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Gibt es entitätsspezifische Kriterien für den Beginn der spezialisierten Palliativversorgung für nicht heilbare Krebserkrankungen? Ein Scoping Review
Abstract
Zusammenfassung
Hintergrund/Ziel Patienten mit nicht heilbaren Krebserkrankungen eine spezialisierte Palliativversorgung zum richtigen Zeitpunkt anzubieten, stellt eine Herausforderung dar. Ziel des Scoping Reviews war, geeignete entitätsspezifische Kriterien zu finden.
Methode Im Februar 2020 wurde in den Online-Datenbanken PubMed und Scopus ein Scoping Review durchgeführt. Ziel der Literatursuche war die Identifikation von englisch- und deutschsprachigen Originalarbeiten, die zwischen 2009 und Februar 2020 veröffentlicht wurden und Hinweise darauf geben, welche entitätsspezifischen und entitätsunabhängigen Kriterien nicht heilbarer Krebserkrankungen herangezogen werden, um betroffene Patienten zeitgerecht in die spezialisierte Palliativversorgung zu integrieren. Insgesamt wurden 13 relevante Artikel identifiziert. Der Methode des Scoping Reviews entsprechend, wurde auf eine formale Bewertung der methodischen Qualität der eingeschlossenen Literatur verzichtet.
Ergebnisse Unter den relevanten Publikationen waren 6 Reviews und 7 Originalarbeiten. In keiner der analysierten Publikationen wurden explizit charakteristische Kriterien zu spezifischen Krebsentitäten angeführt. Für die Integration in eine spezialisierte Palliativversorgung wurden unabhängig der Krebsentität als Kriterien Unheilbarkeit/fortgeschrittenes Tumorleiden, Lebensqualität, belastende Symptome, ECOG-Status, psychosoziale Bedürfnisse, Komorbiditäten, tumorassoziierte Komplikationen, Behandlungsentscheidung/keine Behandlungsmöglichkeiten und begrenzte Lebenszeitprognose herangezogen oder vorgeschlagen. Die Erhebung der Kriterien erfolgte mittels Instrumenten, für die keine konkreten Kennwerte angegeben waren, die eine zur Einbindung in spezialisierte Palliativversorgung relevante Ausprägung der Kriterien detektieren könnten.
Schlussfolgerung Für den Zeitpunkt einer zeitgerechten Integration der spezialisierten Palliativversorgung bei nicht heilbaren Krebserkrankungen gibt es bislang keine entitätsspezifischen Kriterien und Kennwerte. Aus der Analyse lässt sich jedoch ableiten, dass entitätsunabhängig alle Patienten mit einer nicht heilbaren bzw. fortgeschrittenen Krebserkrankung, die unter Verminderung/Verlust ihrer Lebensqualität und einer komplexen Symptomlast, v.a. Depressionen und Schmerzen leiden, das Angebot einer spezialisierten Palliativversorgung erhalten sollten. Kriterien generell als Kennwerte festzulegen und konsekutiv einen Messwert bzw. Cut-off-Wert zu definieren, könnte eine Möglichkeit sein, über z.B. ein Scoringsystem eine zeitgerechte Integration der Palliativmedizin zu erleichtern. Unklar ist bislang, welche Kombinationen von Erhebungsinstrumenten oder Screeningtools der Erfassung einer zeitgerechten Integration dienen könnten.
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Introduction
Health-related quality of life (HRQoL) is an important end point to measure in cancer patients and survivors. This study investigated whether differences in HRQOL exist between cancer patients, cancer survivors, and the general population, in addition to how employment status interplays in this relationship.
Methods
Data were from the 2019 Korea National Health & Nutrition Examination. HRQoL was measured using the HRQoL Instrument with 8 Items (HINT-8) index, which encompasses physical, mental, social, and health-related aspects. All variables were entered simultaneously into the fully adjusted model. Multiple regression analysis was used to evaluate the association between HRQoL in cancer patients and cancer survivors compared to the general population. An interaction analysis was conducted based on current employment status.
Results
A total of 3805 cancer patients, 109 cancer survivors, and 3609 individuals of the general population were included in this study. The HRQoL scores of cancer patients (β: − 0.0221, p-value: 0.0218) were poorer compared to the general population with statistical significance. In contrast, the HRQoL scores of cancer survivors did not show statistically significant differences. The interaction term between cancer status and economic activity status was statistically significant for cancer patients * unemployed (β: − 0.0557, p-value: 0.0020).
Conclusion
Cancer patients had lower HRQoL than the general population. Additionally, the interaction analysis reveals that unemployed cancer patients have poorer HRQoL scores than the employed general population. The results reveal that cancer patients are vulnerable to decreases in HRQoL, in particular those who are currently unemployed.
Cancer cachexia is an unmet clinical need that affects more than 50% of patients with cancer. The systemic inflammatory response, which is mediated by a network of cytokines, has an established role in the genesis and maintenance of cancer as well as in cachexia; yet, the specific role of the cytokine milieu in cachexia requires elucidation. This systematic review aims to examine the relationship between cytokines and the cachexia syndrome in patients with incurable cancer. The databases MEDLINE, EMBASE, CINAHL, CENTRAL, PsycINFO, and Web of Science were searched for studies published between 01/01/2004 and 06/01/2020. Included studies measured cytokines and their relationship with cachexia and related symptoms/signs in adults with incurable cancer. After title screening (n = 5202), the abstracts (n = 1264) and the full-text studies (n = 322) were reviewed independently by two authors. The quality assessment of the selected papers was conducted using the modified Downs and Black checklist. Overall, 1277 patients with incurable cancer and 155 healthy controls were analysed in the 17 eligible studies. The mean age of the patients was 64 ± 15 (mean ± standard deviation). Only 34% of included participants were female. The included studies were assessed as moderate-quality to high-quality evidence (mean quality score: 7.8; range: 5-10). A total of 31 cytokines were examined in this review, of which interleukin-6 (IL-6, 14 studies) and tumour necrosis factor-α (TNF-α, 12 studies) were the most common. The definitions of cachexia and the weight-loss thresholds were highly variable across studies. Although the data could not be meta-analysed due to the high degree of methodological heterogeneity, the findings were discussed in a systematic manner. IL-6, TNF-α, and IL-8 were greater in cachectic patients compared with healthy individuals. Also, IL-6 levels were higher in cachectic participants as opposed to non-cachectic patients. Leptin, interferon-γ, IL-1β, IL-10, adiponectin, and ghrelin did not demonstrate any significant difference between groups when individuals with cancer cachexia were compared against non-cachectic patients or healthy participants. These findings suggest that a network of cytokines, commonly IL-6, TNF-α, and IL-8, are associated with the development of cachexia. Yet, this relationship is not proven to be causative and future studies should opt for longitudinal designs with consistent methodological approaches, as well as adequate techniques for analysing and reporting the results.
Distress is defined in the NCCN Guidelines for Distress Management as a multifactorial, unpleasant experience of a psychologic (ie, cognitive, behavioral, emotional), social, spiritual, and/or physical nature that may interfere with the ability to cope effectively with cancer, its physical symptoms, and its treatment. Early evaluation and screening for distress leads to early and timely management of psychologic distress, which in turn improves medical management. The panel for the Distress Management Guidelines recently added a new principles section including guidance on implementation of standards of psychosocial care for patients with cancer.
Zusammenfassung
Hintergrund Ein Palliativdienst ist in der Beratung und Versorgung von Patienten mit einer Tumorerkrankung als Qualitätsindikator anerkannt und in National Cancer Institutes, Vorbild der deutschen Comprehensive Cancer Center (CCC), flächendeckend (92 %) umgesetzt. Daher stellt sich die Frage, wie die Palliativdienste aktuell in die CCCs integriert sind.
Methode Durch eine papierbasierte quantitative Befragung an 16 Standorten der bisher geförderten CCCs wurden von Juli bis August 2017 Angaben zum Vorhandensein, zur personellen Situation, Inanspruchnahme und zu Perspektiven eines Palliativdienstes erfasst. Die Befragung richtete sich an die Leiter der palliativmedizinischen Einheiten der CCCs. Die Daten wurden in SPSS ausgewertet (Häufigkeit, Median, Mittelwert, Spannweite).
Ergebnisse 15 CCCs haben an der Befragung teilgenommen (Rücklauf 94 %). 13 der 15 CCCs verfügen über einen Dienst, der Palliativpatienten mitbehandelt. In 12 von 13 CCCs sind diese in den Regelarbeitszeiten (wochentags 8–16 Uhr) erreichbar. Alle Dienste sind ärztlich besetzt, 11 zusätzlich pflegerisch. 7 Dienste sind neben Arzt und Pflege mit einer weiteren Profession besetzt. Es wurden im Jahr 2016 im Median 4482 Mitbehandlungen durch die Dienste erbracht, davon 80 % als Zusatzentgelte (ZE) ohne Erlös und ohne kodierbaren OPS. Im Jahr 2017 planen 5 Zentren das ZE 2017-133, 2 Zentren das ZE 60 und 3 Zentren beide ZE abzurechnen.
Diskussion Dienste für Palliativpatienten sind in den deutschen CCCs regelhaft vorhanden, erfüllen jedoch nur zur Hälfte die in der S3-Leitlinie geforderte Bedingung der Multiprofessionalität. Das im Jahr 2017 neu eingeführte, stundengenau abrechenbare Zusatzentgelt könnte hier Verbesserungen schaffen und zur Kostendeckung beitragen. Dadurch können entgegen der bisherigen Regelung notwendige und sinnvolle Leistungen mit einer Behandlungsdauer auch unter 7 Tagen abgerechnet werden.
Abstract Background One challenge in caring for cancer patients with incurable disease is the adequate identification of those in need for specialized palliative care (SPC). The study’s aim was to validate an easy to use phenomenological screening tool. Methods The German tool is based on the National Comprehensive Cancer Network (NCCN) Palliative Care guidelines and contains ten items in five domains that focus e.g. on diagnosis, functional status, complications, comorbidities, and palliative care relevant problems such as symptom management, distress, and support of family and team members. Sum score ranges from 0 to 14 (no need to great need). Assessment to identify SPC needs was done in university hospital wards between 1 and 08/2017 by health care professionals on admission of the patient if the disease was incurable and expected prognosis
Background/aim:
To observe changes in symptoms and health-related quality of life (HRQoL) over 7 years among cancer patients at different stages of the disease.
Patients and methods:
This prospective cross-sectional study at the Helsinki University Hospital Cancer Center, was carried out in 2006 and repeated in 2013. All participants filled in the EORTC-QLQ-C30 questionnaire.
Results:
Altogether, 581 patients responded (49% in 2006 and 54% in 2013). The disease was local in 51% and advanced in 49% of patients. The HRQoL was significantly lower, except for emotional and cognitive functions, and the symptom burden more severe in advanced cancer. The most prevalent symptoms were fatigue (93% and 85%; moderate/severe 22% and 9%), pain (65% and 47%; moderate/severe 16% and 5%), and insomnia (64% and 60%; moderate/severe 20 and 21%), respectively. No changes in HRQoL or symptoms were found at 7 years.
Conclusion:
There is a need for early integrated palliative care to improve HRQoL during cancer treatments.
Palliative Care - not just for the final phase. A rewiev of evidence Abstract. Already in early stages of their disease, patients with incurable, advanced cancer and non-cancer disease suffer from a range of limitations of their quality of life due to symptoms (i. e. pain, dyspnoea) or psychical, social or spiritual problems. Palliative Care aims to maintain the patients' quality of life and is applicable already early in the disease trajectory and not only at the end of life. As providers of general (basic) palliative care, all health care providers from all disciplines should therefore hold basic expertise in symptom control and communication. Also, they should be aware of psychical, social and spiritual dimensions of suffering. The integration and cooperation of health care services should be driven by the actual needs and demands of the individual patient. In addition to general palliative care, specialist palliative care is provided by multi-professional teams, for example, as specialist palliative home care teams or palliative care services in hospitals. In the future, it will be paramount to routinely identify patients with complex needs and severe (symptom) burden who will benefit most from early integration of specialist palliative care.
Purpose:
Specialized palliative care (SPC) is currently underutilized or provided late in cancer care. The aim of this systematic review and meta-analysis is to critically evaluate the impact of SPC on patients' health-related quality of life (HRQoL).
Methods:
Five databases were searched through June 2016. Randomized controlled trials (RCTs) and prospective studies using a pre- and post- assessment of HRQoL were included. The PRISMA reporting statement was followed. Criteria from available checklists were used to evaluate the studies' quality. A meta-analysis followed using random-effect models separately for RCTs and non-RCTs.
Results:
Eleven studies including five RCTs and 2939 cancer patients published between 2001 and 2014 were identified. There was improved HRQoL in patients with cancer following SPC especially in symptoms like pain, nausea, and fatigue as well as improvement of physical and psychological functioning. Less or no improvements were observed in social and spiritual domains. In general, studies of inpatients showed a larger benefit from SPC than studies of outpatients whereas patients' age and treatment duration did not moderate the impact of SPC. Methodological shortcomings of included studies include high attrition rates, low precision, and power and poor reporting of control procedures.
Conclusions:
The methodological problems and publication bias call for higher-quality studies to be designed, funded, and published. However, there is a clear message that SPC is multi-disciplinary and aims at palliation of symptoms and burden in line with current recommendations.
Objective
To assess the effect of specialist palliative care on quality of life and additional outcomes relevant to patients in those with advanced illness.
Design
Systematic review with meta-analysis.
Data sources
Medline, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, and trial registers searched up to July 2016.
Eligibility criteria for selecting studies
Randomised controlled trials with adult inpatients or outpatients treated in hospital, hospice, or community settings with any advanced illness. Minimum requirements for specialist palliative care included the multiprofessional team approach. Two reviewers independently screened and extracted data, assessed the risk of bias (Cochrane risk of bias tool), and evaluated the quality of evidence (GRADE tool).
Data synthesis
Primary outcome was quality of life with Hedges’ g as standardised mean difference (SMD) and random effects model in meta-analysis. In addition, the pooled SMDs of the analyses of quality of life were re-expressed on the global health/QoL scale (item 29 and 30, respectively) of the European Organization for Research and Treatment of Cancer QLQ-C30 (0-100, high values=good quality of life, minimal clinically important difference 8.1).
Results
Of 3967 publications, 12 were included (10 randomised controlled trials with 2454 patients randomised, of whom 72% (n=1766) had cancer). In no trial was integration of specialist palliative care triggered according to patients’ needs as identified by screening. Overall, there was a small effect in favour of specialist palliative care (SMD 0.16, 95% confidence interval 0.01 to 0.31; QLQ-C30 global health/QoL 4.1, 0.3 to 8.2; n=1218, six trials). Sensitivity analysis showed an SMD of 0.57 (−0.02 to 1.15; global health/QoL 14.6, −0.5 to 29.4; n=1385, seven trials). The effect was marginally larger for patients with cancer (0.20, 0.01 to 0.38; global health/QoL 5.1, 0.3 to 9.7; n=828, five trials) and especially for those who received specialist palliative care early (0.33, 0.05 to 0.61, global health/QoL 8.5, 1.3 to 15.6; n=388, two trials). The results for pain and other secondary outcomes were inconclusive. Some methodological problems (such as lack of blinding) reduced the strength of the evidence.
Conclusions
Specialist palliative care was associated with a small effect on QoL and might have most pronounced effects for patients with cancer who received such care early. It could be most effective if it is provided early and if it identifies though screening those patients with unmet needs.
Systematic review registration
PROSPERO CRD42015020674.
Background
This pilot study aimed to investigate quality of life, psychological burden, unmet needs, and care satisfaction in family caregivers of advanced cancer patients (FCs) during specialized inpatient palliative care (SIPC) and to test feasibility and acceptance of the questionnaire survey.
Methods
During a period of 12 weeks, FCs were recruited consecutively within 72 h after the patient’s admission. They completed validated scales on several outcomes: quality of life (SF-8), distress (DT), anxiety (GAD-7), depression (PHQ-9), supportive needs (FIN), palliative care outcome (POS), and satisfaction with care (FAMCARE-2). We used non-parametric tests, t-tests and correlation analyses to address our research questions.
Results
FCs showed high study commitment: 74 FCs were asked to participate whereof 54 (73%) agreed and 51 (69%) returned the questionnaire. Except for “bodily pain”, FCs’ quality of life (SF-8) was impaired in all subscales. Most FCs (96%) reported clinically significant own distress (DT), with sadness, sorrows and exhaustion being the most distressing problems (80–83%). Moderate to severe anxiety (GAD-7) and depression (PHQ-9) were prevalent in 43% and 41% of FCs, respectively. FCs scored a mean number of 16.3 of 20 needs (FIN) as very or extremely important (SD 3.3), 20% of needs were unmet in >50% of FCs. The mean POS score assessed by FCs was 16.6 (SD 5.0) and satisfaction (FAMCARE-2) was high (73.4; SD 8.3).
Conclusions
This pilot study demonstrated feasibility of the questionnaire survey and showed relevant psychosocial burden and unmet needs in FCs during SIPC. However, FCs’ satisfaction with SIPC seemed to be high. A current multicenter study evaluates these findings longitudinally in a large cohort of FCs.
Purpose:
The purposes of the present study were to classify the palliative care population (PCP) in a comprehensive cancer centre by using information on antineoplastic treatment options and to analyse associations between socio-demographic factors, cancer diagnoses, treatment characteristics and receiving specialist palliative care (SPC).
Methods:
This is a cross-sectional screening study of patients with cancer in the Department of Oncology, Rigshospitalet, Copenhagen University Hospital for 6 months. Patients were assessed to be included in the DOMUS study: a randomised controlled trial of accelerated transition to SPC at home (NCT01885637). The PCP was classified as patients with incurable cancer and limited or no antineoplastic treatment options. Patients with performance status 2-4 were further classified as the essential palliative care population (EPCP).
Results:
During the study period, 3717 patients with cancer were assessed. The PCP comprised 513 patients yielding a prevalence of 14 %. The EPCP comprised 256 patients (7 %). The EPCP was older, more likely inpatients, had a higher comorbidity burden and 38 % received SPC. Women, patients without caregivers and patients with breast cancer were more likely to receive SPC.
Conclusions:
By using objective criteria from clinical data and systematic screening, the observed prevalence of the PCP of 14 % may be generalisable to comprehensive cancer centres with similar composition of cancer diagnoses.
Multiple myeloma is an incurable cancer with a rising incidence globally. Less toxic treatments are increasingly available, so patients are living longer and treatment decisions are increasingly guided by QOL concerns. There is no QOL assessment tool designed specifically for use in the clinical care of people with myeloma. This study aimed to develop and test the psychometric properties of a new myeloma-specific QOL questionnaire designed specifically for use in the clinical setting - the MyPOS.
The MyPOS was developed using findings from a previously reported literature review and qualitative study. The prototype MyPOS was pretested using cognitive interviews in a purposive sample of myeloma patients and refined prior to field testing. The psychometric properties of the MyPOS were evaluated in a multi-centre, cross sectional survey of myeloma patients recruited from 14 hospital trusts across England.
The prototype MyPOS contained 33 structured and open questions. These were refined using cognitive interviews with 12 patients, and the final MyPOS contained 30 items taken forward for field-testing. The cross-sectional survey recruited 380 patients for the MyPOS validation. Mean time to complete was 7 minutes 19 seconds with 0.58% missing MyPOS items overall. Internal consistency was high (α = 0.89). Factor analysis confirmed three subscales: Symptoms & Function; Emotional Response and Healthcare Support. MyPOS total scores were higher (worse QOL) in those with active disease compared to those in the stable or plateau phase (F = 11.89, p < 0.001) and were worse in those currently receiving chemotherapy (t = 3.42, p = 0.001). Scores in the Symptoms & Function subscale were higher (worse QOL) in those with worse ECOG performance status (F = 31.33, p < 0.001). Good convergent and discriminant validity were demonstrated.
The MyPOS is the first myeloma-specific QOL questionnaire designed specifically for use in the clinical setting. The MyPOS is based on qualitative enquiry and the issues most important to patients. It is a brief, comprehensive and acceptable tool that is reliable and valid on psychometric testing. The MyPOS can now be used to support clinical decision making in the routine care of myeloma patients.
This integrative literature review aimed to characterize scientific articles on health-related quality of life - HRQoL - among patients with advanced cancer from national and international literature, and summarize those factors evidenced in the literature that contributed to the improvement or worsening of HRQoL among patients with advanced cancer. The search for materials was conducted in the following databases: CINAHL, EMBASE, PubMed, SciELO and LILACS. Among the 21 articles in the sample, 13 showed an improvement of HRQoL among patients with advanced cancer related to the development of physical, emotional and spiritual interventions. In eight studies, we identified predictive symptoms of low HRQoL, such as pain, fatigue, sleep disorders, depression, nutritional changes, and others. The results showed that clinical manifestations, which many times were inherent in cancer, such as factors that can lower patients' HRQoL, while physical, psychological and spiritual benefits resulting from therapeutic interventions may promote its improvement.
As the benefit of early palliative care for the quality of life of patients with advanced cancer is currently receiving widespread recognition, cancer specialists increasingly inquire about the practical implications of this concept. This publication presents the available information about how to provide early palliative care for patients with advanced cancer.
Oncologists and other cancer specialists provide general palliative care from the time of diagnosis of incurable cancer together with the patients' family doctors. This includes basic assessment of symptoms and distress, their initial management as well as sensitive communication with the patient, including advance care planning and end-of-life issues and hope. The additional integration of a specialized palliative care team early in the care trajectory has been found to be beneficial for quality of life and survival. This concept is known as 'early palliative care' or 'early integration' and has become recommended by institutions such as the American Society of Clinical Oncology.
Palliative care is warranted from the time of diagnosis of incurable cancer. From this early stage, palliative care consists of general palliative care provided by cancer specialists and family doctors and additional support of a specialized palliative care program. Guidance from different guidelines is presented alongside practical recommendations derived from our experience with an early palliative care program for comprehensive cancer care over the last 7 years.
Context
The Primary Care Evaluation of Mental Disorders (PRIME-MD) was developed
as a screening instrument but its administration time has limited its clinical
usefulness.Objective
To determine if the self-administered PRIME-MD Patient Health Questionnaire
(PHQ) has validity and utility for diagnosing mental disorders in primary
care comparable to the original clinician-administered PRIME-MD.Design
Criterion standard study undertaken between May 1997 and November 1998.Setting
Eight primary care clinics in the United States.Participants
Of a total of 3000 adult patients (selected by site-specific methods
to avoid sampling bias) assessed by 62 primary care physicians (21 general
internal medicine, 41 family practice), 585 patients had an interview with
a mental health professional within 48 hours of completing the PHQ.Main Outcome Measures
Patient Health Questionnaire diagnoses compared with independent diagnoses
made by mental health professionals; functional status measures; disability
days; health care use; and treatment/referral decisions.Results
A total of 825 (28%) of the 3000 individuals and 170 (29%) of the 585
had a PHQ diagnosis. There was good agreement between PHQ diagnoses and those
of independent mental health professionals (for the diagnosis of any 1 or
more PHQ disorder, κ = 0.65; overall accuracy, 85%; sensitivity, 75%;
specificity, 90%), similar to the original PRIME-MD. Patients with PHQ diagnoses
had more functional impairment, disability days, and health care use than
did patients without PHQ diagnoses (for all group main effects, P<.001). The average time required of the physician to review the
PHQ was far less than to administer the original PRIME-MD (<3 minutes for
85% vs 16% of the cases). Although 80% of the physicians reported that routine
use of the PHQ would be useful, new management actions were initiated or planned
for only 117 (32%) of the 363 patients with 1 or more PHQ diagnoses not previously
recognized.Conclusion
Our study suggests that the PHQ has diagnostic validity comparable to
the original clinician-administered PRIME-MD, and is more efficient to use.
Figures in this Article
Mental disorders in primary care are common, disabling, costly, and
treatable.1- 5
However, they are frequently unrecognized and therefore not treated.2- 6
Although there have been many screening instruments developed,7- 8
PRIME-MD (Primary Care Evaluation of Mental Disorders)5
was the first instrument designed for use in primary care that actually diagnoses
specific disorders using diagnostic criteria from the Diagnostic
and Statistical Manual of Mental Disorders, Revised Third Edition9(DSM-III-R) and Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition10(DSM-IV).
PRIME-MD is a 2-stage system in which the patient first completes a
26-item self-administered questionnaire that screens for 5 of the most common
groups of disorders in primary care: depressive, anxiety, alcohol, somatoform,
and eating disorders. In the original study,5
the average amount of time spent by the physician to administer the clinician
evaluation guide to patients who scored positively on the patient questionnaire
was 8.4 minutes. However, this is still a considerable amount of time in the
primary care setting, where most visits are 15 minutes or less.11
Therefore, although PRIME-MD has been widely used in clinical research,12- 28
its use in clinical settings has apparently been limited. This article describes
the development, validation, and utility of a fully self-administered version
of the original PRIME-MD, called the PRIME-MD Patient Health Questionnaire
(henceforth referred to as the PHQ).
DESCRIPTION OF PRIME-MD PHQ
ABSTRACT
|
DESCRIPTION OF PRIME-MD PHQ
|
STUDY PURPOSE
|
METHODS
|
RESULTS
|
COMMENT
|
REFERENCES
The 2 components of the original PRIME-MD, the patient questionnaire
and the clinician evaluation guide, were combined into a single, 3-page questionnaire
that can be entirely self-administered by the patient (it can also be read
to the patient, if necessary). The clinician scans the completed questionnaire,
verifies positive responses, and applies diagnostic algorithms that are abbreviated
at the bottom of each page. In this study, the data from the questionnaire
were entered into a computer program that applied the diagnostic algorithms
(written in SPSS 8.0 for Windows [SPSS Inc, Chicago, Ill]). The computer program
does not include the diagnosis of somatoform disorder, because this diagnosis
requires a clinical judgment regarding the adequacy of a biological explanation
for physical symptoms that the patient has noted.
A fourth page has been added to the PHQ that includes questions about
menstruation, pregnancy and childbirth, and recent psychosocial stressors.
This report covers only data from the diagnostic portion (first 3 pages) of
the PHQ. Users of the PHQ have the choice of using the entire 4-page instrument,
just the 3-page diagnostic portion, a 2-page version (Brief PHQ) that covers
mood and panic disorders and the nondiagnostic information described above,
or only the first page of the 2-page version (covering only mood and panic
disorders) (Figure 1).
Figure 1. First Page of Primary Care Evaluation
of Mental Disorders Brief Patient Health QuestionnaireGrahic Jump Location+View Large |
Save Figure |
Download Slide (.ppt)
|
View in Article ContextCopyright held by Pfizer Inc, but may be photocopied ad libitum.
For office coding, see the end of the article.
The original PRIME-MD assessed 18 current mental disorders. By grouping
several specific mood, anxiety, and somatoform categories into larger rubrics,
the PHQ greatly simplifies the differential diagnosis by assessing only 8
disorders. Like the original PRIME-MD, these disorders are divided into threshold
disorders (corresponding to specific DSM-IV diagnoses,
such as major depressive disorder, panic disorder, other anxiety disorder,
and bulimia nervosa) and subthreshold disorders (in which the criteria for
disorders encompass fewer symptoms than are required for any specific DSM-IV diagnoses: other depressive disorder, probable alcohol
abuse or dependence, and somatoform and binge eating disorders).
One important modification was made in the response categories for depressive
and somatoform symptoms that, in the original PRIME-MD, were dichotomous (yes/no).
In the PHQ, response categories are expanded. Patients indicate for each of
the 9 depressive symptoms whether, during the previous 2 weeks, the symptom
has bothered them "not at all," "several days," "more than half the days,"
or "nearly every day." This change allows the PHQ to be not only a diagnostic
instrument but also to yield a measure of depression severity that can be
of aid in initial treatment decisions as well as in monitoring outcomes over
time. Patients indicate for each of the 13 physical symptoms whether, during
the previous month, they have been "not bothered," "bothered a little," or
"bothered a lot" by the symptom. Because physical symptoms are so common in
primary care, the original PRIME-MD dichotomous-response categories often
led patients to endorse physical symptoms that were not clinically significant.
An item was added to the end of the diagnostic portion of the PHQ asking
the patient if he or she had checked off any problems on the questionnaire:
"How difficult have these problems made it for you to do your work, take care
of things at home, or get along with other people?" As with the original PRIME-MD,
before making a final diagnosis, the clinician is expected to rule out physical
causes of depression, anxiety and physical symptoms, and, in the case of depression,
normal bereavement and history of a manic episode.
STUDY PURPOSE
ABSTRACT
|
DESCRIPTION OF PRIME-MD PHQ
|
STUDY PURPOSE
|
METHODS
|
RESULTS
|
COMMENT
|
REFERENCES
Our major purpose was to test the validity and utility of the PHQ in
a multisite sample of family practice and general internal medicine patients
by answering the following questions:
Are diagnoses made by the PHQ as accurate as diagnoses
made by the original PRIME-MD, using independent diagnoses made by mental
health professionals (MHPs) as the criterion standard?Are the frequencies of mental disorders found by
the PHQ comparable to those obtained in other primary care studies?Is the construct validity of the PHQ comparable
to the original PRIME-MD in terms of functional impairment and health care
use?Is the PHQ as effective as the original PRIME-MD
in increasing the recognition of mental disorders in primary care patients?How valuable do primary care physicians find the
diagnostic information in the PHQ?How comfortable are patients in answering the questions
on the PHQ, and how often do they believe that their answers will be helpful
to their physicians in understanding and treating their problems?
Background
Repeated self-assessment of symptoms and problems of patients is required for quality assurance in palliative care. In Germany, the Minimal Documentation System (MIDOS) has been designed specifically for palliative care patients. To adapt MIDOS as a German version of the Edmonton Symptom Assessment Scale (ESAS) a revised version of MIDOS2 has now been validated. Two original items on average and highest pain intensity (11-step NRS) were replaced by one item on pain intensity on a 4-step VRS and the assessment of vomitus, lack of appetite and depressive mood were added to the assessment of nausea, dyspnoea, constipation, weakness, tiredness, anxiety, others and well-being which were already part of the original version.
Method
All patients admitted to the palliative care unit were asked to participate voluntarily in this study. MIDOS2, the German versions of the ESAS and the quality of life questionnaire EORTC QLQ-C15-Pal were completed on the same day during their inpatient stay. MIDOS2 was repeated on the next day.
Results
From August 2009 to March 2010, 60 patients (55% men, 45% women; mean age = 64.3, range = 23.6–92.4 years) treated in the palliative care unit completed the study. Self-assessment with MIDOS2 was reported to burden the patients only slightly (mean burden = 1.1, range: 0 = no to 10 = maximum burden on a NRS), application of MIDOS2 took between 1 and 7 min (mean duration = 2.4 min) and 61.7% of the patients preferred MIDOS2 (with VRS) to ESAS (30%) (with NRS) for routine daily documentation. External criterion validity by inter-item correlations of MIDOS2 with ESAS varied between r = .533 (anxiety) and .881 (nausea) and between r = .348 (depressive mood) and .717 (constipation) for the corresponding items of the EORTC QLQ-C15-Pal. Test-retest reliability between the sum scores of symptoms and problems reported in MIDOS2 on the first day and on the second day was .688, and r = .573 for well-being.
Conclusion
MIDOS2 can be recommended for routine daily documentation in palliative care because of low burden, little expenditure of time and high participation of patients. Statistical evaluation indicated good external validity and reliability.
Background
The lack of a clear definition of the palliative care patient hampers the comparison of results across different studies and impedes implementation of research findings in everyday practice.
Aim
The aim of this article is to propose minimum characteristics that define a palliative care patient.
Design
The design involved a systematic review of medical literature searching randomised controlled trials (RCTs) in palliative care for clear descriptions of their palliative care patients. We systematically describe relevant characteristics of the study populations of 60 eligible RCTs.
Data sources
The data sources used were MEDLINE, EMBASE, CINAHL, and PSYCHINFO, including all non-cancer RCTs (1 January 1995–4 March 2010) and an equivalent number of the most recent cancer RCTs (1 January 2003–4 March 2010).
Results
Half of the non-cancer studies were excluded because they did not relate to palliative care. We conclude that published RCTs have no clear definitions of their palliative care patients and illustrate the diversity of this patient, the lack of consensus concerning the attributes of illnesses needing palliation and the ambiguous use of the adjective ‘palliative’.
Conclusions
We propose elements of the patients’ health status (e.g. a progressive, life-threatening disease with no possibility of obtaining remission or stabilisation, or modifying the course of the illness) and the care delivered to them (e.g. a holistic interdisciplinary approach that focuses on supporting the quality of the end of life) to be included in the definition of a palliative care patient. We also suggest considering the patients’ readiness to accept palliative care and a vision of palliative care shared by the patient and all caregivers involved as potentially important elements in this definition.
The recommendation to screen for distress and supportive care needs among cancer patients focuses on improving the quality, effectiveness, and efficiency of comprehensive cancer care. The purpose of this study was to test the psychometric properties of the German version of the Short-Form Supportive Care Needs Survey (SCNS-SF34-G).
One thousand forty-seven participants with heterogeneous tumor entities were recruited in inpatient and outpatient cancer care facilities (female, 51%; median age, 57 years; breast cancer, 26%; prostate cancer, 22%). Concurrent and divergent validity of the SCNS-SF34-G was analyzed through associations with measures of distress, depression, anxiety, and social support.
Principal component analyses revealed five dimensions replicating the factorial structure of the original SCNS-SF34 (health system and information, psychological, physical and daily living, patient care and support, sexuality needs) explaining 68% of variance. Cronbach's alpha values ranged from 0.82 to 0.94. Convergent validity was supported by significant correlations between all SCNS-SF34-G subscales and psychosocial burden. Divergent validity was indicated by marginal correlations with social support. The SCNS-SF34-G was able to discriminate patient groups with respect to sex and age but not regarding tumor stage.
The SCNS-SF34-G is an instrument with excellent psychometric properties for assessing supportive care needs among patients with various cancer entities. It seems to be useful to integrate the questionnaire into diagnostic assessment to tailor interventions according to patient needs. Further research is needed to gain knowledge of the development of unmet needs during the illness trajectory as well as of associations with offer and utilization of healthcare services.
In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials.
We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures are also included.
The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity.
The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient > or = .70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe.
These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials.
Zusammenfassung
Patienten in palliativer Erkrankungsphase leiden häufig unter einer Vielzahl belastender Symptome mit deutlicher Einschränkung der Lebensqualität. Die Behandlung gestaltet sich hierbei oftmals schwierig. Zum einen, da die Patienten zumeist mehrere Probleme gleichzeitig mitbringen, und zum anderen, weil die notwendigen Medikamente an anderer Stelle Nebenwirkungen hervorrufen können, die ihrerseits wiederum behandelt werden müssen. Im vorliegenden Artikel erläutern wir einen Großteil dieser Symptome und geben Behandlungsempfehlungen anhand der aktuellen Literatur (ausgenommen Schmerztherapie). Im Speziellen ist der Artikel in folgende Unterpunkte gegliedert: Mukositis/Stomatitis, Atemnot, Übelkeit, Obstipation, Angst, Depression, Schwäche/Fatigue, Delir, Schlafstörungen und terminale Unruhe, Pruritus, Pleuraerguss, Aszites. Nur selten kann man in der Arbeit mit Palliativpatienten nach Lehrbuch vorgehen. Man muss improvisieren, Medikamente abseits ihrer Zulassung (Off-Label) gebrauchen oder manchmal auch einfach nur da sein. Der wichtigste Grundsatz in der Arbeit mit Palliativpatienten liegt in der Erhaltung oder Wiederherstellung der Lebensqualität. Unsere Therapie sollte immer an die Bedürfnisse des Patienten angepasst sein und es gilt, die Autonomie des Betroffenen zu wahren.
Background:
Little is known on symptom burden, psychosocial needs, and perception of prognosis in advanced lung cancer patients at the time of diagnosis, although early assessment is strongly recommended within the setting of daily routine care.
Methods:
Twelve study sites cross-sectionally assessed symptoms and psychosocial needs of patients suffering from newly diagnosed incurable lung cancer. Assessment comprised NCCN distress thermometer, FACT-L, SEIQoL-Q, PHQ-4, and shortened and modified SCNS-SF-34 questionnaires. Additional prognostic information from both patients and physicians were collected.
Results:
A total of 208 patients were evaluated. Mean age was 63.6 years, 58% were male, 84% suffered from stage IV lung cancer, and 71% had an ECOG performance status of 0-1. Mean distress level was 5.4 (SD 2.5), FACT-L total score was 86 (21.5), and TOI 50.5 (14.9). PHQ-4 was 4.6 (3.3), and shortened and modified SCNS-SF-34 showed 9 (8.7) unmet needs per patient. According to their physicians' perspective, 98.1% of patients were reflecting on and 85.2% were accepting incurability, while 26.5% of patients considered the treatment to be of curative intent.
Conclusion:
Our findings emphasize substantial domains of symptom burden seen in newly diagnosed, incurable lung cancer patients. Oncologists should be aware of these features and address prognostic issues early in the disease trajectory to facilitate opportunities to improve coping, advance care planning, and appropriate integration of palliative care, thus improving quality of life.
Zusammenfassung
Reviews zu Studien der Primärforschung werden zunehmend wichtiger, da das Konzept der evidenzbasierten Praxis in der Gesundheitsversorgung immer mehr an Einfluss gewinnt und die Zahl der Forschungsvorhaben enorm gestiegen ist. Zu den eher weniger bekannten Review-Typen gehört der „Scoping Review“. Scoping Reviews werden eingesetzt, wenn zunächst eine Orientierung über den Stand der Forschungsliteratur erlangt werden soll. Sie werden beispielsweise erstellt, um vorläufige Arbeitsdefinitionen festzulegen oder Themen bzw. Themenfelder konzeptionell abzugrenzen. Die Erstellung eines Scoping Reviews ist auch dann sinnvoll, wenn die Literatur noch nicht umfassend bewertet wurde oder wenn sie eine komplexe bzw. heterogene Problematik aufweist, so dass ein präziserer systematischer Review der Evidenz nicht angezeigt ist. Scoping Reviews können auch dazu dienen, die Bedeutung und den Umfang eines angedachten klassischen systematischen Reviews zu bestimmen. Scoping Reviews sind schließlich eine gute Methode, um Forschungsergebnisse zu bündeln bzw. zu kommunizieren, Forschungslücken auszuweisen und Empfehlungen für die zukünftige Forschungsarbeit zu unterbreiten. Dieser Artikel vermittelt den Leser*innen die Methodik der Scoping Reviews, konkretisiert die Unterschiede zu systematischen Reviews und erklärt, warum sie durchgeführt werden könnten. Diese Anleitung für die Durchführung von Scoping Reviews basiert auf der vom Joanna Briggs Institute (JBI) entwickelten Methodik.
Background:
Patients with multiple myeloma, an incurable haematological cancer, often receive palliative care only late in their trajectory. Criteria for early referral are lacking.
Aim:
To identify which patients might benefit from early integration, by identifying trajectories of health-related quality of life and the determinants for declining or poor Health related quality of life .
Design:
Prospective, longitudinal cohort study.
Participants:
Multiple myeloma patients at all stages (newly diagnosed, first-line or second-line treatment, early or later treatment-free interval, refractory disease) from in- and outpatient units at 14 hospitals in England were recruited. In addition to clinical information and standardised Health related quality of life and psychological aspects, the Myeloma Patient Outcome Scale (MyPOS) measured palliative care concerns.
Results:
A total of 238 patients were recruited, on average 3.5 years ( SD: 3.4) post-diagnosis. Latent mixture growth models identified four Health related quality of life trajectories. Classes 3 and 4 represent trajectories of stable poor Health related quality of life or declining Health related quality of life over an 8-month period. The strongest predictors of poor outcome at the end of follow-up were general symptom level (odds ratio (OR): 1.3, 95% CI: 1.0-1.6, p = 0.028), presence of clinically relevant anxiety (OR: 1.2, 95% confidence interval (CI): 1.0-1.4, p = 0.019), and presence of pain (OR: 1.02, 95% CI: 1.0-1.1, p = 0.018), all being more predictive than demographic or clinical characteristics.
Conclusion:
General symptom level, pain and presence of anxiety predict declining Health related quality of life in multiple myeloma. Identification of patients with palliative care needs should focus on assessing patient-reported symptoms and psychosocial well-being for identifying those at risk of deterioration.
We describe a simple method for the assessment of symptoms twice a day in patients admitted to a palliative care unit. Eight visual analog scales (VAS) 0–100 mm are completed either by the patient alone, by the patient with nurse's assistance, or by the nurses or relatives at 10:00 and 18:00 hours, in order to indicate the levels of pain, activity, nausea, depression, anxiety, drowsiness, appetite, and sensation of well-being. The information is then transferred to a graph that contains the assessments of up to 21 days on each page. The sum of the scores for all symptoms is defined as the symptom distress score. The Edmonton Symptom Assessment System (ESAS) was carried out for 101 consecutive patients for the length of their admission to our unit. Of these, 84% were able to make their own assessment sometime during their admission. However, before death 83% of assessments were completed by a nurse or relative. Mean symptom distress score was 410±95 during day 1 of the admission, versus 362±83 during day 5 (p<0.01). Mean symptom distress scores throughout the hospitalization were 359±105, 374±93, 359±91 and 406±81 when the ESAS was completed by the patient alone, patient with nurse's assistance (p=N.S.), nurse alone (p=N.S.), or relative (p<0.01) respectively. We conclude that this is a simple and useful method for the regular assessment of symptom distress in the palliative care setting.
Purpose
The early integration of oncology and palliative care (EIPC) improves quality of life (QOL) and mood for patients with advanced cancer. However, the mechanisms by which EIPC benefits these outcomes remain unclear. We therefore examined whether EIPC improved patients’ coping strategies and if changes in coping accounted for intervention effects on QOL and depressive symptoms.
Patients and Methods
For this secondary analysis of an EIPC trial, we examined data from 350 patients with newly diagnosed incurable lung or GI cancer. Participants completed assessments of QOL (Functional Assessment of Cancer Therapy–General), depressive symptoms (Patient Health Questionnaire–9), and coping (Brief COPE) at baseline and 24 weeks. We used linear regression to test intervention effects on use of coping strategies and mediation regression models with bias-corrected bootstrapping to examine whether improvements in coping mediated the effects of early palliative care on patient-reported outcomes.
Results
Compared with usual oncology care, EIPC significantly increased patient use of approach-oriented coping strategies ( B = 1.09; SE = 0.44; P = .01) and slightly reduced use of avoidant strategies ( B = −0.44; SE = 0.23; P = .06) from baseline to 24 weeks. Also, the increased use of approach-oriented coping and reduction in avoidant coping were associated with higher QOL and lower depressive symptoms at 24 weeks. The positive changes in approach-oriented coping, but not avoidant coping, significantly mediated the effects of EIPC on QOL (indirect effect, 1.27; 95% CI, 0.33 to 2.86) and depressive symptoms (indirect effect, −0.39; 95% CI, −0.87 to −0.08).
Conclusion
Patients with incurable cancer who received EIPC showed increased use of approach-oriented coping, which was associated with higher QOL and reduced depressive symptoms. Palliative care may improve these outcomes by providing patients with the skills to cope effectively with life-threatening illness.
Answer questions and earn CME/CNE Scientific advances in novel cancer therapeutics have led to remarkable changes in oncology practice and longer lives for patients diagnosed with incurable malignancies. However, the myriad options for treatment have established a culture of cancer care that has not been matched with a similar availability of efficacious supportive care interventions aimed at relieving debilitating symptoms due to progressive disease and treatment side effects. Accumulating data show that the introduction of palliative care services at the time of diagnosis of advanced cancer leads to meaningful improvement in the experiences of patients and family caregivers by emphasizing symptom management, quality of life, and treatment planning. In this review article, the rationale and evidence base for this model of early palliative care services integrated into standard oncology care are presented. In addition, the implications and limitations of the existing data to 1) elucidate the mechanisms by which early palliative care benefits patients and families; 2) guide the dissemination and application of this model in outpatient settings; and 3) inform health care policy regarding the delivery of high-quality, cost-effective, and comprehensive cancer care are discussed.
Objectives:
Lung cancer is associated with a greater symptom burden than other cancers, yet little is known about the prevalence of emotional problems and how emotional problems may be related to the physical symptom burden and quality of life in newly diagnosed patients with lung cancer. This study aimed to identify the patient and disease characteristics of patients with lung cancer experiencing emotional problems and to examine how emotional problems relate to quality of life and symptom burden.
Patients and methods:
A total of 2205 newly diagnosed patients with lung cancer completed questionnaires on emotional problems, quality of life, and symptom burden.
Results:
Emotional problems at diagnosis were associated with younger age, female gender, current cigarette smoking, current employment, advanced lung cancer disease, surgical or chemotherapy treatment, and a lower Eastern Cooperative Oncology Group performance score. Additionally, strong associations were found between greater severity of emotional problems, lower quality of life, and greater symptom burden.
Conclusion:
Certain characteristics place patients with lung cancer at greater risk for emotional problems, which are associated with a reduced quality of life and greater symptom burden. Assessment of the presence of emotional problems at the time of lung cancer diagnosis provides the opportunity to offer tailored strategies for managing negative mood, and for improving the quality of life and symptom burden management of patients with lung cancer.
Background:
Little is known about the physical symptoms and psychosocial burden of patients at the time of diagnosis of an incurable situation, although cancer treatment guidelines demand early assessment and integration of palliative care concepts, beginning from the diagnosis of incurability.
Methods:
Therefore, we initiated a prospective longitudinal multicenter cohort study assessing the symptoms and needs of patients suffering from incurable cancer (various entities), from the time of diagnosing incurability (i.e., before palliative anticancer treatment was initiated) and in 3-monthly intervals thereafter, by using validated self-reporting tools. Here, we focus on patients with head and neck cancer and present preliminary results on symptoms and need prevalences, on clinical implications, and on the feasibility of a methodologically complex assessment procedure in a particularly vulnerable study population.
Results:
22 patients completed the first visit. The Eastern Cooperative Oncology Group (ECOG) performance scores and most physical symptoms and psychosocial items varied between the extremes, from a virtually uncompromised condition to extremely perceived symptoms and needs. If intense face-to-face study support was provided, the study concept proved to be feasible, despite the complexity of assessment, problems in interdisciplinary and patient communication, comorbidities, and early death from complications.
Conclusions:
The striking variability in the perceived symptom and need intensities requires a highly individualized approach. For clinical purposes, a less complex screening procedure would be desirable, in order to enable a routine, early and comprehensive support, including palliative care services.
Purpose:
The National Comprehensive Cancer Network (NCCN) palliative care (PC) guideline recommends PC screening for all patients and provides criteria for identifying those in need of referral to a PC specialist. This two-step process has not yet been validated as accurately identifying patients in need. The aim of this study was to validate a simplified method for screening and referral based on the existing guideline criteria.
Methods:
An 11-item screening tool was created, with scores from 0 to 14. Content validity was assessed by a panel of local PC experts. Construct and criterion validities were evaluated using data obtained from a previous study of guideline-based screening and referral.
Results:
Content validity of the tool was high, with eight items rated as essential. Patients who were closer to death had significantly higher scores, indicating its construct validity. Scores were also higher in patients who were identified as needing a consult and in those who had worse pain and other symptoms, indicating its criterion validity. Using a score of ≥ 5 as the trigger, approximately one third of hospitalized patients in the previous study would have been referred to a PC specialist, twice as many as occurred when the attending oncologist relied on his or her clinical judgment.
Conclusion:
The tool seems to be a valid method for identifying patients with cancer with complex PC needs who would benefit from a PC consult. Reliability testing, external validation, and demonstration of the utility of the tool as a decision aid all await confirmation.
The difficulties in defining a palliative care patient accentuate the need to provide stringent descriptions of the patient population in palliative care research.
To conduct a systematic literature review with the aim of identifying which key variables have been used to describe adult palliative care cancer populations in randomized controlled trials (RCTs).
The data sources used were MEDLINE (1950 to January 25, 2010) and Embase (1980 to January 25, 2010), limited to RCTs in adult cancer patients with incurable disease. Forty-three variables were systematically extracted from the eligible articles.
The review includes 336 articles reporting RCTs in palliative care cancer patients. Age (98%), gender (90%), cancer diagnosis (89%), performance status (45%), and survival (45%) were the most frequently reported variables. A large number of other variables were much less frequently reported.
A substantial variation exists in how palliative care cancer populations are described in RCTs. Few variables are consistently registered and reported. There is a clear need to standardize the reporting. The results from this work will serve as the basis for an international Delphi process with the aim of reaching consensus on a minimum set of descriptors to characterize a palliative care cancer population.
This paper focuses on scoping studies, an approach to reviewing the literature which to date has received little attention in the research methods literature. We distinguish between different types of scoping studies and indicate where these stand in relation to full systematic reviews. We outline a framework for conducting a scoping study based on our recent experiences of reviewing the literature on services for carers for people with mental health problems. Where appropriate, our approach to scoping the field is contrasted with the procedures followed in systematic reviews. We emphasize how including a consultation exercise in this sort of study may enhance the results, making them more useful to policy makers, practitioners and service users. Finally, we consider the advantages and limitations of the approach and suggest that a wider debate is called for about the role of the scoping study in relation to other types of literature reviews.
STANDARD CRITERIA FOR TOXICITY and for response to treatment are important prerequisites to the conduct of cancer trials. The Eastern Cooperative Oncology Group criteria for toxicity and response are presented to facilitate future reference and to encourage further standardization among those conducting clinical trials.
(C) Lippincott-Raven Publishers.
Context:
Symptom assessment by computers is only effective if it provides valid results and is perceived as useful for clinical use by the end users: patients and health care providers.
Objectives:
To identify factors associated with discontinuation, time expenditure, and patient preferences of the computerized symptom assessment used in an international multicenter data collection project: the European Palliative Care Research Collaborative-Computerized Symptom Assessment.
Methods:
Cancer patients with incurable metastatic or locally advanced disease were recruited from 17 centers in eight countries, providing 1017 records for analyses. Observer-based registrations and patient-reported measures on pain, depression, and physical function were entered on touch screen laptop computers.
Results:
The entire assessment was completed by 94.9% (n = 965), with median age 63 years (range 18-91 years) and median Karnofsky Performance Status (KPS) score of 70 (range 20-100). Predictive factors for noncompletion were higher age, lower KPS, and more pain (P ≤ 0.012). Time expenditure among completers increased with higher age, male gender, Norwegian nationality, number of comorbidities, and lower physical functioning (P ≤ 0.007) but was inversely related to pain levels and tiredness (P ≤ 0.03). Need for assistance was predicted by higher age, nationality other than Norwegian, lower KPS, and lower educational level (P < 0.001). More than 50% of patients preferred computerized assessment to a paper and pencil version.
Conclusion:
The high completion rate shows that symptom assessment by computers is feasible in patients with advanced cancer. However, reduced performance status reduces compliance and increases the need for assistance. Future work should aim at identifying the minimum set of valid screening questions and refine the software to optimize symptom assessment and reduce respondent burden in frail patients.
ABSTRACT– A self-assessment scale has been developed and found to be a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. The anxiety and depressive subscales are also valid measures of severity of the emotional disorder. It is suggested that the introduction of the scales into general hospital practice would facilitate the large task of detection and management of emotional disorder in patients under investigation and treatment in medical and surgical departments.
Comprehensive cancer care requires the integration of palliative care practices and principles across the trajectory of the cancer experience. It complements the treatment of curable disease and may be the sole focus of care for those patients with advanced incurable disease. As the incidence of cancer increases worldwide and the burden of cancer rises, especially in low and middle resource countries, the need for palliative care is greater than ever before. There are numerous barriers to the provision of integrated care, including the ongoing misconception that palliative care is end-of-life care, the "cure-care dichotomy," inadequate training of health professionals and lack of resources. This article reviews the essential elements of comprehensive cancer care and the challenges to providing integrated cancer and palliative care to patients world-wide.
The timely integration of palliative care services into standard oncology care is essential to providing comprehensive individualized care for patients with advanced and incurable cancer and their families. Herein we discuss five important areas in which this integration is critical to optimize management, namely: symptom management, transitioning from disease-focused care to palliative care, discussing goals of care and advance care planning, community care, and psychosocial support for the patient and family.
The German Hospice and Palliative Care Evaluation (HOPE) is a national, long-term quality assurance project. Every year, German hospice and palliative care institutions document a core data set for their patients for a period of three months.
To validate the multidimensional symptom and problem checklist (HOPE-SP-CL) of the core data set and report details on reliability and validity.
Data from yearly evaluation periods between 2002 and 2009 were used to calculate construct and convergent validity, internal consistency, test-retest reliability, and documentation discipline and acceptance of the core documentation system.
The HOPE-SP-CL includes items on physical, nursing, psychological, and social symptoms and problems. Factor analysis extracted four low to moderately intercorrelating factors with eigenvalues greater than 1.0 explaining 56% of the total variance. Discriminant validity of the HOPE-SP-CL showed good properties in detecting patient groups with different symptom intensities and overall symptom burden using the Eastern Cooperative Oncology Group performance status and primary cancer diagnosis as external validation criteria. The global sum score of the HOPE-SP-CL correlated most closely with the Palliative Outcome Scale staff version (r=0.750). Internal consistencies ranged between α=0.768-0.801 at three different times of assessment. Test-retest coefficients showed moderate to high correlations at one-week intervals.
Analyses of reliability and validity of the HOPE-SP-CL showed satisfactory to good psychometric properties; therefore, the HOPE-SP-CL can be recommended for standard implementation in German hospice and palliative care institutions.
The 4-item Patient Health Questionnaire-4 (PHQ-4) is an ultra-brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2). Given that PHQ-4, PHQ-2, and GAD-2 have not been validated in the general population, this study aimed to investigate their reliability and validity in a large general population sample and to generate normative data.
A nationally representative face-to-face household survey was conducted in Germany in 2006. The survey questionnaire consisted of the PHQ-4, other self-report instruments, and demographic characteristics.
Of the 5030 participants (response rate=72.9%), 53.6% were female and mean (SD) age was 48.4 (18.0) years. The sociodemographic characteristics of the study sample closely match those of the total populations in Germany as well as those in the United States. Confirmatory factor analyses showed very good fit indices for a two-factor solution (RMSEA .027; 90% CI .023-.032). All models tested were structurally invariant between different age and gender groups. Construct validity of the PHQ-4, PHQ-2, and GAD-2 was supported by intercorrelations with other self-report scales and with demographic risk factors for depression and anxiety. PHQ-2 and GAD-2 scores of 3 corresponded to percentile ranks of 93.4% and 95.2%, respectively, whereas PHQ-2 and GAD-2 scores of 5 corresponded to percentile ranks of 99.0% and 99.2%, respectively.
A criterion standard diagnostic interview for depression and anxiety was not included.
Results from this study support the reliability and validity of the PHQ-4, PHQ-2, and GAD-2 as ultra-brief measures of depression and anxiety in the general population. The normative data provided in this study can be used to compare a subject's scale score with those determined from a general population reference group.
The present investigation was intended principally as a concurrent validation study for a new self-report symptom inventory: the SCL-90. A sample of 209 'symptomatic volunteers' served as subjects and were administered both the SCL-90 and the MMPI prior to participation in clinical therapeutic drug trials. The MMPI was scored for the Wiggins content scales and the Tryon cluster scales in addition to the standard clinical scales. Comparisons of the nine primary symptom dimensions of the SCL-90 with the set of MMPI scales reflected very high convergent validity for the SCL-90. Peak correlations were observed with like constructs on eight of the nine scales, with secondary patterns of correlations showing high interpretative consistency.
This paper reports the development of a self-report instrument designed to assess pain in cancer and other diseases. It is argued that issues of reliability and validity should be considered for every pain questionnaire. Most research on measures of pain examine reliability to the relative neglect of validity concerns. The Wisconsin Brief Pain Questionnaire (BPQ) is evaluated with regard to both reliability and validity. Data from patients with cancer at 4 primary sites and from patients with rheumatoid arthritis suggest that the BPQ is sufficiently reliable and valid for research purposes. Additional methodological and theoretical issues related to validity are discussed, and the need for continuing evaluation of the BPQ and other measures of clinical pain is stressed.
The FACT-L (version 3) is a 44-item self-report instrument which measures multidimensional quality of life. Available in eight languages, it is currently being used in several Phase II and III lung cancer clinical trials. Reliability and validity of the 33-item version 2 of the FACT-General (FACT-G) have previously been published. This paper reports further validation data on the FACT-G with a subsample of lung cancer patients from the original publication and, more importantly, presents data on the Lung Cancer Subscale (LCS). The nine LCS questions were administered along with the FACT-G to 116 patients with lung cancer. Internal consistency (coefficient alpha) was improved from 0.53 to 0.68 by dropping two questions which were uncorrelated with the others. A subset of 41 patients was tested again at 2 months to evaluate sensitivity to change in performance status rating (PSR) and to obtain estimates of a clinically meaningful change score for the FACT-G and the 7-item LCS. Using a linear test for trend, sensitivity to change in performance status rating (PSR) was obtained with the Total score (P = 0.03), the Physical Well Being (PWB) subscale (P = 0.02), the Functional Well Being (FWB) subscale (P = 0.05), and the LCS (P = 0.03). A 21-item Trial Outcome Index (TOI), combining scores on PWB, FWB and LCS, was highly reliable (coefficient a = 0.89) and sensitive to change in PSR F(1,38) = 4.84 (P = 0.01). This TOI is probably the most relevant and precise indicator of patient-reported quality of life available for lung cancer patients who complete the FACT-L while participating in an oncology clinical trial. The FACT-L may also be of benefit in evaluating quality of life in patients with lung diseases other than cancer.
Despite the increasing importance of assessing quality of life (QoL) in patients with advanced cancer, relatively little is known about individual patient's perceptions of the issues contributing to their QoL. The Schedule for the Evaluation of Individual Quality of Life (SEIQoL) and the shorter SEIQoL-Direct Weighting (SEIQoL-DW) assess individualized QoL using a semistructured interview technique. Here we report findings from the first administration of the SEIQoL and SEIQoL-DW to patients with advanced incurable cancer.
QoL was assessed on a single occasion using the SEIQoL and SEIQoL-DW in 80 patients with advanced incurable cancer.
All patients were able to complete the SEIQoL-DW, and 78% completed the SEIQoL. Of a possible score of 100, the median QoL global score was as follows: SEIQoL, 61 (range, 24 to 94); SEIQoL-DW, 60.5 (range, 6 to 95). Psychometric data for SEIQoL indicated very high levels of internal consistency (median r =.90) and internal validity (median R(2) = 0.88). Patients' judgments of their QoL were unique to the individual. Family concerns were almost universally rated as more important than health, the difference being significant when measured using the SEIQoL-DW (P =.002).
Patients with advanced incurable cancer were very good judges of their QoL, and many patients rated their QoL as good. Judgments were highly individual, with very high levels of consistency and validity. The primacy given to health in many QoL questionnaires may be questioned in this population. The implications of these findings are discussed with regard to clinical assessment and advance directives.