Int J Sports Med 2018; 39(12): 902-908
DOI: 10.1055/a-0649-1040
Training & Testing
© Georg Thieme Verlag KG Stuttgart · New York

Do Exercise Trials for Hypertension Adequately Report Interventions? A Reporting Quality Study

Claudia Hacke
1   Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
,
David Nunan
2   Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
,
Burkhard Weisser
3   Department of Sports Medicine, Christian-Albrechts-University, Kiel, Germany
› Author Affiliations
Further Information

Publication History



accepted 15 June 2018

Publication Date:
21 August 2018 (online)

Abstract

Non-pharmacological treatment, including exercise, is an important therapy option for patients with hypertension. The study assessed the reporting quality of exercise-based interventions included in the latest meta-analysis on that topic in order to evaluate the transferability of findings into clinical practice. Reporting quality of 24 randomised controlled trials from a meta-analysis assessing blood pressure lowering effects of endurance training in 1,195 hypertensive patients was evaluated using TIDieR (Template for Intervention Description and Replication) and CERT (Consensus on Exercise Reporting Template) guidelines. Associations between reporting quality, publication year and impact factor of the publishing journals were examined. None of the studies described all intervention components completely. On average 61% (95%CI: 52-69) (TIDieR) and 57% (95%CI: 49-64) (CERT) of core items required for replication were reported. Frequent shortcomings were the reporting of adherence, intervention provider, and adverse events. Details about exercise dosage were missing in 22% (95%CI: 4-40). Publication year was related to the adherence to TIDieR (r=0.549, P=0.007) but not to CERT. No associations with journal impact factor were found. Reporting of exercise-based interventions for hypertension is not sufficient to allow for replication and limits translation of evidence into clinical practice. Researchers should apply, and review authors, journal editors and reviewers should check adherence to reporting guidelines.

Supplementary Material

 
  • References

  • 1 Abell B, Glasziou P, Hoffmann T. Reporting and replicating trials of exercise-based cardiac rehabilitation. Circ Cardiovasc Qual Outcomes 2015; 8: 187-194
  • 2 Agoritsas T, Vandvik PO, Neumann I, Rochwerg B, Jaeschke R, Hayward R, Guyatt G, McKibbon KA. Finding the current best evidence. In: Guyatt G, Rennis D, Meade M, Cook D. eds Users’ Guides to the Medical Literature: a Manual for Evidence-based Clinical Practice. 3rd ed. Chicago, IL: AMA Publications; 2002: 29-51
  • 3 Ammann BC, Knols RH, Baschung P, de Bie RA, de Bruin ED. Application of principles of exercise training in sub-acute and chronic stroke survivors: a systematic review. BMC Neurol 2014; 14: 167
  • 4 Campbell KL, Neil SE, Winters-Stone KM. Review of exercise studies in breast cancer survivors: attention to principles of exercise training. Br J Sports Med 2012; 46: 909-916
  • 5 Chan A, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. Spirit 2013 statement: Defining standard protocol items for clinical trials. Ann Intern Med 2013 158: 200-207
  • 6 Charlton PC, Drew MK, Mentiplay BF, Grimaldi A, Clark RA. Exercise interventions for the prevention and treatment of groin pain and injury in athletes: a critical and systematic review. Sports Med 2017; 47: 2011-2026
  • 7 Conn VS, Cooper PS, Ruppar TM, Russell CL. Searching for the intervention in intervention research reports. J Nurs Scholarsh 2008; 40: 52-59
  • 8 Cornelissen VA, Smart NA. Exercise training for blood pressure: a systematic review and meta-analysis. J Am Heart Assoc 2013; 2: e004473
  • 9 Dijkers M, Kropp GC, Esper RM, Yavuzer G, Cullen N, Bakdalieh Y. Quality of intervention research reporting in medical rehabilitation journals. Am J Phys Med Rehabil 2002; 81: 21-33
  • 10 Douet L, Milne R, Anstee S, Habens F, Young A, Wright D. The completeness of intervention descriptions in published National Institute of Health Research HTA-funded trials: a cross-sectional study. BMJ Open 2014; 4: e003713
  • 11 Duff JM, Leather H, Walden EO, LaPlant KD, George Jr TJ. Adequacy of published oncology randomized controlled trials to provide therapeutic details needed for clinical application. J Natl Cancer Inst 2010; 102: 702-705
  • 12 Eckel RH, Jakicic JM, Ard JD, de Jesus JM, Houston Miller N, Hubbard VS, Lee IM, Lichtenstein AH, Loria CM, Millen BE, Nonas CA, Sacks FM, Smith Jr. SC, Svetkey LP, Wadden TA, Yanovski SZ, Kendall KA, Morgan LC, Trisolini MG, Velasco G, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith Jr. SC, Tomaselli GF. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014; 63 (25 Pt B): 2960-2984
  • 13 GBD 2016 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet 2017; 390: 1345-1422
  • 14 Gianola S, Castellini G, Agostini M, Bolotta R, Corbetta D, Frigerio P, Gasparini M, Gozzer P, Guariento E, Li LC, Pecoraro V, Sirtori V, Turolla A, Andreano A, Moja L. Reporting of rehabilitation intervention for low back pain in randomized controlled trials: Is the treatment fully replicable?. Spine (Phila Pa 1976) 2016; 41: 412-418
  • 15 Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from descriptions of treatment in trials and reviews?. BMJ 2008; 336: 1472
  • 16 Hoffmann TC, Erueti C, Glasziou PP. Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials. BMJ 2013; 347: f3755
  • 17 Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan A-W, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014; 348: g1687
  • 18 Holden S, Rathleff MS, Jensen MB, Barton CJ. How can we implement exercise therapy for patellofemoral pain if we don't know what was prescribed? A systematic review. Br J Sports Med 2018; 52: 385
  • 19 Jacquier I, Boutron I, Moher D, Roy C, Ravaud P. The reporting of randomized clinical trials using a surgical intervention is in need of immediate improvement: a systematic review. Ann Surg 2006; 244: 677-683
  • 20 Jessup M, Brozena S. Heart failure. N Engl J Med 2003; 348: 2007-2018
  • 21 Lewington S, Clarke R, Qizilbash N, Peto R, Collins R. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002; 360: 1903-1913
  • 22 Mack DE, Wilson PM, Santos E, Brooks K. Standards of reporting: the use of CONSORT PRO and CERT in individuals living with osteoporosis. Osteoporos Int 2018; 29: 305-313
  • 23 Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 2013; 31: 1281-1357
  • 24 Nieuwlaat R, Schwalm JD, Khatib R, Yusuf S. Why are we failing to implement effective therapies in cardiovascular disease?. Eur Heart J 2013; 34: 1262-1269
  • 25 OCEBM Levels of Evidence Working Group. The Oxford 2011 Levels of Evidence 2 [Internet]. In. Oxford (UK): Oxford Centre for Evidence-Based Medicine;
  • 26 Robb SL, Carpenter JS. A review of music-based intervention reporting in pediatrics. J Health Psychol 2009; 14: 490-501
  • 27 Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010 152: 726-732
  • 28 Simera I, Moher D, Hirst A, Hoey J, Schulz KF, Altman DG. Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR Network. BMC Med 2010; 8: 24
  • 29 Slade SC, Dionne CE, Underwood M, Buchbinder R. Consensus on exercise reporting template (CERT): explanation and elaboration statement. Br J Sports Med 2016; 50: 1428-1437
  • 30 Tew GA, Brabyn S, Cook L, Peckham E. The completeness of intervention descriptions in randomised trials of supervised exercise training in peripheral arterial disease. PLoS One 2016; 11: e0150869
  • 31 Thompson PD, Arena R, Riebe D, Pescatello LS. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep 2013; 12: 215-217
  • 32 von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol 2008; 61: 344-349
  • 33 Wells M, Williams B, Treweek S, Coyle J, Taylor J. Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions. Trials 2012; 13: 95
  • 34 Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines. Hypertension 2018; 71: 1269–1324
  • 35 Winters-Stone KM, Neil SE, Campbell KL. Attention to principles of exercise training: a review of exercise studies for survivors of cancers other than breast. Br J Sports Med 2014; 48: 987-995
  • 36 World Health Organization. Global Status Report on Noncommunicable Diseases 2010. Geneva: World Health Organization; 2011
  • 37 Yamato TP, Maher CG, Saragiotto BT, Hoffmann TC, Moseley AM. How completely are physiotherapy interventions described in reports of randomised trials?. Physiotherapy 2016; 102: 121-126