539718 research-article2014

PMJ0010.1177/0269216314539718Palliative MedicineCatania et al.

Review Article

Effectiveness of complex interventions focused on quality-of-life assessment to improve palliative care patients’ outcomes: A systematic review

Palliative Medicine 2015, Vol. 29(1) 5­–21 © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0269216314539718 pmj.sagepub.com

Gianluca Catania1,2, Monica Beccaro3, Massimo Costantini4, Donatella Ugolini5,6, Annalisa De Silvestri7, Annamaria Bagnasco2 and Loredana Sasso2

Abstract Background: One of the most crucial palliative care challenges is in determining how patient’ needs are defined and assessed. Assessing quality of life has been defined as a priority in palliative care, and it has become a central concept in palliative care practice. Aim: To determine to what extent interventions focused on measuring quality of life in palliative care practice are effective in improving outcomes in palliative care patients. Design: Systematic review according to the recommendations of the Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA) statement and hand searches. Data sources: MEDLINE, CINAHL, EMBASE, PsycINFO, and the Cochrane Library were searched for articles published until June 2012, and through hand searching from references lists of included articles. Only studies that included adult palliative care patients, in any palliative care clinical practice setting of care, and with an experimental, quasi-experimental, or observational analytical study design were eligible for inclusion. All studies were independently reviewed by two investigators who scored them for methodological quality by using the Edwards Method Score. Results: In total, 11 articles (of 8579) incorporating information from 10 studies were included. Only three were randomized controlled trials. The quality of the evidence was found from moderate to low. Given a wide variability among patients’ outcomes, individual effect size (ES) was possible for 6 out of 10 studies, 3 of which found a moderate ES on symptoms (ES = 0.68) and psychological (ES = 0.60) and social (ES = 0.55) dimensions. Conclusion: Effectiveness of interventions focused on quality-of-life assessment is moderate. Additional studies should explore the complexity of the real palliative care world more accurately and understand the effects of independent variables included in complex palliative care interventions.

Keywords Palliative care, outcome assessment, quality of life, complex intervention, systematic review

1U.O.S.

Regional Palliative Care Network, IRCCS Azienda Ospedaliera Universitaria San Martino—IST—Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy 2Department of Health Sciences, University of Genoa, Genoa, Italy 3Academy of Sciences of Palliative Medicine, Bologna, Italy 4Palliative Care Unit, IRCCS Arcispedale S Maria Nuova, Reggio Emilia, Italy 5Department of Internal Medicine, University of Genoa, Genoa, Italy 6Unit of Clinical Epidemiology, IRCCS Azienda Ospedaliera

Universitaria San Martino—IST—Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy 7Biometry Unit, IRCCS Policlinico San Matteo Foundation, Pavia, Italy Corresponding author: Gianluca Catania, U.O.S. Regional Palliative Care Network, IRCCS Azienda Ospedaliera Universitaria San Martino—IST—Istituto Nazionale per la Ricerca sul Cancro, Largo Rosanna Benzi, 10, 16132 Genoa, Italy. Email: [email protected]

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Palliative Medicine 29(1)

What is already known about the topic? •• A large variety of quality-of-life (QoL) measurement instruments are appropriate for use in palliative care. •• A clinical intervention focused on QoL assessment has been described as a typical complex intervention. •• Little is known about the effectiveness of interventions focused on QoL assessment in palliative care clinical settings. What this paper adds? •• Overall implementing interventions focused on QoL assessment in palliative care practice does result in improved patients’ outcomes. •• Effectiveness was found on symptoms, psychosocial dimension, and overall QoL. •• Highlight the need to incorporate the patients’ perspective in planning their care. Implications for practice, theory or policy •• A thorough exploration of interventions focused on QoL assessment would require more rigorous studies. •• Future interventions may benefit from mainly considering that QoL assessment in palliative care practice is a complex intervention. •• Interventions focused on QoL assessment in palliative care practice should be developed and implemented according to well-designed frameworks.

Introduction As a result of medical advances, life expectancy is progressively increasing. This contributed to a twofold consequence, an increase in aging people living with chronic disease and a growing need of palliative care (PC).1 One of the most crucial PC challenges is in determining how patient’ needs are defined and assessed.2 More than a decade has passed since the World Health Organization (WHO) defined PC as an approach that improves the quality of life (QoL) of patients and their families facing the problem associated with life-threatening illness.3 Assessing QoL has become a central concept in PC clinical practice.4 QoL is a highly individual concept,5 with a collection of interacting subjective dimensions6 and changes over time along with circumstances and context of the individual, also known as response shift phenomena.5,7 Nowadays, PC is provided more widely to patients and their families across a variety of healthcare services including malignant and non-malignant diseases.8 Although trajectories of functional decline toward the end of life were outlined,9 literature shows that PC interventions are usually delivered late in the disease trajectory when symptoms are uncontrolled10 resulting in deteriorating QoL. Thus, addressing patient’s QoL issues becomes essential for patients with incurable disease and their families by providing initial and ongoing appropriate QoL assessments, delivering appropriate interventions within agreed policies, and facilitating advance care planning.11 Currently, there is an increasing interest in QoL as an outcome indicator to monitor the quality of care delivered,5 and as such, QoL assessment in clinical practice has been identified as a holistically oriented outcome.12 There is evidence that assessing QoL in patients with advanced disease can improve detection of problems including psychological and social needs and facilitate

communication.13 Data collected from patient’s perspective guide healthcare professionals in making decisions, planning interventions, and monitoring outcomes.14 As a plethora of outcome measures are available for using in PC practice5 and, specifically for assessing QoL,15 there is increasing emphasis placed on reaching an international consensus on defining a core set of instruments5,15 and on their implementation considering the barriers and facilitators recently systematically reviewed.16 Lately, some systematic reviews reported that PC has been proven to be more effective than standard approaches.17–19 Conversely, little is known about the effectiveness of interventions focused on QoL measurement in PC clinical settings. Starting from the definition of complex interventions proposed by the Medical Research Council (MRC),20 we lately argued that a procedure of QoL assessment in clinical practice (i.e. a routine procedure and a thorough QoL assessment in PC patients) can be defined as a complex clinical intervention focused on QoL assessment about which is essential to identify the optimal intervention (i.e. effectiveness) and then analyze all its components and underlying mechanisms.11 We proposed the QoL Assessment Principles in Palliative Care outlining the 11 essential principles to be considered in developing and/or evaluating clinical interventions focused on QoL assessment, such as understanding the trajectory of the problem to anticipate and address it; availability of appropriate treatments/interventions for patients with recognized problem, including professionals trained for the treatment/intervention; and practical and easy-to-use QoL tools made up of questions not distressing for the patients.11 Exploring the different components of such complex interventions is beyond the scope of this article. The aim of

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Catania et al. this systematic review is to identify and appraise the evidence of effectiveness of complex interventions focused on assessing QoL in PC clinical practice.

Methods Based on the study by Petticrew et al.,21 we selected a pragmatic approach to address a simple question regarding effectiveness of complex interventions focused on QoL assessment. A more complex perspective identifying the components of the QoL assessment interventions and their impact on patients, family, and professionals will be published elsewhere. For the purpose of this systematic review article, we use the terms intervention or complex intervention interchangeably to refer to the complex intervention as defined by the MRC.20,22 The review question was to what extent interventions focused on QoL measurement in clinical practice are effective in improving outcomes in PC patients? This systematic review was conducted according to the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.23

Search strategies Studies were identified through searching five databases: CINAHL, EMBASE, MEDLINE, PsycINFO, and the Cochrane Library, and through hand searching from references lists of included articles. One reviewer (D.U.) performed the searches in each database from its inception to June 2012 with no limits of date. The search strategy follows the PICO model:24 (1) Problem/Population: adult patients with PC needs in all settings of practice (i.e. “PC” and all related terms); (2) Intervention: any clinical intervention focused on QoL measurement (i.e. “measure” and all related terms); (3) Comparison: any comparison; and (4) Outcome: any patient’s outcome (i.e. “QoL,” “outcome measure,” and all related terms). Specific keywords for each database and free text terms were combined with Boolean operators. According to different terms and rules of searching for each database, the effective combination of search terms was designed and set up by one reviewer (D.U.) and discussed with other three reviewers (G.C., M.B., and M.C.) (Appendix 1).

Study selection criteria Inclusion and exclusion criteria were based on the research question as follows. Inclusion criteria Types of studies.  This systematic review considered any experimental, quasi-experimental, or observational analytical studies, aimed at describing and/or assessing complex clinical interventions focused on QoL measurement and

published in articles written in English (regardless of the year of publication). Complex intervention is defined as an activity that contains a number of component parts with the potential for interactions between them which, when applied to the intended target population, produces a range of possible and variable outcomes.20,22 Whereas such definition is quite recent, for the purpose of this systematic review, studies were considered for their inherent complexity, even if they were not defined as complex by their authors. Types of participants.  Any adult patient—aged 18 years or more—with PC needs according to the WHO definition and regardless of primary disease in any PC clinical practice setting of care. Types of intervention.  Any clinical intervention focused on QoL measurement, specifically on QoL measured by either patient’s self-report or proxy and including at least two or more QoL dimensions. Types of outcome measures.  Any objectively measured patients’ outcomes in PC clinical setting. Exclusion criteria.  Studies focusing on validation aimed at assessing the psychometric properties of a QoL measure. Furthermore, studies focused solely on caregivers’ QoL measurement and on the prognostic value of measuring QoL. Editorials, case report, descriptive and qualitative studies, and dissertations were also excluded.

Identification of studies, data extraction, and quality assessment According to Hawe et al.’s25 viewpoint, we mapped complexity assuming that interventions focused on QoL assessment in PC are made up of multiple components with both constant (e.g. the QoL measure) and variable aspects (e.g. assessment time frame) and that the interventions are variably delivered through PC settings. Such source of complexity requires tailoring of implementation and raises specific problems in assessing effectiveness. Three PC experts (G.C., M.B., and M.C.) independently searched for eligible studies assessing title, abstract and full text against the inclusion criteria. Data extraction with a standardized form including aim, sample, intervention, outcome measure, and results was first piloted and then completed by two reviewers (G.C. and M.B.). Discrepancies between reviewers were resolved by discussion. Methodological quality was scored independently by two reviewers (G.C. and M.B.) using the Edwards Method Score (Appendix 2) for experimental and observational studies and checked by one reviewer (A.D.S.). The Edwards Method Score evaluates the key issues for methodological quality of the studies using scores between 0 and 2.

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Idenficaon

Palliative Medicine 29(1)

Records idenfied through database searching (n = 8564)

Addional records idenfied through other sources (n = 15)

Records aer duplicates removed (n = 5805)

Screening

Records screened at tle level (n = 5805)

Included

Eligibility

Records screened at abstract level (n = 157)

Full-text arcles assessed for eligibility (n = 27)

Studies included in qualitave synthesis (n = 10 reported in n = 11 papers)*

Records excluded at tle level (n = 5794)

Records excluded at abstract level (n = 130)

Full text excluded, with reasons (n = 16) Validaon study/describing QoL tool

n=7

Qualitave study

n=3

Descripve study

n=2

No palliave care needs

n=2

Trajectories of QoL

n=1

Intervenon no QoL measurement

n=1

Figure 1.  Flow diagram of systematic review.

QoL: quality of life. *Detmar et al.28 and Snyder et al.29 were pooled because reported different analyses from the same study.

The total maximum score is 22 for experimental studies or 16 for observational studies; higher scores correspond to higher quality.26 Supplemental information about the studies was requested to the authors when necessary.

Effect size To answer the review question concerning to what extent clinical interventions focused on QoL measurement improve PC patients’ outcomes, within each study standardized mean difference was calculated according to Cohen27 as the differences between the means of intervention and control groups, divided by the pooled standard deviation (SD).

Results The stages of the review process are summarized in the PRISMA23 flowchart (Figure 1). The searches of

electronic databases and hand searches of reference lists yielded 8579 references, which were included in this review. On the basis of the titles and the abstracts, 27 met the inclusion criteria, and the full-text articles were obtained. After reading the full-text articles, 11 fulfilled the inclusion criteria, and 2 of those were pooled28,29 because they reported different analyses from the same study. As a result, 10 studies were submitted to qualitative synthesis. Table 1 provides details of the characteristics and quality assessment of the included studies (Table 1). At full-text level, 16 articles were excluded: 7 articles were excluded because they were either validation studies or articles describing QoL tools, 3 articles were excluded because they had a qualitative study design, 2 articles were descriptive studies, 2 articles did not include patients with PC needs, 1 article described QoL’s trajectories, and 1 article was not an intervention focused on QoL measurement.

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Aims

1. To evaluate the efficacy of standardized QoL assessment in facilitating patient–physician communication. 2. To evaluate 2(a) The physicians’ awareness of their patients’ QoL; 2(b) Clinical management activities; 2(c) Patients’ and physicians’ satisfaction with their medical interactions; 2(d) Patients’ reported QoL over time.

1. To determine the efficacy of providing systematic feedback from standardized assessment tools for hospice patients and caregivers in improving hospice outcomes compared with the usual clinical practice.

Author, year, country

Detmar et al. (2002), the Netherlands28

McMillan et al. (2011), USA30

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Sample size: NA.

Power (%): NA.

RCT

Sample size: NA.

Power (%): 80.

709 advanced cancer patients and caregivers in two home PC services: ExpA: 338 dyads (patients age: mean 72.65 years; caregivers age: mean 65.24 years); CtrlA: 371 dyads (patients age: mean 72.67 years; caregivers age: mean 65.49 years).

Patient age: 24–84 years (mean age 57 years).

214 Cancer patients receiving outpatient palliative chemotherapy;

Both groups completed the same standardized assessment by the RAs and not received suggestions for changing care plans. ExpA: team members received structured reports at two staff meetings from the RAs. The oral report lasted less than 4 min. CtrlA: no reports.

1. Patients’ tools: (a) PPS; (b) MSAS; (c) HQLI-14; (d) Chart audit: reporting number of home visits, by nurses, aides, social workers/counselors, or chaplains during the 2-week participation of RA in the IDT conference. 2. Dyads tools: (a) Center for Epidemiological Study–Depression Scale (Boston Short Form); (b) SNI; (c) SPMSQ.

No other patient outcomes or caregiver outcomes were significantly different.

Statistically significant effect of time was observed for patient HQLI in both groups (p < 0.001).

2(d) Patients’ self-reported QoL: no differences at V4. - S ignificant improvement in MH: ExpA: 43%, CtrlA: 30% (p = 0.04); - S ignificant improvement in RF: ExpA: 22%, CtrlA: 11% (p = 0.05). Patients in ExpA compared to CtrlA showed greater improvement in depression (p < 0.001).

2(c) Overall patient satisfaction high in both groups. - E motional support received: mean (SD) ExpA: 4.3 (0.72); CtrlA: 4.0 (0.89) (p = 0.05, ES = 0.37);

2(b) Patient management: - Between-group difference in the mean number of actions taken per patient was ExpA: 0.6 and CtrlA: 0.5; -N  o differences in the prescription of medications, ordering of tests, and referrals to other healthcare practitioners. -C  ounseling from their physicians on problems’ management: ExpA: 23%, CtrlA: 16% (p = 0.05);

(Continued)

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1. Composite communication score: Mean (SD) score at V4 ExpA: 4.5 (2.3); CtrlA: 3.7 (1.9) (p = 0.01, ES = 0.38);

1. Patient–physician communication: composite communication score; 2(a) Physician’ awareness of patients’ QoL: V1 and V4, physicians and patients completed the COOP and the WONCA; 2(b) Patient management: composite patient management score; 2(c) Patient satisfaction: Patient Satisfaction Questionnaire C; Physicians’ satisfaction: “How satisfied were you with the communication with your patient during this visit?”; 2(d) Patients’ self-reported QoL: SF-36; 2(e) Patient evaluation of the intervention: patients completed a questionnaire and a brief telephone interview; 2(f) Physicians’ evaluation of the intervention: semi-structured interview.

1. V1 is baseline assessment for both arms. 2. ExpA: started at V2–V4; 2(a) The QLQ-C30 before each visit; 2(b) Graphic summary profile was given to patient and physician before consultation (current and previous scores); 2(c) Physicians received a single half-hour educational session on how to interpret the scores; 2(d) Patients received at home a pamphlet about QoL. 3. CtrlA: standard care and procedure.

10 Oncologists; Age: 35–53 years (mean age 44 years);

RCT (crossover design). 10 Physicians assigned randomly to experimental or control arm. For each physician, two cohorts of patients. Buffer period: 2 months within the two cohorts.

Edwards Score

Results

Outcome measures

Intervention

Participants

Study design

Table 1.  Characteristics and quality assessment of the included studies (N = 10).

Catania et al. 9

1. To compare changes in self-rated QoL in two patient groups in hospice setting before and after the intervention. 2. To compare nurses’ and patients’ ratings of patients’ QoL before and after the intervention.

1. To assess the impact of systematic and ongoing use of the Palliative Care Needs Assessment Guidelines (Guidelines) and the NAT: PD-C on patient outcomes including level of need (primary outcome), QoL, anxiety and depression (secondary outcomes).

Waller et al. (2012), UK33

1. To examine the effect of weekly completion of a patient-held QoL diary in routine oncology practice for PC patients.

Mills et al. (2009), UK31

Hill (2002), New Zealand32

Aims

Author, year, country

Table 1. (Continued)

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Sample size: 407.

Power (%): 80.

Interrupted time series design

Sample size: NA.

Power (%): NA.

Quasi-experimental design

Sample size: 100.

219 outpatient advanced cancer patients (demographic baseline data available for 198 patients; patients age: mean 66.1 years).

- 1 0 registered nurses with PC experience of at least 18 months in hospice setting; - 72 terminally ill patients; Patients age: 20–89 years.

115 newly diagnosed inoperable lung cancer patients. Patients age: mean 64 years.

RCT Power (%): 80.

Participants

Study design 1. ExpA: patients received a structured QoL diary (QLQ-C30 and the LC13) to complete at home each week for 16 weeks. 2. Patients were encouraged to share the QoL information with health professionals involved in their care. 3. The questionnaire layout was adapted to suit an A5 diary format covering a 4-week period. 4. The hospital team received basic training sessions from the researcher on the content and layout of the diary, whereas the primary care team received this information in written form via mail. 5. No training on how to interpret QoL data. 6. CtrlA: patients did not receive QoL questionnaire. 1. In both groups, QoL selfassessment using the MVQOLI questionnaire at T1 (within 3 days) and T2 (7–10 days later). 2. ExpA: T1 assessment used as a basis of care planning by patients and nurses. 3. CtrlA: standard therapy which includes the formation of care plans by nurses alone. Systematic use of Palliative Care Needs assessment Guidelines and NAT: PD-C. 1. Patients completed CATIs every 2 months over a period of 18 months or until their death or withdrawal: trained interviewers performed the CATI in assessing unmet needs, depression, anxiety, and QoL. 2. Healthcare professionals received an individual (medical staff) or group (nursing, allied healthcare professionals) training in the use of NAT: PD-C and the Guidelines after patients had completed at least two baseline CATIs including purpose, structure, potential barriers and strategies to address them.

Intervention

Primary outcome: - SCNS-SF34; -N  A-ACP: only 6 out of 132 items assessing spirituality. Changes in the percentage of patients reporting at least one moderate or high need. Secondary outcomes: -T  he EORTC QLQ-C30 only two global questions assessing overall health and overall well-being of the QOL; - HADS; Changes in the percentage of prevalence of 10% between preand post-intervention.

QoL change over time: QoL was significantly higher at T3 compared with T0.

Post-intervention: statistically significant reduction at T1: p < 0.05, T2: p < 0.05, and T3: p < 0.01.

Pre-intervention: highest health system and information needs.

Patients with moderate or high need(s)—T0: 64%, T1: 61%, and T2: 51% (p = 0.08).

QoL changes no statistically significant differences in the QoL subscales and overall QoL between groups. Changes within group, statistically significant improvement for - E xpA: symptoms (p < 0.05, ES = 0.47), function (p < 0.05, ES = 0.48), overall QoL (p < 0.001, ES = 0.40). - CtrlA: symptoms (p < 0.01). Patients’ needs: Highest levels of need in physical, daily living, and psychological domains.

Both groups reported high levels of satisfaction with their care.

Similar differences in overall PQLI score were observed between the two groups using AUC analysis (p = 0.04, ES = 0.56);

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No significant difference between the two groups in TOI scores (p = 0.14, ES = −0.38);

Primary outcome measure: - The TOI summary score; Secondary outcome measure: - The FACT-L; - The LCS; - The PLQI; -D  iary utilization: patients recorded in the diary whether or not they shared the diary information with any health professional;  ommunication and discussion -C of problems: patients were asked about general problem using a checklist and the PLQI section on communication; - S atisfaction with care: patients were asked six questions about their expectations and satisfaction with care using questions from previous studies in this area. The MVQOLI Mean FACT-L scores from baseline ExpA: −6.3 points; CtrlA: +3.5 points (p = 0.05, ES = 0.59);

Edwards Score

Results

Outcome measures

10 Palliative Medicine 29(1)

Jocham et al. (2009), German34

Author, year, country

1. To describe the feasibility of collecting QoL data in different PC settings. 2. To compare the outcomes and changes in a German sample of terminally ill cancer patients receiving palliative care.

Aims

Table 1. (Continued)

Longitudinal prospective study Power (%): NA. Sample size: NA.

Study design

121 advanced cancer patients (hospital: 64 patients; home care: 57 patients); Patient age: 35–94 years (mean age 63 years).

Participants

1. Patients completed the EORTC QLQ-C30 questionnaire within the first 24 h upon admission (T1) to the hospital unit or the palliative home-care services. 2. The EORTC QLQ-C30 7 days later (T2). 3. Patients received instruction on how to complete it. 4. Staff trained on completing the forms. 5. Staff gave patients their contact numbers as they were on-call.

3. Trained clinical staff, staff members from SPCSs and patients’ general practitioners completed NAT: PD-C monthly during their patient consultations. 4. Patients continued to complete bimonthly CATIs following the introduction of the intervention.

Intervention

1. The KPS. 2. The EORTC QLQ-C30.

Outcome measures

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Mean scores change in QoL for functional scales (SD): -P  hysical function—T1: 30.9 (24.4); T2: 35.8 (25.1) (p≤ 0.01, ES = 0.37); -R  ole function—T1: 21.7 (22.8); T2: 26.6 (24.6) (p≤ 0.05, ES = 0.30); - Emotional function—T1: 41.3 (23.2); T2: 51.8 (23.5) (p≤ 0.01, ES = 0.60); -C  ognitive function—T1: 58.6 (30.3); T2: 63.2 (25.7) (p≤ 0.05, ES = 0.27); - Social function—T1: 38.5 (29.9); T2: 48.5 (29.7) (p≤ 0.01, ES = 0.55).

Mean scores change in QoL for the eight symptom scales: - F atigue—T1: 72.5(21.1); T2: 64 (25.3) (p≤ 0.01, ES = 0.47); - Nausea/vomiting: T1: 46.3 (33.7); T2: 30.6 (30.0) (p≤ 0.01, ES = 0.63); -P  ain—T1: 60.7 (31.9); T2: 46.0 (30.6) (p≤ 0.01, ES = 0.68); -D  yspnea—T1: 61.5 (35.3); T2: 49.6 (35.6) (p≤ 0.01, ES = 0.51); - L ack of appetite—T1: 64.8 (29.5); T2: 55.4 (29.5) (p = < 0.01, ES = 0.47); -C  onstipation—T1: 36.6 (36.2); T2: 28.1 (32.0) (p≤ 0.05, ES = 0.33); -D  iarrhea—T1: 16.8 (31.1); T2: 11.6 (23.5) (p≤ 0.05, ES = 0.30).

No significant changes occurred in the percentage of clinically anxious participants. Mean scores change in global health (SD)—T1: 31.6 (19.1); T2: 38.2 (21.0) (p≤ 0.01, ES = 0.58).

Depression and anxiety: depressed patients increased significantly in the pre-intervention period; in the post-intervention, changes were not statistically significant.

No significant changes were found following the intervention.

Results

(Continued)

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Edwards Score

Catania et al. 11

Aims

1. To describe the implementation of the MSQ and its effect on patients and the staff in a Day Therapy Unit of Supportive and Palliative Care Center.

1. To assess the feasibility of daily ESAS administration by staff to identify a subgroup of patients with high symptom distress. 2. To identify the extent of moderate to severe symptom distress experienced. 3. To identify symptom changes at 48 h.

Author, year, country

Chapman et al. (2008), UK35

Brechtl et al. (2006), USA36

Table 1. (Continued)

Sample size: NA.

Power (%): NA.

Longitudinal prospective study

Sample size: NA.

46 late-stage chronic disease patients mostly with advanced AIDS (67%) Patient age: 30–85 years (median: 47.1).

Gender: 67% female

Patient age: 18–80 years

75 terminally ill patients

Longitudinal retrospective study Power (%): NA.

Participants

Study design 1. The MSQ: assessment of 10 psychosocial issues with a VAS and recorded on a 0–10 scale; 2. Patients assessment: twice at baseline and at week 12; 3. The MSQ completed by patient with a staff member present and results are discussed at the same time; 4. Verbatim comments written on the form; 5. Patients’ needs addressed by psychotherapeutic interventions, family work, individualized program (often 12 weeks). - Start-up period about using the ESAS; - Mode of delivery: (a) Physician was asked the surprised question; (b) Initially interview with the ESAS performed by day-shift nurses three times per day, then the protocol was changed to daily assessment; (c) ESAS score ≥ 5: treatment prescription.

Intervention

1. Feasibility parameters: (a) Completion rate: proportion of patients with completed assessment; (b) Time for assessment; (c) Acceptability for patients and nurses; (d) Staff training on the use of the ESAS. 2. The ESAS scores ≥ 5: moderate/severe symptom distress; 3. Symptom changes at 48 h.

Symptom changes at 48 h: pain (p = 0.001); tiredness (p = 0.004); wellbeing (p = 0.003); depression (p = 0.009); insomnia (p = 0.001).

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Change scores over time: significantly different for: “feeling frustrated” (p = 0.011, X = −2.537, ES = 0.673) (N = 20);

1. Changes score over time: the MSQ scores at baseline and at week 12. 2. Patient verbatim responses: assessment of whether patients’ qualitative responses correlate to the scores of questionnaire (high, medium, and low scores). 3. Staff comments.

“worry about pain” (p = 0.017, X = 2.396, ES = 0.533).

Edwards Score

Results

Outcome measures

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1. To assess whether or not the POS identified problem areas. 2. To demonstrate change over time in patient QoL. 3. To verify whether staff and patient ratings correlated. 4. To assess staff experiences of using the POS (before and after the intervention).

1. To describe the daily use of a system based on the VAS for symptom assessment in PC unit (inpatient).

Stevens et al. (2005), UK37

Bruera et al. (1991), Canada38 Sample size: NA.

Power (%): NA.

Longitudinal prospective study

Sample size: NA.

101 cancer patients; patient age: mean age 65 ± 13 years

30 advanced cancer patients Patients age: 25–91 years (median age 65 years) 48 staff members of 2 PC wards.

Longitudinal prospective study Power (%): NA.

Participants

Study design

- The ESAS; Mode of delivery: (a) Patients’ assessment twice per day (at 10:00 a.m. and 06:00 p.m.); (b) Data transferred to a symptom assessment graph—up to 21 days; (c) The ESAS completed by patient (un)assisted, nurse, relative; (d) Nurse team leader each morning decided as to who would be in charge of the assessment.

Symptom distress score: sum of the ESAS score for all symptoms (800 mm).

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Problem identified: four issues were scored as being important and had a significant improvement compared to baseline: - Pain (p < 0.05); - Other symptoms (p < 0.05); - Anxiety (p = 0.006); -P  atient’s perception of family anxiety (p < 0.05).

The POS questionnaire Staff opinion assessment questionnaire (how easy, relevant, and appropriate POS was to practice and patient population).

Patients’ and staff’ assessment with POS: at admission and then twice weekly until discharge (five assessments).

Change over time: overall patientassessed scores significantly improved by days 5–9 (p < 0.05). No further improvement. Mean symptom distress score: at admission = 410 ± 95; at day 5 = 362 ± 83 (p < 0.01, ES = 0.53).

Edwards Score

Results

Outcome measures

Intervention

QoL: quality of life; RCT: randomized controlled trial; NA: not available; ExpA: experimental arm; CtrlA: control arm; EORTC QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; COOP: The Dartmouth Primary Care Cooperative Information Functional Health Assessment; WONCA: The World Organization Project of National Colleges and Academics; SF-36: The Medical Outcomes Study 36-item Short-Form Health Survey; SD: standard deviation; RA(s): research assistant(s); PPS: Palliative Performance Scale; MSAS: Memorial Symptom Assessment Scale–Revised; HQLI-14: Hospice Quality of Life Index 14; IDT: Inter Disciplinary Team; SNI: Spiritual Needs Inventory; SPMSQ: Short Portable Mental Status Questionnaire; LC13: Quality of Life Questionnaire Lung Cancer; TOI: Trial Outcome Index; FACT-L: Functional Assessment of Cancer Therapy-Lung; LCS: Lung Cancer Symptom-specific Scale; PQLI: Palliative Care Quality of Life Index; PC: palliative care; MVQOLI: Missoula-VITAS Quality of Life Index; NAT: PD-C: Needs Assessment Tool: Progressive Disease–Cancer; CATIs: computer-assisted telephone interviews; SPCSs: specialist palliative care services; SCNS-SF34: Supportive Care Needs Survey–Short Form 34; NA-ACP: Needs Assessment for Advanced Cancer Patients; HADS: Hospital Anxiety and Depression Scale; DL: daily activities: KPS: Karnofsky Performance Status Scale; MSQ: Mood and Symptom Questionnaire; VAS: visual analog scales; ESAS: Edmonton Symptom Assessment System; AIDS: Acquired Immunodeficiency Syndrome; POS: Palliative Care Outcome Scale; ES: effect size.

Aims

Author, year, country

Table 1. (Continued)

Catania et al. 13

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Study designs and aims Study design comprised three randomized controlled trials (RCTs),30,31 and one of those was a crossover trial,28 all designed to evaluate the efficacy of a standardized QoL measurement; one quasi-experimental study designed to compare changes in QoL in two patient groups;32 and one interrupted time series study33 and five longitudinal prospective studies34–38 designed to identify patient’s needs, demonstrate a QoL change over time, and evaluate feasibility of QoL measurement among healthcare professionals (HPs). Only one study30 reported using a conceptual framework based on the model published by Emanuel and Emanuel39 and revised for such study to reflect the importance of the patient–caregiver dyad as the unit of care. The unit of randomization in RCTs in one study was the home-care team30 and for the remaining trials were the patients31 and the physicians.28 In all the three trials, data were mainly collected at individual patient level.

Quality of the evidence Overall, the quality of the evidence was found to be relatively moderate to low (Table 1). We identified three RCTs, and the remaining were mostly observational prospective studies with heterogeneity in study designs. One experimental study out of three30 and six observational studies out of seven did not report how sample size or power was determined.32,34–38 The observational studies were mostly suffered from limited number of subjects and observations (dropouts); only one study was retrospective in design.35 All of the observational studies used convenience samples32,33,35–38 except for Jocham et al.34 than randomly selected participants. Only one study34 provided effect size (ES). In addition, the attrition rates were high and predictable due to impaired conditions of the study populations. Regarding the experimental studies, only one RCT31 demonstrated adequate concealment. Determining whether attrition had an impact on the results, intention to treat analysis was used in only one study,28 and the other two RCTs used the area under the curve31 or random effect models.30

Populations and settings Four studies were conducted in the United Kingdom, two studies in the United States, and the remaining were set in Canada, the Netherlands, New Zealand, and Germany. Most of the studies (90%) included advanced-stage cancer patients, at any site,28,30–35,37,38 while the remaining study included mostly patients with advanced AIDS.36 The study population across studies was diverse and ranged in size from 30 to 709 participants; the median sample size was

108. Patients formed the study group in six studies, patients and HPs in three studies, and dyads of patients and caregivers in one study. The median proportion of female patients was 53%. The interventions were delivered either in outpatient,28,31,33,35 inpatient,32,36–38 home care,30 or combinations of these services.34

Effectiveness of interventions focused on QoL assessment Overall, the analysis of the single ES could be estimated for 5 out of 10 eligible studies,28,31,32,35,38 and it was primarily reported only in Jocham et al.34 The results of single ES for patients’ outcomes are presented in Table 2. All but one study31 showed a positive ES ranging from Cohen’s d = 0.27 (cognitive function) to Cohen’s d = 0.68 (pain symptom). Only one RCT examining the effect of weekly completion of a patient-held QoL diary on QoL showed a negative ES for overall QoL (d = −0.38), but the results have to be interpreted with caution because they did not reach statistical significance.31 A positive but small ES was revealed for the randomized trial of Detmar et al.28 for satisfaction and communication about QoL topic. The largest magnitude of effect was revealed in pain response (d = 0.68) in the observational study testing the feasibility of an intervention designed to compare QoL changes in terminally ill cancer patients receiving PC.34 At 7 days upon admission (T2), compared with baseline (T1), patients experienced significantly less pain (T1 mean: 60.7 (SD) = 31.9); T2 mean: 46.0 (SD = 30.6); p≤ 0.01).

Type of interventions and patients’ outcomes Four longitudinal prospective studies were mainly designed to study QoL assessment in daily practice: Brechtl et al.’s36 pilot study was designed to determine in 46 patients in a PC inpatient service both the feasibility of a routine nursing assessment protocol to active prompt treatment of symptoms using the Edmonton Symptom Assessment System (ESAS) and the symptom change over a 48-h time course after onset. The authors demonstrated that in the case of pain, tiredness, and well-being, prompt treatment led to significantly improved distress scores within 48 h. The ESAS was recognized feasible and informative for nurses. Bruera et al.38 focused on describing the daily use of the ESAS on 101 patients and the symptom change over a 5-day time course from admission; they reported a significant improvement in patients’ symptom distress. Stevens et al.’s37 pilot study was concerned with using on 30 patients the Palliative Care Outcome Scale (POS)—both patient and staff questionnaire—in daily practice and how it identified patients’ needs and QoL change over time in a PC unit. Such pilot study was also focused on ascertaining staff opinion of 48 staff members using the POS. A significant improvement in overall patient POS score at week 1 was

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Catania et al. Table 2.  Effect size of interventions focused on QoL assessment on patients’ outcomes. Outcome Overall QoL   Jocham et al.34  Hill32   Mills et al.31 Symptom   Bruera et al.38  Hill32   Jocham et al.34   Pain   Nausea/vomiting   Dyspnea   Fatigue    Lack of appetite   Constipation   Diarrhea Physical function  Hill32   Jocham et al.34 Emotional function   Jocham et al.34   Chapman et al.35   Feeling frustrated    Worry about pain Social function   Jocham et al.34 Role function   Jocham et al.34 Cognitive function   Jocham et al.34 Satisfaction   Detmar et al.28 Communication about QoL topic   Detmar et al.28

Study design

Sample (n)

Effect size

Longitudinal prospective Quasi-experimental Randomized controlled trial

121 36 74

0.58 0.40 −0.38

95 36 121 121 121 121 121 121 121

0.53 0.47   0.68 0.63 0.51 0.47 0.47 0.33 0.30

Quasi-experimental Longitudinal prospective

36 121

0.48 0.37

Longitudinal prospective Longitudinal retrospective

121 20 20

0.60   0.67 0.53

Longitudinal prospective

121

0.55

Longitudinal prospective

121

0.30

Longitudinal prospective

121

0.27

Randomized controlled trial

199

0.37

Randomized controlled trial

199

0.38

Longitudinal prospective Quasi-experimental Longitudinal prospective

QoL: quality of life.

shown. Pain, other symptoms, anxiety, and patient’s perception of family anxiety were scored as important for patients and significantly improved within the first week. Staff recognized that measuring outcomes was important. Jocham et al.34 aimed to describe the feasibility of collecting QoL data in different PC settings—hospital and home care—and QoL change over a 7-day period on 121 patients. They demonstrated improvement in symptoms and in each of the six functional dimensions included in the Quality of Life Questionnaire Core 30 (QLQ-C30) tool. The only longitudinal retrospective study included in this systematic review was concerned with describing implementation of the Mood and Symptom Questionnaire (MSQ) and its effect on 75 patients and staff’s perception of a day therapy unit delivering specialized psychotherapeutic interventions or family work.35 Over a 12-week period, change scores were significantly different for two

constructs: “feeling frustrated” and “worry about pain” on 20 patients. The quasi-experimental study with a before and after design had a twofold aim to compare changes in self-rated QoL in two patient groups (72 patients) in an inpatient hospice unit and to compare nurses’ and patients’ ratings of patients’ QoL. The intervention consisted of using baseline QoL assessment as a basis of care planning by patients and nurses.32 The author did not demonstrate statistically significant difference in change of QoL scores between groups at baseline and 7–10 days later. A statistically significant QoL improvement was shown within groups for symptoms (both groups), function, and overall QoL (intervention group only). In an interrupted time series study, Waller et al.33 compared how outcomes changed in 195 outpatients prior to and following the implementation of the Palliative Care Needs Assessment Guidelines and the Needs Assessment

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Tool: Progressive Disease–Cancer (NAT: PD-C). The intervention resulted in a significant reduction in “health system and information” and “patient care and support” needs. QoL was significantly higher at 6 months preintervention than at the baseline time point, and no significant changes were found following the intervention. The remaining three studies were RCTs. Detmar et al.28 included 214 patients and evaluated the efficacy of standardized QoL assessment using a graphic summary of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 responses in facilitating patient–physician communication and increasing physicians’ awareness of their patients’ QoL-related problems. The authors found that QoL issues were discussed significantly more frequently in the intervention when compared with patients in standard care and procedure, and physicians in the intervention group identified more patients with impaired QoL dimensions than did those in the control group. Of note, the authors in a secondary data analysis29 compared two approaches for interpreting QLQ-C30 scores, and they found that absolute scores identified patients’ most bothersome QoL issues better than change scores. Mills et al.31 recruited 115 patients and examined the effect of weekly completion of a patient-held QoL diary in routine oncology practice for PC lung cancer patients. The authors found no evidence of a significant difference in the primary outcome measure scores between the two groups. Over a 4-month period, the diary group had a poorer QoL in many dimensions. The majority of patients did not share their diary information with HPs. Both groups reported high levels of satisfaction with their care. The largest and the most recent RCT included30 was designed to improve hospice outcomes in 709 dyads of patients and caregivers; the authors found that a systematic feedback from standardized assessment tools in hospice home care significantly improved patient depression in the intervention group and patients’ QoL in both groups. Most of the studies reported using a set of outcome measures for use with PC patients. However, some studies used either validated measures,30,32,34,36–38 a non-validated author-developed tool,35 or a mix of them including checklists and tailor-made multiple-item measures using some items taken from existing questionnaires.28,31,33

Discussion As a result of our systematic review, the following evidence can be summarized: interventions focused on QoL assessment can have a moderate practical significance in patients with PC needs on symptoms,38 psychosocial dimension,34,35 and overall QoL.34 In 6 out of 10 studies, Cohen’s d effect was calculated or reported in the original article to determine the magnitude of the interventions on patients’ outcomes/QoL dimensions.

Although a moderate intervention effect on symptoms,38 psychosocial dimension,34,35 and overall QoL34 was found on three observational studies, they should be considered as prone to yield systematically greater estimates of intervention effects than randomized trials.40 All three RCTs included were heterogeneous in terms of outcomes measured, but the populations included were comparable. Two reported some positive effect and showed an improvement in the discussion of QoL issues related to psychosocial dimension, which commonly are underestimated or unaddressed by HPs.28,30 Systematic feedback from standardized QoL assessment tools showed greater improvement in depressive symptoms,30 and structured feedback from a QoL summary profile indicated a significant higher frequency with which unmet needs (i.e. social health, dyspnea, and fatigue) were discussed and higher patients’ satisfaction in the perceived emotional support received from HPs.28 The QoL summary profile implemented was useful in enhancing physicians’ awareness of patients’ problems in outpatient setting and in facilitating communication about QoL issues between the following dyads: patients and medical specialists, patients and their families, and patients and their primary care physicians.28 The exception resulting from the third included RCT31 was the poorer QoL in inoperable lung cancer patients who completed a patient-held QoL diary weekly compared to not receiving QoL assessments. Although baseline data between the two groups did not show significant differences, the authors indicated and discussed how the following QoL assessment–related factors negatively impact QoL: (1) raising patients’ awareness and expectations, (2) completing and holding at home the QoL diary spanning a 4-week period, which may raise negative repetitive thoughts of the patients—rumination,41 (3) lack of feedback and appropriate responses from HPs, and then (4) the response shift phenomena.7 Overall, observational studies’ results included in our review may suggest that patients receiving an intervention focused on QoL assessment experienced improvement in some QoL dimensions. However, they suffered from selection, performance, attrition bias, and small sample size. Particularly, in a time frame ranging from assessment at admittance to after 2–7 days, such studies showed a significant reduction in healthcare support and information patients’ needs,33 a moderate positive effect on physical, emotional, social function, and global health.34 They also indicated a significant improvement in symptom distress38 especially for pain, fatigue, well-being, and insomnia36 and in issues that were important for the patients such as pain, other symptoms, anxiety, and patient-perceived family anxiety.37 Differences in changes in QoL within groups were statistically significant for symptoms, function, and overall QoL,32 and for two psychological constructs: feeling of frustration and worry about pain.35

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Catania et al. It was not the purpose of this systematic review to examine palliative treatments delivered to patients as a consequence of QoL assessment; however, our results reinforce the need to incorporate patient’s perspective to PC teams’ discussions both to inform their work and to plan and deliver interventions according to patient’s priorities, preferences, and values.

Implications for research Future interventions may benefit from mainly considering that QoL measurement in PC practice is a complex intervention,11 and as such, research should be conducted (1) including validated QoL tools; (2) scheduling baseline assessment within 3 days from admittance and further assessment 7–10 days after; (3) training staff and educating patients and caregivers; (4) developing a practical way to share and discuss QoL results with patients and their caregiver immediately after performing QoL assessment (e.g. QoL summary profile); (5) using QoL measurement scores to design care plans to address patients’ needs involving, whenever possible, patients and their families in any case according to patients’ values and preferences; and then (6) identifying a coordinator who could undertake responsibility of the intervention within staff. To define and assess the growing needs of PC patients, further studies are necessary using well-defined frameworks such as the MRC framework20 and the Promoting Action on Research Implementation in Health Services (PARIHS)42 and the components identified in the Methods Of Researching End of life Care (MORECare) statement.43 A thorough exploration of interventions focused on QoL measurement would require rigorous studies with larger and more diverse in–out patient samples and multicenter trials, not only including advanced cancer patients but also patients with PC needs.

Limitations of the review Our review has some limitations. First, although three authors according to our eligibility criteria performed the study selection, we cannot be completely sure that we identify all relevant studies. Second, the restriction to the English language could represent a limitation, and it is possible that interventions published in overseas language journals were not identified. Third, the selected studies reported variability in the type of interventions and methodological approaches, thus it is difficult to compare results between studies, and generalizability could be compromised. The generalizability of the findings of the RCTs is limited because of the high attrition rate,30,31 high proportion of patients who refused to participate,31 small sample of a single setting, and likely carryover effect in the crossover trial.28

Observational studies were the most numerous in our review, but as they are prone to bias, results need to be interpreted cautiously.44 Differences in reporting and measurement of QoL dimensions also prevented pooling to allow overall ES estimation. Also, results can be biased by sampling, attrition, and performance bias. Although our review includes an RCT reporting negative findings, it is also possible that there is a publication bias in studies in this area.

Conclusion Overall, implementing interventions focused on QoL assessment in PC practice does result in improved patients’ outcomes. The results of our review should be interpreted with caution because they are based mainly on observational studies with weaknesses in their designs. However, the findings of our review could be used to further develop the QoL assessment principles in PC recently proposed by Catania et al.11 and to inform local procedures to identify and address patients’ needs in clinical practical settings, develop education–training programs for novice and expert HPs in PC, and promote further research in this area. Also, although the level of evidence is limited, results might contribute to a more close professional relationship between HPs, patients, and their families along the disease trajectory through a slightly more confidence that the QoL measurement can improve PC patients’ outcomes in terms of physical (e.g. pain), psychological, and social dimensions, and overall QoL. Finally, our findings might have important implications as being part of the wider impulse to advance PC outcome measurement research agenda, as fostered in the outcome measurement in PC’s guidance drew up by the PC experts of the European PRISMA project,45 and in the two following latest summaries: the systematic review of tools, which measure QoL in PC setting,15 and more recently in the systematic review of facilitators and barriers in implementing outcome measurement in PC.16 Declaration of conflicting interests The authors declare that there is no conflict of interest.

Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

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Appendix 1 Database: PubMed (http://www.ncbi.nlm.nih.gov/pubmed) Date: no limits/last searched April 2012 Total: 4805 Strategy: (quality of life[mesh] OR “quality of life”[tiab] OR “well being”[tiab] OR QOL[tiab] OR “outcome measure”[tiab]) AND (measure[tiab] OR measures[tiab] OR measuring[tiab] OR measurement[tiab] OR assessment[tiab] OR model[tiab] OR models[tiab] OR modeling[tiab] OR method[tiab] OR methods[tiab] OR methodology[tiab] OR instrument[tiab] OR instruments[tiab] OR procedure[tiab] OR procedures[tiab] OR program[tiab] OR programs[tiab] OR system[tiab] OR systems[tiab] OR tool[tiab] OR tools[tiab] OR models, theoretical[mesh] OR evaluation[tiab] OR outcome assessment[mesh] OR “patient reported outcome*”[tiab]) AND (palliative care[mesh] OR palliat*[tiab] OR terminal care[mesh] OR terminally ill[mesh] OR hospices[mesh] OR hospice care[mesh] OR respite care[mesh] OR “end of life”[tiab] OR hospice*[tiab] OR terminal*[tiab] OR “advanced disease*”[tiab] OR “dying patient*”[tiab]) NOT (animals[mesh] NOT humans[mesh]) NOT (child[mesh] OR infant[mesh] OR adolescent[mesh] OR addresses[pt] OR biography[pt] OR case reports[pt] OR comment[pt] OR directory[pt] OR editorial[pt] OR festschrift[pt] OR interview[pt] OR lectures[pt] OR legal cases[pt] OR legislation[pt] OR letter[pt] OR news[pt] OR newspaper article[pt] OR patient education handout[pt] OR popular works[pt] OR congresses[pt] OR consensus development conference[pt] OR consensus development conference, nih[pt] OR historical article[pt] OR in vitro[pt]) AND English[la] Database: EMBASE (http://www.elsevier.com/online-tools/embase) Date: no limits/last searched April 2012 Total: 2105 (400 excluding MEDLINE duplicates) Strategy: (“quality of life”:de,ab,ti OR “well being”:ab,ti OR “well-being”:ab,ti OR qol:ab,ti OR “outcome measure”:ab,ti) AND (measure:ab,ti OR measures:ab,ti OR measuring:ab,ti OR measurement:ab,ti OR assessment:ab,ti OR model:ab,ti OR models:ab,ti OR modeling:ab,ti OR method:ab,ti OR methods:ab,ti OR methodology:ab,ti OR instrument:ab,ti OR instruments:ab,ti OR procedure:ab,ti OR procedures:ab,ti OR program:ab,ti OR programs:ab,ti OR system:ab,ti OR systems:ab,ti OR tool:ab,ti OR tools:ab,ti OR “theoretical model”/exp/mj OR evaluation:ab,ti OR “outcome assessment”/exp/mj OR “patient reported outcome”:ab,ti OR “patient reported outcomes”:ab,ti) AND (“palliative therapy”/exp/mj OR “terminal care”/exp/ mj OR “terminally ill patient”/exp/mj OR “hospice”/exp/mj OR “hospice care”/exp/mj OR “respite care”/exp/mj OR “end of life”:ab,ti OR hospice*:ab,ti OR terminal*:ab,ti OR “advanced disease”:ab,ti OR “advanced diseases”:ab,ti OR “dying patient”:ab,ti OR “dying patients”:ab,ti) AND ([article]/lim OR [article in press]/lim OR [review]/lim) AND [humans]/lim AND [english]/lim NOT ([embryo]/lim OR [fetus]/lim OR [newborn]/lim OR [infant]/lim OR [preschool]/lim OR [school]/lim OR [child]/lim OR [adolescent]/lim) AND [embase]/lim NOT [medline]/lim AND [90% of patients enrolled/approached 1: 80%–90% of patients 0: