Breakthrough Pain Report of an explorative study on breakthrough pain

2009, November 6th

Breakthrough Pain Report of an explorative study on breakthrough pain

Research group ‘Breakthrough pain’ Radboud University Nijmegen Medical Centre Department of Anesthesiology, Pain and Palliative Medicine

Project Members Kris C. P. Vissers, MD PhD FIPP Professor of Palliative Care and Pain Medicine Oliver H. G. Wilder Smith, MBChB MD PhD Associate Professor of Nociception and Pain Head Pain and Nociception Research Group Monique A. H. Steegers, MD Anesthesiologist Head of the acute pain service Anne G. H. Niezink, MD Junior researcher Radboud University Nijmegen Medical Centre Department of Pain and Palliative care Internal postal code 630 P.O. Box 9101 6500 HB Nijmegen The Netherlands email: [email protected]

Concept report breakthrough pain

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Content Page Samenvatting

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Summary

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1. Preface

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2. Introduction

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3. Method

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4. Results a. Literature review

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b. Questionnaire

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c. Interviews

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5. Conclusions and recommendations

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6. Appendices Appendix 1: Questionnaire in Dutch

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Appendix 2: Questionnaire in English

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Appendix 3: Brochure

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Appendix 4: Questions interviews

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Appendix 5: Respondents categorized in profession

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Appendix 6: Results questionnaire

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Appendix 7: Specific research questions on breakthrough pain

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Samenvatting Achtergrond: Doorbraakpijn is een voorbijgaande verhoging van de pijnintensiteit bij een continue achtergrondpijn. Doorbraakpijn is de laatste 15 jaar meer onder de aandacht gekomen. Er is echter nog steeds discussie over de definitie, terminologie, behandeling en mogelijkheden voor preventie.

Doel: Inventariseren van onderzoeksvragen op het gebied van doorbraakpijn ter voorbereiding op een mogelijk onderzoeksprogramma bij ZonMw.

Methode: Review van de literatuur van januari 1990 tot en met juni 2009. Een enquête over doorbraakpijn verzonden naar 54 experts op het gebied van palliatieve zorg of pijnbehandeling, nationaal en internationaal. Interviews van een deel van de respondenten naar aanleiding van de enquête. Een werkbijeenkomst waarin aan de categorieën van onderzoeksvoorstellen een prioritering werd gegeven.

Resultaten: Literatuur: in totaal werden 133 relevante artikelen gevonden via Pubmed, waarvan 71 data bevatten, 33 reviews, 1 systematische review, 28 opinie artikelen. Enquête: in totaal werden 35 enquêtes volledig ingevuld (respons rate 65 %). De respondenten waren het met elkaar eens dat doorbraakpijn bestaat en hadden een eenduidige mening over de beste definitie. Over de terminologie en of er sprake moet zijn van (adequaat behandelde) achtergrondpijn is geen duidelijke consensus. De meeste respondenten gebruiken de anamnese om doorbraakpijn te diagnosticeren. Men zou graag zien dat er een vragenlijst of gevalideerde meetmethode als aanvullende diagnostiek wordt ontwikkeld. Als behandeling kiezen de meeste respondenten voor het voorschrijven van ‘rescue medicatie’. Er wordt met name gebruik gemaakt van Morfine, Fentanyl en Oxycodon. Interviews: in totaal werden tien mensen geïnterviewd. Iedereen was tevreden over de methode zoals die gebruikt werd voor de enquête. Iedereen had zeer diverse aanvulling over het onderwerp doorbraakpijn. Werkbijeenkomst: er werden 11 onderzoeksvragen geformuleerd met hoge prioriteit en relevantie.

Conclusie In een schema is aangegeven welke categorieën van onderzoeksvoorstellen in aanmerking komen voor nader onderzoek. Daarin is tevens aangegeven aan welke voorwaarden moet worden voldaan om dit onderzoek te kunnen uitvoeren. Er zijn zes onderzoeksvragen geselecteerd die het meest belangrijk zijn om te beantwoorden.


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Summary

Background: Breakthrough pain is a temporally increase of the intensity of the pain which occurred on a continuous background pain. In the past 15 years, there has been increasing interest in breakthrough pain. However there is still debate on a number of issues including definition assessment, management and prevention.

Goal: Explore the research proposals in the domain of breakthrough pain as a preparation for a research program with ZonMw.

Method: A review of the literature from January 1990 until June 2009. A questionnaire about breakthrough pain was send to 54 experts in the palliative care or the pain medicine, national and international. Part of the respondents were interviewed about the questionnaire. During a expert meeting the results of the questionnaire were presented and a priority was given to the different categories of the research proposals.

Results: Literature: The results yielded 133 relevant articles in Pubmed, 71 included data, the rest consists of 33 reviews, 1 systematic review and 28 opinion papers. Questionnaire: The results of the questionnaire are based on the 35 completed questionnaires (response rate 65 %). The experts agree that breakthrough pain is a distinct entity. The best definition of breakthrough pain is the one introduced by Davies in 2009. The respondents did not agree on the terminology and if it is necessary to have (adequately controlled) background pain. Most respondents diagnose breakthrough pain through history taking, but there is need for a questionnaire and a validated assessment tool. For the treatment most respondents prescribe rescue medication. Morphine, Fentanyl and Oxycodone are most used. Interviews: Ten respondents were interviewed. Everyone was satisfied with the program used for the questionnaire. Every respondent had different comments on the subject breakthrough pain. Expert meeting: during the expert meeting 11 research questions with high and estimated as very relevant were formulated.

Conclusions: In a diagram the different categories of research proposals are reported. These categories should be considered for further research. In the schedule is also described at which conditions the research should be done. Six research questions of upmost importance in the further eradication of breakthrough pain were selected.


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Chapter 1: Preface

This report is initiated by ZonMw a Dutch organization for health research and development. The goal of this project was to explore the possibility to initiate research proposals and specific granting in the domain of breakthrough pain as a preparation for a research program with ZonMw. This report is the result of this project and was made by the research group ‘Breakthrough pain’ of the department of pain and palliative Medicine of the Radboud University Nijmegen Medical Centre.


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Chapter 2: Introduction Pain is one of the most feared symptoms in patients with cancer and has a major impact on quality of life. Usually, patients experience fluctuations in their pain intensity. In most acute and chronic pains, there is a continuous and a variable component of pain. The continuous component is mostly referred to as ‘background pain’. The variable component consists of transitory flares of pain and is usually described as ‘breakthrough pain 1,3,4. The prevalence of breakthrough pain has been reported to be 19 -95% in various groups of patients 5. This variation is due to a number of factors including differences in the definition applied and differences in the specific populations studied. The definition of breakthrough pain varies in the literature and there is still disagreement about it 1,3.

The clinical features of breakthrough pain vary inter-individually and intra-individually over time. However, there are common characteristics that are experienced in most patients, such as: frequency in occurrence, acute in onset, short in duration, severe in intensity and often precipitated by an event 1,4.

Successful management of breakthrough pain depends on adequate assessment, appropriate treatment and adequate reassessment

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. A number of tools have been developed for the

assessment of cancer related pain. These tools focus on the background pain and most of these tools provide only little information about the breakthrough pain. Recently a new assessment tool has been developed for research purposes; the Alberta Breakthrough Pain Assessment Tool for Cancer Patients 2.

Most patients with cancer-related pain achieve acceptable baseline pain control with treatment based on the World Health Organization (WHO) analgesic ladder

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. The preferred treatment of

breakthrough pain is a causal treatment, focused on the underlying disease causing the pain symptoms.

Symptomatic treatment includes both pharmacological (opioid and / or non-opioid analgesics) and non-pharmacological methods (psychological support, adjustments of lifestyle, physiotherapy).


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Optimizing the around-the-clock analgesia according to the principles of the World Health Organization analgesic ladder may help ameliorate breakthrough pain 4. The use of supplemental doses of analgesics (also known as rescue medication) is the most common pharmacological treatment strategy for managing breakthrough pain 1,4.

In the past 15 years, there has been increasing interest in breakthrough pain, reflected in the increasing number of published studies in the literature which, in turn, has led to a debate on a number of issues including definition, assessment and management 4.

Reference List 1. A.N. Davies, et al., “The management of cancer-related breakthrough pain: recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland,” Eur. J. Pain 13 (4), 331 (2009). 2. N.A. Hagen, et al, “The Alberta Breakthrough Pain Assessment Tool for cancer patients: A validation study using a Delphi process and patient think-aloud interviews,” J. Pain Symptom. Manage. 35 (2), 136 (2008). 3. S. Mercadante, et al, “Episodic (breakthrough) pain: consensus conference of an expert working group of the European Association for Palliative Care, “Cancer 94 (3), 832 (2002). 4. G. Zeppetella, “Impact and management of breakthrough pain in cancer, “Curr. Opin. Support. Palliat. Care 3 (1), 1 (2009). 5. Richtlijn ‘diagnostiek en behandeling van patiënten met kanker’, Nederlandse Vereniging voor Anesthesiologie 2008. 6. A.N. Davies, Cancer-related breakthrough pain, Oxford University Press, 2006.


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Chapter 3. Method Literature review For this literature review, all articles about breakthrough pain from January 1990 until June 2009 were included. Because there is no MesH-term for breakthrough pain, the following research term was used for PubMed: ‘breakthrough pain’. Only abstracts written in English or Dutch were used. All the relevant studies were selected on title and abstract. Articles about pain in general, postoperative pain, pain during labour or headaches were excluded, the articles without abstract and full text were also excluded. From all the selected literature data were collected about the subject, the number of patients, the type of scientific trail and the publication details. As a part of our literature review we studied the power point presentations about breakthrough pain from the Congress of the World Institute of Pain, New York March 2009, and the Congress of the special interest group of the International Association for the Study of Pain (IASP) on cancer pain, Chicago June 2009. Questionnaire A questionnaire was made by the members of the project team. The questionnaire contained different subjects: definition, assessment, treatment, prevention. There were both open-ended and closed questions (appendix 1 en 2). A total of 54 questionnaires were sent to experts in the palliative care and/or pain medicine. Together with an email with the link for the questionnaire, the experts in the Netherlands got a personal letter and a brochure containing more information (appendix 3). After ten days we sent a reminder by email. In total 54 persons were invited for the questionnaire (43 national and 11 international). We received 35 completed questionnaire and 9 not fully completed questionnaires. The incomplete questionnaires were withdrawn from the survey. Telephone interviews National respondents could fill in that they would like to be interviewed about the questionnaire. A total of 22 of the Dutch respondents answered this question with yes. They all received an invitation by email to participate to this interview. Ten of the 22 interested respondents made time to respond fully to this interview. They were all interviewed by the junior researcher of the project team (A.N.), three respondents in person and seven by telephone. A Dutch format was made for the interviews and for each respondent there were a couple of individual questions based on their answers in the questionnaire (appendix 4).


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Chapter 4. Results A. Literature review The results yielded 133 publications including patients studies, case reports, letters, reviews, commentaries and more. There is an increase of published articles in the period from 1990 until 2009. In the last five years 79 of the 133 articles were published. Of the 133 articles, 71 included data: 40 included patient data in prospective design, 17 included data in retrospective design and 14 included case reports. Of the other 63 articles 33 were reviews, 1 was a systematic review and 28 were opinion papers. Of all the articles 102 reported about the treatment of breakthrough pain, 19 reported about epidemiology, 2 reported about definition, 2 reported about assessment. Eight of the articles reported about more than one subject. During the two congresses there were three relevant PowerPoint presentations given. The design of all three of the presentations was that of a review. All experts agreed that breakthrough pain is a problem, especially because of the difficult assessment and because it is not possible to do research about breakthrough pain in animals.

B. Questionnaire The results of the questionnaire are based on the completed questionnaires (appendix 6). Of the respondents 28 are medical doctors and 7 are nurses. A total of 35 questionnaires of the 54 sent questionnaires were completed (65% response rate). Of the respondents, 28 are medical doctors and 7 are nurses (appendix 5). All respondents are experts in the palliative care and/or pain medicine.

Definition The definition of Davies from 2009 is by far the most chosen as the best definition of breakthrough pain (24 respondent,67%). Some respondents answered the question about prevalence with a question mark. The number of patients with pain visiting the medical centre each week varies from 5 up to 300. The number of cancer patients visiting each week varies from 2 up to 300, of these patients 2 to 135 have breakthrough pain. The number of patients with chronic pain visiting each week varies from 0 up to 300, of these patients 0 to 135 have breakthrough pain. Most of the respondents said there is no need for a new definition of breakthrough pain (23 respondents, 70%). The respondents do not agree on the questions if it is necessary to have (adequately controlled) background pain. 22 respondents (65%) state that it is not necessary to have background pain in


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order to speak of breakthrough pain and 18 respondents (51%) state that it is not necessary that the background pain is adequately controlled. Most of the respondents think end-of-dose pain and breakthrough pain caused by inadequately controlled background pain are not subtypes of breakthrough pain. Most respondents state that breakthrough pain is not always cancer related (32 respondents, 91%).

All respondents agree that breakthrough pain does exist (35 respondents, 100%) and that breakthrough pain and persistent or background pain are two distinct clinical entities (27 respondents (77%). In clinical and research setting most respondents prefer the following classification of breakthrough pain: spontaneous pain, incident pain or end-of-dose pain.

Most respondents indicate that the term ‘doorbraakpijn’ ( the Dutch translation of breakthrough pain) is useful in the Dutch clinic (24 respondents, 77%). Most of the respondents use the term breakthrough pain (‘doorbraakpijn’), but there are several other terms used. Multiple terms are used for background pain (‘achtergrondpijn’) and for the medical treatment of breakthrough pain.

Assessment Most respondents feel capable of diagnosing breakthrough pain through history taking (30 respondents, 88%). Two third of the respondents think a questionnaire would be a useful tool (24 respondents, 67%). All the aspects mentioned in question 5.4. (see appendix 1 and 2) should be included in an assessment tool for breakthrough pain. Most respondents state that there should be a validated tool for these aspects (30 respondents, 91%).

Most respondents diagnose breakthrough pain through history taking. Other methods include the use of a pain diary, unidimensional or multidimensional assessment tools and physical examination. These are also the methods that should be further researched. The characteristics mentioned in question 4.4. (see appendix 1 and 2) are all diagnosed by the respondents.

Treatment 28 of the respondents quantify background pain and breakthrough pain separately, before starting pain treatment (80%). There are different aspects the respondents take into account when assessing


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breakthrough pain. The frequency (32 respondents, 94%) and intensity (30 respondents, 88%) of the pain are mentioned most.

All the characteristics of symptomatic treatment mentioned in question 6.1. (see appendix 1 and 2) were important according to the respondents, with ‘provide a durable response to resolve the pain’ as most mentioned (97%). The most important shortcoming is by far the slow onset of medicines currently used for breakthrough pain (58%), this is also the characteristic that should be part of future research state 27 (87%) of the respondents. Respondents also mentioned safe use and side effects. The most mentioned routes of administration that should be part of further research are the transnasal, sublingual and transmucosal route.

The questions about the pharmacological treatment were split into questions about opioid analgesics and non-opioid analgesics.

A lot of different treatment strategies are used by the respondent in case the treatment of breakthrough pain with an opioid is ineffective. If the respondents can choose one option most choose ‘prescribing rescue medication’ (65%). But when they can choose multiple options also ‘opioid rotation’ and ‘increase the dose of the around-the-clock medication’ are often mentioned. Another option mentioned are ‘increase the dose of the short acting opioid’. The opioids used as rescue medication for breakthrough pain are almost the same for a patient at home and the inhospital patient. Morphine, Fentanyl and Oxycodone are prescribed most. For 69% of the respondents it is no option to treat breakthrough pain by increasing the dose of the around-the-clock medication.

The respondents use different non-opioid analgesics as rescue medication for breakthrough pain. Paracetamol and Non-steroidal Anti-Inflammatory drugs are most mentioned for the patient at home. For the in-hospital patient part of the respondents besides also prescribe Ketamine. Seventeen (52%) of the respondents consider to treat breakthrough pain by increasing the dose of around-the-clock medication with non-opioid analgesics.

All the mentioned non-pharmacological treatment strategies are considered for the treatment for breakthrough pain by a part of the correspondents, especially ‘improving the patient’ knowledge’ This is also the most mentioned that should be further researched.


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The respondents disagree about the possibility to prevent breakthrough pain (52% answered ‘yes’). Most respondents agree that ‘elimination of the cause of the pain’ is the way that breakthrough pain can be prevented best.

C. Interviews Of the 35 respondents, 22 were interested in a short telephone interview. Of the 22 interested respondents, we interviewed ten. Three respondents in person and seven respondents by telephone. Of the interviewed respondents, 8 are medical doctors and 2 are nurses.

All respondents were very satisfied with the program (Survey Monkey) used for the questionnaire and appreciated the brochure and email that came along with the invitation for the questionnaire. Besides that a part of the respondents thought the questionnaire was too long, there were no problems reported.

A couple of the respondents said it was sometimes difficult to choose between the answer possibilities, because they would like to nuance their answer. But there were enough possibilities to write down their own opinion. The question about prevalence was hard to answer for almost all of the respondents.

Every respondent had different comments on the subject breakthrough pain. There were three categories they were classified in: definition, assessment and treatment. There are different opinions about the need for an assessment tool. Most respondents are satisfied with the treatment options that are on the market. Some reported that they are interested in research of the new medication that are available in the near future and other were more interested in researching the existing medication.


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Chapter 5. Conclusions and recommendations A. Conclusions of literature, questionnaire and interviews There is little known about breakthrough pain in the literature. However among the clinical experts, there is a lot of interest in the subject of breakthrough pain, according to the high response rate of 65% and the increase in published articles. The experts all agree that breakthrough pain is an entity on its own. The best definition of breakthrough pain is the one introduced by Davies in 2009. There is, however, some disagreement about different parts of the definition, especially the need of (adequately controlled) background pain in order to speak of breakthrough pain. Diagnoses of breakthrough pain is mostly done through history taking. Future research is needed to make a good questionnaire and a validated measurement tool. Research is also needed to evaluate the use of a pain diary. There is no consensus about how the treatment of breakthrough pain should be evaluated. The most important way to improve medications for breakthrough pain is to provide a rapid onset of analgesia, within minutes. This is in accordance with the first choice of treatment, which is prescribing rescue medication. Opioid analgesics, especially Morphine, Fentanyl and Oxycodone are used most. Future research is needed for both pharmacological and non-pharmacological treatment. The following items and research questions are of upmost importance in the further eradication of breakthrough pain (BTP) from the presentation of the expert report on the meeting on breakthrough pain ZonMw in September 2009 (Appendix 7): 1. How should the definition of BTP be operationalised in the different settings? 2. Can a new systematic review be done in order to have the latest data on the prevention, diagnosis and treatment of BTP? 3. Can specific registration tools be optimized to make BTP better visible in the different settings of care? 4. Can an international questionnaire or assessment tool for BTP be developed? 5.

Can prospective randomized control trials be initiated on the different interventions dealing with BTP?

6. Can different pharmacological treatment schemes and algorithms be researched to optimize the fast and efficient treatment of BTP?


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B. Diagram of future research Need for description and registration

Need for care standards and implementation

Need for observation

Assessment and Therapy Research agenda

Terminology -

-

Systematic Review

Education High risk population Develop measurement and registration tools Pharmacological (dose, route) nonpharmacological therapy

Epidemiology

Guidelines

Characteristics Pathology / Common causes High risk patients

National / International

Prevention Education - Medical doctors - Nurses - Patient + caretaker (empowerment) - Society Prevention of the causes of BTP

Digital Registration

ZonMw program for better description and registration

ZonMw program for better observation

ZonMw program for better care standards and implementation

Figure 1: Future research in breakthrough pain, BTP = breakthrough pain (Copyright Niezink and Vissers et al.)


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Comment on the diagram

General The diagram is categorized in three different levels and hence needs for further research and granting: ‘need for description and registration’, ‘need for observation’ and ‘need for care standards and implementation’ (the white boxes with a purple line above the diagram). To get to the next level there are conditions formulated to meet (the dark green boxes). To meet these conditions further research is needed. The research categories are formulated in the boxes under the conditions (the white boxes with a green line). The conditions and research categories are based on the results of the questionnaire and the interviews. All different levels and research categories should be included in a specific research program.

Conditions and research categories The conditions formulated for the level ‘need for description and registration’ are: terminology, systematic review and digital registration. First concerning terminology: In the questionnaire, interviewees showed disagreement about the terminology and definition used for breakthrough pain. It is part of a research plan to delineate the exact terminology, which defines the research field and makes strict in- and exclusion of a study possible. The better definitions are clear the less discussion will be present about the identified study groups. Before starting further research it should be clear which terminology and definition is used nationally and internationally Without a clear definition, terminology and glossary, it will not be possible to do comparative research in the future. Secondly, we found 133 publications about breakthrough pain. Only one of these publications was a systematic review. Before starting further research a systematic review should be made to make an inventory of all the research that has been done in the past and to systematically review the knowledge already published. Finally, it is important to set up a national digital registration system, using the national terminology and definition formulated, to start collecting data for further research, in the near future to get data for epidemiology and later to evaluate new therapy, assessment and prevention.

Once these conditions are met the next level is ‘need for observation’. The condition formulated for this level is epidemiology. Data for epidemiology are provided by the digital registration, the terminology formulated in the first category ‘need for description and registration’. There is little


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known in literature about characteristics of breakthrough pain and about common causes and pathologies that are seen in patients with breakthrough pain. With this information it is possible to identify groups of patients at increased or high risk for the development of breakthrough pain.

This information is relevant and needed for the next level of research ‘need for care standards and implementation’. We identified a high need to develop or improve specific assessment tools of breakthrough pain, evidence based therapy and prevention programs. First, specific research programs must be started on the development of better and objective validated measurement instruments. This validation trajectory asks for a specific research program in centres specialized in the treatment of (cancer)pain. Nowadays, we could not identify specific validated measurement tools for breakthrough pain. These tools should be especially useful for all medical doctors and nurses who come daily into contact with patients with breakthrough pain. Once these measurement instruments are available, studies to evaluate specific and new therapies for breakthrough pain should be initiated by a program of ZonMw.

Finally, further research is needed to improve and evaluate current and new pharmacological and non-pharmacological therapies. There is need for knowledge about the best dose and route for pharmacological therapy for breakthrough pain. There is little known about non-pharmacological therapies that can improve breakthrough pain. Therefore these therapies are often not considered for the treatment of BTP. All respondents of our questionnaire where interested in this kind of therapies.

A better Knowledge of breakthrough pain can generate and improve the assessment, therapy and prevention of breakthrough pain. It is upmost importance to improve the education of health care workers, of patients, caretakers and society about breakthrough pain and pain in general. At this moment there are no specific information packages of courses about prevention of breakthrough pain for specific groups. If we know more about the high risk population and the causes of breakthrough pain, we can improve prevention.

All this research will give rise to publications and evidence that can induce national and international guidelines. Because of the digital registration system of patients there will be feedback and new data to improve the guidelines. All these aspects are important to be categorized in a specific research program of ZonMw so that relevant research can be started.


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Appendix 1: Questionnaire in Dutch 1. Definitie a. Wat vindt u de beste definitie van doorbraakpijn? i. 'A transitory exacerbation of pain that occurs on an background of otherwise stable ii. iii. iv. v.

pain in a patient receiving opiod therapy' (Portenoy 1990) ‘In the cancer population, breakthrough pain is a transitory, severe or excruciating pain, which lasts seconds to hours and is superimposed on a baseline pain controlled to a moderate or better intensity by an opioidregimen'(Mercadante 2002) 'A transitory exacerbation of pain experienced by the patient who has relatively stable and adequately controlled baseline pain'(Portenoy 2004) 'een voorbijgaande verhoging van de pijnintensiteit bij een continue achtergrondpijn' (Richtlijn diagnostiek en behandeling van pijn 2008) 'A transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain' (Davies 2009)

b. Bestaat doorbraakpijn volgens u? i. Ja ii. Nee

c. Kunt u uw antwoord op de vorige vraag motiveren? d. Hoeveel pijn patiënten worden er in uw centrum per week gezien? e. Hoeveel patiënten met pijn bij kanker worden er per week in uw centrum gezien? Hoeveel van deze patiënten hebben doorbraakpijn? f. Hoeveel patiënten met chronische pijn worden er per week in uw centrum gezien? Hoeveel van deze patiënten hebben doorbraakpijn? 2. Definitie a. In het Engels spreekt men van background pain, ook in de richtlijn ‘diagnostiek en behandeling van pijn bij kanker’ wordt de term achtergrondpijn gebruikt: Is dit volgens u een bruikbare term? i. Ja ii. Nee

b. Zijn doorbraakpijn en achtergrondpijn volgens u twee verschillende entiteiten? i. Ja ii. Nee

c. Is de aanwezigheid van achtergrondpijn volgens u noodzakelijk om bij een patiënt te kunnen spreken van doorbraakpijn? i. Ja ii. Nee

d. Moet achtergrondpijn adequaat behandeld zijn om bij een patiënt met pijn te kunnen spreken van doorbraakpijn?


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i. Ja ii. Nee

e. Is ‘end of dose’pijn volgens u een vorm van doorbraakpijn i. Ja ii. Nee

f. Valt achtergrondpijn die onvoldoende is behandeld en daardoor een verhoging geeft van de pijnintensiteit onder de term doorbraakpijn? i. Ja ii. Nee

g. Moet er sprake zijn van oncologische pathologie om te kunnen spreken van doorbraakpijn? i. Ja ii. Nee

h. Welke van de volgende termen gebruikt u wanneer u spreekt over ‘doorbraakpijn’? (meerdere antwoorden mogelijk) i. ii. iii. iv. v. vi.

Episodische pijn Tijdelijke pijn (letterlijke vertaling van ‘transient pain’) Doorbraakpijn (letterlijke vertaling van ‘breakthrough pain’) Variërende pijn Incidentele pijn Anders, namelijk …

3. Definitie a. Welke van de volgende termen gebruikt u wanneer u spreekt over achtergrondpijn? (meerdere antwoorden mogelijk) i. ii. iii. iv.

Basis pijn (vertaling van ‘baseline pain’) Continue pijn Achtergrondpijn (vertaling van ‘background pain’) Anders, namelijk …

b. Welke van de volgende termen gebruikt u voor de medicamenteuze behandeling van doorbraakpijn? (meerdere antwoorden mogelijk) i. ii. iii. iv.

Escape medicatie Rescue medicatie Medicatie voor ‘zo nodig’gebruik Anders, namelijk …

c. Is er volgens u behoeft aan een nieuwe definitie van doorbraakpijn? i. Ja ii. Nee

d. Welke van de onderstaande drie indelingen vindt u klinisch en welke wetenschappelijk het meest relevant voor doorbraakpijn? (per rij is slechts één antwoord mogelijk) Indeling 1 - Pijn door de onderliggende pathologie (het nieuw ontstaan of doorgroeien van tumor of metastasen) - Pijn als gevolg van de (oncologische) behandeling - Pijn door een bijkomende ziekte of factoren Indeling 2 - Spontane pijn (onafhankelijk van een stimulus)


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Incidente pijn (treedt op als gevolg van een specifieke aanleiding. Daarbij is onderscheidt temaken tussen vrijwillige stimulus (vb. lopen) en niet-vrijwillige stimulus (vb. hoesten) - ‘end of dose’ pijn (pijn als gevolg van een inadequate dosering van analgetica) Indeling 3 - Nociceptieve pijn, op te delen in viscerale- en somatische pijn - Inflammatoire pijn - Neuropatische pijn Indeling 1

Indeling 2

Indeling 3

Klinische indeling Wetenschappelijke indeling

e. Wilt u uw keuze toelichten? 4. Diagnostiek a. Voelt u zich voldoende in staat om doorbraakpijn anamnestisch te diagnosticeren? i. Ja ii. Nee

b. Zou u een vragenlijst een nuttige aanvulling voor kunnen zijn? i. Ja ii. Nee

c. Welke methoden gebruikt u om doorbraakpijn te diagnosticeren? (meerdere antwoorden mogelijk) i. ii. iii. iv. v. vi. vii. viii. ix. x.

Anamnese Unidimensionele vragenlijsten Multidimensionele vragenlijsten Pijndagboek Lichamelijk onderzoek (inclusief neurologische onderzoek) Quantitative Sensory Testing (QST-meting) Magnetic Resonance Imaging (MRI) Elektromyogram (EMG) Positron Emissie Tomografie (PET) Anders, namelijk …

d. Welke van de volgende kenmerken van doorbraakpijn komen over een met uw eigen klinische ervaring bij patiënten? (meerdere antwoorden mogelijk) i. ii. iii. iv. v.

Tijdsduur tot de maximale intensiteit van de pijn: gemiddeld 3 – 5 minuten Ernst van de pijn: van ernstig tot onhoudbaar Duur van de doorbraakpijn: gemiddeld 15 – 3- minuten Aantal episodes per dag: gemiddeld 1 – 5 per dag Bij gemiddeld 55 – 60% van de patiënten is er een duidelijke uitlokkende factor van de doorbraakpijn vi. Bij gemiddeld 50 – 60% van de patiënten is de doorbraakpijn voorspelbaar vii. Anders, namelijk …

e. Welke van de onderstaande diagnostische methoden dienen nader onderzocht te worden in verband met doorbraakpijn? i. Anamnese ii. Unidimensionele vragenlijsten


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iii. iv. v. vi. vii. viii. ix. x.

Multidimensionele vragenlijsten Pijndagboek Lichamelijk onderzoek (inclusief neurologische onderzoek) Quantitative Sensory Testing (QST-meting) Magnetic Resonance Imaging (MRI) Elektromyogram (EMG) Positron Emissie Tomografie (PET) Anders, namelijk …

5. Behandeling; algemeen a. Kwantificeert u voordat u start met pijnbehandeling zowel de achtergrondpijn als de doorbraakpijn? i. Ja ii. Nee

b. Hoe kwantificeert u de doorbraakpijn? i. ii. iii. iv. v.

Anamnese Unidimensionaal meetinstrument Multidimensionaal meetinstrument Geen meetmethode beschikbaar Anders, namelijk …

c. Op welke van de onderstaande aspecten let u, bij het bepalen van het effect van uw pijnbehandeling op de doorbraakpijn? i. ii. iii. iv. v. vi. vii. viii.

Afname van de intensiteit van de pijn Afname van het aantal episodes van doorbraakpijn Door pijn veroorzaakte distress Pijn vermindering Tevredenheid over de behandeling Verbetering in functioneren in het dagelijks leven Verbetering van kwaliteit van leven Anders, namelijk …

d. Welke van de onderstaande aspecten moeten aan de orde komen in een goede meetmethode voor doorbraakpijn? i. ii. iii. iv. v. vi. vii.

Intensiteit van de pijn Aantal episodes van doorbraakpijn Door pijn veroorzaakte distress Tevredenheid over de behandeling Verbetering in functioneren in het dagelijks leven Verbetering van kwaliteit van leven Anders, namelijk …

e. Zou u graag zien dat deze aspecten worden omgezet naar een gevalideerde meetmethode? i. Ja ii. Nee

6. Farmacologische behandeling; Algemeen a. Aan welke van de volgende kenmerken moet de farmacologische symptomatische behandeling van doorbraakpijn (‘rescue medicatie’ bij voorkeur voldoen? (meerdere antwoorden mogelijk) i. Werkzaam binnen enkele minuten Concept report breakthrough pain

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ii. iii. iv. v. vi. vii.

Adequaat verminderen van pijn Gedurende ongeveer 30 minuten werkzaam zijn Goed te combineren zijn ‘around the clock’medicatie Makkelijk zelfstandig door de patiënt te gebruiken Flexibele dosering en makkelijk aan te passen dosering Anders, namelijk …

b. Welke van de volgende farmacodynamische kenmerken vormt volgens u de grootste tekortkoming van de medicijnen voor de symptomatische behandeling (‘rescue medicatie’) van doorbraakpijn? (één antwoord mogelijk) i. ii. iii. iv. v. vi. vii.

Werkzaam binnen enkele minuten Adequaat verminderen van pijn Gedurende 30 minuten werkzaam zijn Goed te combineren zijn ‘around the clock’ medicatie Makkelijk zelfstandig door de patiënt te gebruiken Flexibele dosering en makkelijk aan te passen dosering Anders, namelijk …

c. Welke van de volgende farmacodynamische kenmerken is dermate belangrijk dat deze voor nader onderzoek in aanmerking komt? (maximaal twee antwoorden mogelijk) i. ii. iii. iv. v. vi. vii.

Werkzaam binnen enkele minuten Adequaat verminderen van pijn Gedurende 30 minuten werkzaam zijn Goed te combineren zijn ‘around the clock’ medicatie Makkelijk zelfstandig door de patiënt te gebruiken Flexibele dosering en makkelijk aan te passen dosering Anders, namelijk …

d. Welke routes van toediening komen in aanmerking voor nader onderzoek? (meerdere antwoorden mogelijk) i. ii. iii. iv. v. vi. vii. viii. ix. x. xi. xii. xiii.

Intraveneus Intramusculair Intrathecaal Subcutaan Oraal Transmucosaal Transdermaal Intranasaal Intrapulmonaal Sublinguaal Buccaal Rectaal Anders, namelijk …

7. Farmacologische behandeling: opioiden De volgende vragen gaan over de behandeling van doorbraakpijn met opioiden a. Welke van de onderstaande behandelingsstrategieën heeft uw voorkeur, wanneer de behandeling van doorbraakpijn met een opioid onvoldoende effectief is? (één antwoord mogelijk) Welke van de onderstaande behandelings strategieën gebruikt u om doorbraakpijn effectiever te Concept report breakthrough pain

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behandelen, wanneer de behandeling met een opioid onvoldoende is? (meerdere antwoorden mogelijk) i. ii. iii. iv. v. vi. vii.

Frequentie verhogen van de kort werkende medicatie In plaats van kort werkende medicatie, lang werkende medicatie voorschrijven Opioid rotatie ‘Rescue medicatie’ voorschrijven Verhogen van de dosering van de ‘around the clock’ medicatie Verhogen van de lang werkende medicatie Anders, namelijk

b. Welke opioiden gebruikt u als ‘rescue medicatie’ bij de behandeling van doorbraakpijn. Aangenomen dat de doorbraakpijn goed behandeld is. (meerdere antwoorden mogelijk) 1) Bij een klinische patiënt? 2) Bij een patiënt die thuis is? i. ii. iii. iv. v. vi. vii. viii. ix. x. xi.

Codeine Tramadol Morfine Fentanyl Sufentanil Hydromorfon Methadon Oxycodon Piritramide Buprenorfine Anders, namelijk

c. Is het voor u een optie doorbraakpijn te behandelen door de dosering van de ‘continue medicatie’ met opioiden te verhogen? Aangenomen dat de achtergrondpijn goed behandeld is. i. Ja ii. Nee

8. Farmacologische behandeling: niet-opioiden De volgende vragen gaan over de behandeling van doorbraakpijn met niet-opioiden a. Welke van de onderstaande medicijnen gebruikt u als ‘rescue medicatie’ voor de behandeling van doorbraakpijn. Aangenomen dat de achtergrondpijn goed behandeld is. (meerdere antwoorden mogelijk). 1) Bij een klinische patiënt? 2) Bij een patiënt die thuis is? i. ii. iii. iv. v. vi. vii. viii. ix.

Paracetamol Non-Steroidal Anti-Inflammatory Drugs (NSAID’s) Tricyclische antidepressica (TCA’s) Selectieve Serotine Re-uptake Inhibitors (SSRI’s) Anti-epileptica Bisfosfonaten Ketamine Levomepromazine Anders, namelijk


23

b. Is het voor u een optie doorbraakpijn te behandelen door de dosering van de ‘continue medicatie’ met niet-opioiden te verhogen? Aangenomen dat de achtergrondpijn goed behandeld is. i. Ja ii. Nee

9. Niet farmacologische behandeling a. Vraag 1: Welke van de onderstaande niet-farmacologische multimodale strategieën gebruikt u voor de behandeling van doorbraakpijn? (meerdere antwoorden mogelijk) Vraag 2: Welke van deze strategieën zijn relevant voor nader onderzoek in verband met de behandeling van doorbraakpijn (meerdere antwoorden mogelijk) i. ii. iii. iv. v. vi. vii. viii. ix. x. xi.

Psychologische ondersteuning Kennis van de patiënt verbeteren Aanpassingen van levensstijl Pijn-Bio-Feedback Fysiotherapie: koude en warmte packings Fysiotherapie: ontspanningsoefeningen Fysiotherapie: Transcutane Elektrische Neuro Stimulatie (TENS)-therapie Interventies: injecties Interventies: neurostimulatie Interventies: neurodestructieve technieken Anders, namelijk

10. Preventie a. Is volgens u preventie van doorbraakpijn mogelijk? i. Ja ii. Nee

b. Hoe denkt u dat doorbraakpijn te voorkomen is? i. Het voorkomen van de oorzaak van de pijn (bv. door het verbeteren van de ii. iii. iv. v. vi.

oncologische behandeling waardoor minder complicaties ontstaan die pijn veroorzaken) Verbeteren van de kennis van de patiënt Verbeteren van de implementatie van de richtlijnen Voorkomen van opioid schommelingen Verbeteren van de kennis over genetica en de invloed hiervan op de werking van medicijnen Anders, namelijk

11. Open vragen a. Zijn er nog aanvullingen die u wilt geven over de discussie rondom de definitie van doorbraakpijn b. Is er een bepaalde groep patiënten warbij u vaker doorbraakpijn ziet? c. Hoe zou u bij voorkeur de diagnostiek van doorbraakpijn verbeteren? d. Welk onderzoeksvoorstel over doorbraakpijn vindt u relevant voor nader onderzoek? (denk hierbij aan onderzoek met een duur van maximaal één jaar met een beperkt budget i. Onderzoeksvoorstel 1: ii. Onderzoeksvoorstel 2: Concept report breakthrough pain

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iii. Onderzoeksvoorstel 3:

12. Afsluiting a. Wilt u naar aanleiding van deze enquête op korte termijn deelnemen aan een interview over het onderwerp doorbraakpijn? i. Ja ii. Nee

b. Stelt u het op prijs de resultaten van deze enquête te ontvangen i. Ja ii. Nee

c. Heeft u interesse om op de hoogte gehouden te worden over ontwikkelingen omtrent doorbraakpijn? i. Ja ii. Nee

d. Zou u belangstelling hebben om mee te doen aan een multicenter onderzoek over doorbraakpijn? i. Ja ii. Nee

e. Wilt u, wanneer u positief heeft geantwoord op een van de bovenstaande vragen, hieronder uw naam en emailadres opschrijven zodat wij met u in contact kunnen komen? i. Name: ii. Adress:

f. Wilt u hieronder aangeven of u arts of verpleegkundige bent i. Ik ben arts ii. Ik ben verpleegkundige

g. Heeft u nog op- of aanmerkingen over deze enquête?


25

Appendix 2: Questionnaire in English 1. Definition a. Which of the following is the best definition for breakthrough pain? i. 'A transitory exacerbation of pain that occurs on an background of otherwise stable pain in a patient receiving opiod therapy' (Portenoy 1990)

ii. ‘In the cancer population, breakthrough pain is a transitory, severe or excruciating pain, which lasts seconds to hours and is superimposed on a baseline pain controlled to a moderate or better intensity by an opioidregimen'(Mercadante 2002) iii. 'A transitory exacerbation of pain experienced by the patient who has relatively stable and adequately controlled baseline pain'(Portenoy 2004) iv. 'een voorbijgaande verhoging van de pijnintensiteit bij een continue achtergrondpijn' (Richtlijn diagnostiek en behandeling van pijn 2008) v. 'A transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain' (Davies 2009)

h. Do you think that breakthrough pain exists? i. Yes ii. No

i. How many patients with pain visit your medical centre each week? j. How many patients with cancer-related pain visit your medical centre each week? How many of these patients do have breakthrough pain? k. How many patients with chronic pain visit you medical centre every week? How many of these patients have breakthrough pain? 13. Definition a. Are persistent pain and breakthrough pain two distinct clinical entities? i. Yes ii. No

b. Is it necessary for the patient to have background pain in order to speak of breakthrough pain? i. Yes ii. No

c. Is it necessary that the patient has adequately controlled background pain, to be able to speak of breakthrough pain? i. Yes ii. No

d. Is end-of-dose pain a subtype of breakthrough pain? i. Yes ii. No

e. Is the type of pain that caused by inadequately controlled background pain, a subtype of breakthrough pain? i. Yes ii. No

f. Is breakthrough pain always cancer-related? i. Yes ii. No


26

g. Which of the following terms do you use for breakthrough pain? (multiple answers possible) i. ii. iii. iv. v. vi.

Episodic pain Transient pain Breakthrough pain Incident pain Other (please specify)

14. Definition a. Which of the following terms do you use for background pain? (multiple answers possible) i. ii. iii. iv.

Baseline pain Persistent pain Background pain Other (please specify)

b. Which of the following terms do you use for the medical treatment of breakthrough pain? (multiple answers possible) i. Escape medication ii. Rescue medication iii. Other (please specify)

c. Are we in need of a new definition of breakthrough pain? i. Yes ii. No

d. Which of the following three classifications is the most relevant in a clinical setting and in a research setting? Classification

A -

Breakthrough pain due to direct effect of the cancer Breakthrough pain due to anti-cancer treatment Breakthrough pain due to a concomitant illness

-

Spontaneous pain (occurs unexpectedly) Incident pain (is related to specific volitional acts (e.g. walking) or non-volitional acts (e.g. coughing)) End-of-dose pain (pain related to analgesic dosing)

-

Nociceptive pain (sub classified in somatic pain and visceral pain) Inflammatory pain Neuropathic pain

Classification B

Classification C

Classification A

Classification B

Classification C

Clinical setting Research setting

e. Would you please give an interpretation of your answer on the previous question 15. Assessment a. Do you feel capable to diagnose breakthrough pain through history taking?


27

i. Yes ii. No

b. Would a questionnaire be a useful tool for you to diagnose breakthrough pain? i. Yes ii. No

c. Which of the following methods do you use to diagnose breakthrough pain? (multiple answers possible) i. ii. iii. iv. v. vi. vii. viii. ix. x.

History taking Unidimensional assessment tool Multidimensional assessment tool Pain diary Physical examination Quantitative Sensory Testing (QST) Magnetic Resonance Imaging (MRI) Electromyography (EMG) Positron emission tomography (PET) Other (please specify)

d. Which of the following characteristics of breakthrough pain have you diagnosed with your own patients (multiple answers possible) i. ii. iii. iv. v. vi. vii.

Time to peak severity, average 3-5 minutes Severity of breakthrough pain, average severe-excruciating Duration, average 15-30 minutes Number of episodes per day, average 1-5 Precipitated by event, average of 55-60% of the patients Predictability of the breakthrough pain, average 50-60% of the patients Other (please specify)

e. Which of the following methods should have further research in relation to breakthrough pain? (multiple answers possible) i. ii. iii. iv. v. vi. vii. viii. ix. x.

History taking Unidimensional assessment tool Multidimensional assessment tool Pain diary Physical examination Quantitative Sensory Testing (QST) Magnetic Resonance Imaging (MRI) Electromyography (EMG) Positron emission tomography (PET) Other (please specify)

16. Treatment: general a. Before starting pain treatment, do you quantify separately background pain and breakthrough pain? i. Yes ii. No

b. How do you quantify breakthrough pain? (multiple answers possible) i. History taking ii. Unidimensional measuring method iii. Multidimensional measuring method


28

iv. There is no measuring method available v. Other (please specify)

c. Which of the following aspects do you take into account when assessing the treatment of breakthrough pain? (multiple answers possible) i. ii. iii. iv. v. vi. vii. viii.

Intensity of pain Distress of pain Frequency of pain Pain relief Satisfaction with treatment Improvement in function Improvement in quality of life Other (please specify)

d. Which of the following aspects should be included in the assessment tools for breakthrough pain? (multiple answers possible) i. ii. iii. iv. v. vi. vii. viii.

Intensity of pain Distress of pain Frequency of pain Pain relief Satisfaction with treatment Improvement in function Improvement in quality of life Other (please specify)

e. Should there be a validated assessment tool for all these aspects? i. Yes ii. No

17. Pharmacological treatment: general a. To which of the following characteristics should the symptomatic treatment (the rescue treatment) of breakthrough pain comply? (multiple answers possible) i. ii. iii. iv. v. vi. vii.

A rapid onset of analgesia, within minutes Provide a durable response to resolve the pain experienced Sustain pain relief for up to 30 minutes Combines well with around-the-clock medication Easy for patients to self administer Flexible dosing and easy to dose-adjust Other (please specify)

b. Which of the following pharmacodynamic characteristics is the most important shortcoming of the medicines currently used for symptomatic treatment of breakthrough pain? (one answer possible) i. ii. iii. iv. v. vi. vii.


c. Which of the following pharmacodynamic characteristics should be part of future research (multiple answers possible)


29

i. ii. iii. iv. v. vi. vii.


d. Which routes of administration should be part of future research? (multiple answers possible) i. ii. iii. iv. v. vi. vii. viii. ix. x. xi. xii.

Intravenous Intramuscular Intrathecal Subcutaneous Oral Transmucosal Transdermal Intranasal Sublingual Rectal Intrapulmonary Other (please specify)

18. Pharmacological treatment: opioid analgesics The following questions are about treatment of breakthrough pain with opioid analgesics. a. Which of the following treatment strategies would you prefer in case the treatment of breakthrough pain with an opioid is ineffective? (one answer possible) Which of the following treatment strategies do you use in case the treatment of breakthrough pain with an opioid is ineffective? (multiple answers possible) i. ii. iii. iv. v. vi. vii.

Increase the frequency of the short acting opioid Replace a short acting opioid with a long acting opioid Opioid rotation Prescribe rescue medication Increase the dose of the around-the-clock medication Increase the dose of the long acting opioid Other (please specify)

b. Which of the following medications would you use as rescue medication? Assuming that breakthrough pain is treated well. 1) for an in-hospital patient? 2) for an patient at home? i. ii. iii. iv. v. vi. vii. viii. ix.

Codeine Tramadol Morphine Fentanyl Sufentanil Hydromorphone Methadone Oxycodone Piritramide


30

x. Buprenorphine xi. Other (please specify)

c. Do you consider to treat breakthrough pain by increasing the dose of aroundthe-clock medication with opioid analgesics? (assuming that the breakthrough pain is well treated.) i. Yes ii. No

19. Pharmacological treatment: non-opioid analgesics The following questions are about the treatment of breakthrough pain with nonopioid analgesics. a. Which of the following drugs do you use as ‘rescue medication’ in the treatment of breakthrough pain? Assuming that the background pain is well treated. 1) For an in-hospital patient? 2) for an patient at home? i. ii. iii. iv. v. vi. vii. viii.

Paracetamol Non-Steroidal Anti-Inflammatory drugs Tricyclic antidepressants Selective serotonin reuptake inhibitors Anticonvulsants Bisphosphonates Ketamine Levomepromazine

b. Do you consider to treat breakthrough pain by increasing the dose of aroundthe-clock medication with non-opioid analgesics assuming the background pain is well treated i. Yes ii. No

20. Non-pharmacological treatment a. Which of the following non-pharmacological multimodal strategies do you consider for the treatment of breakthrough pain? Which of these strategies should be further researched in relation to the treatment of breakthrough pain? i. ii. iii. iv. v. vi. vii. viii. ix. x. xi.

Psychological support Improvement of patient’ knowledge Adjustments of lifestyle Pain-biofeedback Physiotherapy: cold and warm packings Physiotherapy: relaxation exercises Physiotherapy: Transcutaneous Electric Nerve Stimulation (TENS) therapy Interventions: injections Interventions: neurostimulation Interventions: neurosdestructive techniques (neuroablation) Other (please specify)

21. Prevention a. Do you think that prevention of breakthrough pain is possible? i. Yes


31

ii. No

b. If yes, how can breakthrough pain be prevented? i. Elimination of the cause of the pain (e.g. by improving the oncological treatment resulting in less pain inducing complications) Improvement of the patients’ knowledge Improvement of the implementation of guidelines Prevention of unstable opioid blood levels Improvement of knowledge on genetics and its influence on the pharmacodynamics and kinetics vi. Other (please specify)

ii. iii. iv. v.

22. Open-ended questions a. Are there any elements you want to add to the discussion about the definition of breakthrough pain? b. Are there in your opinion certain groups of patients that experience breakthrough pain more often than others? c. In what way would you like to improve the diagnostics of breakthrough pain? d. Could you please state a research proposal which you would like to be included in future research (assuming there is limited time (<1 year) and limited budget available for research) i. Research proposal 1: ii. Research proposal 2: iii. Research proposal 3:

23. General questions a. Would you like to receive the results of this questionnaire? i. Yes ii. No

b. Would you like to be informed on future developments towards breakthrough pain? i. Yes ii. No

c. Are you interested in participating in a multicentre study on breakthrough pain? i. Yes ii. No

d. Please fill in you contact information when you have answered one of the previous questions with yes. i. ii. iii. iv. v. vi. vii. viii.

Name: Hospital: Address: City/Town: State: ZIP/Postal Code: Country: Email Address:

e. Do you have any comments about this questionnaire? i. Yes ii. No Concept report breakthrough pain

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Appendix 3: Brochure

Figure 2: Frontpage brochure

Figure 3: Inner site brochure Concept report breakthrough pain

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Appendix 4: Questions interviews Procedurele onderbouwing -

Wat vond u van het invullen van de enquête online

-

Beviel het programma waarin de enquête was gemaakt?

-

Heeft u adviezen voor de toekomst, over het op deze wijze maken, verzenden en beantwoorden van een digitale enquête

Inhoudelijke onderbouwing -

Waren er vragen die moeilijk te beantwoorden waren, zo ja welke?

-

Was het mogelijk om goede betrouwbare/valide antwoorden te geven? Hoe betrouwbaar zijn uw antwoorden?

-

Zijn er vragen die u gemist heeft?

-

Heeft u aanvulling op het onderwerp doorbraakpijn?

Aanvullende vragen naar aanleiding van de enquête (voor iedereen apart geformuleerd)


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Appendix 5: Respondents categorized in profession

Profession

Number

Anesthesiologist

16

Nurse

6

Nursing home doctor

5

Oncologist

3

General practitioner

1

Nurse practitioner

1

Pharmacologist

1

Physiotherapist

1

Unknown

1

Total

35

Figure 4: respondents categorized in profession


35

Appendix 6: Results questionnaire 1. Definition

Figure 1.1.: Question 1.1. Which of the following is the best definition for breakthrough pain? (n=35)

Figure 1.2.: Question 1.2. Do you think That breaktrough pain exists? (n=35)

Figure 1.3.: In English they use the term breakthrough pain, is the dutch term ‘doorbraakpijn’ useful for you? (n=31)


36

Figure 1.4.: Question 2.2. Are persistent pain and breakthrough pain two distinct clinical entities?(n=34)

Figure 1.5.: Question 2.3. Is it necessary for the patient to have background pain in order to speak of breakthrough pain? (n=34)

Figure 1.6.: Question 2.4. Is it necessary that the patient has adequately controlled background pain, to be able to speak of breakthrough pain? (n=35)

Figure 1.7.: Question 2.5. Is end-of-dose pain a subtype of breakthrough pain? (n=34)


37

Figure 1.8.: Question 2.6. Is the type of pain that is caused by inadequately controlled background pain, a subtype of breakthrough pain? (n=35)

Figure 1.9.: Question 2.7. Is breakthrough pain always cancer-related? (n=35)

Figure 1.10.: Question 2.8. Which of the following terms do you use for breakthrough pain? (n=35, multiple answers possible)

Figure 1.11.: Question 3.1. Which of the following terms do you use for background pain? (n=34, multiple answers possible)


38

Figure 1.12.: Question 3.2. Which of the following terms do you use for the medical treatment of breakthrough pain? (n= 35, multiple answers possible)

Figure 1.13.: Question 3.3. Are we in need of a new definition of breakthrough pain? (n=33)


39

Figure 1.14.: Question 3.4. Which of the following three classifications is the most relevant in a clinical setting and in a research stetting? Classification A (Breakthrough pain is due to direct effect of the cancer or is due to anti-cancer treatment or is due to a concomitant illness) Classification B (Spontaneous pain or Incident pain or end-of-dose pain) Classification C (Nociceptive pain, inflammatory pain or neuropathic pain) (n=34)

2. Assessment

Figure 2.1.: Question 4.1. Do you feel capable to diagnose breakthrough pain through history taking? (n=34)

Figure 2.2.: Question 4.2. Would a questionnaire be a useful tool for you to diagnose breakthrough pain? (n=35)


40

Figure 2.3.: Question 4.3. Which of the following methods do you use to diagnose breakthrough pain? (n=34, multiple answers possible)

Figure 2.4.: Question 4.4. Which of the following characteristics of breakthrough pain have you diagnosed with your own patients? (n=32, multiple answers possible)


41

Figure 2.5.: Question 4.5. Which of the following methods should have further research in relation to breakthrough pain? (n=33, multiple answers possible)

3. Treatment: general questions

Figure 3.1.: Question 5.2. Before starting pain treatment, do you quantify separately background pain and breakthrough pain? (n=35)


42

Figure 3.2.: Question 5.2. How do you quantify breakthrough pain? (n=34, multiple answers possible)

Figure 3.3.: Question 5.3. Which of the following aspects do you take into account when assessing the treatment of breakthrough pain? (n=34, multiple answers possible)

Figure 3.4.: Question 5.4.Which of the following aspect should be included in the assessment tools for breakthrough pain? (n=34, multiple answers possible)


43

Figure 3.5.: Question 5.5. Should there be a validated assessment tool for all these aspects? (n=33)

4. Pharmacological treatment

Figure 4.1.: Question 6.1. To which of the following characteristics should the symptomatic treatment (the rescue treatment) of breakthrough pain comply? (n=35, multiple answers possible)


44

Figure 4.2.: Question 6.2. Which of the following pharmacodynamic characteristics is the most important shortcoming of the medicines currently used for symptomatic treatment of breakthrough pain? (n=31, one answer possible)

Figure 4.3.: Question 6.3. Which of the following pharmacodynamic characteristics should be part of future research (n=31, multiple answers possible)


45

Figure 4.4.: Question 6.4. Which routes of administration should be part of future research? (n=33 , multiple answers possible)

Figure 4.5.: Question 7.1. Which of the following treatment strategies would you prefer in case the treatment of breakthrough pain with an opioid is ineffective? (one answer possible) Which of the following treatment strategies do you use in case the treatment of breakthrough pain with an opioid is ineffective? (n=31, multiple answers possible)


46

Figure 4.6.: Question 7.2. Which of the following medications would you use as rescue medication? Assuming that background pain is treated well. A. for an in-hospital patient? B. for an patient at home? (n=34, multiple answers possible)

Figure 4.7.: Question 7.3. Do you consider to treat breakthrough pain by increasing the dose of around-the-clock medication with opioid analgesics? Assuming that the background pain is well treated. (n=35)


47

Figure 4.8.: Question 8.1. Which of the following drugs do you use as ‘rescue medication’ in the treatment of breakthrough pain? Assuming that the background pain is well treated. A. For an in-hospital patient? B. for an patient at home? (n=26, multiple answers possible)

Figure 4.9.: Question 8.2. Do you consider to treat breakthrough pain by increasing the dose of around-theclock medication with non-opioid analgesics assuming the background pain is well treated. (n=33)


48

5. Non-pharmacological treatment

Figure 5.1.: Question 9.2. Which of the following non-pharmacological multimodal strategies do you consider for the treatment of breakthrough pain? Which of these strategies should be further researched in relation to the treatment of breakthrough pain?(n=33)

6. Prevention

Figure 6.1.: Question 10.1. Do you think that prevention of breakthrough pain is possible? (n=33)


49

Figure 6.2.: Question 10.2. If yes, how can breakthrough pain be prevented?(n=24)

7. General questions

Figure 7.1. Question 12.1. would you like participate in a interview (n=30)

Figure 7.2.: Question 12.2. Would you like to receive the results of this questionnare? (n=34)


50

Figure 7.3.: Question 12.3. Would you like to be informed on future developments towards breakthrough pain? (n=34)

Figure 7.4.: Question 12.4. Are you interested in participating in a multicentre study on breakthrough pain? (n=34)

Figure 7.5.: Question 12.5. Are you a medical doctor or nurse? (n=35)


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Appendix 7: Specific research questions on breakthrough pain

From the presentation of the expert report on the meeting on breakthrough pain ZonMw in September 2009. Introduction As a part of defining good research questions a meeting was organized on 15th of September 2009 with invited experts in the field of pain treatment in patients and pain research. Specific research questions were formulated for each topic listed below during this brainstorm session. After this brainstorm everybody had the opportunity to mark independently, the most relevant and innovative research questions in the different fields. These research questions can be considered as an important result of this report and are meant to further induce financial agreements so that this questions can be researched in the near future in collaboration with ZonMw.

Results In the diagrams below the results of the session are presented and formulated as specific research questions.

General comment: Research questions scored as not useful or already extensively researched: ‘Patient education on Breakthrough pain’.


52

Figure 1: Research questions ‘the need for description and registration’

Figure 2: Research question ‘need for observation


53

Figure 3: Research questions ‘need for care standards and implementation

General conclusion: The following items and research questions are of upmost importance in the further eradication of Breakthrough pain (BTP): 1. How should the definition of BTP be operationalised in the different settings? 2. Can a new systematic review be done in order to have the latest data on the prevention, diagnosis and treatment of BTP? 3. Can specific registration tools be optimized to make BTP better visible in the different settings of care? 4. Can an international questionnaire or assessment tool for BTP be developed? 5.

Can prospective randomized control trials be initiated on the different interventions dealing with BTP?

6. Can different pharmacological treatment schemes and algorithms be researched to optimize the fast and efficient treatment of BTP?


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Breakthrough Pain Report of an explorative study on breakthrough pain

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