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The challenges of clinical case reporting.
ARTICLE IN PRESS Homeopathy (2003) 92, 229–231 r 2003 The Faculty of Homeopathy doi:10.1016/j.homp.2003.08.007, available online at www.sciencedirect.com
REPORT
The challenges of clinical case reporting. Delphi Project Conference, London, 2 April 2003 Cees Baas* Artsenpraktijk voor Homeopathie, Robijnring 51, 5629 GJ Eindhoven, The Netherlands
The Delphi Project organised a conference on clinical case research as a satellite session to the fourth edition of the biannual ‘Improving Homeopathy’ conferences organized by the Royal London Homeopathic Hospital. The main objective of the conference was to reflect on the five main challenges in clinical case research encountered by the Delphi Project. Each challenge was briefly introduced, then the 25 participants discussed them in subgroups, after which the results were compared in plenary sessions. The Delphi Project had originally hoped to find definitive answers to these challenges. It now appeared, however, that clinical case research will work better within a scientific community with naturally evolving consensus on topics that continue to spark debates. This conference was intended as the first step towards building such a scientific community. Virtually all participants had previous experience with the dilemmas in clinical case research. They enjoyed a day of very practical discussions, and mutual support and respect.
Challenge 1: How to communicate a case The cases that were presented to the Delphi Project vary greatly in size and detail. Peer reviewers found it difficult to judge cases because of this problem, different formats seem to suit different goals. Dr Elizabeth Thompson (Bristol Homeopathic Hospital) introduced this topic, stating that communicating a case should encourage accurate prescribing. This requires that the individuality of the patient’s story be reflected and the ‘Gestalt’ of that story be apparent. She also said she was sometimes uncomfortable with the detailed information: ‘Whom does the information
*Correspondence: C Baas, Artsenpraktijk voor Homeopathie, Robijnring 51, 5629 GJ Eindhoven, The Netherlands. E-mail: [email protected]
belong to, and with whom can I share it?’ Perhaps we do not need all the information: sometimes a part represents the whole very well. We must also face the risk that if you want to publish everything, you get a selected population of patients who are willing to be exposed. The plenary discussion yielded many questions, worries and suggestions. They were summed up by one subgroup: It seems that if you solve one thing, six others pop up. Selection of data remains a pivotal point. What does the prescriber choose to report? Can we determine at the beginning of treatment which points will be followed up? Can the prescriber write or type quickly enough to record sufficient data? Language is only a part of the communication. How will the rest be reported? Some homeopathic teachers show the first 5 min of a consultation on video. We should be aware that research goals may influence the questions asked during a consultation. It was suggested that the ELPS (Electronic Long, Paper Short) approach could be used. In journals the case report could be presented in abbreviated form, highlighting why a prescription was made, and how the case evolved. The complete description could be made available through a web site. A rating system was also suggested, describing the complexity of the case (length, seriousness of condition treated). This would prevent reporters feeling inhibited when their case seems too simple, or overly complex. Other feedback underlined that studying effectiveness is not the same as evaluating the therapeutic strategies of prescribers, the latter is the objective of clinical case research. It was noted several times that we need to know how the barriers to submitting cases can be lowered.
Challenge 2: What criteria to observe Criteria for the quality of cases are a stumbling block for clinical case research projects. The basic criteria that everybody in the Delphi Project agreed on were not seen by the peer reviewers as providing enough support to judge cases. This topic was introduced by
ARTICLE IN PRESS Conference Report C Baas
230
Dr Annette Sneevliet (Bakkeveen, Nl). She illustrated that strict rules will not solve this issue. What to think of a man doing very well on Conium, who dies a year later of a heart attack, totally unrelated to the symptoms he was treated for? What to think of a woman who does fine on Ignatia repeated bi-monthly, but 2 years later needs Conium? A woman doing fine on Spongia, but who later develops breast cancer? A child whose colds disappear with Aconite, but his ADHD is no better? And what of placebo effects? Why do the gurus seem to have all the beautiful cases? Whose cases can we accept? Those of an enthusiastic beginner? Only medical doctors? Non-medical prescribers? Or anybody? Which colleagues do we trust? The plenary feedback involved much discussion about criteria. Some points raised were: The objective is not to create certainty but to reduce uncertainty. There is not one single truth anyway. Six prescribers would give six different descriptions of the same case. The basic criterion must be that you learned something that is worth sharing with others. And sharing should be done with openness and transparency. If a case is not optimal, can it still be useful? We need evidence of self-criticism by authors. Was there anything else that can explain the improvement? One participant made the (tongue in cheek) suggestion of banning people who love to publish cases! Deciding whether a remedy was helpful could be done by the patient, patient feedback could be sent separately from the doctors report. One subgroup suggested the use of scales for perceived veracity and meaningfulness in the peer review process. Collateral information, like test results and third party reports, should play a role.
Challenge 3: How to meta analyse cases How can we condense information from several cases, and from different prescribers? A committee of the Dutch Union of Homeopathic Physicians (VHAN) has been working on this topic for several years. Two members of this committee introduced the topic: Dr Lex Rutten (Breda, Nl) and Dr Eric Stolper (Heerden, Nl). The objective is to evaluate what information led to a prescription, and, upon review, how reliable was that information. The study of 16 successful cases of Lachesis showed that seven of 16 cases were loquacious, and only four exhibited jealousy. Yet, these qualities are widely believed to be crucial features of Lachesis. Many pitfalls complicate this kind of research. Different forms of bias in reporting and selecting cases play a role. Confirmation bias for example means that we only publish successful cases, and forget the unsuccessful cases with similar symptoms. The small number of cases submitted continues to be a problem. Homeopathy
Cases must be written with sound judgement and realistic observation. But semantic issues are a major hurdle: jealousy, for example, can be expressed in many ways. An aspect to note was the consistent use of the concept of trigger symptom, the symptom that first made the prescriber think of the remedy that was eventually prescribed. The feedback from the subgroups showed that different forms of bias had been the main topic of discussion: Bias is who we are. You cannot perceive the world from any other perspective but your own, and it is also who you are today. Your bias changes over time. You prescribe what you know. If you know ten remedies well, you may be very good at prescribing them. Prescribing patterns change depending on who you heard teaching at the weekend. How representative are selected cases for everyday practice? Should you send in every case? Or every first case of every Monday? Reporting an unsuccessful case is much more difficult: you do not know what is really important to report. Motivations may be influential for selecting the cases, and for how they are presented. Some people think it is clever to prescribe small remedies. Some attention was given to the question how many cases are needed to do adequate research in this area. The concept of theoretical saturation was mentioned: the number of cases you need to be able to predict the next one. In qualitative research the typical maximum is about 20, and usually at least 12.
Challenge 4: Ethical aspects of homeopathic clinical case research Uncertainty about legal and ethical aspects played a main role in slowing down the Delphi Project, the project has encountered a surprising lack of insight in ethical matters within the homeopathic community. Prof Andrew George, Chair of the Research Ethics Committee of Hammersmith Hospital, London, introduced this subject. Prof George’s basic message was that ethics are not something that can be decided for you. Researchers themselves have to be aware of what they are doing, and how this compares to contemporary ethical standards. His presentation was very interactive, prompting lots of questions. If patients consent to undergoing some kind of experiment, and the results are never published, that is unethical. In medicine, research is doing more or different things than you would in a normal clinical setting. Doing a more profound interview may be research! In clinical case research the patient will not benefit from his case being reported. The good news from Prof George’s experience was that homeopaths do seek informed consent, usually better than other doctors. On the other hand, practitioners in alternative medicine often have a close relationship with their patients. Can patients really say
ARTICLE IN PRESS Conference Report C Baas
231
no without hurting this relationship and the quality of their treatment? He illustrated that confidentiality is a difficult subject. Even biochemical data may make it possible to trace a patient. Access to data has to be restricted. On the internet, password protection is an option. If data are made available through the internet, the rules apply of the country from where the data is accessed, not of that where the database server is located. In Europe protection of confidentiality is stricter than in the USA. Prof George confirmed that ‘reflective practice’, exchanging experiences in order to help colleagues, is part of good clinical practice. A main differentiating point is that in research, there is an objective to publish. Sharing cases within one practice may not even need explicit consent. If the group is larger, we enter a grey area. The bottom line is that we will have to define our own ethics and anything that looks like research should be evaluated by a Medical Ethics Committee. The subgroups were invited to think of non-coercive ways to ask patients for consent, and judge confidentiality aspects of three homeopathic cases (supplied by Delphi). The subgroups mainly focused on the confidentiality aspects, and several potential identifiers which it would have been better not to mention, such as medical information about family members, and names of hospitals and towns were found.
Challenge 5: Peer review of homeopathic cases Dr Bastian van Eynatten (Cork, Ireland) introduced the subject of peer review. He had submitted, among others, a case of Germanium prescribed for dyslexia and warts. The case was sent to three anonymous reviewers: ‘My cases were the first ones to be scrutinised in this way. I heard nothing for quite a while. Two reviewers were neutral to positive, but not
very useful as a learning experience. The third was quite critical. I first felt that it was not a good case at all. But in hindsight I saw that this was the feedback that I needed to improve the case. She wanted to see more of the own words of the patients, and know more about the world of the patient, as she didn’t know Germanium’. ‘The reviewer was also very critical about whether the remedy had been effective, because with dyslexia you have so many other interventions. In fact nothing else was done but I had not reported this.’ ‘I wondered why this person was so critical. The info about Germanium came from the Dynamis school group proving, I thought maybe for her it was a nonremedy anyway. But thanks to the reviewer the quality was improved. The feedback was very critical, but very positive and stimulating.’ Participants were then invited to review each other’s cases. One participant stated that with all due respect, she would never have the time to study such detailed descriptions, and the case would not help her clinical work. Other feedback showed the desire for more literal and extensive descriptions of the patient’s words. It was apparent that there were very different expectations. It was felt that every case should have a paragraph or section explaining the analysis and conclusions. Peer review should not be so critical as to hurt the author’s feelings. It was underlined that peer review is an iterative process. It is not pass/fail, but a procedure to stimulate improvement. Dr Bob Leckridge (Glasgow Homeopathic Hospital) summed up the day. He stated that, overall, it had shown that clinical case research is more complicated than we expected, which is already a great achievement. The author thanks the speakers and participants for their contributions, the Royal London Homeopathic Hospital for their help and support in organising this congress, and the Marion Meyenburg foundation for its support of the Delphi Project.
Homeopathy
REPORT
The challenges of clinical case reporting. Delphi Project Conference, London, 2 April 2003 Cees Baas* Artsenpraktijk voor Homeopathie, Robijnring 51, 5629 GJ Eindhoven, The Netherlands
The Delphi Project organised a conference on clinical case research as a satellite session to the fourth edition of the biannual ‘Improving Homeopathy’ conferences organized by the Royal London Homeopathic Hospital. The main objective of the conference was to reflect on the five main challenges in clinical case research encountered by the Delphi Project. Each challenge was briefly introduced, then the 25 participants discussed them in subgroups, after which the results were compared in plenary sessions. The Delphi Project had originally hoped to find definitive answers to these challenges. It now appeared, however, that clinical case research will work better within a scientific community with naturally evolving consensus on topics that continue to spark debates. This conference was intended as the first step towards building such a scientific community. Virtually all participants had previous experience with the dilemmas in clinical case research. They enjoyed a day of very practical discussions, and mutual support and respect.
Challenge 1: How to communicate a case The cases that were presented to the Delphi Project vary greatly in size and detail. Peer reviewers found it difficult to judge cases because of this problem, different formats seem to suit different goals. Dr Elizabeth Thompson (Bristol Homeopathic Hospital) introduced this topic, stating that communicating a case should encourage accurate prescribing. This requires that the individuality of the patient’s story be reflected and the ‘Gestalt’ of that story be apparent. She also said she was sometimes uncomfortable with the detailed information: ‘Whom does the information
*Correspondence: C Baas, Artsenpraktijk voor Homeopathie, Robijnring 51, 5629 GJ Eindhoven, The Netherlands. E-mail: [email protected]
belong to, and with whom can I share it?’ Perhaps we do not need all the information: sometimes a part represents the whole very well. We must also face the risk that if you want to publish everything, you get a selected population of patients who are willing to be exposed. The plenary discussion yielded many questions, worries and suggestions. They were summed up by one subgroup: It seems that if you solve one thing, six others pop up. Selection of data remains a pivotal point. What does the prescriber choose to report? Can we determine at the beginning of treatment which points will be followed up? Can the prescriber write or type quickly enough to record sufficient data? Language is only a part of the communication. How will the rest be reported? Some homeopathic teachers show the first 5 min of a consultation on video. We should be aware that research goals may influence the questions asked during a consultation. It was suggested that the ELPS (Electronic Long, Paper Short) approach could be used. In journals the case report could be presented in abbreviated form, highlighting why a prescription was made, and how the case evolved. The complete description could be made available through a web site. A rating system was also suggested, describing the complexity of the case (length, seriousness of condition treated). This would prevent reporters feeling inhibited when their case seems too simple, or overly complex. Other feedback underlined that studying effectiveness is not the same as evaluating the therapeutic strategies of prescribers, the latter is the objective of clinical case research. It was noted several times that we need to know how the barriers to submitting cases can be lowered.
Challenge 2: What criteria to observe Criteria for the quality of cases are a stumbling block for clinical case research projects. The basic criteria that everybody in the Delphi Project agreed on were not seen by the peer reviewers as providing enough support to judge cases. This topic was introduced by
ARTICLE IN PRESS Conference Report C Baas
230
Dr Annette Sneevliet (Bakkeveen, Nl). She illustrated that strict rules will not solve this issue. What to think of a man doing very well on Conium, who dies a year later of a heart attack, totally unrelated to the symptoms he was treated for? What to think of a woman who does fine on Ignatia repeated bi-monthly, but 2 years later needs Conium? A woman doing fine on Spongia, but who later develops breast cancer? A child whose colds disappear with Aconite, but his ADHD is no better? And what of placebo effects? Why do the gurus seem to have all the beautiful cases? Whose cases can we accept? Those of an enthusiastic beginner? Only medical doctors? Non-medical prescribers? Or anybody? Which colleagues do we trust? The plenary feedback involved much discussion about criteria. Some points raised were: The objective is not to create certainty but to reduce uncertainty. There is not one single truth anyway. Six prescribers would give six different descriptions of the same case. The basic criterion must be that you learned something that is worth sharing with others. And sharing should be done with openness and transparency. If a case is not optimal, can it still be useful? We need evidence of self-criticism by authors. Was there anything else that can explain the improvement? One participant made the (tongue in cheek) suggestion of banning people who love to publish cases! Deciding whether a remedy was helpful could be done by the patient, patient feedback could be sent separately from the doctors report. One subgroup suggested the use of scales for perceived veracity and meaningfulness in the peer review process. Collateral information, like test results and third party reports, should play a role.
Challenge 3: How to meta analyse cases How can we condense information from several cases, and from different prescribers? A committee of the Dutch Union of Homeopathic Physicians (VHAN) has been working on this topic for several years. Two members of this committee introduced the topic: Dr Lex Rutten (Breda, Nl) and Dr Eric Stolper (Heerden, Nl). The objective is to evaluate what information led to a prescription, and, upon review, how reliable was that information. The study of 16 successful cases of Lachesis showed that seven of 16 cases were loquacious, and only four exhibited jealousy. Yet, these qualities are widely believed to be crucial features of Lachesis. Many pitfalls complicate this kind of research. Different forms of bias in reporting and selecting cases play a role. Confirmation bias for example means that we only publish successful cases, and forget the unsuccessful cases with similar symptoms. The small number of cases submitted continues to be a problem. Homeopathy
Cases must be written with sound judgement and realistic observation. But semantic issues are a major hurdle: jealousy, for example, can be expressed in many ways. An aspect to note was the consistent use of the concept of trigger symptom, the symptom that first made the prescriber think of the remedy that was eventually prescribed. The feedback from the subgroups showed that different forms of bias had been the main topic of discussion: Bias is who we are. You cannot perceive the world from any other perspective but your own, and it is also who you are today. Your bias changes over time. You prescribe what you know. If you know ten remedies well, you may be very good at prescribing them. Prescribing patterns change depending on who you heard teaching at the weekend. How representative are selected cases for everyday practice? Should you send in every case? Or every first case of every Monday? Reporting an unsuccessful case is much more difficult: you do not know what is really important to report. Motivations may be influential for selecting the cases, and for how they are presented. Some people think it is clever to prescribe small remedies. Some attention was given to the question how many cases are needed to do adequate research in this area. The concept of theoretical saturation was mentioned: the number of cases you need to be able to predict the next one. In qualitative research the typical maximum is about 20, and usually at least 12.
Challenge 4: Ethical aspects of homeopathic clinical case research Uncertainty about legal and ethical aspects played a main role in slowing down the Delphi Project, the project has encountered a surprising lack of insight in ethical matters within the homeopathic community. Prof Andrew George, Chair of the Research Ethics Committee of Hammersmith Hospital, London, introduced this subject. Prof George’s basic message was that ethics are not something that can be decided for you. Researchers themselves have to be aware of what they are doing, and how this compares to contemporary ethical standards. His presentation was very interactive, prompting lots of questions. If patients consent to undergoing some kind of experiment, and the results are never published, that is unethical. In medicine, research is doing more or different things than you would in a normal clinical setting. Doing a more profound interview may be research! In clinical case research the patient will not benefit from his case being reported. The good news from Prof George’s experience was that homeopaths do seek informed consent, usually better than other doctors. On the other hand, practitioners in alternative medicine often have a close relationship with their patients. Can patients really say
ARTICLE IN PRESS Conference Report C Baas
231
no without hurting this relationship and the quality of their treatment? He illustrated that confidentiality is a difficult subject. Even biochemical data may make it possible to trace a patient. Access to data has to be restricted. On the internet, password protection is an option. If data are made available through the internet, the rules apply of the country from where the data is accessed, not of that where the database server is located. In Europe protection of confidentiality is stricter than in the USA. Prof George confirmed that ‘reflective practice’, exchanging experiences in order to help colleagues, is part of good clinical practice. A main differentiating point is that in research, there is an objective to publish. Sharing cases within one practice may not even need explicit consent. If the group is larger, we enter a grey area. The bottom line is that we will have to define our own ethics and anything that looks like research should be evaluated by a Medical Ethics Committee. The subgroups were invited to think of non-coercive ways to ask patients for consent, and judge confidentiality aspects of three homeopathic cases (supplied by Delphi). The subgroups mainly focused on the confidentiality aspects, and several potential identifiers which it would have been better not to mention, such as medical information about family members, and names of hospitals and towns were found.
Challenge 5: Peer review of homeopathic cases Dr Bastian van Eynatten (Cork, Ireland) introduced the subject of peer review. He had submitted, among others, a case of Germanium prescribed for dyslexia and warts. The case was sent to three anonymous reviewers: ‘My cases were the first ones to be scrutinised in this way. I heard nothing for quite a while. Two reviewers were neutral to positive, but not
very useful as a learning experience. The third was quite critical. I first felt that it was not a good case at all. But in hindsight I saw that this was the feedback that I needed to improve the case. She wanted to see more of the own words of the patients, and know more about the world of the patient, as she didn’t know Germanium’. ‘The reviewer was also very critical about whether the remedy had been effective, because with dyslexia you have so many other interventions. In fact nothing else was done but I had not reported this.’ ‘I wondered why this person was so critical. The info about Germanium came from the Dynamis school group proving, I thought maybe for her it was a nonremedy anyway. But thanks to the reviewer the quality was improved. The feedback was very critical, but very positive and stimulating.’ Participants were then invited to review each other’s cases. One participant stated that with all due respect, she would never have the time to study such detailed descriptions, and the case would not help her clinical work. Other feedback showed the desire for more literal and extensive descriptions of the patient’s words. It was apparent that there were very different expectations. It was felt that every case should have a paragraph or section explaining the analysis and conclusions. Peer review should not be so critical as to hurt the author’s feelings. It was underlined that peer review is an iterative process. It is not pass/fail, but a procedure to stimulate improvement. Dr Bob Leckridge (Glasgow Homeopathic Hospital) summed up the day. He stated that, overall, it had shown that clinical case research is more complicated than we expected, which is already a great achievement. The author thanks the speakers and participants for their contributions, the Royal London Homeopathic Hospital for their help and support in organising this congress, and the Marion Meyenburg foundation for its support of the Delphi Project.
Homeopathy