Hugh MacPherson, BSc, PhD; Helen Tilbrook, BSc, MSc; Stewart Richmond, BSc, MSc, PhD; Julia Woodman, BSc, PhD; Kathleen Ballard, BSc, PhD; Karl Atkin, BA, DPhil; Martin Bland, BSc, PhD; Janet Eldred, BA, PhD; Holly Essex, MSc, PhD; Catherine Hewitt, BSc, MSc, PhD; Ann Hopton, RGN, BSc, MSc; Ada Keding, BSc, MSc; Harriet Lansdown, MSc; Steve Parrott, BSc, MSc; David Torgerson, MSc, PhD; Aniela Wenham, PhD; Ian Watt, BSc, MB, ChB, MPH
Note: Dr. MacPherson (the manuscript's guarantor) affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Acknowledgment: The authors thank the participants, Alexander teachers, acupuncturists, and general medical practitioners; David Laverack and Anthony Murray, their patient representatives; Elaine Hay, Debbie Sharp, and David Geddes, their collaborators; Matthew Bailey, Sue Collins, Ben Elliot, Pauline Holloway, Dionysios Pallas, Lucy Revell, and Val Wadsworth from the ATLAS research team; and Cindy Cooper (Chair), Sarah Brown, and Gareth Jones, who were members of the independent steering group.
Financial Support: The trial was sponsored by the University of York. This research was funded by clinical studies grant 19702 from Arthritis Research UK.
Disclosures: Drs. MacPherson and Lansdown report that they are members of the British Acupuncture Council. Drs. Woodman and Ballard report that they are members of the Society of Teachers of the Alexander Technique. Dr. Atkin reports a grant from Arthritis Research UK during the conduct of the study. Dr. Eldred reports a grant from Arthritis Research UK during the conduct of the study. Dr. Hewitt reports a grant from Arthritis Research UK during the conduct of the study. Dr. Torgerson reports a Programme Grant from the National Institute for Health Research during the conduct of the study. Dr. Watt reports a grant from Arthritis Research UK during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0667.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Reproducible Research Statement:Study protocol: Available in reference 19. Statistical code and data set: Relevant anonymized patient-level data are available from Dr. MacPherson (e-mail, firstname.lastname@example.org).
Requests for Single Reprints: Hugh MacPherson, BSc, PhD, Department of Health Sciences, University of York, York YO10 5DD, United Kingdom; e-mail, email@example.com.
Current Author Addresses: Drs. MacPherson, Atkin, Bland, Eldred, Essex, Hewitt, Torgerson, Wenham, and Watt; Ms. Tilbrook; Ms. Hopton; Ms. Keding; Ms. Lansdown; and Mr. Parrott: Department of Health Sciences, University of York, York YO10 5DD, United Kingdom.
Dr. Richmond: Sydera Research Associates, 34 Shipman Road, Market Weighton, York YO43 3RB, United Kingdom.
Drs. Woodman and Ballard: Society of Teachers of the Alexander Technique, Grove Business Park, Unit 48, 560-568 High Road, London N17 9TA, United Kingdom.
Author Contributions: Conception and design: H. MacPherson, H. Tilbrook, S. Richmond, J. Woodman, K. Ballard, K. Atkin, M. Bland, H. Lansdown, S. Parrott, D. Torgerson, I. Watt.
Analysis and interpretation of the data: H. MacPherson, H. Tilbrook, S. Richmond, J. Woodman, K. Ballard, K. Atkin, M. Bland, H. Essex, C. Hewitt, A. Keding, H. Lansdown, S. Parrott, D. Torgerson, I. Watt.
Drafting of the article: H. MacPherson, H. Tilbrook, S. Richmond, J. Woodman, K. Ballard, K. Atkin, J. Eldred, H. Essex, S. Parrott, D. Torgerson, I. Watt.
Critical revision of the article for important intellectual content: H. MacPherson, H. Tilbrook, S. Richmond, J. Woodman, K. Ballard, C. Hewitt, H. Lansdown, S. Parrott, D. Torgerson, I. Watt.
Final approval of the article: H. MacPherson, H. Tilbrook, S. Richmond, J. Woodman, K. Ballard, K. Atkin, M. Bland, J. Eldred, H. Essex, C. Hewitt, A. Hopton, A. Keding, H. Lansdown, S. Parrott, D. Torgerson, A. Wenham, I. Watt.
Provision of study materials or patients: H. MacPherson, J. Woodman, K. Ballard.
Statistical expertise: M. Bland, H. Essex, C. Hewitt, A. Keding.
Obtaining of funding: H. MacPherson, S. Richmond, J. Woodman, K. Ballard, K. Atkin, M. Bland, A. Hopton, S. Parrott, D. Torgerson, I. Watt.
Administrative, technical, or logistic support: H. MacPherson, H. Tilbrook, S. Richmond, J. Woodman, K. Ballard, J. Eldred, A. Hopton, D. Torgerson, I. Watt.
Collection and assembly of data: H. MacPherson, H. Tilbrook, S. Richmond, A. Wenham.
MacPherson H., Tilbrook H., Richmond S., Woodman J., Ballard K., Atkin K., Bland M., Eldred J., Essex H., Hewitt C., Hopton A., Keding A., Lansdown H., Parrott S., Torgerson D., Wenham A., Watt I.; Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial. Ann Intern Med. 2015;163:653-662. doi: 10.7326/M15-0667
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Published: Ann Intern Med. 2015;163(9):653-662.
This article has been corrected. The original version (PDF) is appended to this article as a Supplement.
Management of chronic neck pain may benefit from additional active self-care–oriented approaches.
To evaluate clinical effectiveness of Alexander Technique lessons or acupuncture versus usual care for persons with chronic, nonspecific neck pain.
Three-group randomized, controlled trial. (Current Controlled Trials: ISRCTN15186354)
U.K. primary care.
Persons with neck pain lasting at least 3 months, a score of at least 28% on the Northwick Park Questionnaire (NPQ) for neck pain and associated disability, and no serious underlying pathology.
12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone.
NPQ score (primary outcome) at 0, 3, 6, and 12 months (primary end point) and Chronic Pain Self-Efficacy Scale score, quality of life, and adverse events (secondary outcomes).
517 patients were recruited, and the median duration of neck pain was 6 years. Mean attendance was 10 acupuncture sessions and 14 Alexander lessons. Between-group reductions in NPQ score at 12 months versus usual care were 3.92 percentage points for acupuncture (95% CI, 0.97 to 6.87 percentage points) (P = 0.009) and 3.79 percentage points for Alexander lessons (CI, 0.91 to 6.66 percentage points) (P = 0.010). The 12-month reductions in NPQ score from baseline were 32% for acupuncture and 31% for Alexander lessons. Participant self-efficacy improved for both interventions versus usual care at 6 months (P < 0.001) and was significantly associated (P < 0.001) with 12-month NPQ score reductions (acupuncture, 3.34 percentage points [CI, 2.31 to 4.38 percentage points]; Alexander lessons, 3.33 percentage points [CI, 2.22 to 4.44 percentage points]). No reported serious adverse events were considered probably or definitely related to either intervention.
Practitioners belonged to the 2 main U.K.-based professional associations, which may limit generalizability of the findings.
Acupuncture sessions and Alexander Technique lessons both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained.
Arthritis Research UK.
Henry Drysdale, Ioan Milosevic, Ben Goldacre
Centre for Evidence Based Medicine, University of Oxford
November 23, 2015
Discrepancies between pre-specified and reported outcomes in MacPherson et al
Dear Editor, Your recent publication MacPherson et al  reports outcomes that are different to those initially registered . There were 3 pre-specified primary outcomes (one score at 3 timepoints). Although data for all 3 time points is reported in the paper, it is also incorrectly stated that the primary endpoint was at 12 months, when no such ranking is given in the registry entry. In addition, there were 17 pre-specified secondary outcomes (9 outcomes to be measured at between one and 3 time points each) of which 6 were reported in the paper; while 11 are not reported anywhere in the publication. In addition, the trial reports various non-prespecified analytic approaches, such as regression models, only declaring some of these as novel. Annals of Internal Medicine has endorsed the CONSORT guidelines on best practice in trial reporting . In order to reduce the risk of selective outcome reporting, CONSORT includes a commitment that all pre-specified primary and secondary outcomes should be reported; and that, where new outcomes are reported, it should be made clear that these were added at a later date, with an explanation of when and for what reason. This letter has been sent as part of the COMPare project . We aim to review all trials published from now in a sample of top journals, including Annals of Internal Medicine. Where outcomes have been incorrectly reported we are writing letters to correct the record, and to audit the extent of this problem, in the hope that this will reduce its prevalence. We are maintaining a website at COMPare-Trials.org where we will be posting the submission date and publication date of this letter, alongside a summary of the data on each trial and journal. We hope that you will publish this letter so that those using the results of this trial to inform decision making are aware of the discrepancies.Yours faithfully, Henry Drysdale, Ioan Milosevic and Ben Goldacre on behalf of the COMPare project team. MacPherson H et al, Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial, Ann Intern Med. 2015;163:653-662 Trial registry entry: http://www.controlled-trials.com/ISRCTN15186354 Moher D et al, CONSORT 2010 Explanation and Elaboration: updatedguidelines for reporting parallel group randomised trials, BMJ 2010; 340:c869. COMPare project website www.COMPare-Trials.org
Hugh MacPherson, BSc, PhD
University of York
December 11, 2015
We would like to respond to the recent Comment by Drysdale et al on our recent publication(1).When we registered(2) our primary outcome measure, the Northwick Park Neck Pain Questionnaire, we specified that it would be “measured at baseline, 3, 6 and 12 months”. The authors of the Comment incorrectly stated that there were “3 pre-specified primary outcomes (one score at 3 timepoints)”. In our protocol, published 2 years before the main trial results,(3) we specified that the 12 months outcome on this questionnaire was our primary outcome end-point. Hence, the 12 month end-point was the one we reported as the primary end-point in our published paper(1). It is important that the primary outcome is identified in advance of analysis of the main trial results to avoid ‘cherry picking’ trial outcomes: and this is what we did. Of the 17 secondary pre-specified outcome measures, all of them have been or will be reported in the primary paper or in secondary papers that are currently being prepared. These papers will report on the as yet unpublished outcomes that are part of our pre-specified mediator-based analyses that have been described in detail in our published protocol(3).While we support the CONSORT guidelines on best practice in trial reporting(4), we are concerned about the ambiguity of Registry entry labelling and scope for misinterpretation either by researchers when entering data at the outset of a trial, or by commentators, as is the case we discuss here. For example, we perhaps naively assumed that we correctly completed our Registry entry by entering not just the primary measure but also the time points at which we measured it. The Registry entry does not ask for a primary end-point. Likewise with secondary measures, we erred on the side of fully reporting all outcomes and yet, as set out in our protocol, many of the secondary measures were related to mediator-based analyses to be published in secondary papers. While we support the principles of COMPare, if this initiative is to succeed, the COMPare website needs to provide a means of responding to limitations and inaccuracies in their reporting. Moreover given the limited scope of Registry entry data, we suggest that a trial’s published protocol should also be reviewed by COMPare in tandem with its Registry entry as part of their process.Yours faithfully,Hugh MacPherson, on behalf of the ATLAS project team.References1. MacPherson H, Tilbrook H, Richmond S, Woodman J, Ballard K, Atkin K, et al. Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial. Ann. Intern. Med. 2015 Nov 3;163(9):653–62. 2. Trial registration: Current Controlled Trials. ISRCTN15186354. 2012. Available from: http://www.controlled-trials.com/ISRCTN151863543. MacPherson H, Tilbrook HE, Richmond SJ, Atkin K, Ballard K, Bland M, et al. Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial. Trials. 2013 Jul 10;14(1):209. 4. Schulz KF, Altman DG, Moher D, For the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340(mar23_1):c332.
Annals of Internal Medicine
December 14, 2015
"Please see http://annals.org/article.aspx?articleid=2478526 for the Editors' response to the COMPare Project's comments on the MacPherson trial (Ann Intern Med 2015; 163: 653-662). Until the COMPare Project’s methodology is modified to provide a more accurate, complete and nuanced evaluation of published trial reports, we caution readers and the research community against considering COMPare’s assessments as an accurate reflection of the quality of the conduct or reporting of clinical trials."
Henry Drysdale, Ben Goldacre, Ioan Milosevic, Carl Heneghan and Kamal Mahtani Henry Drysdale, Ben Goldacre, Ioan Milosevic, Carl Heneghan and Kamal Mahtani on behalf of the COMPare team
Centre for Evidence-Based Medicine, University of Oxford
January 26, 2016
“Pre-specification” must, by definition, be before trial commencement
We thank Dr MacPherson for his response to our comment on ATLAS . However, it contains a number of misunderstandings.To reduce the risk of selective outcome reporting and false positive results, all primary and secondary outcomes must be specified before trial commencement, as stated in the CONSORT guidelines . The protocol cited in Dr MacPherson’s comment was published over a year after trial commencement and therefore cannot, by definition, be a source of pre-specified outcomes. Hence the reader is only able to extract pre-specified outcomes from the trial’s registry entry.On the issue of multiple time-points being pre-specified, Dr MacPherson expresses a view that we believe is not widely used or recognised. Specifically; that time-points pre-specified for an outcome in a registry entry refer to the multiple times that a primary outcome is measured, but that the registry entry “does not ask for a primary end-point” among these (apparently using end-point to refer to time-point). As stated by CONSORT, adequate pre-specification of an outcome includes the variable being measured, the measurement method, and the time-point at which it is measured . Trial registers require specification of outcomes: an outcome without a time-point is inadequately specified. Dr MacPherson argues it is acceptable for 11 of the 17 pre-specified secondary outcomes to be left unreported because they will be reported in a subsequent publication. We agree. However, as CONSORT states, this deferral must be declared in the trial publication, informing readers that the reported outcomes represent only a subset of those pre-specified, and that those remaining will be reported elsewhere. It seems Dr MacPherson and Annals’ editors share this view, because the paper states: “Dr. MacPherson (the manuscript's guarantor) affirms that ... any discrepancies from the study as planned (and, if relevant, registered) have been explained.” Unfortunately, we have demonstrated that this was not done. Lastly, Dr MacPherson states that registry entries can be ambiguous, and allow “scope for misinterpretation”. This is concerning. The purpose of trial registers is to prospectively define key information on each clinical trial, including its pre-specified outcomes, so that this can be assessed against results publications in order to spot discrepancies and omissions. Trialists are responsible for ensuring that information in trial registries and protocols is not “ambiguous”. Where outcomes are sufficiently poorly pre-specified that they cannot be used to assess deviations from the initial plan, this fact should be disclosed in the paper.We initiated COMPare because of widespread concern that permissiveness around misreporting pre-specified outcomes facilitates cherry-picking and biased reporting of trial results throughout medicine. We continue to welcome critical feedback on details of our assessments on firstname.lastname@example.org. Yours faithfully,Henry Drysdale, Ben Goldacre, Ioan Milosevic, Carl Heneghan and Kamal Mahtani on behalf of the COMPare team. MacPherson H et al, Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial, Ann Intern Med. 2015;163:653-662 Moher D et al, CONSORT 2010 Explanation and Elaboration: updatedguidelines for reporting parallel group randomised trials, BMJ 2010; 340:c869.
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