Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Implementation Science
Published in: Implementation Science 1/2014

Open Access 01-12-2014 | Study protocol

Study protocol of an economic evaluation of an extended implementation strategy for the treatment of low back pain in general practice: a cluster randomised controlled trial

Authors: Cathrine Elgaard Jensen, Allan Riis, Kjeld Møller Pedersen, Martin Bach Jensen, Karin Dam Petersen

Published in: Implementation Science | Issue 1/2014

Login to get access

Abstract

Background

In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners' adherence to the guidelines. In addition to usual dissemination, the extended implementation strategy is composed of visits from a guideline facilitator, stratification tools, and feedback on guideline adherence. The aim of this paper is to provide the considerations on the design of the health economic evaluation.

Methods/design

The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region. An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled. The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis. Effectiveness measures include referral to secondary care, health-related quality of life measured by EQ-5D-5L, and disability measured by the Roland Morris disability questionnaire. Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation. The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon.

Discussion

It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care. It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes, thereby rendering the extended implementation strategy cost-effective.

Trial registration

ClinicalTrials.gov: NCT01699256
Appendix
Available only for authorised users
Literature
1.
WHO Scientific Group: The burden of musculoskeletal conditions at the start of the new millennium. WHO Technical Report Series; 2003.
2.
3.
Koes BW, van Tulder M, Lin C-WC, Macedo LG, McAuley J, Maher C: An updated overview of clinical guidelines for the management of non-specific low back pain in primary care. Eur Spine J. 2010, 19: 2075-2094. 10.1007/s00586-010-1502-y.CrossRefPubMedPubMedCentral
4.
Krismer M, van Tulder M: Low back pain (non-specific). Best Pract Res Clin Rheumatol. 2007, 21: 77-91. 10.1016/j.berh.2006.08.004.CrossRefPubMed
5.
Guidelines on LBP treatment: retningslinjer for visitation og henvisning af degenerative lidelser i columna. Danish. 2010, 1 (Danish Regions): 1-7.
6.
Riis A, Jensen CE, Bro F, Maindal HT, Petersen KD, Jensen MB: Enhanced implementation of low back pain guidelines in general practice: study protocol of a cluster randomised controlled trial. Implementation Sci. 2013, 8: 124-10.1186/1748-5908-8-124.CrossRef
7.
Okkes IM, Becker HW, Bernstein RM, Lamberts H: The March 2002 update of the electronic version of ICPC-2. A step forward to the use of ICD-10 as a nomenclature and a terminology for ICPC-2. Family Practice. 2002, 19: 543-546. 10.1093/fampra/19.5.543.CrossRefPubMed
8.
9.
Hill JC, Dunn KM, Lewis M, Mullis R, Main CJ, Foster NE, Hay EM: A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis Rheum. 2008, 59: 632-641. 10.1002/art.23563.CrossRefPubMed
10.
Morsø L, Albert H, Kent P, Manniche C, Hill J: Translation and discriminative validation of the STarT back screening tool into Danish. Eur Spine J. 2011, 20: 2166-2173. 10.1007/s00586-011-1911-6.CrossRefPubMedPubMedCentral
11.
Rasmussen C, Leboeuf-Yde C, Hestbaek L, Manniche C: Poor outcome in patients with spine-related leg or arm pain who are involved in compensation claims: a prospective study of patients in the secondary care sector. Scand J Rheumatol. 2008, 37: 462-468. 10.1080/03009740802241709.CrossRefPubMed
12.
Stapelfeldt CM, Christiansen DH, Jensen OK, Nielsen CV, Petersen KD, Jensen C: Subgroup analyses on return to work in sick-listed employees with low back pain in a randomised trial comparing brief and multidisciplinary intervention. BMC Musculoskelet Disord. 2011, 12: 112-10.1186/1471-2474-12-112.CrossRefPubMedPubMedCentral
13.
Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stoddart GL: Methods for the Economic Evaluation of Health Care Programmes. 2005, Oxford University Press, New York
14.
Koopmanschap MA, Rutten FFH: A practical guide for calculating indirect costs of disease. Pharmaco Economics. 1996, 10: 460-466. 10.2165/00019053-199610050-00003.CrossRef
15.
Ostelo RWJG, de Vet HCW: Clinically important outcomes in low back pain. Best Pract Res Clin Rheumatol. 2005, 19: 593-607. 10.1016/j.berh.2005.03.003.CrossRefPubMed
16.
Deyo RA, Battie M, Beurskens AJ, Bombardier C, Croft P, Koes B, Malmivaara A, Roland M, Von Korff M, Waddell G: Outcome measures for low back pain research. A proposal for standardized use. Spine. 1998, 23: 2003-2013. 10.1097/00007632-199809150-00018.CrossRefPubMed
17.
Bombardier C: Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. Spine. 2000, 25: 3100-3103. 10.1097/00007632-200012150-00003.CrossRefPubMed
18.
National Institute for Health and Care Excellence: Guide to the Methods of Technology Appraisal 2013. NICE Article[PMG9]; 2013.
19.
20.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X: Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5 L). Qual Life Res. 2011, 20: 1727-1736. 10.1007/s11136-011-9903-x.CrossRefPubMedPubMedCentral
21.
22.
Glick HA, Doshi JA, Sonnad SS, Polsky D: Economic Evaluation in Clinical Trials. 2007, Oxford University Press, New York
23.
Ramsey S, Willke R, Briggs A, Brown R, Buxton M, Chawla A, Cook J, Glick H, Liljas B, Petitti D, Reed S: Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report. Value Health. 2005, 8: 521-533. 10.1111/j.1524-4733.2005.00045.x.CrossRefPubMed
24.
Campbell MK, Piaggio G, Elbourne DR, Altman DG: CONSORT 2010 statement: extension to cluster. BMJ. 2012, 345: e5661-10.1136/bmj.e5661.CrossRefPubMed
25.
Andersen JS, Olivarius NDF, Krasnik A: The Danish National Health Service Register. Scand J Public Health. 2011, 39 (7 Suppl): 34-37. 10.1177/1403494810394718.CrossRefPubMed
26.
Wayman JC: Paper presented at the 2003 Annual Meeting of the American Educational Research Association, Chicago, IL. Multiple Imputation For Missing Data: What Is It And How Can I Use It?; 2003
27.
Sterne JAC, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR: Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. Res Methods Reporting. 2009, 339 (July): 157-160.
28.
Briggs A, Claxton K, Sculpher M: Decision Modelling for Health Economic Evaluation. 2006, Oxford University Press, New York
29.
O'Sullivan AK, Thompson D, Drummond MF: Collection of health-economic data alongside clinical trials: is there a future for piggyback evaluations?. Value Health. 2005, 8: 67-79. 10.1111/j.1524-4733.2005.03065.x.CrossRefPubMed
30.
Johnston K, Buxton M, Jones D, Fitzpatrick R: Assessing the costs of healthcare technologies in clinical trials. Health Technol Assess. 1999, 3 (6): 17-
Metadata
Title
Study protocol of an economic evaluation of an extended implementation strategy for the treatment of low back pain in general practice: a cluster randomised controlled trial
Authors
Cathrine Elgaard Jensen
Allan Riis
Kjeld Møller Pedersen
Martin Bach Jensen
Karin Dam Petersen
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2014
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/s13012-014-0140-x

Other articles of this Issue 1/2014

Implementation Science 1/2014 Go to the issue

Research

Involving patients in setting priorities for healthcare improvement: a cluster randomized trial

Research

Adaptation of an evidence-based intervention to promote colorectal cancer screening: a quasi-experimental study

Study protocol

Protocol for the economic evaluation of the diarrhea alleviation through zinc and oral rehydration salt therapy at scale through private and public providers in rural Gujarat and Uttar Pradesh, India

Study protocol

Designing and evaluating an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes in clinical care - systematic decision aid development and study protocol

Study protocol

Improving outcomes of hospitalized patients: the Physician Relationships, Improvising, and Sensemaking intervention protocol

Research

The effect of a national quality improvement collaborative on prehospital care for acute myocardial infarction and stroke in England