Top

Published in:

01-02-2018 | Review

Standards of reporting: the use of CONSORT PRO and CERT in individuals living with osteoporosis

Authors: D. E. Mack, P. M. Wilson, E. Santos, K. Brooks

Published in: Osteoporosis International | Issue 2/2018

Abstract

The Consolidated Standards of Reporting Trials for Patient-Reported Outcomes (CONSORT PRO) and the Consensus on Exercise Reporting Template (CERT) have been developed to improve the quality and transparency of reporting standards in scientific research. The purpose of this study was to provide evidence for the adoption of CONSORT PRO and CERT by researchers examining the link between exercise and quality of life in individuals living with osteoporosis. A systematic search was conducted to identify randomized control trials published in English evaluating exercise interventions on quality of life in individuals living with osteoporosis. Reporting standards were assessed using CONSORT PRO and CERT. A total of 127 studies were identified with 23 meeting inclusion criteria. “Good” evidence for eight (42.1%) CONSORT PRO and two (12.5%) CERT items was found. Adherence to CONSORT PRO was not related to the year of publication, journal impact factor, or study quality. Adherence to CONSORT PRO and CERT reporting standards is inadequate in the literature examining exercise interventions on quality of life in individuals living with osteoporosis. Sufficient reporting is paramount to knowledge translation, interpretation by interventionists, and clinician confidence in understanding if (and how) exercise is associated with quality of life outcomes in this cohort. Concerns associated with failure to include this information are highlighted.

Please email dmack@brocku.ca for a complete list of primary sources.

APA Publications and Communications Board Working Group on Journal Article Reporting Standards (2008) Reporting standards for research in psychology. Why do we need them? What might they be? Am Psychol 63:839–851. https://doi.org/10.1037/0003-066X.63.9.839 CrossRefPubMedCentral

Goodman SN, Fanelli D, Ioannidis JPA (2016) What does research reproducibility mean? Sci Translat Med 8:341. https://doi.org/10.1126/scitranslmed.aaf5027 CrossRef

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ et al (2010) CONSORT 2010 Explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiology 63:e1–e37. https://doi.org/10.1016/j.jclinepi.2010.03.004 CrossRef

Schulz KF, Altman DG, Moher D, for the CONSORT Group (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med 8:18. https://doi.org/10.1186/1741-7015-8-18 CrossRefPubMedPubMedCentral

EQUATOR Network online Library for Health Research Reporting. Enhancing the quality and transparent of health research. http://www.equator-network.org/. Accessed 15 June 2017

Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD, for the CONSORT PRO Group (2013) Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 309:814–822. https://doi.org/10.1001/jama.2013.879 CrossRefPubMed

United States Food and Drug Administration (2009) Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. http://www.fda.gov/cder/guidance/index.htm. Accessed 13 June 2017

Mercieca-Bebber R, Routte J, Calvert M, King MT, McLeod L, Holch P et al (2017) Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension. Qual Life Res 26:1427–1437. https://doi.org/10.1007/s11136-017-1508-6 CrossRefPubMed

Stevens DJ, Blencowe NS, McElnay PJ, Macefield RC, Savović J, Avery KNL, Blazeby JM (2016) A systematic review of patient-reported outcomes in randomized controlled trials of unplanned general surgery. World J Surg 40:267–276. https://doi.org/10.1007/s00268-015-3292-1 CrossRefPubMed

10.

Glasziou P, Meats E, Heneghan C, Shepperd S (2008) What is missing from descriptions of treatment in trials and reviews? BMJ 336:1472. https://doi.org/10.1136/bmj.39590.732037.47

11.

Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D et al (2014) Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 348:1687. https://doi.org/10.1136/bmj.g1687

12.

Slade SC, Dionne CE, Underwood M, Buchbinder R (2016) Consensus on exercise reporting template (CERT): explanation and elaboration statement. Br J Sports Med 50:1428–1437. https://doi.org/10.1136/bjsports-2016-096651 CrossRefPubMed

13.

Slade SC, Dionne CE, Underwood M, Buchbinder R, Beck B, Bennell K et al (2016) Consensus on exercise reporting template (CERT): modified Delphi study. Phys Ther 96:1514–1524. https://doi.org/10.2522/ptj.20150668 CrossRefPubMed

14.

Slade SC, Keating JL (2011) Exercise prescription: a case for standardised reporting. Br J Sports Med 46:1110–1113. https://doi.org/10.1136/bjsports-2011-090290 CrossRefPubMed

15.

Abell B, Glasziou P, Hoffmann T (2015) Reporting and replicating trials of exercise-based cardiac rehabilitation. Do we know what the researchers actually did? Cir Cardiovasc Qual Outcomes 8:187–194. https://doi.org/10.1161/CIRCOUTCOMES.114.001381 CrossRef

16.

Gianola S, Castellini G, Agostini M, Bolotta R, Corbetta D, Frigerio P et al (2016) Reporting of rehabilitation intervention for low back pain in randomized controlled trials: is the treatment fully replicable? Spine 41:412–418. https://doi.org/10.1097/BRS.0000000000001290 CrossRefPubMed

17.

Tew GA, Brabyn S, Cook L, Peckham E (2016) The completeness of intervention descriptions in randomized trials of supervised exercise training in peripheral arterial disease. PLoS One 11:e0150869. https://doi.org/10.1371/journal.pone.0150869 CrossRefPubMedPubMedCentral

18.

Yamato TP, Maher CG, Saragiotto BT, Hoffmann TC, Moseley AM (2016) How completely are physiotherapy interventions described in reports of randomised trials? Physiother 102:121–126. https://doi.org/10.1016/j.physio.2016.03.001 CrossRef

19.

Charlton PC, Drew MK, Mentiplay BF, Grimaldi A, Clark RA (2017) Exercise interventions for the prevention and treatment of groin pain and injury in athletes: a critical and systematic review. Sports Med 47:2011–2026. https://doi.org/10.1007/s40279-017-0742-y

20.

Giangregorio LM, Macintyre NJ, Heinonen A, Cheung AM, Wark JD, Shipp K et al (2014) Too fit to fracture: a consensus on future research priorities in osteoporosis and exercise. Osteoporos Int 25:1465–1472. https://doi.org/10.1007/s00198-014-2652-2 CrossRefPubMedPubMedCentral

21.

Howe TE, Shea, B, Dawson LJ, Downie F, Murray A, Ross C et al (2011) Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev 7. https://doi.org/10.1002/14651858.CD000333.pub2

22.

Sherrington C, Tiedemann A, Fairhall N, Close J, Lord SR (2011) Exercise for preventing falls in older adults: an updated exercise for improving outcomes after osteoporotic vertebral fracture meta-analysis and best practice recommendations. NSW Public. Health Bull 22:78–83

23.

Caputo EL, Zanusso Costa M (2014) Influence of physical activity on quality of life in post-menopausal women with osteoporosis. Rev Bras Reumatol 54:467–473. https://doi.org/10.1016/j.rbr.2014.02.008 CrossRefPubMed

24.

Giangregorio LM, MacIntyre NJ, Thabane L, Skidmore CJ, Papaioannou A (2013) Exercise for improving outcomes after osteoporotic vertebral fracture. Cochrane Database Syst Rev 1:CD008618. https://doi.org/10.1002/14651858.CD008618.pub2 CrossRef

25.

Mack DE, Wilson PM, Gunnell KE (2017) Land of confusion: unpacking the relationship between physical activity and well-being in individuals living with osteoporosis. Int Rev Sport Exercise Psychol 10:212–229. https://doi.org/10.1080/1750984X.2016.1216149 CrossRef

26.

Svensson HK, Olsson LE, Hansson T, Karlsson J, Hansson-Olofsson E (2017) The effects of person-centred or other supportive intervention in older women with osteoporotic vertebral compression fractures—a systematic review of the literature. Osteoporos Int 28:2521–2540. https://doi.org/10.1007/s00198-017-4099-8

27.

Wilhelm M, Roskovensky G, Emery K, Manno K, Valek K, Cook C (2012) Effect of resistance exercises on function in older adults with osteoporosis or osteopenia: a systematic review. Physiother Can 64:386–394. https://doi.org/10.3138/ptc.2011-31BH CrossRefPubMedPubMedCentral

28.

Efficace F, Fayers P, PusicA CY, Yanagawa J, Jacobs M, la Sala A et al (2015) Quality of patient-reported outcome (PRO) reporting across cancer randomized controlled trials according to the CONSORT PRO extension: a pooled analysis of 557 trials. Cancer 121:3335–3342. https://doi.org/10.1002/cncr.29489 CrossRefPubMedPubMedCentral

29.

Weingärtner V, Dargatz N, Weber C, Mueller D, Stock S, Voltz R, Gaertner J (2016) Patient reported outcomes in randomized controlled cancer trials in advanced disease: a structured literature review. Expert Rev Clinical Pharm 9:821–829. https://doi.org/10.1586/17512433.2016.1164595 CrossRef

30.

Dirven L, Taphoorn MJB, Reijneveld JC, Blazeby J, Jacobs M, Pusic A et al (2014) The level of patient-reported outcome in reporting in randomised controlled trials of brain tumour patients: a systematic review. Eur J Cancer 50:2432–2448. https://doi.org/10.1016/j.ejca.2014.06.016 CrossRefPubMed

31.

Maher CG, Sherrington C, Herbert RD, Moseley AM, Elkins M (2003) Reliability of the PEDro scale for rating quality of randomized controlled trials. Phys Ther 83:713–721PubMed

32.

PEDro: Physiotherapy Evidence Database. https://www.pedro.org.au/english/downloads/pedro-scale/. Accessed 27 July 2017

33.

Rouette J, Blazeby J, King M, Calvert M, Peng Y, Meyer RM et al (2015) Integrating health-related quality of life findings from randomized clinical trials into practice: an international study of oncologists’ perspectives. Qual of Life Res 24:1317–1325. https://doi.org/10.1007/s11136-014-0871-9 CrossRef

34.

Zagadailov E, Fine M, Sheilds A (2013) Patient-reported outcomes are changing the landscape in oncology care: challenges and opportunities for payers. Am Health Drug Benefits 6:364–374

35.

Linke SE, Gallo LC, Norman GJ (2011) Attrition and adherence rates of sustained vs. intermittent exercise interventions. Ann Behav Med 42:197–209. https://doi.org/10.1007/s12160-011-9279-8 CrossRefPubMedPubMedCentral

36.

American Educational Research Association, American Psychological Association & National Council on Measurement in Education (2014) Standards for educational and psychological testing. American Educational Research Association, Washington, DC

37.

National Research Council (2010) The prevention and treatment of missing data in clinical trials. Panel on handling missing data in clinical trials. Committee on National Statistics, Division of Behavioral and Social Sciences and Education. The National Academies Press, Washington, DC

38.

Bowling A (2005) Mode of questionnaire administration can have serious effect of data quality. J Public Health 27:281–291. https://doi.org/10.1093/pubmed/fdi031 CrossRef

39.

Puhan MA, Ahuja A, Van Natta ML, Ackatz LE, Meinert C (2011) Interviewer versus self-administered health-related quality of life questionnaires—does it matter? Health Qual Life Outcomes 9:30. https://doi.org/10.1186/1477-7525-1189-1130 CrossRefPubMedPubMedCentral

40.

Rutherford C, Costa D, Mercieca-Bebber R, Rice H, Gabb L, King M (2016) Mode of administration does not cause biases in patient-reported outcome results: a meta-analysis. Qual Life Res 25:559–574. https://doi.org/10.1007/s11136-015-1110-8 CrossRefPubMed

41.

Harlow LL, Mulaik SA, Steiger JH (eds) (1997) What if there were no significance tests? Erlbaum, Mahwah NJ

42.

Kyte D, Duffy H, Fletcher B, Gheorghe A, Merieca-Bebber R, King M et al (2014) Systematic evaluation of the patient-reported outcome (PRO) content of clinical trial protocols. PLoS One 9:e110229. https://doi.org/10.1371/journal.pone.0110229 CrossRefPubMedPubMedCentral

43.

Page P, Hoogenboom B, Voight M (2017) Improving the reporting of therapeutic exercise interventions in rehabilitation research. Int J Sports Phys Ther 12:297–304PubMedPubMedCentral

44.

Küçükçakır N, Altan L, Korkmaz N (2013) Effects of Pilates exercises on pain, functional status and quality of life in women with postmenopausal osteoporosis. J of Bodyw Mov Therapies 17:204–211. https://doi.org/10.1016/j.jbmt.2012.07.003 CrossRef

45.

Tüzün S, Aktas I, Akarirmak U, Sipahi S, Tüzün F (2010) Yoga might be an alternative training for the quality of life and balance in postmenopausal osteoporosis. Eur J Phys Rehab Med 46:69–72

46.

American College of Sports Medicine (2014) ACSM’s guidelines for exercise testing and prescription, 9th edn. Lippioncott, Williams & Wilkins, Baltimore, MD

47.

Bennell KL, Matthews B, Grief A, Briggs A, Kelly A, Sherburn M et al (2010) Effects of an exercise and manual therapy program on physical impairments, function and quality of life in people with osteoporotic vertebral fracture: a randomised, single-blind controlled pilot trial. BMC Musculoskelet Disord 11:36. https://doi.org/10.1186/1471-2474-11-36 CrossRefPubMedPubMedCentral

48.

Hoffmann TC, Maher CG, Briffa T, Sherrington C, Bennell K, Alison J, Singh MF, Glasziou PP (2016) Prescribing exercise interventions for patients with chronic conditions. CMAJ 188:510–518. https://doi.org/10.1503/cmaj.150684 CrossRefPubMedPubMedCentral

49.

Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W et al (2015) Process evaluation for complex interventions: Medical Research Council guidance. BMJ 350. https://doi.org/10.1136/bmj.h1258

50.

Quested E, Ntoumanis N, Thøgersen-Ntoumani C, Hagger MS, Hancox JE (2017) Evaluating quality of implementation in physical activity interventions based on theories of motivation: current challenges and future directions. Int Rev Sport Exercise Psychol 10:252–269. https://doi.org/10.1080/1750984X.2016.1217342 CrossRef

Title: Standards of reporting: the use of CONSORT PRO and CERT in individuals living with osteoporosis
Authors: D. E. Mack
P. M. Wilson
E. Santos
K. Brooks
Publication date: 01-02-2018
Publisher: Springer London
Published in: Osteoporosis International / Issue 2/2018
Print ISSN: 0937-941X
Electronic ISSN: 1433-2965
DOI: https://doi.org/10.1007/s00198-017-4249-z

At a glance: The STEP trials

Springer Medicine

Standards of reporting: the use of CONSORT PRO and CERT in individuals living with osteoporosis

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 2/2018

Worsening of soft tissue dystrophic calcification in an osteoporotic patient treated with teriparatide

Serum parathyroid hormone is associated with increased cortical porosity of the inner transitional zone at the proximal femur in postmenopausal women: the Tromsø Study

The effect of exercise on bone mineral density in adult cancer survivors: a systematic review and meta-analysis

Geisinger high-risk osteoporosis clinic (HiROC): 2013–2015 FLS performance analysis

Reviewers 2017

Two threshold levels of vitamin D and the prevalence of comorbidities in outpatients of a tertiary hospital