trends in descriptions of palliative care in cancer CPGs in Japan before and after enactment of the Cancer Control Act.Content analysis was used to count the lines in all relevant CPGs. We then compared the number of lines and the proportion of descriptions mentioning palliative care at two time points: the first survey (selection period: February to June 2007) and the second survey (selection period: February to December 2015). Descriptions from the CPGs were independently selected from the Toho University Medical Media Center and Medical Information Network Distribution Service databases, and subsequently reviewed, by two investigators.Descriptions were analyzed for 10 types of cancer. The proportion of descriptions in the first survey  was similar to that in the second survey .After the enactment of the Cancer Control Act, an increase was observed in the number, but not in the proportion, of palliative care descriptions in Japanese cancer CPGs. In the future, CPGs can be expected to play a major role in helping cancer patients to incorporate palliative care more smoothly. According to the Institute of Medicine in the United States, clinical practice guidelines (CPGs) are statements that include recommendations intended to optimize patient care . They arIn 1981, cancer surpassed stroke as the leading cause of death in Japan . EnactedA study reviewing 91 CPGs for nine life-threatening diseases  published between 1987 and 2002 in the United States reported that palliative and end-of-life care were seldom mentioned . HoweverIn the present study, we used content analysis of existing literature , 17 to cCancer CPGs published between January 2002 and December 2006 were analyzed. Databases from the Toho University Medical Media Center  search .Table 1DFifteen criteria were used based on those reported by Mast et al . In addiThe proportion of descriptions was calculated by dividing by the total number of lines for each criterion. Since Japanese cancer CPGs are in the same form, we adopted this method to compare quantitatively the number of descriptions of palliative care. We defined two classifications: “minimal content”, which referred to words that did not include any specific information regarding the 17 criteria, and “helpful content”, which referred to a description that included specific and useful information about the 17 criteria. If classification between “minimal content” and “helpful content” was difficult, we classified the description as “helpful content”. Descriptions were independently selected from each CPG by two investigators.These data were then compared by the two investigators, and any disagreement was resolved through discussion before the data analysis. If any discrepancies between the two investigators remained, a consensus was reached through deliberation with all study members.We evaluated the most current versions of the CPGs at the time of review in 2015 . The data were analyzed in the same manner as that in the first survey.Among 47 cancer CPGs in the first survey, 35 were excluded based on the exclusion criteria; therefore, we finally analyzed 12 CPGs for the following 10 types of cancer: esophageal, gastric, breast , colorectal, lung, liver, prostate, pancreatic, uterine, and ovarian  was very similar to that in the second (4.5%)  regarding the relationship with the Palliative Medical Society. As a result, we confirmed that there was no mention of these items in CPGs at either time point. In addition, there was no description as to whether the guideline creator was a member of the Japanese Society for Palliative Medicine.The most commonly mentioned items were “pain” and “non-pain symptoms”, whereas four of the 17 items—“spiritual issues”, “family roles and responsibilities”, “ethics, laws, and policies”, and “physician roles in advocacy and policy”—were never mentioned Fig. . “HelpfuBased on a comparison of cancer CPGs during two periods between 2007 and 2015, the number of palliative care descriptions increased as follows: 1.85-fold (from 75 to 139 lines) for “minimal content” and 1.38-fold (from 858 to 1186 lines) for “helpful content”. In addition, since the implementation of the Cancer Control Act in 2007, the number of CPGs describing “palliative care from the time when cancer is diagnosed” had increased; thus, recognition of the concept has come a long way.This development was probably influenced by the significant changes in healthcare policies regarding palliative care over the last 10 years in Japan. One of these changes was the Cancer Control Act,  which waHowever, the proportion of palliative care descriptions remained almost the same (4.4 and 4.5%). The reasons for this lack of substantial change in the proportion of descriptions are thought to be as follows: 1) there was a substantial increase in the total number of lines in CPGs, and 2) several CPGs encouraged reference to cancer pain guidelines  . In 2007From these circumstances, palliative care appears to be gaining more widespread attention. However, CPGs for palliative care are still developed independent of other cancer CPGs; no CPGs have been created by any cancer clinical society in collaboration with the Japanese Society for Palliative Medicine.The number and proportion of palliative care descriptions varied widely among the CPGs depending on the type of cancer Table . For exaOn the other hand, the CPGs for hepatocellular carcinoma (HCC) had the fewest number of descriptions regarding palliative care. About 70–80% of HCC cases are associated with chronic hepatitis B or C infection, and there is often a long asymptomatic period . TherefoIn both the 2007 and 2015 surveys, the highest number of descriptions contained “helpful content”, specifically in regard to “pain” (Fig. Since the Cancer Control Act was enacted in 2007, CPGs describing terms related to palliative care have increased, and interest in palliative care appears to be increasing.In palliative care, communication between the patient and the physician is important to understand patients’ intentions about where and how they wish to approach the end of life and whether these wishes can be carried out . In helpThis study was conducted using content analysis, with “line” used as a concrete index for the number of descriptions of “palliative care”. Although a consensus of definitions was reached among the co-investigators, there may have been some variation in the classifications. For example, for cancers with relatively gradual progression such as prostate cancer, there was often a direct mention of the “mortality rate.” Conversely, for cancers with rapid progression, such as pancreatic cancer, the use of the word “prognosis” to convey remaining time was noted. This may have resulted from different framing by investigators regarding the characteristics of cancer progression. In these instances, although mortality rate in “necrology” and prognosis in “natural history” may have similar meanings, they were counted as separate items. Thus, when a similar circumstance was expressed in two different ways, selected items may have been divided. Therefore, these variations were taken into consideration, and the results were carefully interpreted in relation to differences in the proportion of descriptions. In addition, if classification of “minimal content” and “helpful content” was difficult, it was regarded as “helpful content” This may account for the increased amount of “helpful content”. However, even when the above considerations were taken into account, a comparison between the two survey periods showed an increasing trend in the number of palliative care descriptions in the CPGs.As a method of analysis, we used “content analysis,” which is an established qualitative analysis method. Therefore, our analysis is based on only the information included in CPGs. In AGREE II, which is a popular method for evaluating CPGs, only the content of description in CPGs is checked. Therefore, there is no target of analysis other than the information described above.We considered palliative care as “care given to a patient when there is no response to curative treatment and life expectancy is less than one year” based on the content of cancer control programs, the situation in Japan in 2007, and descriptions in a previous study . AlthougAfter enactment of the Cancer Control Act, an increase was observed in the number but not in the proportion of palliative care descriptions in Japanese cancer CPGs. In the future, CPGs can be expected to play a role in helping cancer patients to incorporate palliative care smoothly by collaborating with individual clinical societies for various types of cancer and the Japanese Society for Palliative Medicine, which provides common ground.


The Pittsburgh Sleep Quality Index (PSQI) is a measure of self-reported sleep quality and sleep disturbance. Though the PSQI is widely used, it is unclear if it adequately assesses self-reported sleep disturbance in people with schizophrenia spectrum disorders. We used mixed methods to examine the relationship between scores on the PSQI and qualitative self-report during in-depth interview in a group of participants diagnosed with schizophrenia spectrum disorders (N = 15). Although the PSQI appears to accurately capture issues related to sleep initiation, average duration, and interruption by physical complaints, it did not adequately assess other salient issues including irregularity in sleep duration and timing, shallow unrefreshing sleep, prolonged sleep inertia, hypersomnia, and sleep interrupted by mental or psychological complaints. In interview by contrast these types of problems were readily reported and described as important by participants. Our findings suggest that using the PSQI summary score as a measurement of general sleep disturbance in this population may be misleading, as this failed to capture some of the types of sleep problems that are particularly common in this group. The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-reported questionnaire measure of sleep . The PSQThe PSQI was initially developed with a sample of people with depression, healthy sleepers, and people with sleep disorders . Many auThe PSQI is often used as a global measure of self-reported sleep disturbance in people with schizophrenia spectrum disorders, but the validity of the PSQI (English version) as a global measure of sleep disturbance in this population has, to our knowledge, not been evaluated. We explored the content validity of the PSQI for assessing patient-reported sleep quality and sleep disturbance in people with schizophrenia spectrum disorders.We recruited 15 adults with schizophrenia spectrum disorders, who were in contact with specialist mental health services in the United Kingdom, and had a self-reported problem with sleep initiation, maintenance, quality, timing, or refreshingness. People whose predominant complaint was of parasomnia or sleep apnea were not included, in order to focus on insomnia and circadian rhythm problems. All participants’ data are included in the current analysis. Written informed consent was obtained after participants reviewed the participant information sheet and had sufficient opportunity for further explanation or questions. Ethical approval was obtained through the NHS Research Ethics Committee Proportionate Review Service (14/NS/1085).Demographic data were collected, and symptoms and functioning were rated using the Global Assessment of Functioning (GAF) split version (GAF-F and GAF-S). Participants completed the PSQI and were invited to report their experience as they went through the questionnaire; this was followed by an in-depth interview that further explored their sleep experiences and complaints see . The useTranscription noted long pauses and we made field notes on nonverbal expressions . Analysis was facilitated by Nvivo , creating an audit trail, and ensuring themes were linked back to the data. Transcript content was coded in relation to the PSQI question each section related to, and in relation to emergent themes and subthemes from in-depth analysis of participant interviews. The qualitative analysis used a framework approach, and samples of the data were independently analyzed by a second researcher to enhance reliability. The mixing of methods was approached through qualitization of individual PSQI component scores, and summarizing and classification of the sleep problems described in interviews, to facilitate comparison of component and total PSQI scores, with the clinical presentation as described in each participant’s qualitative account .Fifteen participants were recruited, including acute inpatients (n = 2), outpatients receiving intensive (daily) support (n = 3), those under Community Mental Health Teams n = 8), and under outpatient clinic only (n = 2); none were currently in paid employment. There were 10 males and 5 females, with a mean age of 45.9 (SD = 10.55), diagnosed with schizophrenia (n = 8), schizoaffective disorder (n = 6), and delusional disorder (n = 1). All were prescribed either one (n = 8) or two antipsychotics (n = 7); dosages as a fraction of defined daily doses Hypersomnia was seen as a potential health concern, and a cause for negative self-concept:“you’re lazy … you’re wasting your life away” (r12).Participants who described a large amount of nightly variation found average sleep duration difficult to calculate accurately:“sometimes [waking up] will be 6 o’clock for like three weeks, but very rarely it’s 11 o’clock [ … ] if I’m feeling too enthusiastic I’ll be awake all night because of the excitement from the day [ … ] yeah so it asks for a fixed time, but it’s quite hard to estimate, it varies a lot” Seven of the 15 participants tried to give ranges, which were sometimes several hours apart; three participants described nights of getting almost no sleep at all, followed by very long sleep when they did eventually sleep. These participants’ mean total sleep time did not capture this issue as the very long and very short sleep times were averaged to a normal duration. Some distinguished “actual sleep” from light sleep/partial sleep, so were unsure how best to respond. Some answers weren’t internally consistent . It should be acknowledged that the latter of these issues could affect many retrospective self-report measures.It is important also to note that daytime naps are not included within the sleep duration total, and for over half in this sample (eight participants), naps were a significant source of sleep:“Respondent: [ … ] I always go to sleep in the afternoonInterviewer: Most days?Respondent: Yeah I’d say every day.Interviewer: How long for?Respondent: One and a half to two hours” Other participants described 3- or 4-h naps; hence, the PSQI total sleep time question missed roughly half of their actual total sleep for that day.Average sleep timings are measured by the PSQI, but do not contribute directly to the score. The times recorded give useful information for clinicians on circadian preference or social commitments when sleep timing is regular; in this group, however, times varied and averages may be less meaningful. This variability may have been missed altogether if times were averaged by participants without comment. Dissatisfaction with sleep timing, and unpredictability of sleep timing, were significant sources of dysfunction and distress in participant accounts; participants described the impact on their ability to take on work, education, or social commitments. Satisfaction with or regularity of sleep timing is not part of the PSQI scoring so a problem with sleep timing does not directly impact the score.Sleep latencies reported in answering the PSQI and in interview were similar. While it is interesting that some participants had long sleep latency  and were untroubled by this, this constitutes a quantitative aspect of their sleep disturbance, which is accurately summarized by the PSQI.It is not clear how decisions were made regarding what are considered normal frequencies for some of the listed types of sleep disturbance, resulting in floor and ceiling effects. Participants who described “problems” with going to the bathroom at night went several times per night, the highest option to select being ×3 per week. Someone who woke to use the toilet twice a week explained that they felt this was probably less than most people. With regards to the impact of bad dreams, it seemed that frequency of bad dreams bore limited relation to the distress caused; in this sample, no one endorsed 3× per week, but some described less frequent but intense bad dreams causing significant distress, which was not well captured:“Oh jeeze I’m always having bad dreams … I’d say maybe twice a week.” (r12)Significantly, in interview the vast majority of the sample complained of problems with poor sleep maintenance and depth, in terms of “broken” sleep, sleep that was “not deep,” or was not “proper sleep”; however, the average score for sleep disturbance was 1.0 . This can largely be attributed to the aggregation of scores from physical and psychological causes of sleep disturbance where there are more physical causes listed. It was noted that sleep, which was disturbed by a wide range of causes, scored higher than sleep very often disturbed, but generally by the same cause. Comparison of individual accounts and sleep disturbance scores showed that sleep that felt broken, but without a complete awakening, did not readily translate to a high score for “sleep disturbance.”Although perhaps a trivial matter, the phrasing of this question proved problematic for well over half of participants, causing a pause in completion and questions regarding either the first part or both parts of this question:“…but what does that mean, how often during the past month have you had trouble sleeping because of this, because of what?” (r10)It was also noted that this question rarely elicited information, as participants brought up many “other reasons” in interview , but wrote “N/A” on the PSQI. This may contribute to the unusually low scores for sleep disturbance, as these “other reasons” were not scored.The PSQI asks about trouble staying awake “while driving, eating meals, or engaging in social activity”; this question appeared not to be sensitive to sleepiness in those who did not drive and socialized infrequently:“My sleep’s a bit spontaneous, my body don’t plan it [ … ] I’m always falling asleep watching films [ … ] but no, I’m trying to think now how often I do a social activity, it’s less than once a week isn’t it. So it’s less than once a week isn’t it falling asleep.” Many asked if falling asleep in front of the television counted, and some then answered yes for this question.The other question concerns “enthusiasm to get things done”; some noted they had difficulty with enthusiasm due to mood or psychotic symptoms, rather than their sleep. Daytime dysfunction questions did not pick up on the impact on daytime functioning, where participants were napping or sleeping for excessive periods to counter tiredness:“I’m really fed up because I’d like to get out and do things instead of sleeping the days away” “It can be as short as half an hour or as long as two hours [ … ] I go to sleep because I’m tired in the day time, not because I’m bored.” Sleep inertia and difficulty waking were also major complaints discussed by participants within the current study (n = 6 of 15). These should be detected as a form of daytime dysfunction; however, half of those expressing this complaint scored 0 for daytime dysfunction see 2.Sleep efficiency has been found to be lower on average in groups with schizophrenia ; in thisInterestingly, over half of participants rated quality as very good (0) or fairly good (1), but went on to state significant concerns with their sleep and its impact on their life, including that their sleep was not restorative, that their poor sleep pattern was a barrier to getting a job, or that their sleep was “medicated sleep” and therefore substandard:“[If I wasn’t on medication] That I’d actually sleep, yeah. And I think I’d be able to do more things as well, you know, in the day, if I wasn’t on the medication, sometimes, if I managed to get natural sleep.” For some, there seemed to be a direct contradiction between self-reported “sleep quality” on the PSQI and their view of their sleep during interview:“Interviewer: …how would you describe your sleep, if you were sort of telling someone about it?Respondent: Umm, not very good.Interviewer: No?Respondent: No. Not like other people … go on like sleep’s supposed to be, you know?Interviewer: What?Respondent: Like, when they say have a nice sleep and you’ll feel refreshed and all this nonsense.Interviewer: They say that.Respondent: Yes, and I don’t feel like that.Interviewer: No.Respondent: I feel like, jeez, what’s happened?” In the context of the rest of the analysis , this caThe present sample’s highest scoring domain was use of sleeping medication. This did not, however, represent high levels of hypnotic use in this sample; in six out of seven of those scoring 3 (highest), their answer related to their oral antipsychotic being “sleeping medication” . Some described in interview using their antipsychotic to control their sleep onset, but answered “never” to this question on the PSQI, and some raised the dilemma of whether their antipsychotic counted or not. Answers were therefore dictated by semantic interpretation rather than any meaningful differences between perceptions or behaviors.difficulty breathing:The PSQI includes questions regarding snoring or breathing among its sleep disturbance questions, and also a section for completion by the person’s bed partner/roommate to screen for sleep disordered breathing, in acknowledgement of people’s reduced awareness of their own breathing during sleep. Participants in this study did endorse snoring, but rarely endorsed “cannot breathe comfortably,” rather clarifying that they breathed heavily, not had “…cause I’m a big lad as well so when I’m lying down … I’d say not it’s hard to breathe but I breathe heavily.” .It was never designed as such, and it is important that the PSQI is not considered to be an effective screening for sleep disordered breathing, particularly without the bed partner/roommate questions being completed.The total PSQI scores indicated that seven participants were either good sleepers or had only mild sleep problems . Of these seven, four described significant and severe concerns during interview, while the other three described milder but definite problems. Of those whose PSQI scores suggested moderate or severe problems (score 8–18), the global impression from the interview was also of moderate or severe problems.The sample reported multiple and complex problems with sleep initiation, continuity, quality, and timing, with attendant daytime dysfunction; the PSQI was capable to assess some, but not all, of these issues. The PSQI appeared to be suitable for identifying self-reported short sleep, long sleep latency, or complete awakenings during the night, but poorly represented some other problems such as variable and inconsistent sleep length, poor sleep depth or quality, increased sleep inertia, hypersomnia, and inappropriate or inconsistent sleep timing. While issues with sleep timing are beyond the intended scope of the PSQI, sleep duration, quality, and daytime dysfunction are within its scope and were poorly captured. Furthermore, it is common for total PSQI scores to be treated as a global measure of sleep disturbance, which these findings suggest is not valid. Reliance on total PSQI score as a measure of sleep dysfunction is particularly inappropriate for those with schizophrenia spectrum disorders whose sleep problems include more circadian dysregulation than other groups , and whoAs some participants feared, both excessively short and excessively long sleep are indeed associated with increased mortality , and it Participant PSQI scores were similar to those from research with the Japanese version of this instrument in a similar sample , where sInsufficient detection of problems with sleep depth is significant particularly for this population, for whom levels of shallow sleep (stage 1) are often elevated, and deeper sleep (Stage 2 and Stage 3 non-REM sleep) is often reduced . AlthougOur findings are consistent with those of Waters et al.  who founFor current clinical practice, supplementary questions or additional measures should be used when using the PSQI as a screening for sleep problems. For instance, the PSQI should not be relied upon to screen for sleep disordered breathing; a ready alternative is the STOP-Bang questionnaire, which has been found to be reasonably accurate in detection  and is fWhether for research or clinical outcome measurement for quality improvement, the findings of the present study caution against relying on the PSQI total score alone, as improvements in sleep timing or regularity  may go undetected. There are more recently developed tools, including the PROMIS sleep dysfunction item bank , and theThese tools, however, are designed to measure change for research or clinical outcome measurement; they do not simultaneously help to characterize the sleep problem—as might be desired by a clinician. And in this respect, they do not replace the PSQI. Asking the patient to specify sleep latency, sleep times, and causes of sleep disturbance, as the PSQI does, can help identify the problem and therefore direct treatment. Unfortunately, the PSQI alone is likely to give an incomplete and sometimes misleading picture, in the case of people with schizophrenia spectrum disorders, and possibly many other groups.The generalizability of the findings from a small sample might be questioned, although as the types of problems described are similar to those found in larger samples studied using quantitative methodologies, we believe these findings are transferable. Although the diversity in the type and extent of problems is potentially representative of the diverse problems experienced in this group, it also limits the number of cases with each particular type of problem . Furthermore, diversity in the environmental context of the participants, particularly the inclusion of both inpatients and outpatients, complicates interpretation. It would also have been useful to find out the approximate length of time since diagnosis, and length of time on antipsychotic medication, to better describe the sample and facilitate comparison with other studies. In hindsight, it would also have been useful if participants had been asked to comment on the recommended interpretation of their component or total PSQI scores , which might have provided a further point of reference.This study did not set out to make statistical analysis of sensitivity or specificity, but these findings suggest a hypothesis of too low sensitivity, and missed cases, but no issues with overdetection. Future studies comparing PSQI to other measures such as actigraphy or polysomnography might confirm or quantify this, and could further examine which types of problem are underdetected in a larger sample. More detailed description of the weaknesses this study has highlighted would support improved interpretation of the considerable body of important work, which has used the PSQI to describe their sample or to measure change.Our analysis demonstrates that the PSQI is insensitive to some sleep issues, which are described as important to people with schizophrenia spectrum disorders. This disparity between the range of issues highlighted in our interviews and those covered by the PSQI may suggest a need for a disease-specific measure to achieve high sensitivity to the particular problems of this group. Another possibility is the development of a measure of sleep disturbance, which can equally measure sleep problems of circadian, insomniac, or combined cause and nature, which could be used trans-diagnostically. A future measure could attempt also to take into account different environmental contexts; for instance, in many institutional settings, patients may more commonly go “to bed” far in advance of intending to sleep, as their bedroom may be the only private space in which to wind down for sleep. This can lead to underestimation of sleep efficiency, as has previously been noted in relation to sleep diaries ; and altThe PSQI is of course not unique among self-report measures in being affected by participants calibrating some of their responses in relation to their own context and peer group, as we found here regarding rating of sleep quality. Similar findings of peer group-dependent evaluations were presented by Adamson et al.  regardin“Mrs K: Oh, I suppose for my age my health is excellent., I mean to say, it wasn’t until I went up for the assessment I knew there was anything wrong with my heart” This context-dependent evaluation may equally measure a difference in a person’s perceived peer group, as much as based on a change in self-perceived sleep, and makes it difficult to use exclusively self-evaluated items to compare between populations. It may therefore be desirable to include some quantitative self-report elements, which are more influenced by the individual’s perception of their sleep than contextual factors.Future research should develop a valid and reliable tool, with a similar shared utility for both clinicians and researchers as the PSQI has uniquely offered; this shared utility no doubt facilitates understanding between clinicians and researchers, and accounts for its enduring popularity. The authors suggest the development of a new measure that can act as a clinical screening and initial interview, and as an outcome measure in research.Ethical approval was obtained through the NHS Research Ethics Committee Proportionate Review Service (14/NS/1085), North of Scotland Research Ethics Committee 1. Written informed consent was obtained after participants reviewed the participant information sheet and had sufficient opportunity for further explanation or questions. A disclosure or risk protocol and a distress protocol were followed during data collection, and information sharing with care providers was discussed with participants in advance .SF designed and conducted the study, collected and analyzed the data, and wrote the first draft of the manuscript. SF and CS-G were involved in editing, conceptual formulation, and discussion of the findings and implications of the study.This work was supported by the National Institute of Health Research (NIHR), through funding support received independently by SF and CS-G during completion of this study. The NIHR had no direct involvement in study design, conduct, or dissemination.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.