Alexandru C. Grigorescu Senior research degree I, MD, PhD Institute of Oncology Buchraest. ESMO SNOMR Symposium Bucharest April 2015

Transcription

1 Alexandru C. Grigorescu Senior research degree I, MD, PhD Institute of Oncology Buchraest ESMO SNOMR Symposium Bucharest April 2015

2 Topics of discussion: 1.Why is Palliative Care Research Needed? 2. An overview of the of the research process 3.Ethical and practical issues 4.Types of research 5.Using appropriate measures Assessment tools 6. Symptom measurement and assessment

3 By 2030, 20 percent of the United State's population will be over age 65. For most, the years after age 65 are a time of good health, independence, and integration of a life's work and experience. Eventually, most adults will develop one or more chronic illnesses with which they will live for years before death. These years are characterized by physical and psychological symptom distress; progressive functional dependence and frailty; and high family support needs. Recent studies suggest that medical care for patients with advanced illness is characterized by inadequately treated physical distress; fragmented care systems; poor communication between doctors, patients, and families; and enormous strains on family caregiver and support systems.

4 Unlike other areas of medicine, however, the knowledge base to support the basic elements of palliative care clinical practice (i.e., pain and symptom management, communication skills, care coordination) is small and inadequate and systems of care that truly support the needs of patients and families have yet to be developed.

5 Research is important in any area of science, health, and medicine to help professionals find new observations, understandings disease, and treatments. Palliative care is a relatively new field and could be a challenge for researcher clinicians. The research should be a systematic investigation or evaluation, done with a clear purpose or objective, based on observable experience in an unbiased way, leading to the possible or probable answer to the investigative question. The research should be such that is of benefit or definite implications like either adding to existing knowledge, providing better understanding of a phenomenon, or a new finding or intervention. Indian J Palliat Care Jan; 17(Suppl): S4 S7.doi: /

6 Before thinking about undertaking a piece of research it is helpful to have an idea of what steps are involved and the kinds of issues that may have to be considered along the way. It is a good idea to identify potential collaborators and sound out some ideas with others before beginning. Though these are set out in a flowchart, the stages do not necessarily follow on from each other in a straightforward fashion, since many stages will overlap or happen simultaneously, and the exact order in which things happen will depend on circumstances.

7 RESEARCH PROCESS Identify a research idea and come up with a hypothesis Undertake a literature review Design the study Write a research proposal Obtain funding Gain appropriate approvals for your research Collect and collate research data Analyze and interpret the data Write up research Disseminate research findings

8 3.Ethical and practical issues 1.Ethical issues in clinical trials 2. Ethical issues in qualitative research In PC clinical trials(ct) provide evidence for effectiveness, efficiency and tolerance of clinical interventions. One of the important issues in PC is that clinical research has not evolved at the same pace as clinical and educational PC program. By extending PC trials we could create the premise to improve the evidence base PC intervention.

9 Ethical principles Beneficence is the obligation to further the welfare or wellbeing of others and also includes the obligation to prevent and remove harms and to wait and balance risks and benefits of the action. Non maleficence It refers to avoiding the affection of evil or harm and promoting good. Autonomy refers to the potential of the individual to be selfdetermining, and include recognizing a patient s capability and perspectives, including his or her rights to hold views, to make choices and to take actions based on the personal values and beliefs. Justice refers to how benefits and burdens are distributed among all members of society.

10 Recent years have seen a dramatic increase in palliative care research. This growth has created a heterogeneous field that encompasses both qualitative and quantitative techniques, and descriptive as well as interventional study designs. Despite the valuable knowledge that has been produced by this research, and the promise of future important advances, its progress has been impeded by a persistent uncertainty about the ethics of these studies. David Casarett, DOI: /med/

11 Five ethical aspects of palliative care research that investigators and clinicians should consider in designing and conducting palliative care research. These include: 1) the study s potential benefits to future patients; 2) the study s potential benefits to subjects; 3) the study s risks to subjects; 4) subjects decision making capacity; and 5) the voluntariness of subjects choices about research participation.

12 Epidemiological research Quantitative research, Methodology Qualitative Research Other types of research

13 Epidemiological research methods Refers to the observational and quasi experimental designs. All study design have in common the aim to obtain the highest degree of internal validity from their results. Internal validity is the degree to which the results of a study are likely to be true and free of bias.

14 Kleinbaum: 1. Observational 2. Quasi experimental Artificial manipulation of the study factor 3. Experimental Artificial manipulation of the study factor + Randomization (treatment or an intervention)

15 OS: Descriptive (D) Analytic(A) D: estimate the frequency of a disease, symptoms or problems in a population and in a different subgroups. This kind of study is useful when little is known about a problem, or little is known about the occurrence of a known problem. (Ex.: the proportion of occurrence of pain, communication problems etc.) A: examine an association between a dependent variable and one or more independent variables Possible causative factors are examined. Independent variable: characteristic of patient or of the disease, therapy, intervention. Dependent variable: outcome of interest(pain control, satisfaction, one or more dimensions of quality of life)

16 QES is a study in which an intervention is deliberately introduced to observe its effect(the artificial manipulation of the study factor) without using randomization to create the comparison from which the effect are inferred.

17 Meta analysis is a method which uses statistical techniques to combine the results from previous independent studies to give a quantitative estimate of a particular intervention or variable on a defined outcome. A meta analysis is likely to produce a stronger conclusion than can be provided by any one individual study. Systematic Review A systematic review is a review of previous research that aims to be principled, methodical and explicit. It addresses a clearly defined research question and uses explicit and standardized methods to identify and review the literature. It involves objective means of searching the literature, applying predetermined inclusion and exclusion criteria to this literature, critically appraising the relevant literature, and extraction and synthesis of data from the evidence base to formulate findings. Scottish Partnership for Palliative Care ( ) or by downloading from

18 Randomised Controlled Trial (RCTs) evaluate the effectiveness and safety of healthcare interventions by giving different interventions to different groups of patients and comparing the effects of these interventions over time. The RCT is the most common type of clinical trial, and is designed to compare two treatments by randomly allocating a treatment to participants in the trial and then monitoring the effects of each. Cohort Study A cohort study compares a particular outcome (such as asthma) in groups of individuals who are alike in many ways but differ by a certain characteristic (for example, middle class children living 30 with families who smoke compared with those living with families who do not smoke) Scottish Partnership for Palliative Care ( ) or by downloading from

19 Case Control Study A case control study compares two groups of people: those with the disease or condition under study (cases) and a very similar group of people who do not have the disease or condition (controls). Researchers study the medical and lifestyle histories of the people in each group to learn what factors may be associated with the disease or condition. For example, one group may have been exposed to a particular substance that the other was not. This type of study is also known as a retrospective study. Case Series A case series is a group or series of case reports involving patients who were given similar treatment. Reports of case series usually contain detailed information about the individual patients. This includes demographic information (for example, age, gender, ethnic origin) and information on diagnosis, treatment, response to treatment, and follow up after treatment. (National Cancer Institute, n.d.) Case Reports A case report is a detailed report of the diagnosis, treatment, and follow up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin). (National Cancer Institute, n.d.) Case reports are not strictly research and are not a robust source of evidence. However, they do raise questions which can lead to further research, and are often used to guide practice in palliative care when there is a lack of more robust Scottish Partnership for Palliative Care ( ) or by downloading from

20 Survey research Most survey research involves the use of questionnaires, which are a quick and cost effective way of gathering data from a relatively large number of subjects. If using questionnaires it is worth bearing in mind that only a small percentage of those who receive the questionnaires are likely to return them. Also, there are limits to the type of information a questionnaire can collect, and respondents may not follow the questionnaire s instructions for completion. Since high quality questionnaires are difficult to create and must be piloted and tested for validity and reliability, it is a good idea to search the relevant literature to see if a suitable questionnaire already exists. However, it is important to check whether or not you need to obtain permission to use a particular assessment tool. Scottish Partnership for Palliative Care ( ) or by downloading from

21 Qualitative research is a popular method in palliative care. Is promoted a naturalistic interpretive approach, concerned with understanding the meanings people attach to phenomena such as actions, decisions, beliefs and values within their social world (Richie and Lewis, 2003). It is also widely held to be a useful stage in theoretical development prior to designing and implementing an intervention. These are based on detailed interviews, focus groups, case studies, guided interviews, and knowledge attitude behavior patterns studies. It is important to recognize that there is no single accepted way of doing qualitative research. Indeed, how researchers undertake qualitative research depends on a range of factors, including their beliefs about the nature of the social world and what is known about it (ontology), and their beliefs about the nature of knowledge and how it is obtained (epistemology).

22 Methods used to collect data in qualitative research include interviews and observation. How the interviews and observation are conducted and analyzed will depend on the methodology used, and qualitative research is an umbrella term for a variety of different methods which differ in their philosophical background and approach. Commonly used qualitative research approaches in palliative care include: grounded theory drawn from sociology and, in particular, social interaction theory, with the y purpose of the research being to produce an inductive theory. phenomenology drawn from existential philosophy, the researcher describes and interprets y phenomena from the viewpoint of the subject. This approach is often termed a study of lived experience.

23 Commonly used qualitative research approaches in palliative care: narrative inquiry a narrative inquiry story telling or life history approach ethnography the researcher studies a subject s world from the viewpoint of the subject, and this y usually involves participant observation.

24 Action Research Action research addresses practical issues in a real world setting. Example, an action research project might be set up to address identified inefficiencies within a workplace environment. The research project would first plan interventions aimed at increasing efficiency, then take action on these interventions, then observe the results of these actions, evaluate these results, and then critically reflect on whether interventions had been successful in increasing efficiency, and what other actions could be taken to further increase efficiency. Case Studies Yin (1984) as sited by Soy (1997) defines the case study research method as: an empirical inquiry that investigates a contemporary phenomenon within its real life context; when the boundaries between phenomenon and context are not clearly evident; and in which multiple sources of evidence are used Scottish Partnership for Palliative Care ( ) or by downloading from

25 It may suit some studies to use a combination of methodologies, or to combine quantitative methods with qualitative methods to gain a fuller picture of the situation. For example, quantitative research can allow generalization of some qualitative work, and qualitative research can explore in more depth issues highlighted by quantitative work. Scottish Partnership for Palliative Care ( ) or by downloading from

26 Reliability, validity and application A reliable research tool produces comparable results time and again in similar groups. A method is valid when it measures what it set out to measure. Application of a tool also needs to be standardized, since different people can apply the same (validated) tool in different ways and obtain different results. Therefore, if a tool is used by more than the primary researcher (for example a trials nurse or ward doctor) it is essential that they receive appropriate training and ongoing support in how to use the tool. This is especially important when applying more qualitative methods, when it can be helpful to mention as part of the write up who undertook each interview. Scottish Partnership for Palliative Care ( ) or by downloading from

27 It is a good idea to use assessment tools that already have established their validity and reliability, since the more validated are the tools that are used, the more credible the finished research will be. However, it is important to check whether or not you need to obtain permission to use a particular will have an application form for this purpose that can be submitted electronically. Scottish Partnership for Palliative Care ( ) or by downloading from

28 Instruments for assessment of symptoms in palliative care Charlson Comorbidity Scale ECOG Performance Status Karnofsky Performance Scale FACT G (FACT L) FAST Stages of Alzheimer s Disease Katz Index of Activities of Daily Living NY Heart Association Classification for Congestive Heart Failure (CHF) Palliative Performance Scale Geriatric Depression Scale Hamilton Depression Scale Scales of Psychological Well Being Spiritual Well Being Scale Caregiver Burden Scale Chronic Respiratory Disease Questionnaire

29 Validation of the Edmonton Symptom Assessment Scale Victor T. Chang, M.D. 1 2 *, Shirley S. Hwang, R.N., A.O.C.N., M.S , Martin Feuerman, M.S et all The Edmonton Symptom Assessment Scale (ESAS)is a 10 item patient rated symptom visual analogue scale developed for use in symptom assessment of palliative care patients. In the ESAS, patients rate the severity of the following nine symptoms: pain, activity, nausea, depression, anxiety, drowsiness, lack of appetite, well being, and shortness of breath on a 10 cm line. There is an optional tenth symptom, which can be added by the patient. The sum of patient responses to these nine symptoms, in millimeters, is the ESAS distress score The purpose of this study is to describe the validation of the ESAS in a population of cancer patients who concurrently completed two other instruments: the Memorial Symptom Assessment Scale (MSAS) and the Functional Assessment of Cancer Therapy (FACT). Validation of the Edmonton Symptom Assessment Scale, Victor T. Chang M.D. 1,2,*, Shirley S. Hwang R.N., A.O.C.N., M.S. 1,2,3,4 and Martin Feuerman M.S. 5,, Article first published online: 20 NOV 2000, DOI: /(SICI) ( )88:9<2164::AID CNCR24>3.0.CO;2 5, Cancer Volume 88, Issue 9, pages , 1 May 2000

30 ESAS validation conclusions In this study, was extended the ESAS to a general cancer population and compared it with scores from the FACT and the MSAS. We conclude that the ESAS is a valid instrument for symptom assessment in the cancer population. However, it may not reflect psychological symptoms very well and may have limited test retest applicability. This is important because no time window is stipulated on the form. The results of this study suggest that the ESAS may be a valid instrument for use in a medical oncology population, and that the ESAS distress score may predominantly reflect physical well being. This instrument may be useful in future QOL and symptom assessment studies in this population

31 POS POS was developed in 1999 for use with patients with advanced disease, and to improve outcome measurement by evaluating many essential and important outcomes in palliative care. The Support Team Assessment Schedule (STAS), developed in 1986, was the precursor to POS. STAS was constructed to evaluate the work of palliative care support teams and consisted of 17 items, to be rated from 0 (best) to 4 (worst) by a professional caring for the patient. POS builds on some of the strengths of the STAS, such as clinical application and ease of use. Importantly, POS also allows patients to self complete the assessments. POS is therefore a patient reported outcome measure when the patient version of POS is used. POS has demonstrated construct validity acceptable test/re test reliability for seven items, and good internal consistency. Importantly, POS takes less than 10 minutes to complete by staff or patients.

32 IPOS The IPOS New International Standard of Quality Cancer Care: integrating the psychosocial domain into routine care Jimmie Holland 1, Maggie Watson 2 and Jeff Dunn 3,4,5 Article first published online: 24 JUN 2011 DOI: /pon.1978 IPOS is an exciting development, integrating the best of POS, POS S and the APCA African POS. It has been welcomed by patients and professionals as a more streamlined measure which is brief, yet which still captures their most important concerns both in relation to symptoms, but also extending to information needs, practical concerns, anxiety or low mood, family anxieties, and overall feeling of being at peace. It has been welcomed by patients and professionals as a more streamlined measure which is brief, yet which still captures their most important concerns both in relation to symptoms, but also extending to information needs, practical concerns, anxiety or low mood, family anxieties, and overall feeling of being at peace.

33 IPOS Patient Version Patient name : Date (dd/mm/yyyy) : Patient number : (for staff use) Q1. What have been your main problems or concerns over the past 3 days? Q2. Below is a list of symptoms, which you may or may not have experienced. For each symptom, please tick one box that best describes how it has affected you over the past 3 days.

34 Not at all Slightly Moderately Severely Over whelmingly Pain Shortness of breath Weakness or lack of energy Nausea (feeling like you are going to be sick) Vomiting (being sick) Poor appetite Constipation Sore or dry mouth Drowsiness Poor mobility Please list any other symptoms not mentioned above, and tick one box to show how they have affected you over the past 3 days

35 Q3. Have you been feeling anxious or worried about your illness or treatment? Q4. Have any of your family or friends been anxious or worried about you? Q5. Have you been feeling depressed? Always Most of the time Sometimes Occasionally Not at all Q6. Have you felt at peace? Q7. Have you been able to share how you are feeling with your family or friends as much as you wanted? Q8. Have you had as much information as you wanted? Q9. Have any practical problems resulting from your illness been addressed? (such as financial or personal) Q10. How did you complete this questionnaire?

36 A person s symptoms and the distress they cause is a major part of their experience of illness. Given the importance of assessing and relieving symptoms in clinical care, symptom measurement is an essential element of much palliative care research, including survey research as well as clinical trials. The measurement of symptoms needs to be undertaken with an understanding of the multidimensional nature of symptoms and quality of life, and should reflect the complexity of patient perceptions (Ingham et al, 2010). There are various factors that should be considered when planning research involving the measurement and assessment of symptoms, and additional complications arise when cognitive impairment affects a patient s ability to report their symptoms. Scottish Partnership for Palliative Care ( ) or by downloading from

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38 EPCCS is an international, multi center, prospective data collection with participating centers in Europe, Canada and Australia. The main study objectives are to: gain a better understanding of the symptom prevalence and symptom variation over time in palliative cancer patients further evaluate and validate the assessment and classification systems for pain, cachexia and other symptoms gain knowledge about the organization and delivery of palliative care within and across nations and institutions continue the work towards a standardized assessment system to improve symptom management study presentation