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ID 08768The ScenarioI am a member of a practice committee for Quit Line, a government funded programme to support people to stop smoking. I am aware that Nicotine replacement therapy does not work for everyone and evidence has come to my attention suggesting Nortriptylline as a second line therapy.
College Essays on Evidence based nursing
Before going to the practice committee, I need to review this further. My search reveals a Randomised Controlled Trial, the only study available at present.In this assignment I intend to critically appraise the given research article using the JAMA framework, and discuss the validity and applicability in relation to the given scenario.The StudyProchazka, A.E., Weaver, M.J., Keller, R.T., Fryer, G.E., Licari, P.A., and Lofaso, D.A. (1). A randomised trial of Nortriptylline for smoking cessation. Archives of Internal Medicine, 158, 05-0.The SummaryConducted in two medical centres in Colorado, Canada the objective of this study was to determine the effects of Nortriptylline on smoking cessation rates and withdrawal symptoms of subjects in a smoking cessation programme. 14 subjects between 17 and 80 years, who smoked 10 cigarettes or more a day and expressed a readiness to quit, were randomly assigned to either Nortriptylline (108 subjects) or Placebo (106 subjects). There was no significant difference between the baseline characteristics of the two study groups and inclusion/exclusion criteria were included. Subjects in each group took one capsule, either Nortriptylline Hydrochloride 5mg or placebo, 10 days prior to quit day. This was increased over the next 6 days up to 75mg as tolerated. The maximal dose was continued for eight weeks following quit date, then tapered and stopped by week 10.ID 08768The primary outcome measure was sustained abstinence defined as self reported cessation within one week of quit date, a carbon monoxide level of ppm or less and a urine cotinine level less than 50ng/ml at the six-month follow up visit. It was approximated that there would be an absolute difference of 10% in favour of the treatment group. The Beck Depression Inventory was used to identify depressive symptoms at commencement, one week following cessation and on completion of the therapy.Results indicated that the Nortriptylline group had a six-month sustained abstinence rate higher than the placebo group with an absolute difference of 11%. There was also an improvement in withdrawal symptoms but an increase in adverse effects within the intervention group. Results also demonstrated that there was no difference in the Beck Depression Inventory scores between the two groups.PRIMARY GUIDESAre the results valid?Was assignment of patients to treatment randomised?UnclearThe article states that subjects were stratified by study site and randomised following completion of the group cessation sessions. It is unclear however as to what method of randomisation was used ie. computer generated numbers.Was the randomisation list concealed?Don't knowIt is not clear if or how the randomised list was concealed.CommentsThe method of randomisation should be clearly evident in a study to prevent doubt and reduced confidence by the reader.Randomisation assists in forming groups of individuals at the beginning of a trial whom are similar in their risk for the event the study is hoping to prevent. (Sackett, Strauss, Richardson, Rosenberg & Haynes, 000). ID 08768Randomisation ensures that the known and unknown determinants of outcome are evenly placed throughout the two groups, therefore balancing out the confounding variables. Dicenso & Cullum (18) explain that this in effect prevents an influence on the findings of the study. As a result, if there is a difference between the two groups in the findings, it is likely to be related to the intervention. Allocation concealment is an added security in the randomisation process. Schultz (001) states that concealment of the randomisation list protects those involved in the trial from knowing any subject allocation in advance. Without list concealment, bias may become an issue with the possibility that study personnel may be able to influence the allocation, making the two groups unequal. As a result of this Sackett et al., (000) claim that findings and treatment effects can become distorted making them appear bigger or smaller than what they really are. Was follow up of patients sufficiently long and complete?YesAll 14 patients that entered the trial were accounted for in the conclusion and no patients were lost to follow up.Subjects were followed up at six months and tested for carbon monoxide and urine cotinine levels.Were patients analysed in groups to which they were allocated?YesAn intention to treat principal was followed. All subjects randomised into the trial was included in the analysis and were analysed in the group to which they were assigned. CommentsTo provide strength and reduce bias of the findings, subjects should not be lost to follow up in a study. These subjects may have outcomes that effect the conclusion of the study such as detrimental effects or even death. As discussed by Sackett et al., (000), as a result the exclusion of patients ID 08768may distort the efficacy of the intervention and dispute the validity of the study.An intention to treat analysis adds strength to the validity of a study. Hollis & Campbell, (1) state that if an intention to treat is not followed through or conducted correctly, the clinical effectiveness of a treatment may be overestimated. They reported that of 11 studies that mentioned an intention to treat analysis, 1 studies excluded patients who didn't start the intended intervention and failed to analyse all randomised subjects as allocated. This in turn can threaten the validity of a study and reduce confidence in the results. SECONDARY GUIDESAre the results valid?Were patients/health workers/study personnel blind to treatmentNoUnclearDouble blinding is stated.An unblind pharmacist was used to determine the dose of the intervention drug in response to therapeutic levels of blood results. The pharmacist was not involved in data collection, therefore this should not effect the outcome.Even though not initially stated it appears that patients were blind to treatment as it is later stated to maintain blinding , dose was also randomly changed in the placebo group. Unclear as to whether study personnel were blind to treatment as not documented, however it was noted that due to the common side effect of a dry mouth both the study nurse and subjects knew they were taking the intervention drug.CommentsAs a reader I feel quite confident that patients were initially blind to treatment, but am unclear as to who else is. As Schultz, (001) explains ID 08768double blinding usually refers to the patients, clinicians and outcome assessors, but points out that the author should report on all who were blind to treatment. Blinding assists in preventing bias. As suggested by Guyatt, Sackett & Cook, (1) if either the subject or study personnel know treatment, they may have an optimistic or pessimistic opinion to it. Either way this can distort findings and reduce validity of the results. Were groups similar at the beginning of the trial?YesA table was produced showing the "Baseline Characteristics" of the subjects within the two groups. This indicated the two groups were well balanced for prognostic factors. CommentsAs noted by Guyatt et al., (1) to reassure readers on the validity of the trial, they should be informed that both groups were similar for all indicators that determine outcomes and that prognostic factors are equally balanced. Again if prognostic factors are equally balanced it reduces the risk of outcomes being a result of confounding variables. If this is so, the outcomes are more likely to be a result of the intervention thus strengthening the findings. Aside from the experimental intervention, were the groups treated equally?YesParticipants received their capsules before bedtime. Blood samples were drawn from all subjects one week after quit day. Subjects completed a diary on a daily basis of the number of cigarettes smoked and rated withdrawal symptoms on a 1-5 scale. All were subjected to the Beck Depression inventory to identify depressive symptoms at baseline, one week, and at the end of the trial. CommentIf there are differences within the care received by the two groups, the outcome may appear weak. This is important to note because if groups are treated in different ways it can impact heavily on the results, adding doubt and raising questions on the accuracy of the findings. Guyatt et al (1) supports this claiming that differences in care can weaken or distort the findings. For example, if the treatment group had received additional therapy, it could manipulate the results in the researcher's favour and eliminate any validity.Summary of Judgement of ValidityWhile there are areas in this article that provide evidence of validity, there are some area's that create doubt or question. Subjects were stratified into groups which aids in balancing out the two comparison groups, yet they failed to explain their method of randomisation. As well as this, they failed to explain, in detail allocation list concealment thus reducing confidence in the studies validity. However, the follow up of patients was sufficiently long and complete and an intention to treat analysis was conducted which added strength to the clinical efficacy of the intervention. As the two groups were well balanced for prognostic factors and treated equally, the risk of outcomes being a result of confounding variables or unequal treatment was greatly reduced. ID 08768ID 08768WHAT WERE THE RESULTS?What were the treatment effects?At the six month completion period of the trial 15 of the 108 subjects in the intervention group and of the 106 subjects in the control group had sustained abstinence from smoking. OutcomeNortriptyllinePlaceboAbsolute DifferenceRelative DifferenceNNTCessation Rates @ 6/15% CI14%(15/108)%(/106)11.1%4-18%0.7%5-6These statistics indicate that at the six month completion period the event rate for smoking cessation was 14% in the Nortriptylline group, whereas the control group receiving placebo was %. The absolute difference between the two groups is 11%. The absolute difference compares the outcome effect of the two groups. From this one could conclude that the use of Nortriptylline for smoking cessation increases abstinence from smoking at six months by an estimated 11%. What I also found to be of significance was the number of 'drops out' between the two groups. It was noted in a flow chart that 5% of the subjects in the placebo group dropped out as a result of ineffective therapy, in comparison there was 41% in the intervention group. Withdrawal symptoms were higher in the control group and this reflects the above results. Even so, adverse effects were noted to be higher in the treatment group with 10 out of the 108 subjects 'dropping out' as a result of adverse effects. In the control group of the 106 subjects pulled out because of this. How precise was the estimate of the treatment effect?The absolute difference is an estimate (also known as point estimate) meaning that from the results of the study, the researcher provides an estimate of where the true event rate lies within the given population. ID 08768Guyatt, Sackett, & Cook., (14) point out that the point estimate is very unlikely to be completely accurate and that the true event rate lies within that estimate. The precision of the results is measured as the confidence interval (CI). Confidence intervals are a statistical calculation that quantifies the uncertainty of the measurement of the estimate. (Sackett et al., 000). Most commonly a 5% confidence interval is used and a range of values relating to this will be reported. This translates to demonstrate that 5% of the time the true value will lie within the range of values given and only 5% of the time will it fall outside of this range. In this research article the confidence interval calculated was 4-18%, the same as my calculation. This suggests that while the absolute difference for this study is 11%, the confidence interval indicates that the true value could be as little as 4% or as large as 18% and lie anywhere in between. According to Sackett et al., (000) the wider the confidence interval the less precise estimates of the outcome. This appears to be a fairly narrow interval and results suggested a positive study with the lower limit of +4 providing some clinical significance. CLINICAL BOTTOM LINEThis study demonstrates that the use of oral Nortriptylline Hydrochloride, 5mg-75mg is effective in providing abstinence in smoking cessation by 11% at six months following cessation. Side effects such as dry mouth and dysgeusia were common, but appeared to be fairly well tolerated as no one withdrew from the study regarding this. A narrow confidence interval of 14% and positive results suggest some clinical significance. Cost and availability of product is not established. WILL THIS HELP ME IN CARING FOR MY PATIENTS?Can the results be applied to my patient care?Yes, from a socio-economic point of view, the variety of subjects used within this study would be similar to people within our smoking cessation programme. ID 08768 Is the treatment feasible in our setting?As indicated in the scenario Nortriptylline is a subsidised treatment within New Zealand and is highly recommended by ASH New Zealand (00) as a smoking cessation adjunct. Arroll (00) claims it is affordable and can be accessed, for as little as three dollars, by individuals through a general practitioner. Were all clinically important outcomes considered?As Guyatt et al., (14) points out it is not enough to demonstrate an intervention works, it is important that the intervention improves outcomes that are important to our patients. This study does demonstrate that Nortriptylline improves smoking cessation rates, but what will be more significant to the subject is that this intervention also reduces withdrawal symptoms such as cravings, anger, and anxiety that are closely related to nicotine dependence. Prochazka et al., (18) points out that anxiety and stress are important factors in preventing smoking cessation and as Nortriptylline has anxiolytic effects it may help to reduce these factors. In contrast, it was also noted that Nortriptylline contributed to many side effects with a total of % withdrawals as a result. This also may impact on the individual's decision as to whether to use this treatment.Are the likely treatment benefits worth the potential harm of costs?The numbers needed to treat (NNT) with Nortriptylline was calculated as . This indicates that for every nine people treated with Nortriptylline, one will be abstinent from smoking at the six-month period. The NNT using the Confidence Interval of 5% was calculated out at 5-6, which means that anywhere from 5 to 6 subjects may need to be treated in order to see one abstain from smoking at 6 months. While there was a % withdrawal rate for adverse effects in the treatment group, none appeared to be life threatening and no one died as a consequence. When looking at the total number of 'drop outs' for each group, the comparison was evident at 74% in the control group and 61% ID 08768for the intervention group. This was mainly due to ineffective therapy hence therapy appeared more effective in the intervention group. RECOMMENDATIONS TO PRACTICE COMMITTEEI would explain to the committee, that on critically appraising the articleɨ The research appears to have omitted information that raises question as to its validity, such as random allocation method and allocation concealment. Subsequently this may raise the issue of possible elements of bias. Yet follow up was sufficient, intention to treat principal was used and there was equal treatment, thus strengthening findings.ɨ The results at six months did show an increase in the number of abstinence from smoking in the intervention group by 11% compared to that of the control.ɨ The confidence interval demonstrates that as little as 4% or as much as 18% are estimated at having abstained from smoking at the six month interval with the use of Nortriptylline.ɨ There were a number of adverse effects in the Nortriptylline group, but did not appear to cause any harm or long term detrimental effects, and common effects such as dry mouth and dysgeusia were well tolerated.ɨ Overall there was a 74% drop out rate in the control group compared with 61% in the treatment group, most commonly for ineffectiveness of the therapy, indicating that the intervention was more effective than the control. ɨ That in order for one person to abstain from smoking at six months, nine people needed to be treated with Nortriptylline. The confidence interval for the number needed to treat was 5-6. I would explain to the committee that while I do have some questions as to the validity of this study, there is also some strong, valid evidence to indicate Nortriptyllines clinical effectiveness in a smoking cessation programme. ID 08768I am unable to recommend an appropriate dose as the article explained that ideal dosage and duration remained undetermined. (Prochazka et al., 1). Availability of the drug in this country and its low cost to the subject is another factor to consider.CONCLUSIONWithin this assignment I have critically appraised a randomised controlled trial and commented on its validity and applicability in regard to a given scenario. While this study has some flaws in regard to documentation of allocation method and concealment it also provides evidence of validity with an intention to treat analysis and equal treatment. Its accessibility and cost make it an ideal treatment choice and its applicability within our socio-economic demography is encouraging. I would suggest that Nortriptylline is effective in reducing nicotine withdrawal symptoms, but agree with the author in identifying that further research into ideal dosage and duration of treatment is required.ID 08768REFERENCEAltman, D.G., & Bland, J.M. (1). Treatment allocation in controlled trials why randomise? BMJ, 1, 10. Arroll, B. (00, June). Another drug available to GPs to help their patients quit smoking. Media Update. Retrieved August , 00, from www.ash.co.nzDicenso, A., & Cullum, N. (18). Implementing evidence-based nursing some misconceptions. Evidence-Based Nursing, 1(), 8-40.Guyatt, G.H., Sackett, D.L., & Cook, D.J. (1). Users Guide to the Medical Literature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? JAMA, 70(1), 58-601.Guyatt, G.H., Sackett, D.L., & Cook, D.J. (14). Users Guide to Medical Literature. II. How to use an article about therapy or prevention. B. What were the results and will they help me in caring for my patient. JAMA, 71 (1), 5-6.Hollis, S., & Campbell, F. (1). What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ, 1, 670-674.Sackett, D.L., Strauss, S.E, Richardson, S.W, Rosenberg, W, & Haynes, R.B. (000). Evidence-Based Medicine. How to Practice and Teach EBM (nd ed.). Churchill Livingstone.Schultz, K.F. (001). Assessing allocation concealment and blinding in randomised controlled trials why bother? Evidence-Based Nursing, 4, 4-5. Please note that this sample paper on Evidence based nursing is for your review only. In order to eliminate any of the plagiarism issues, it is highly recommended that you do not use it for you own writing purposes. 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