We had difficulty rating risk of attrition bias for the Zimmermann 2014 study, in which higher attrition in the intervention group reached borderline significance over the control group. Khatib J, Timelag bias would lead to overestimation of true effect sizes. We assessed methods as having low risk of bias (telephone or central randomisation, consecutively numbered sealed opaque envelopes) or unclear risk of bias (method of allocation concealment not clearly stated). We made a closecall decision favouring low risk of other bias, as high risk of selection bias was already detected. Higher percentages suggest greater observed heterogeneity. Meerbeeck JP. Temel JS, Back A, For example, within the recursive cumulative metaanalysis approach, a metaanalysis performed at the end of each year for studies ordered chronologically notes changes in the summary effect (Borenstein 2009). et al. 2. Topics on the checklist were adapted from the Temel 2010 trial. Bostwick JM, We ultimately conducted available case analyses and included data only on cases for which results are known (Higgins 2011d). Dibble SL, To explore heterogeneity, we conducted a categorical subgroup analysis for 'models of early palliative care (solo practice, coordinated care, integrated care)'. Blinding of outcome assessment is essential, as is its explicit reporting in publications. DallAgata M, Lawyers: To make your wishes clear, you can use two different legal forms called "advance directives.". We combined different scales measuring this outcome of interest across studies by applying SMDs. However, accounting for imbalance in statistical analysis did not change results. Emergency departmentinitiated palliative care for advanced cancer patients: protocol for a pilot randomized controlled trial. American Society of Clinical Oncology statement: toward individualized care for patients with advanced cancer, Has CONSORT improved the reporting of randomized controlled trials in the palliative care literature? Palliative care: needs of advanced breast cancer patients Minimal clinically important differences in the Edmonton Symptom Assessment Scale in cancer patients: a prospective multicenter study. Six of the seven studies listed quality of life as a primary outcome, although Bakitas 2015 did not differentiate between primary and secondary outcomes and also targeted quality of life as a study outcome. Effect of early palliative care on chemotherapy use and endoflife care in patients with metastatic nonsmallcell lung cancer. This systematic review of a small number of trials indicates that early palliative care interventions may have more beneficial effects on quality of life and symptom intensity among patients with advanced cancer than among those given usual/standard cancer care alone. No genuine early palliative care intent, No explicit focus on physical domain/symptom control. Altman DG, According to the latest consensus definition of palliative care, such treatment is called 'early' when it is administered within eight weeks of diagnosis of advanced cancer (Ferrell 2017). workforce challenges) differ between countries (Gaertner 2015; Hui 2015a; Janssens 2016). More financial support from Government for palliative care from 2024 Phillips J, Judgement: N = 60 completers in intervention group vs N = 47 completers in control group (Fisher's exact test with 2tailed P value at 0.07). Early palliative care for patients with metastatic nonsmallcell lung cancer. Tassinari D, Parikh 2013 mentioned the Bakitas 2009, Temel 2010, and Zimmermann 2014 trials and drew similar conclusions, emphasising that early provision of specialty palliative care [] lowers spending", and that "more evidence is needed to show the potential gains of early palliative care in other populations. Incurable cancer, which often constitutes an enormous challenge for patients, their families, and medical professionals, profoundly affects the patient's physical and psychosocial wellbeing. Positive SMDs reflect harm (higher symptom intensity); negative SMDs indicate benefit (lower symptom intensity). How systematic reviews cause research waste. The test for subgroup differences indicated that the difference was not statistically significant (P = 0.51). We have to interpret current results with caution owing to very low to low certainty of current evidence and betweenstudy differences regarding participant populations, interventions, and methods. Cassel B, Early palliative care for patients with metastatic nonsmallcell lung cancer in Khyber Pakhtunkhwa. Most of the studies included participants older than 65 years of age on average, diagnosed with different tumour types and receiving treatment in tertiary care centres in North America. Drawing on a comprehensive literature search with assistance from the PaPaS Group, we were able to minimise availability, familiarity, and citation bias for records more difficult to detect. We tailored searches to individual databases. Abstract Full Text PDF Figures and Tables The evidence base demonstrating the benefits of an early focus on palliative care for patients with serious cancers, including advanced lung cancer, is substantial. However, trial registration was conducted after recruitment of participants. Hurria A, 11 th ed. Woodcock J, Tosteson T, Lennes IT, Recruitment is a major challenge in the palliative care context, justifying more pragmatic methods such as cRCTs (median attrition rate at 40%, according to Zimmermann 2008). Cella D. General population and cancer patient norms for the Functional Assessment of Cancer TherapyGeneral (FACTG), Systematic review: the relationship between clinical experience and quality of health care, Statistical Power Analysis in the Behavioral Sciences. Walczak A, Disclaimer: The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of the NIHR, the National Health Service (NHS), or the Department of Health. People with cancer may receive palliative care at any time from the point of diagnosis, throughout treatment, and beyond. Sydes MR. Alesi ER, However, study did not follow a proactive palliative care intent as characteristic for early palliative care, Psychosocial intervention applying narrative interviews. Bottomley A, Effects of a problemsolving intervention (COPE) on quality of life for patients with advanced cancer on clinical trials and their caregivers: simultaneous care educational intervention (SCEI): linking palliation and clinical trials. Subgroup analyses are in their nature entirely observational and may include potential bias through confounding by other studylevel characteristics. Lowery AW, Fliedner MC, most participants had to be enrolled shortly after diagnosis of advanced disease.' Compared with usual/standard cancer care alone, early palliative care significantly improved healthrelated quality of life at a small effect size (SMD 0.27, 95% confidence interval (CI) 0.15 to 0.38; participants analysed at post treatment = 1028; evidence of low certainty). In contrast, Temel 2010 focussed on exclusive enrolment of participants with metastatic nonsmall cell lung cancer, whereas Maltoni 2016 focussed on exclusive enrolment of participants with metastatic pancreatic cancer. Friedman R, However, referral to or application of palliative measures are not usually offered actively to all patients. For clusterrandomised trials, we applied the methods described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011d). We claim that we arrived at a meaningful summary but underscore that evidence for most outcomes lacks adequate robustness at this point. Jacobsen J, Redd WH. Temel 2010 reported that participants assigned to early palliative care achieved significantly lower symptom intensity on the LCS of the FACTL at three months (estimated mean 21.0 with an SD of 3.9 for the early palliative group vs 19.3 with an SD of 4.2 for the standard care group), which translates into an SMD or effect size of g = 0.42 with an SE of 0.2. The intervention followed a telehealth concurrent palliative care model, commencing within 30 to 60 days of an advanced cancer diagnosis, cancer recurrence, or progression. Please see Appendix 1 for the full MEDLINE search strategy in OVID, and see Appendix 2, Appendix 3, Appendix 4, Appendix 5, and Appendix 6 for all other search strategies. Boyle FM, Boyer MJ, Fayers P, No genuine early palliative care intent, Aerobic exercise, resistance or respiratory training only. Inclusion of only a few studies in this review impeded examination of a priori hypotheses about possible effect modifiers. In the Methods section, we documented our decision to conduct a subgroup analysis for two different models. et al. Heist RS, Jensen W, Participants' quality of life and symptom burden will be assessed at the initial palliative care consultation on the POS, the EORTC QLQC30, and the HADS. Levy MH, To account for use of different scales across studies, we used SMDs as effect measures for continuous data for the primary outcomes healthrelated quality of life, depression, and symptom intensity. Greer JA, Jackson VA, The lifetime MediSave limit of $2,500 will also be lifted for all home palliative care and day hospice patients using their own MediSave, regardless of their conditions. Hull JG, Lidocaine infusion was an effective and safe intervention in both cases of malignant visceral pain in patients with advanced cancer with . Forest plot of comparison: 1 Early palliative care vs standard oncological care, outcome: 1.6 Symptom intensity (sensitivity analysis for study design including RCTs only). Appointments and interventions were oriented by general palliative care guidelines introduced by the US National Consensus Project. Hull J, Prigerson HG, For blinding of outcome assessment, we did not find necessary information in publications for five of the seven included studies (Bakitas 2009; Maltoni 2016; McCorkle 2015; Tattersall 2014; Temel 2010); one study stated that assessors were blinded (Bakitas 2015), and one that they were not (Zimmermann 2014). Gotay CC, Malignant visceral pain is a common symptom in palliative care, often linked to progressive disease and a poor prognosis. Agar M, Liberati A, We expect that in future updates of the review, when more studies on early palliative care have been published, we will be able to explore reporting biases by comparing fixedeffect and randomeffects estimates or L'Abb plots as a visual method of assessing differences in results of individual studies. Wheeler DS, Buss MK, Friederich HC, Le LW, Maltoni 2016, when applying the TOI of the FACTHep, detected higher quality of life for the early palliative care group than for the control group at three months (estimated mean 84.4 with a standard deviation (SD) of 16.3 for early palliative care vs 78.1 with an SD of 21.3 for control), which translates into an SMD or effect size of g = 0.33 with an SE of 0.18. Temel JS, Bakitas M, Results of our review do not support that early palliative care leads to prolonged survival in general. In addition, early palliative care decreases symptom intensity by on average 0.23 standardised mean deviations over controls. Idrees M, Patients with advanced breast cancer and their families have complex needs that have to be addressed in order to minimize severe distress and deterioration in the quality of life of patients and their family members. The most relevant time points used to measure outcome were "medium term" (one to four months after initiation of early palliative care) for selfrated outcomes, and "long term" for survival. Raz DJ, Age and gender moderate the impact of early palliative care in metastatic nonsmall cell lung cancer. et al. Early integration of palliative care services with standard oncology care for patients with advanced cancer. Lindschou C, Uncertainty of findings is almost certainly a result of the small number of studies completed in this newly emerging field, in which many studies are ongoing or have been initiated only recently. Beckett LA. Globally, the most common entities and causes of cancerrelated mortality, measured as disabilityadjusted lifeyears (DALYs), are breast cancer in women and lung cancer in men. Glasziou P, Park ER, Often, early palliative care is combined with anticancer treatment such as chemotherapy or radiotherapy. Use of a simple kappa statistic for interrater variation with regard to study inclusion amounted to = 0.60, which indicated good agreement (Higgins 2011b). However, given the current state of the literature, we cannot completely determine the reason for dispersion in effects. Lesperance M, For healthrelated quality of life, higher scores reflected benefit, but for depression and symptom intensity, higher scores indicated harm, and lower scores suggested benefit. Balboni TA, At the very least, metaanalysis provides clear descriptions and transparency. Randomized controlled trial of a structured intervention to facilitate endoflife decision making in patients with advanced cancer. Random sequence generation (checking for possible selection bias): We assessed the method used to generate the allocation sequence as having low risk of bias (any truly random process, random number table, computer random number generator) or unclear risk of bias (method used to generate sequence not clearly stated). Tambin, pueden ayudarte a sobrellevar los efectos secundarios de los tratamientos mdicos. In the 'Types of interventions' section, we specified as an additional inclusion criterion 'An early palliative care intent had to be stated explicitly or be reflected in the sample composition, i.e. MEDLINE (Medical Literature Analysis and Retrieval System Online) via OvidSP 1946 to 11 October 2016. Raz DJ, Palliative interventions applied early, around the time of diagnosis of incurable advanced cancer, may be more favourable for improving symptom and disease management (Levy 2016), leading some investigators to believe that a paradigm shift has occurred (e.g. Strasser F, A prerequisite for palliative care in such an early situation is readiness of health care professionals to engage in coherent and empathetic communication with the patient (de Haes 2005; Dowsett 2000; Meyers 2003; Morrison 2004; Sinclair 2006). Thus, a simple replacement method did not seem adequate. Overview Despite progress in developing treatments that have improved life expectancies for patients with advanced-stage cancer, the American Cancer Society estimates that 609,820 Americans will die of cancer in 2023. This may include referral to or application of palliative measures at any time along the disease trajectory as initiated by an oncologist, patient, or family member. Lennes IT, 14. For reasons of completeness, we reported results on outcomes in the review that had not been prespecified in the protocol (i.e. Zimmermann 2014 provided data for 151 caregivers in total (McDonald 2016). Interventions should be described under the different models proposed for early palliative care, and frequency and duration of treatment should be stated. Davey Smith G, Thoonsen B, Certainty of the evidence for quality of life and symptom intensity was low. Temel JS, For caregivers, Zimmermann 2014 observed improved satisfaction with care in the early palliative care group compared with the control group at three months (mean change from baseline 1.4 with 95% CI 1.2 to 4.1 vs mean change from baseline 3.1 with 95% CI 6.6 to 0.3; P = 0.007) and at four months (mean change from baseline 0.6 with 95% CI 2.6 to 3.8 vs mean change from baseline 2.4 with 95% CI 5.1 to 0.2; P = 0.02) (McDonald 2016). Given this baseline imbalance, recruitment bias may be present. MD (Professor of Medicine). Rabow MW, Haun MW, Engels Y, Vanbutsele G, Cruz M, (randomized controlled trial OR controlled clinical trial OR placebo OR randomly OR trial) AND ((palliate* OR (terminal* AND ill*) OR (terminal* AND caring) OR (terminal* AND care*) OR bereave* OR hospice*) OR euthanas* OR (attitude* AND death*) OR (assist* AND death*) OR (assist* AND die*) OR (assist* AND suicide*) OR (help* AND death*) OR (help* AND die*) OR (help* AND suicide*) OR (aid* AND death*) OR (aid* AND die*) OR (aid* AND suicide*) OR (right* AND die*) OR (respite AND care*) OR (respite AND caring) OR (living AND will*) OR (advance* AND directive*) OR (advance* AND care AND plan) OR (end of life AND care) OR (end of life AND caring) OR ((chemoth* AND (induced AND vomiting)) OR (chemoth* AND (induced AND sickness))) OR (chemoth* AND (related AND sickness)) OR (chemoth* AND (related AND vomiting))) OR ((induced AND hypersalivation) OR (induced AND hyposalivation)) OR (induced AND xerostomi*) OR ((induced AND cachexi*) OR (related AND cachexi*)) OR ("terminal* ill*"AND "symptom* management"))) OR (((anorexi* AND cancer*) OR (anorexi* AND carcinoma*)) OR ((anorexi* AND radiotherap*)))) OR Search (((cancer AND weightloss) OR (cancer AND weight AND loss) OR (cancer AND weight AND losing) OR (carcinoma* AND weightloss) OR (carcinoma* AND weight AND loss) OR (carcinoma* AND weight AND losing))) OR ((((cancer AND weightgain*) OR (cancer AND weight AND gain*) OR (carcinoma* AND weightgain) OR (carcinoma* AND weight AND gain*)))) OR (((cancer AND appetite AND stimulat*) OR (carcinoma* AND appetite AND stimulat*))) OR (((appetite AND stimulat*) OR ((cancer AND hot AND flush*) OR (cancer AND hot AND flash*)) OR (related AND cachexi*) OR (neoplastic AND cachexi*) OR ((induced AND constipat*) OR (induced AND emesis)) OR (opioid AND induced) OR (morphine AND induced) OR (methadone AND induced) OR (cancer or carcinoma* AND music AND therapy) OR ((cancer or carcinoma*) AND ((aroma AND therapy) OR aromatherapy))) OR ((dysphag* AND cancer) OR ((symptom AND control AND (cancer OR carcinoma*)) OR (radiotherap* AND induced) OR (chemotherap* AND induced) OR (radiotherap* AND related) OR (chemotherap* AND related) OR ((cancer AND related) OR (carcinoma* AND related)) OR (anorexi* AND radiochemotherap*))) AND ((best AND support*) OR (optim* AND support*) OR (best AND care) OR (best AND treatment*) OR supportive care)((best AND support*) OR (optim* AND support*) OR (best AND care) OR (best AND treatment*) OR supportive care) AND (early AND OR timely OR proactive OR (early AND care) OR (early AND treatment*) OR (early AND medicine* OR (early AND surgery) OR (early AND therapy)) AND (cancer OR neoplasm* OR tumor* OR tumour* OR malignan*). On the other hand, palliative care is linked to less aggressive cancer treatment, such as reduced use of questionable chemotherapy and less treatment time in intensive care units (Earle 2008). Dobbins TA, We considered for inclusion only studies of adults, 18 years of age and older, and we excluded studies of adults given the diagnosis during childhood and of people already in the terminal phase of illness (predicted survival of less than three months with eligibility for hospice care) at study enrolment. Gath J, Hurria A, We made a closecall decision favouring low risk at this point against unclear risk of bias, Parallel group clusterrandomised controlled trial (cRCT), Quote: "Eligible patients were randomised for a maximum of 8 weeks after diagnosis and before anticancer treatment to one of the two groups on a 1:1 allocation rate. We removed duplicate records electronically through Endnote X6 and manually after checking study authors, titles, and abstracts. We analysed timetoevent data (survival duration) as death hazard ratio under the proportional hazards assumption that hazard ratio was constant across the followup period. To the best of our knowledge, no minimal clinically important difference has been defined for overall ESAS score. This is close to the minimal clinically important difference of 5 points on the 0 to 108 FACTG scale (Brucker 2005). We assessed risk of bias using the Cochrane 'Risk of bias' tool (see Figure 2 and Figure 3) (Higgins 2011c). Separate randomisation lists using a permuted block balanced procedure were generated for each participating centre", Quote (reply received from principal investigator): "The random assignment was done by a telephone call to the Biostatistics and Clinical Trials Unit of the coordinating center in Meldola using computergenerated randomization lists of permutated blocks of varying sizes stratified for participating center. Wolfson JA, Sullivan F, We regarded an I2 statistic exceeding 75% as considerable (Higgins 2003). When raters disagreed regarding study eligibility, we reached consensus or referred the question to an arbiter (MH). Trend toward higher attrition in the control group, Quote from main publication: "Randomisation was done by the statistical team at Western University (London, ON, Canada) using a computergenerated sequence, was in a 1:1 ratio, and was stratified by clinic size and tumour site []", Quote from main publication: "There was also selection bias, which is common in clusterrandomised studies because of randomisation of clusters before consent of individuals. For metaanalysis of continuous outcome variables using standardised mean differences (SMDs), we extracted mean values and standard deviations of outcome measurements, as well as the number of participants included in each intervention group. MWH: none known; MWH is an internal medicine physician (internist) and a junior research group leader in mental health services research. Kohl S, Helfand M, Available evidence of very low to low certainty suggests that patients with advanced cancers could benefit from early palliative care with respect to small improvements in quality of life and symptom intensity. ColonOtero G. A nurse practitioner directed intervention improves the quality of life of patients with metastatic cancer: results of a randomized pilot study. owing to metastatic disease or inoperability, or both). Palliative care - Mayo Clinic Schofield P, However, according to our results, these claims were likely to be at least premature for the entire group of patients with advanced cancer. Blinding of personnel was neither mandatory for inclusion nor necessary for risk of bias assessment because blinding usually is not feasible in palliative care studies (Piggott 2004); however, we assessed blinding of outcome assessment while assessing risk of bias (Movsisyan 2016a). Grassi L. The experience of cancer in advanced phases of illness: Italian CALM project. high risk of bias) with regard to a point estimate provided evidence of limited certainty and therefore were downgraded in the next step (Guyatt 2011a). Idrees F, To ensure reproducibility of judgements regarding studies to be included, two unblinded raters (MWH and SE) again independently assessed fulltext documents and agreed on which studies should be included in the review. Bhatia S. Impact of care at comprehensive cancer centers on outcome: results from a populationbased study. MT received personal consulting fees from Lilly, Novartis, Roche, AstraZeneca, Pfizer, Boehringer, and BMS in 2014; from Lilly, Novartis, Roche, AstraZeneca, BMS, MSD, Pfizer, Boehringer, and Celgene in 2015; and from Lilly, Novartis, Roche, AstraZeneca, BMS, MSD, Pfizer, Boehringer, and Celgene in 2016 for attending boards. Seibel K, Temel 2010 found longer survival for the early palliative care group (median survival 11.6 months with 95% CI 6.4 to 16.9) than for the control group (8.9 months with 95% CI 6.3 to 11.4), which translates into an adjusted HR of 0.59, with P = 0.01, or an unadjusted HR of 0.63, with P = 0.02 (unpublished data received from study authors upon request), favouring the early palliative care group. [ 1] People with cancer die under various circumstances. Paediatric palliative care specialist Bronwyn Sacks works between the Royal Children's Hospital and Monash Health. Palliative Care. Helft PR, Impact of early palliative care on caregivers of patients with advanced cancer: cluster randomised trial. Oza A, Gough K, Planned interim analysis did not show the expected benefit of intervention A over B (effect size <0.2). You can get palliative care to avoid or to treat side effects from your cancer. Consequently, we did also not incorporate results of the risk of bias assessment in sensitivity analyses limited to highquality studies. Keller M, At three months, Maltoni 2016 did not find any difference in the proportion of depressed participants, as determined through the HADSD (estimated mean 6.35 with an SD of 4.09 for the early palliative group vs 7.41 with an SD of 4.23 for the delayed group; unpublished data received upon study author request), which translates into an SMD or nonsignificant effect size of g = 0.25 with an SE of 0.18. In cases of advanced cancer, early palliative care is provided alongside active disease treatment such as chemotherapy or radiotherapy. We identified 10 studies that had been completed at the time of the search. We prepared a highly sensitive literature search strategy by which to identify eligible studies. ((singl$ or doubl$ or trebl$ or tripl$) adj3 (blind$ or mask$)).tw. However, recommendations made by the palliative care expert on decisionmaking processes had to be shared with the attending oncologist. Trajectories of Health-related quality of life in patients with Forest plot of comparison: 1 Early palliative care vs standard oncological care, outcome: 1.5 Healthrelated quality of life (sensitivity analysis for study design including RCTs only). Temin S, Phase II study: integrated palliative care in newly diagnosed advanced nonsmallcell lung cancer patients. Akl EA, Findings indicate small effects at most along with evidence of very low to low certainty across outcomes. Buchheidt D, Park JC, This difference was not statistically significant. Furberg CD, Webster K, KIm JY, As the next step, two review authors (MWH and SE) independently assessed search results and excluded records that obviously did not fulfil inclusion criteria.
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