Do pharmacy intervention reports adequately describe their interventions? A template for intervention description and replication analysis of reports included in a systematic review

Mícheál de Barra, Claire Scott, Marie Johnston, M De Bruin, Neil Scott, Catriona Matheson, Christine Bond, Margaret Watson, Mícheál de Barra, Claire Scott, Marie Johnston, M De Bruin, Neil Scott, Catriona Matheson, Christine Bond, Margaret Watson

Abstract

Introduction: Scientific progress and translation of evidence into practice is impeded by poorly described interventions. The Template for Intervention Description and Replication (TIDieR) was developed to specify the minimal intervention elements that should be reported.

Objectives: (1) To assess the extent to which outpatient pharmacy interventions were adequately reported. (2) To examine the dimension(s) across which reporting quality varies. (3) To examine trial characteristics that predict better reporting.

Methods: The sample comprised 86 randomised controlled trials identified in a Cochrane review of the effectiveness of pharmacist interventions on patient health outcomes. Duplicate, independent application of a modified 15-item TIDieR checklist was undertaken to assess the intervention reporting. The reporting/non-reporting of TIDieR items was analysed with principal component analysis to evaluate the dimensionality of reporting quality and regression analyses to assess predictors of reporting quality RESULTS: In total, 422 (40%) TIDieR items were fully reported, 395 (38%) were partially reported and 231 (22%) were not reported. A further 242 items were deemed not applicable to the specific trials. Reporting quality loaded on one component which accounted for 26% of the variance in TIDieR scores. More recent trials reported a slightly greater number of TIDieR items (0.07 (95% CI 0.02 to 0.13) additional TIDieR items per year of publication). Trials reported an 0.09 (95% CI 0.04 to 0.14) additional TIDieR items per unit increase in impact factor (IF) of the journal in which the main report was published.

Conclusions: Most trials lacked adequate intervention reporting. This diminished the applied and scientific value of their research. The standard of intervention reporting is, however, gradually increasing and appears somewhat better in journals with higher IFs. The use of the TIDieR checklist to improve reporting could enhance the utility and replicability of trials, and reduce research waste.

Keywords: checklist; clinical trials as topic/standards; pharmacy/standards; reproducibility of results; research report/standards.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Top panel shows the proportion of TIDieR items not/partly or fully included in each of the 86 trial reports. Each bar represents one trial. Bottom panel shows the proportion of trials reports which report each of the 15 TIDieR items fully, partly or not at all. Three TIDieR items (13–15) were frequently scored non applicable. Each bar represents one TIDieR item. TIDieR, Template for Intervention Description and Replication.

References

    1. Cochrane A. Effectiveness and efficiency: Random reflections on health services. Cambridge University Press, 1972.
    1. Glasziou P, Meats E, Heneghan C, et al. . What is missing from descriptions of treatment in trials and reviews? BMJ 2008;336:1472–4. 10.1136/bmj.39590.732037.47
    1. Hoffmann TC, Glasziou PP, Boutron I, et al. . Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014;348:g1687 10.1136/bmj.g1687
    1. Yamato TP, Maher CG, Saragiotto BT, et al. . How completely are physiotherapy interventions described in reports of randomised trials? Physiotherapy 2016;102:121–6. 10.1016/j.physio.2016.03.001
    1. Jones EL, Lees N, Martin G, et al. . How well is quality improvement described in the perioperative care literature? A systematic review. Jt Comm J Qual Patient Saf 2016;42:196–AP10. 10.1016/S1553-7250(16)42025-8
    1. Abell B, Glasziou P, Hoffmann T. Reporting and replicating trials of exercise-based cardiac rehabilitation: do we know what the researchers actually did? Circ Cardiovasc Qual Outcomes 2015;8:187–94. 10.1161/CIRCOUTCOMES.114.001381
    1. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Obstetrics & Gynecology 2009;114:1341–5. 10.1097/AOG.0b013e3181c3020d
    1. Moher D, Schulz KF, Simera I, et al. . Guidance for developers of health research reporting guidelines. PLoS Med 2010;7:e1000217 10.1371/journal.pmed.1000217
    1. Equator Netowk, 2017. Available:
    1. Rotta I, Salgado TM, Felix DC, et al. . Ensuring consistent reporting of clinical pharmacy services to enhance reproducibility in practice: an improved version of DEPICT. J Eval Clin Pract 2015;21:584–90. 10.1111/jep.12339
    1. Salgado TM, Correr CJ, Moles R, et al. . Assessing the implementability of clinical pharmacist interventions in patients with chronic kidney disease: an analysis of systematic reviews. Ann Pharmacother 2013;47:1498–506. 10.1177/1060028013501802
    1. Crespo-Gonzalez C, Fernandez-Llimos F, Rotta I, et al. . Characterization of pharmacists' interventions in asthma management: a systematic review. J Am Pharm Assoc 2018;58:210–9. 10.1016/j.japh.2017.12.009
    1. Lowrie R, Lloyd SM, McConnachie A, et al. . A cluster randomised controlled trial of a pharmacist-led collaborative intervention to improve statin prescribing and attainment of cholesterol targets in primary care. PLoS One 2014;9:e113370 10.1371/journal.pone.0113370
    1. Bruhn H, Bond CM, Elliott AM, et al. . Pharmacist-led management of chronic pain in primary care: results from a randomised controlled exploratory trial. BMJ Open 2013;3:e002361 10.1136/bmjopen-2012-002361
    1. Avery AJ, Rodgers S, Cantrill JA, et al. . A pharmacist-led information technology intervention for medication errors (pincer): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis. The Lancet 2012;379:1310–9. 10.1016/S0140-6736(11)61817-5
    1. Nkansah N, Mostovetsky O, Yu C, et al. . Effect of outpatient pharmacists' non-dispensing roles on patient outcomes and prescribing patterns. Cochrane Database Syst Rev 2010;58 10.1002/14651858.CD000336.pub2
    1. de Barra M, Scott CL, Scott NW, et al. . Pharmacist services for non-hospitalised patients. Cochrane Database Syst Rev 2018;2 10.1002/14651858.CD013102
    1. Cohen J. Weighted kappa: nominal scale agreement with provision for scaled disagreement or partial credit. Psychol Bull 1968;70:213–20. 10.1037/h0026256
    1. Abdi H, Williams LJ. Principal component analysis. Wiley Interdisciplinary Reviews: Computational Statistics 2010;2:433–59. 10.1002/wics.101
    1. Horn JL. A rationale and test for the number of factors in factor analysis. Psychometrika 1965;30:179–85. 10.1007/BF02289447
    1. Hair JF, Black WC, Babin BJ, et al. . Multivariate data analysis. Prentice hall Upper Saddle River, NJ, 1998.
    1. Web of Science Web of science, 2017. Available:
    1. Dechartres A, Trinquart L, Atal I, et al. . Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study. BMJ 2017;357 10.1136/bmj.j2490
    1. Higgins JP, Green S. Cochrane handbook for systematic reviews of interventions. John Wiley & Sons, 2011.
    1. Fleiss L, Levin B, Paik MC. The measurement of interrater agreement : Statistical methods for rates and proportions. John Wiley & Sons, 1981.
    1. Kaiser HF. An index of factorial simplicity. Psychometrika 1974;39:31–6. 10.1007/BF02291575
    1. Schneiderhan ME, Shuster SM, Davey CS. Twelve-month prospective randomized study of pharmacists utilizing point-of-care testing for metabolic syndrome and related conditions in subjects prescribed antipsychotics. The Primary Care Companion for CNS Disorders 2014;16 10.4088/PCC.14m01669
    1. Malone DC, Carter BL, Billups SJ, et al. . Can clinical pharmacists affect SF-36 scores in veterans at high risk for medication-related problems? Med Care 2001;39:113–22. 10.1097/00005650-200102000-00002
    1. Choe HM, Mitrovich S, Dubay D, et al. . Proactive case management of high risk patients with type 2 diabetes mellitus by a clinical pharmacist: a randomised controlled trial. American Journal of Managed Care 2005;11:253–5.
    1. Castejón AM, Calderón JL, Perez A, et al. . A community-based pilot study of a diabetes pharmacist intervention in Latinos: impact on weight and hemoglobin a1c. J Health Care Poor Underserved 2014;24:48–60. 10.1353/hpu.2014.0003
    1. Dixon D, Johnstone M. What competences are required to deliver behaviour change interventions: development of a health behaviour change competency framework. In submission.
    1. Hirsch JD, Steers N, Adler DS, et al. . Primary care–based, pharmacist–physician collaborative medication-therapy management of hypertension: a randomized, pragmatic trial. Clin Ther 2014;36:1244–54. 10.1016/j.clinthera.2014.06.030
    1. Finley PR, Rens HR, Pont JT, et al. . Impact of a collaborative care model on depression in a primary care setting: a randomized controlled trial. Pharmacotherapy 2003;23:1175–85. 10.1592/phco.23.10.1175.32760
    1. Simpson SH, Majumdar SR, Tsuyuki RT, et al. . Effect of adding pharmacists to primary care teams on blood pressure control in patients with type 2 diabetes: a randomized controlled trial. Diabetes Care 2011;34:20–6. 10.2337/dc10-1294
    1. Charrois TL, McAlister FA, Cooney D, et al. . Improving hypertension management through pharmacist prescribing; the rural Alberta clinical trial in optimizing hypertension (rural RxACTION): trial design and methods. Implementation Science 2011;6 10.1186/1748-5908-6-94
    1. Mahwi TO, Obied KA. Role of the pharmaceutical care in the management of patients with type 2 diabetes mellitus. Integr Pharm Res Pract 2013;4.
    1. López Cabezas C, Falces Salvador C, Cubí Quadrada D, et al. . Randomized clinical trial of a postdischarge pharmaceutical care program vs regular follow-up in patients with heart failure. Farm Hosp 2006;30:328–42. 10.1016/S1130-6343(06)74004-1
    1. Lenander C, Elfsson B, Danielsson B, et al. . Effects of a pharmacist-led structured medication review in primary care on drug-related problems and hospital admission rates: a randomized controlled trial. Scand J Prim Health Care 2014;32:180–6. 10.3109/02813432.2014.972062
    1. Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implementation Science 2011;6 10.1186/1748-5908-6-42
    1. Michie S, Carey RN, Johnston M, et al. . From theory-inspired to theory-based interventions: a protocol for developing and testing a methodology for linking behaviour change techniques to theoretical mechanisms of action. Annals of Behavioral Medicine 2018;52:501–12. 10.1007/s12160-016-9816-6
    1. de Barra M. Do pharmacy intervention reports adequately report their interventions? A TIDieR analysis, 2019.
    1. Lee KP, et al. Association of Journal quality indicators with methodological quality of clinical research articles. JAMA 2002;287:2805–8. 10.1001/jama.287.21.2805
    1. Kuroki LM, Allsworth JE, Peipert JF. Methodology and analytic techniques used in clinical research: associations with Journal impact factor. Obstet Gynecol 2009;114:877 10.1097/AOG.0b013e3181b5c9e8
    1. Reveiz L, Chapman E, Asial S, et al. . Risk of bias of randomized trials over time. J Clin Epidemiol 2015;68:1036–45. 10.1016/j.jclinepi.2014.06.001
    1. Kennie NR, Schuster BG, Einarson TR. Critical analysis of the pharmaceutical care research literature. Ann Pharmacother 1998;32:17–26. 10.1177/106002809803200101
    1. Gawande A. The checklist manifesto: How to get things right. Profile Books, 2010.
    1. Hoffmann TC, Erueti C, Glasziou PP. Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials. BMJ 2013;347:f3755 10.1136/bmj.f3755
    1. Figshare Figshare, 2017. Available:
    1. Open Science Foundation. Available:
    1. Cobo E, Cortés J, Ribera JM, et al. . Effect of using reporting guidelines during peer review on quality of final manuscripts submitted to a biomedical Journal: masked randomised trial. BMJ 2011;343:d6783 10.1136/bmj.d6783
    1. de Bruin M, Viechtbauer W, Hospers HJ, et al. . Standard care quality determines treatment outcomes in control groups of HAART-adherence intervention studies: implications for the interpretation and comparison of intervention effects. Health Psychology 2009;28:668–74. 10.1037/a0015989

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