Author's response to reviews Title: A multicentre, double-blind, randomised, controlled, parallel-group study of the effectiveness of a pharmacist-acquired medication history in an emergency department Authors: Jesus Becerra Camargo (jbecerrac@unal.edu.co) Fernando Martinez (femartin@ugr.es) Emilio Garcia-Jimenez (emiliogarciajimenez@gmail.com) Version: 2 Date: 27 June 203 Author's response to reviews: see over
June 27 th 203 Ms Armee Valencia, BMC Health Services Research BioMed Central Dear Ms Armee, We have revised the manuscript entitled, Multicentre, double-blind, randomised, controlled, parallel-group study of the effectiveness of a pharmacist-acquired medication history in an emergency department, by Jesus Becerra MSc, Fernando Martinez PhD and Emilio Garcia-Jimenez PhD. We have checked the manuscript in the light of the reviewers comments and have made all the requested changes and taken the associate editor s comments into account. We are very grateful for their comments which have proved important in improving the quality of the paper. We have provided a table giving a point-by-point response to the reviewers concerns. Best regards, Jesus Becerra Camargo. Teléfono: (57-) 36 5045 Conmutador: (57-) 36 5000 Ext. 465 Fax: 365080
Appendix Associate Editor's comments The statistical approach taken. The methods state that s 30% baseline medication discrepancy rate was used for calculating the sample size. Is this 30% of medications? Of patients? Answer: Regarding patients 2. Is clustering by site or by patient taken into account? Answer: clustering by patient was taken into account 3. The sample size calculation was based on a one-tailed t test, and yet the analysis in the results section is based on a chi square test and a two-tailed logistic regression. Answer: It was based on a two-tailed and exact chi-square test (see Pg, para 3) 4. Finally, why was a -tailed (rather than two tailed) t test used? This needs to be clearly justified. Answer: This was a mistake and has now been corrected. Method. The methods used for assessing the clinical importance of the discrepancies need to be described in the methods section... Answer: the methods used for assessing the clinical importance of the discrepancies were adapted from the method used by Cornish et al., and have been explained in the Methods section (Pg 9, para 3). 2. In the tables, please state the statistical tests used to ascertain the p values cited. Answer: This has now been done (please see Tables). 3. An abstract is needed. Answer: It has now been included. Teléfono: (57-) 36 5045 Conmutador: (57-) 36 5000 Ext. 465 Fax: 365080
4. Authors' contributions: Answer: This has now been included (see Pg 25, para ). 5. Competing interests: Answer: The statement has now been included (see Pg 24, para 4). 6. Requesting name of ethics committee: Answer: This has been included on Pg 24, para 2. Answers to the reviewers comments Reviewer Item Comment Action The correction was Background does not cover the literature and current A definition of MedRec has now been practices on medicines reconciliation included, see Pg 4, para 3. Mentions in the last paragraph what could be a This is a hypothesis, see Pg 5, para 2. hypothesis, but fails to describe what MedRec is... We have included a definition of MedRec (Pg 4, para 3). 2,3 4 5 6 7 The aim of the study is unclear, probably because of The aim has been rewritten (see Pg 5, poor English... para 3) Authors need to explain what the authors mean by Medicine reconciliation (MedRec); this MedRec early on... has now been explained in the text ( as above, Pg 4, para 3) Explain what is meant by triage I and II and how it is The meaning of triage I and II has now relevant to the study been explained on Pg 6, para 3. Text suggests some sort of questionnaire was used. This (hospital-approved questionnaire) But what was this and how does it relate to the has now been referred to as the intervention... A hospital-approved form is also admission medication order form. It mentioned (page 5) - what was this? formed part of the intervention. Figure does if you look very closely indicate the one difference between intervention and control groups This Figure has now been redesigned. but it s hard to spot The accurate medication history was actually The medication history was given to provided to the doctor at a later stage for them to doctors at a later stage so that they could amend prescriptions Authors describes a amend prescriptions. comprehensive and reconciled list of medications How and when the reconciled list of Teléfono: (57-) 36 5045 Conmutador: (57-) 36 5000 Ext. 465 Fax: 365080
(R3) as to how and when this was obtained and medications (R3) was obtained has been used. Standard Group, it states nurses did not described on Pg 8, para and Pg 9, para forward the pertinent list of medications. So does this. mean that in the control group, the gold standard list The gold standard list was used in the was never used?. standard care arm to identify medication discrepancies. Clearly state what was the primary outcome The primary outcome compared the measure. It appears that this was the proportion of numbers of patients having at least 8 patients with at least one discrepancy between medication discrepancy regarding what prescribed medicines list in hospital compared to what they had been taking at home (Pg 0, they were taking at home para ). What other outcomes were measured a range is This paragraph has been rewritten and 9 described throughout the paper. These are not the results reorganised (Pg 0, para 2 explicitly stated, but should be, here in methods. and Pg, para.2). Discrepancy classification is also confusing. One Discrepancies have been grouped so that sentence lists types of discrepancies (omission, they can be associated with any of the duplication, delayed prescription and early following: drug, dosage, frequency, 0 prescription. But then the next sentence describes administration route, appropriateness of prescription discrepancies, which cover a range of restarting medication, therapeutic other issues duplicity and medication lacking indications (Pg 0, para ) states interactions were classed as major, moderate or minor Was it decided a priori that the identification rate of interactions between groups would be a secondary outcome? The drug interactions checker was used; this has now been clarified in outcomes (Pg 0, para 2) 2 Definition cannot be correct please check the English: an incident leading to medication-relation lesion, sentence also does not make sense to me. The definition has been changed and the offending sentence deleted (Pg 0, para 2) 3 Insufficient detail is provided on how pharmacists classed discrepancies for potential to cause harm as an adaptation was made to an existing system Such classification was adapted from the method used by Cornish et al., ( Pg 0, para 2) 4 Sample size calculation not clear... A mistake was made and this has been corrected (Pg, para 3) 5 Use of the term randomisation authority-is this the The randomisation authority is the Teléfono: (57-) 36 5045 Conmutador: (57-) 36 5000 Ext. 465 Fax: 365080
randomisation manager? Is the format actually a randomisation manager and the format form is a form This terminology has now been standarised 6 Implementation of the intervention should be in methods. This has now been changed in line with your suggestion (Pg 2, para 2) Results: Effect of the intervention on 7 discrepancies...discrepancies differed between intervention and control patients. Greater clarity in This has now been clarified (Pg 9, para, 2, 3). describing this is required. Effect of the intervention on discrepancies para 4 8 Mention made of doctor pharmacist agreement on identifying allergies but this is not described in This has now been included in the Methods section (Pg, para ) methods.. 9 Potential discrepancy severity para 3 The findings of the regression analysis are unclear to me. The statistical analysis has been reviewed (Pg 22, para 2) 20 Table 3 no attempt has been made to assess whether the seriousness of discrepancies differed between groups. We are currently working on an adverse events based paper to clarify this result "... No OTC medications were considered by the 2 doctor. The authors cannot really say this, because they did not know what the doctors were considering when they prescribed. All they can say with certainty is that doctors did not prescribe any OTC We have accepted this suggestion and the sentence has been changed accordingly (Pg 9, para 3) medicines..." No attempt has been made to judge whether discrepancies could have been prevented, therefore it is not appropriate to state this in Discussion. similarly We have accepted this suggestion and 22 the processes for recording medication histories were the offending statements have been not studied, so the statement that they were removed. inadequate and potentially dangerous should be removed,2 23 and comment 6 Para 3 New results are presented here which should be in Results section: 00% actions carried out, 4% unknown results, 98% acceptance rate. A mistake was made and has now been corrected. Material has been moved to the Results section (see Pg 7, para 4) Teléfono: (57-) 36 5045 Conmutador: (57-) 36 5000 Ext. 465 Fax: 365080
There is no mention in Discussion of the differing 24 pattern of discrepancies between intervention and control groups... Possible reasons for this need to be This has now been clarified on Pg 9, para, 2, 4 considered No strengths and limitations section is provided in A strengths and limitations section has 25 Discussion. been included in the Discussion (Pg 23, para, 2, 3 and Pg 24, para, 2) Conclusion states pharmacist-acquired medication 26 histories had fewer medication errors in documentation... More care and accuracy is needed This phrase has been rewritten (Pg 24, para 3) in making such statements. Methods: Pre-admission How can patients be interviewed prior to admission? It presumably depends on the definition of admission. Prior to being seen by a doctor may be more accurate. This has now been rewritten and includes your suggestion (Pg 7, para 3) Methods Randomisation, allocation concealment, This has now been summarised (Pg, 2 implementation, blinding This may be excessive and para 4, Pg 2, para 3 and Pg 3, para, could be reduced 2, 3) 3 Effect of the intervention in discrepancies para 3 medications detected this is perhaps not the most ideal word to use here perhaps identified is better?. The term has been changed (Pg 7, para 3) 4 Results Last para The time taken for pharmacist medication history taking could be placed earlier in results The time taken for pharmacist medication history being taken has been placed earlier on in the Results section (Pg 9, para ) and comment reviewer 2 5 and comment 4,5 Suggest: In patients who were interviewed by pharmacists a higher proportion were identified as using home medications (82.8%) compared to those in the standard care arm (42.5%). Is this result presented in the Results section? We have accepted this suggestion made by both reviewers and have changed the sentence (Pg 7, para 3) 6 Discussion Para 8 Need to either use proportions when describing comparative findings other studies (Hayes et al) or provide the denominators (not just 62 versus 60). The information has now been completed (Pg 2, para 3) Teléfono: (57-) 36 5045 Conmutador: (57-) 36 5000 Ext. 465 Fax: 365080
Discussion Para beginning with As 42% had at 7 least one interaction is unclear to me. I find this proportion very high in comparison to studies elsewhere and wonder whether this relates to different The sentence has been rewritten (Pg 8, para 3) definitions or different prescribing practices. Page 20 authors make no attempt to consider why the 8 different hospitals may have had different results. For example, were staff training/procedures different, were there differing demographics of the populations This has been addressed (Pg 2, para 5) they served? Table round up percentages to only one decimal 9 place (or none, depending on editorial requirements)the last section on number of interactions is presumably per patient and does not fit well into this table. This has been corrected (Table, 2, 3, 4) 2 Unclear how physician could be blinded if they received the R form which was generated by the pharmacist. They would not receive this form if they were in the standard care. Find the structure of this methodology quite confusing. Was the F form filled out by the group of pharmacists was that the intervention and then could be used by the physician to order medications. Needs clarity around the The doctors were assigned to receive patients in the intervention or control group during their shifts to ensure blinding. Form F was filled out by the group of pharmacists; this was available for use by a doctor when consulting in an ED methodology and blinding In general I am not clear how the actual intervention There were three independent teams; took place. There were teams of pharmacists and a two teams of pharmacists worked in 2 2 team of doctor and pharmacist - did these differ?... different shifts to obtain records and an independent team consisted of a pharmacist and a doctor (Pg 9, para ) The most common discrepancy (55.%) concerned 2 3 the omission of reordering home medication..." I believe you are trying to say that 66.3% of omission discrepancies were in the standard arm and 34.3% in This suggestion was accepted and the text changed accordingly (Pg 7, para 2) the intervention arm but this is not clear in the Teléfono: (57-) 36 5045 Conmutador: (57-) 36 5000 Ext. 465 Fax: 365080
statement. Needs rewording to make clearer. Corresponding author: Jesús Becerra Camargo, (c) PhD Universidad de Granada, Spain. Associate professor, department of pharmacy, School of Science, Universidad Nacional de Colombia, Ciudad Universitaria, Edificio 450, oficina 204, Telephone (57)--36-50-00, extension 465. e-mail, jbecerrac@unal.edu.co. Teléfono: (57-) 36 5045 Conmutador: (57-) 36 5000 Ext. 465 Fax: 365080