Patient Communication and Consent in Nursing, 6000 words

Section 1: Transcription

 

Self-Assessment

I went into the room to meet the patient making it clear about my role immediately, that I’m a medical student currently in my third year. It did not seem appropriate to shake her hand but I checked with her that it was OK for me to sit down and she said it was. I checked that it was an appropriate time to speak with her and that she was comfortable with speaking to me. I should have also thanked her for having the time to speak with me and checking that she was comfortable with the recording. I did tell her that if she wanted to stop at any point there would be no problem. In doing this I felt that I was respecting her wishes and empowering the patient. I should have recorded this. I did not ask if it was acceptable to take notes as I did not do very much, if any, note taking.

 

To start the interview, I asked ‘Would you please tell me about what first brought you into hospital?’ This can be defined as an open question as it leaves it open for the patient to set the terms of the discussion. While she spoke, I listened while she told me all about her problem. I believe that this use of an open question at the start was most appropriate as she could then use her own language to describe what had happened and what was wrong with her. I attempted to at the beginning of the conversation to inform her that what the doctors have said is not of importance and I want to hear her side of what prompted her to come here from the beginning- ‘ So forgetting about what the Doctors have said prior, tell me about what happened and what bought you here?’ but did not feel it helped. After the open question I then focussed on the aspects dependent on the patients responses. I started early on in the interview to acknowledge the patient when she spoke but found that I kept saying “ok” after her responses. I could have responded to the patient in other ways to sound less repetitive but it did show I was paying attention and acknowledging her. In many cases the response of “ok” led onto another question and found it very useful in the linking of sentences.

 

I used non-verbal behaviour to establish rapport with the patient such as good eye contact, nodding my head when she was speaking and sitting in a relaxed but alert open posture so that the patient knew I was

I employed various methods to establish rapport with the patient. This included non-verbal, as well as verbal, behaviour. For example, I tried to keep eye contact with her, I looked attentive as she spoke, I sat in such a way to keep my posture open to give the impression of being friendly and interested. I paused at points during the summary, this gave her a chance to agree and correct me. I think this summary was vita, suggesting that I was fully listening and that I understood what had occurred. I focussed on the things that were of interest by repeating what she has said and elaborated on these points without much guidance. Even when I asked closed questions, the patient still elaborated. I completed this section by saying I would, ‘ ask a few questions with a slight change in angle’. I attempted to ask a sensitive question regarding the sexual history whilst on holiday in a roundabout kind of way and was worried she may take offence but it seemed appropriate when replaying the recording. It was a very difficult question to ask- ‘With regards to sort of ummmm. Trying to find the words for it really…… is there any chance you interacted with someone of the opposite sex while abroad for a relationship of some form or anything like that.’

I felt that the negatives of the interview were that I listened at the beginning whilst the patient spoke to me, but felt the need to interrupt her and follow my own agenda. I should have let the patient talk a little longer before diverting the conversation in a particular direction. I found myself interrupting the patient quite early on the interview. I unfortunately did not allow her to finish her presenting complaint and started to use closed questions quite early on in the interview. Agenda is another point that I need to think about and improve on. My own agenda was clear to me but the patient’s was not. The patient seemed to be fine with the interview. She focussed very well allowing me to direct the conversation and explain the sequence of events in a logical manner without being sidetracked so it was difficult to ascertain her agenda.  I continued to listen attentively and acknowledged everything that the patient was saying by once again using “OK”. I perhaps could have used a pause instead of the word OK but I was reinforcing this with positive body language such as nodding my head. I felt for the benefit of the tape I had to say something after everything the patient said. This is not always necessary as I have realised.

I clarified unclear statements throughout the interview. For example, when she mentioned that she lost a half a stone in weight prior to coming in hospital, I asked if this was genuinely over a week or over the 5 week period that she has been unwell,

The patient generally has a positive outlook on life. Her life style has been seriously affected by her symptoms. Mrs LS informed me that she is normally very fit and walks 3-4 miles once a week. I attempted to find out just how debilitating her symptoms are by showing empathy when discussing her weekly walking regime by saying  ‘And the effect of this illness I am assuming  I am sure has affected you in a great deal’. She replied ‘Yes it has I can’t believe I am ill. I have never ever been ill in my life. The thing is I came in Wednesday and I felt so ill I felt like my body was being poisoned. That is how I felt on Wednesday. You know. I am happy I came up here. I would have just gone down hill completely. I couldn’t face to see anybody because I was so ill’. I replied ‘You are in the right place, hopefully the doctors will get to the bottom of the problem.’ I should have elaborated more here by asking how her life has been affected day to day because of these symptoms. She is keen to read medical books and already has formulated several possible diagnoses. I attempted to address her concerns regarding the diagnosis by asking her ‘what are your concerns’. The patient was concerned that her diagnosis was stomach or bowel cancer as her grandfather had passed away due to this condition in his fifties.  I did not show any empathy apart from saying ‘I am sorry to hear that’ which now seems a little out of place on hearing the recording. I think the patient was also getting tired at this point and didn’t want her dinner getting cold.

I made summaries as I went along but I could also have made an overall summary at the end and also asked if she had questions for me. This is something I will do in the future.

 

Interview Analysis

Overall, I felt that the patient responded well. She described her symptoms and past medical history in a very clear way.

The way I used an approach which was polite, and respected her helped. I was also empathetic, expressing sorrow at the loss of her grandfather due to cancer and trying to understand how her life must have changed drastically due to these symptoms. By making her feel comfortable and establishing a rapport and sense of trust, I was able to get the information required to assess medical problems and to gain insight into any other issues which could have been relevant to the health of this patient. As such, the interview fulfilled most of the functions of the medical interview.

Recording of a patient clerking has raised many important points and analysing this has been a valuable learning process. I think that Mrs LS reaction appeared positive. However, perhaps I did not give her the opportunity to reflect on the interview process. In future I think I would ask the patient how they found my style of questioning and if she thinks anything could be improved upon. It would have been important to do this as student and use the opportunities to learn from it

On reviewing the interview I felt that it flowed well with few pauses or difficult moments. This was helped by signposting and good preparation. The only areas of repetition arose when I was summarising or clarifying areas, but I think I had to do this to show her that I was being attentive and to make sure that I had understood things in the right way.

She felt able to talk about sensitive topics like bowel habits and micturition. She was helpful on elaborating on things I asked rather than just yes and no answers. When I asked about her life has been affected because of these symptoms, I should have elaborated more on her day to day activities.

I felt embarrassed about asking her with regards to her sexual history whilst abroad. The polite and respectful approach i used helped.

She conveyed frustration that her GMP did not send her straight to the hospital when she was getting progressively worse. Happiness that she is in hospital and that they are running these tests and demonstrated worry that this might be cancer. This can de interpreted from her intonation.

Mrs LS responded well to techniques I used, which included murmuring, or repeating her previous sentence which I find I did many times. She also responded positively to questions which were relaxed and not too aggressive.

I should have asked what the patient’s normal cholesterol level was when she informed me she was on statins for hypercholestoremia. I did not elaborate on why she thinks they stopped it when she came into the hospital.

I feel my communication skills were not tested fully as the patient herself was quite open and helpful in the information provided. I should have listened more and spoke less. She also mentioned a rash on her back which was a cue for me to ask further about because it did not occur at the same time as the onset of these symptoms; I abandoned this avenue of having the rash. I think I was so concerned about the presenting complaint and not missing any other major conditions that I forgot to gather detailed information did not ask about other seemingly unrelated and non-acute symptoms.

I managed to discuss most areas but I missed opportunities to fully explore areas of interest such as what exactly bought her into hospital.

On reflection I could have carefully used open questions more, even though she responded better to direct questioning on some topics. IFurther to this I could have shown more empathy when she discussed how her daily lifestyle has changed. I will also remember in future that if a patient interrupts me to correct me on a point I will stop, acknowledge the patient and pause with my sentence. Other than this I regard the interview process as having been successful and take may positive points from this process. I gained nearly all of the information, which was needed in order to satisfy the requirements of the medical clerking. I successfully managed to build a rapport, which is evident when the patient is freely discussing her concerns over the treatment by her general medical practitioner. When I asked what her concerns and expectations were, she had a positive outlook on life even though her diagnosis maybe bowel cancer, she just wanted to know to put her mind at ease and then can deal with it as one of life’s hurdles.

 

Section 2:  Medical History (see handwritten section).

Section 3a: Examination Findings (see handwritten section).

3b:  Investigation and Tests (below)

              3c:  Initial Assessment (see handwritten section).

 

 

 

 

 

 

 

 

 

 

 

 

Section 3b: Investigations and Tests

Mrs LS had the initial work of investigations and tests in the following order:

Full blood count, urea and electrolytes, liver function tests, bone profile, plasma glucose, Thyroid function tests, amylase and C reactive protein laboratory investigations were done.

All blood results were within normal parameters apart from:

The urea and creatinine levels were 1.4 and 42 respectively. These low levels could indicate a high clearance or malnutrition and reduced muscle mass.

A sample of clotted blood was sent to diagnose coeliac disease. Anti TTG (IgA) levels were 1 (range 1-10), hence negative. Endomysial antibody testing is highly specific (in excess of 90%). 1

Assessment of serologic markers (ESR, CRP) has in general been disappointing, probably because of their lack of sensitivity and specificity, because they are indirect measures of inflammation, and they can be affected by a number of non-intestinal diseases. A possibility is to use surrogate markers for Inflammation and the Rome criteria to distinguish organic from non-organic intestinal disease. 2

Abnormal laboratory data can be helpful in distinguishing functional bowel disorders from IBD or infection. However, elements such as white blood cell count, haemoglobin and haematocrit, platelet count, iron saturation, erythrocyte sedimentation rate, and C-reactive protein can vary from normal to completely abnormal in Crohn’s disease and ulcerative colitis, the same as in non- IBD causes of inflammation. Thrombocytosis, though, does appear more in the case of Crohn’s disease than it does in ulcerative colitis, unless there has been active bleeding. This was not the case in Mrs LS.

Stool sample for culture and sensitivity was requested three times. In the case of Mrs LS, it showed clostridium difficile toxin A and B not detected. stool samples for enteric pathogens, stool samples for ova and parasites, and stool collection for Clostridium difficile toxin assay.3

Colonoscopy is more sensitive than radiographic studies in detecting early changes associated with IBD, and represents the primary modality to obtain tissue for histological evaluation. 5

Section 4: Psychosocial Aspects

Mrs LS had been informed that her illness maybe due to an infective cause and under the hospital infection control policy she was placed in isolation. When making the decision to move a patient into isolation the staff must involve the patient in this process. It is extremely important that patients are involve. The Department of Health’s 1998 publication “A first class service: Quality in the new NHS”6 outlines the importance of this in the delivery of their care. When working in partnership with patients, healthcare staff must communicate effectively with the patients. Communication is a large part of a doctor’s role and should be a two-way process with the patient. It is an important part of building a trusting relationship. The doctor must have good communication skills in order to explain the management plan to the patient and address any issues that may raise. It was after she was endoscoped and biopsied that a formal diagnosis was given of Crohn’s disease. When I took her history, a formal diagnosis had not been made. Saying all of the above, Mrs LS was actually happy with the care and treatment received so far from the whole team.

The aetiology of Crohn’s disease remains unknown, although it is believed to be a response to environmental factors such as infections or drugs, for example, in individuals who are genetically susceptible.

Cigarette smoking increases the risk of Crohn’s disease through unknown mechanisms. The patient did smoke 2 cigarettes a day for the past 25 years but had stopped when her symptoms started. I did not explore the avenue with regards to her restarting if she got better or once her diagnosis is formalised. Studies have shown light smokers are doing worse than non-smokers regarding disease activity and the need for immunosuppressants. Complete smoking cessation should be advised in all smokers with Crohn’s disease.7,8

Another cause could be diet. For example a high-fat, high-sugar diet with little fruit or vegetables.. I unfortunately did not explore this avenue of what her diet has been like over the years when taking her medical history.9

Symptoms can be reduced by changes to diet, for example, having a balanced diet, eating small portions frequently, or keeping a food diary to see what makes symptoms worse. Other important factors are giving up smoking and drinking enough water. It is also important to get enough sleep.  People experience the disease in a variety of ways, some are affected a lot and others hardly at all.

Education, employment, personal relationships, social and family life are all disrupted by the unpredictable occurrence of flare ups. The frequent and urgent need for the toilet, together with loss of sleep and the invisible symptoms of pain and continual or profound fatigue, can severely affect self-esteem and social functioning, particularly among the young and newly-diagnosed. For understandable reasons, a proportion of patients normalise an unnecessarily limited pattern of life either due to inadequate control of symptoms from poor medical management or because of the loss of self-esteem and deep anxiety about losing bowel control if they venture too far from familiar environments.

As Mrs LS now has a confirmed diagnosis of Crohn’s disease, care must be given to a treatment regime and its compliance. Adherence to treatment depends a lot on the patient’s understanding of the aims, benefits, possible side effects and importance of sticking to a management plan, as well as acceptance of their illness and the need to treat it. The main reasons that patients may not adhere to treatment are complex regimes that are hard to remember, no obvious benefits of treatment and the perceived consequences of the illness. If the treatment is likely to have side effects, this can also affect compliance.  It can be difficult for patients to perceive benefits of treatment when there are numerous side effects.

The main factors influencing adherence are illustrated in the following diagram (adapted from Ley 1997).

Understanding

 

 

 

 

 

Satisfaction                                      Memory                                       Adherence

 

It shows that adherence is most likely when patients understand the aims and the benefits of their treatment. Thus it will be very important to explain fully to Mrs LS the above issues to ensure adherence to a possible treatment regime. This will ensure the best possible outcome for the patient.

 Section 5: Ethics  
 Consent is of great importance before starting the recording of the interview. It was necessary to explain to the patient exactly who I was, what the interview process involved and if she was happy about the recording. This consent was not only required for the interview but was essential if I was to examine the patient. Obtaining consent is a fundamental part of good medical practice and allows the development of the all important doctor-patient relationship to occur and fundamentally build up trust.

Informed consent is an important factor with regards to the patient’s autonomy. The patient must be provided with all available options and be competent in making their own decisions. The patient must have a reasonable understanding of the information and they shouldn’t be pressurised or coerced into a decision. If a competent individual has not consented to a procedure or feels that they have been provided with insufficient information to allow an informed decision about treatment, then a doctor can be accused of committing the crime of battery. Further to this, the doctor will not have respected the patients’ autonomy, therefore breaching his second duty of care in medicine. The amount of information given to Mrs LS, should be defined by the Bolam standard of disclosure. 10

The information when informing the patient is as follows:

  • an explanation of the problem;
  • details of all the available treatment options, including no treatment and its outcome;
  • why some treatments may not be appropriate and the reason;
  • treatment benefits and risks;
  • prognosis of each treatment options.

I ensured that the patient was competent, not coerced and informed to a reasonable standard of what will be involved in the recording of the history and examination in order to gain consent.

There were no issues in this case that made obtaining consent difficult and once verbal consent had been obtained Mrs LS signed the attached consent form to state that she was happy for the recording.

Following gaining appropriate consent it is also important to respect the confidentiality of the patient. General information regarding a patient’s health and care is confidential and is confined to those individuals involved in the patient’s treatment. Health care professionals are not permitted to divulge information regarding the patient without the consent of the person involved. If a patient’s case is discussed outside the team involved in their care, then the patient’s identity must not be disclosed.

Any personal information, unrelated to their health, told by a patient during an interview or in conversation must remain confidential unless specified otherwise by the patient. However, sometimes these rules do not apply:

  • If informing authorities about notifiable infectious diseases.
  • If a request of information is made by the police about patients who have been in a road traffic accident.
  • If patients are suspected of involvement in terrorist activity in the UK.
  • If a doctor is presented with a court order by a judge.

General information needs to be given to Mrs LS about Crohn’s disease. It should be explained in terms that she understands such as ‘Although we don’t yet know the exact reasons why you may have developed Crohn’s disease, we can say that is due to inflammation of your bowel wall, it can have effects on your whole digestive system, including mouth, stomach and anus’11. Mrs LS should be offered written and audiovisual information. She should also get information on support groups and the chance to meet a specialist with knowledge of IBD. They can spend time talking to her about the condition as well as her feeling and concerns. It is important to offer counselling to Mrs LS. The point is that patient’s needs to be respected from their own perspective. Physicians have to listen as well as providing advice and information. To do this effectively, particularly in stigmatising conditions, requires what Schneider and Conrad (1983) have termed ‘co-participation in care’. As far as the physician-patient encounters are concerned there are  four guiding principles: 13

1.     Co-participation of care. This means respecting the autonomy of the patient.

2.     Allowing an open agenda.

3.     Not just focusing medically but giving information and advice more generally for the context of the patient.

4.     Counselling skills along side technical skills.

Two major trials have proposed corticosteroids as an effective therapy for Crohn’s disease14-16. There are many side effects to the use of the drugs mentioned.

  

 

 

 

Section 6: Inter-professional Care and Allied Health Care

Mrs LS’s ward was a ‘respiratory’ general medical ward. The patient came under the care of the respiratory physicians who were on call and they asked for the Gastroenterology team’s input ‘post take’. I spoke to the senior staff nurse involved in the care of Mrs LS. She informed me that care for the patient is based on nursing model which encompasses the 12 activities of daily living17. These include:

  • Breathing: Mrs LS’s breathing is not in anyway compromised.
  • Communication: Mr LS’s communication is not in any way affected by bowel habits.
  • Controlling body temperature. Mrs LS did not have a temperature.
  • Maintaining a safe environment: Mrs LS is able to self care and maintains her own environment within the constraints of the hospital.
  • Eating and drinking: Mrs LS is able to feed herself and take her medication independently. She has a decreased appetite and several episodes of diarrhoea. This must be monitored by the nurses. This starts with recording Mrs LS’s weight on admission and then close monitoring during her stay. It is essential to monitor her food intake using a chart. This can be completed in partnership with the patient and nursing staff. In Mrs LS case this had occurred prior to admission and she was referred to the dietician for nutritional support on admission.
  • Eliminating: Mrs LS had problems with frequent visits to the lavatory with her bowel habit. However, due to her decreased food intake, the nursing staff were aware of the increased risk of loss of electrolytes.
  • Personal cleansing and dressing: Mrs LS is able to wash and dress herself independently. The nurse describes her needs as minimal.
  • Mobilising: Mrs LS is mobilising independently at present.
  • Working and playing: Mrs LS clearly stated to the nursing team that her illness had been hard for her husband and her daily lifestyle. The nurses understood that this psychological aspect could affect Mrs LS’s outcome.
  • Expressing sexuality: Mr LS’s expression of her sexuality may have been affected for example when the issue of intimacy arose due to the disturbance of her bowel habits.
  • Sleeping: The patient’s illness had resulted in a month long period of disturbed sleep. This was being addressed on the ward as Mrs LS was in a side room which was quiet with a nearby toilet.
  • Dying: As far as all of the team involved were aware Mrs LS had no fears that her illness would lead to her death. But as the nurses clearly stated you never now how a case will turn out so you must unfortunately be aware of unexpected outcomes.

The activities of the nursing care of patients on the ward was organised in the following way. The nursing team started their morning shift with handover, after which they make the patient’s beds and assist patient’s who require help with their needs. Breakfast is also served at this time and some patients need assistance with eating. During the morning, the nursing staff attend the doctors ward rounds, multi-disciplinary team meetings and feedback the outcomes of these meetings to the rest of the staff. Prior to lunch being served the drug round is carried out. At the same time as all of this is happening the nurses deal with any situations that may arise, for example, new admissions. After lunch there is a second handover to the late staff where any new developments are communicated. The nursing staff attend in the afternoon any remaining doctors rounds and perform outstanding tasks not achieved in the morning. Visiting hours are also during this period. The drug round precedes supper being served and a rest period follows. The night staff receive a handover, they carry out a drug round then settle the patients for sleep. During the night the nurse’s main tasks involved answering patient call bells, helping with hygiene and toilet needs, giving medications and welcoming new emergency admissions. Finally the night staff hand over to the day shift and the whole cycle starts again. The nursing handover thus occurs on 3 occasions between shifts and ensures that all relevant information about Mrs LS would be passed on to the next nursing team. This included any changes in condition, relevant investigations carried out that day, results and the medical teams plan. An example of a nursing handover is:

“Side room 3 is Mrs LS who is 61 years old. She was admitted on the 1st April suffering with watery diarrhoea accompanied by abdominal pain. She has recently been abroad and as the cause maybe infective she is being barrier nursed. She is aware of the possible diagnosis. She is self caring and independently mobile. She is on IV fluids, regular oral analgesia and QDS observations. She has been seen today by the doctors on the ward round, the plan is: continue I.V. fluids, continue QDS observations and colonoscopy tomorrow.  She has voiced no concerns and understands her treatment plan”.

Much emphasis has been placed on the role of the nursing team but there are many more individuals that are involved in Mr LS’s care. The team comprises:

  • Bed manager: providing an isolated room.
  • Cleaners: to keep the environment clean.
  • Catering staff: providing meals
  • Dietician: addressing weight loss and ensuring adequate calorific intake
  • General Practitioner: especially involved in follow up.
  • Health care assistants: working closely with the nurses and involved directly in day to day care of patient.
  • Infection control nurse: involved with barrier nursing.
  • Laboratory staff: processing investigations and making results available
  • Porters: transferring the patient for different types of investigations.
  • Pharmacist: regularly checking the drug chart to ensure they are correct.

Mrs LS was not being considered for discharge at this point but there are factors that must be discussed first. The most important is that the patient has a positive diagnosis of inflammatory bowel disease. This would result in a strict regime of medication that would need to be taken on and off for life with regular out patient reviews. This regime of medication would start whilst in hospital, continued at home. The patient will need to be discharged with an appropriate quantity to take home. The main factor that needs to be taken into consideration is making sure that a TTA (To Take Away) form is filled in and that her medication is ready. It is important to ensure that Mrs LS understands the need and importance of the medication and when exactly to take it. Home situations also need to be considered fully, with particular emphasis on her ability to care for herself and is there adequate home support or does this support need to be provided. The nursing staff would have to speak to her husband and family about discharge, and ensure she has a way to get home. All of this information would then need to be transferred to Mr LS’s general practitioner for future reference and continuity of care.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Section 7:

Selected Study Section – Critique and Summary of Published Articles

 

Srinivasan R, Akobeng AK (2009) Thalidomide and thalidomide analogues for induction of remission in Crohn’s disease (Review). [online] The Cochrane Collaboration, Issue 2. John Wiley & Sons Ltd.

Avaliable from: http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD007350/pdf_fs.htm

l[Accessed 28/04/2009].

The following website was used in the process of critiquing the review paper. http://www.phru.nhs.uk/Doc_Links/S.Reviews%20Appraisal%20Tool.pdf

It intends to evaluate the safety and efficiency of thalidomide and its analogue lenalidomide.

The search strategy involved looking at The Cochrane Central Register of Control Trials Issue 3,2008, PUBMED (1996- 08/2008), EMBASE (1984 to August 2008) and the Cochrane IBD/FBD Specialist Trial Register were searched. Manufacturers of thalidomide and leaders in the field were also contacted to identify any unpublished trials. Study references were also searched for additional trials.

The selection criteria for inclusion was randomised control trials that compared thalidomide or lenalidomide against placebo or any other intervention for induction of remission in Crohn’s disease. Ten potentially relevant studies were identified. Six trials were excluded as they were uncontrolled studies. Two studies were excluded as they were retrospective observational studies. One published study met the inclusion criteria. No published randomised controlled trials were identified for thalidomide.

The review attempted to use the appropriate type of studies by using ones which were longitudinally based, randomised and asking clearly focused questions. However, none of them were blind, which can create bias and not make the study flawless.

The methodological quality of the selected trials were assessed independently by the 2 authors using allocation concealment and direction of effect as well as the Jadad scale  reviewers assessed the quality of the studies to be included using allocation concealment and direction of effect. The participants were of any age with active Crohn’s disease diagnosed by conventional clinical, radiographic, endoscopic and histological criteria.

The results of the studies have been combined in the body of the text and tables at the end of the article. There are some individual result tables and some comparative ones.

The results are expressed as random relative risk with confidence intervals. In one sentence these results can be summarised as:

The use of lenalidomide is not recommended  until data from a definitive study are available.

There were only 89 patients recruited from a multi-centre study involving UK, France, USA and Israel in that one trial that was reviewed.

It now needs to be considered if you can apply these results to the local population. The population samples included in the review come from many countries making coverage extremely diverse. This can be applied to the local population which itself is ethnically broad.

The review considered a number of important outcomes such as:

  • Induction of remission
  • Clinical response
  • Quality of life
  • Adverse events

From an individual’s point of view, the best outcome would be the or a drug that would induce the longest period of remission or even cure the disease. The results suggest due to the adverse effects associated with the use of the thalidomide in clinical practice, it is difficult to justify its use in the induction of remission in Crohn’s disease. Further data is needed from a definitive study on the use of lenalidomide before its use on patients.

For clinicians, further randomised controlled trials of thalidomide are unlikely to be justified due to its teratogenicity. However, the study of thalidomide analogues like lenalidomide may provide a solution to the problem due to its low teratogenicity. As there is only one study with a small number of patients enrolled, a randomised controlled trial is needed to evaluate the efficacy of the safety of the drug.

Considering the points discussed should practice regarding the treatment of Crohn’s change as a result of this review? No. The review highlights the lack of randomised controlled trials on the efficacy of thalidomide or its analogue lenalidomide for the induction of remission in Crohn’s disease. Although definitive large scale studies of lenalidomide are lacking, a well designed study by Mansfield 2007 did not show any benefit. Nonetheless, well designed randomised controlled trials are needed to properly evaluate the efficacy and safety of lenalidomide and other thalidomide analogues for induction of remission in Crohn’s disease. Such studies should have adequate power to allow the detection of any differences between the experimental groups if such differences exist and should also aim to investigate the optimum dosing regimen.

 

 

 

 

 

 

Summary of Key Points

Crohn’s disease is a chronic inflammatory disorder of the bowel. This article is a review on the use of a particular treatment of thalidomide and a similar drug lenalidomide for active Crohn’s disease. The review attempts to look at the benefit and the side effects of using this treatment.

The authors could only find one small but well designed study to ascertain the benefit of taking thalidomide, lenalidomide (similar drug to thalidomide)  and a non- active drug so that to compare them like for like.

The result showed that there is no statistical difference between the use of thalidomide or lenalidomide for the treatment of active Crohn’s disease.

The outcome of the review is that the use of lenalidomide or thalidomide for the treatment of Crohn’s disease is not recommended.

The authors conclude that further research with tighter method guidelines is needed in order to prove the benefits of  thalidomide and the similar drug lenalidamide in Crohn’s disease.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

References

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2) Tibble, JA. Sigthorson, G. Foster, GR. Forgacs, I. Bjarnason, I. Gastroenterology 2002;123:450–460

3) http://ibdcrohns.about.com/od/diagnostictesting/p/dtstoolculture.htm

4) Sands, BE.  From Symptom to Diagnosis: Clinical Distinctions Among Various Forms of Intestinal Inflammation. Gastroenterology 2004;126:1518–1532

5) Farrell RJ, Peppercorn MA. Endoscopy in inflammatory bowel disease. In: Sartor RB, Sandborn WJ, eds. Kirsner’s Inflammatory Bowel Disease. 6th ed. Philadelphia: WB Saunders; 2004:380-398.

6) Department of Health. (1998) A first class service: Quality in the new NHS http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4006902

7) Mahid SS, Minor KS, Soto RE, Hornung CA, Galandiuk S. Smoking and inflammatory bowel disease: a meta-analysis Mayo Clin Proc. 2006 Nov;81(11):1462-71

8) Seksik, P. Nion-Larmurier, I. Beaugerie, L. Cosnes, J. Effects of Light Smoking Consumption on the Clinical Course of Crohn’s Disease. Inflammatory Bowel Disease. 2009 May;15(5):734-41.

9) http://www.ehealthmd.com/library/crohnsdisease/CD_living.html

10) Bolam v Friern Hospital Management Committee ([1957] 1 WLR 583)

11) http://hcd2.bupa.co.uk/fact_sheets/html/crohns_disease.html

12) Guidelines for the management of inflammatory bowel disease in adults. British Society of Gastroenterology. 2004

13) Scambler, G. (1997) Sociology as applied to Medicine

14) Malchow H, Ewe K, Brandes JW, et al. European co-operative Crohn’s disease study (ECCDS): results of drug treatment. Gastroenterology 1984;86:249–66.

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Glossary:

 

PC       Presenting complaint

HPC    History of presenting complaint

PMH    Past medical history

DH       Drug history

SH       Social history

CVS     Cardiovascular system

RS       Respiratory system

GIT      Gastrointestinal system

GUS    Genitourinary system

JVP     Jugular venous pressure

PR       Per rectum

S          Subject

O         Objective

A          Assessment

P          Plan

I           Information for the patient