Loss to follow-up
Open accessAbstract
In this issue, we answer three questions with respect to loss to follow-up in a clinical trial: How important is loss to follow-up? How is loss to follow-up calculated? How many patients can be lost to follow-up without mistrusting the results? 1. How important is loss to follow-up? The simple answer to this question is „very important” because loss to follow-up can severely compromise a study’s validity. Incomplete follow-up biases the results when either: The dropout rates are different between study groups; or The patients who drop out are different from those who do not drop out. Why do these situations make a difference? Because in each situation, those lost to follow-up often have a different prognosis than those who complete the study. For example, patients who receive treatment for cervical myelopathy may not return for follow-up because they became asymptomatic and felt no need to return to see the surgeon. Conversely, some patients may not return because they had a particularly bad outcome (worse pain or function) or complication, or because they died. In either case, bias can affect the validity of the inferences drawn from the study. 2. How is loss to follow-up calculated? There is much confusion about how to determine the proportion of patients lost to follow-up. In order to correctly calculate the follow-up rate, one needs to know the denominator. In a randomized controlled trial (RCT), the denominator for each group is the number of patients who were randomized, not the number who received the treatment. For example, suppose we have an RCT comparing two treatment groups, Group A and Group B. The investigators evaluate 178 patients and randomize 120; 61 to Group A and 59 to Group B (Fig 1). Following the figure, we note that 49 patients received treatment A and 52 received treatment B. At the final follow-up 40 were analyzed in Group A and 41 in Group B. How many were considered lost to follow-up? Many would consider the loss to follow-up rate to be 9 (18 %) of 49 in treatment A and 11 (21 %) of 52 in treatment B using as the denominator only those that were treated. However, the real proportion lost to follow-up must consider those who were randomly assigned, even if they did not receive treatment. In the present example, this is calculated as 21 (34 %) of 61 for treatment A and 18 (31 %) of 59 for treatment B.
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The minimum sample size for each group was identified as 26 (78 in total), but at least an additional 20% will be recruited to take into account expected follow-up attrition; thus, a minimum total sample of 96 participants (32 per group) is estimated.
“The minimum sample size for each group was identified as 26 (78 in total), but at least an additional 20% will be recruited to take into account expected follow-up attrition; thus, a minimum total sample of 96 participants (32 per group) is estimated.15 34”
From Effectiveness of a projection-based augmented reality exposure system in treating cockroach phobia: Study protocol of a randomised controlled trial (2023) · cites this paper as [34]
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Morris, P. O., Hope, E., Foulsham, T., & Mills, J. P. (2021) · International Journal of Developmental Disabilities · doi:10.1080/20473869.2021.1936870 · Cited by 23 · see citing works
Favipiravir exposure and pregnancy outcome of COVID-19 patients
Tırmıkçıoğlu, Z. (2021) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2021.12.001 · Cited by 23 · see citing works
Sun, K., Chen, Y., Wang, Z., Liu, Y., Yue, P., Mao, X., Xu, L., Jin, C., Chen, M., Yu, C., et al. (2022) · BMC Gastroenterology · doi:10.1186/s12876-022-02614-1 · Cited by 22 · see citing works
Al-Asadi, M., Sherren, M., Khalik, H. A., Leroux, T. S., Ayeni, O. R., Madden, K., & Khan, M. (2024) · The American Journal of Sports Medicine · doi:10.1177/03635465231202522 · Cited by 22 · see citing works
Bonciani, M., Rosis, S. D., & Vainieri, M. (2020) · JMIR Research Protocols · doi:10.2196/19073 · Cited by 22 · see citing works
Geense, W. W., van Gaal, B. G. I., Knoll, J. L., Schaaijk, N. M.-V., Kok, G., Cornelissen, E. A. M., & der Sanden, M. W. G. N. (2018) · Journal of Medical Internet Research · doi:10.2196/jmir.9547 · Cited by 21 · see citing works
Bisson, E. F., Mummaneni, P. V., Knightly, J. J., Alvi, M. A., Goyal, A., Chan, A. K.-H., Guan, J., Biase, M., Strauss, A., Glassman, S. D., et al. (2020) · Journal of Neurosurgery Spine · doi:10.3171/2019.12.spine191155 · Cited by 29 · see citing works
Kuteesa, M. O., Weiss, H. A., Abaasa, A. M., Nash, S., Nsubuga, R. N., Newton, R., Seeley, J., & Kamali, A. (2019) · PLoS ONE · doi:10.1371/journal.pone.0210719 · Cited by 20 · see citing works
Tsampalieros, A. K., Knoll, G. A., Fergusson, N. A., Bennett, A., Taljaard, M., & Fergusson, D. A. (2017) · Canadian Journal of Kidney Health and Disease · doi:10.1177/2054358117735523 · Cited by 20 · see citing works
Apolinário-Hagen, J. (2018) · Psychiatry Investigation · doi:10.30773/pi.2018.06.26 · Cited by 20 · see citing works
Drexel, H., Rosano, G. M. C., Lewis, B. S., Huber, K., Vonbank, A., Dopheide, J. F., MADER, A., Niessner, A., Savarese, G., Waßmann, S., et al. (2019) · European Heart Journal - Cardiovascular Pharmacotherapy · doi:10.1093/ehjcvp/pvz029 · Cited by 20 · see citing works
Gebreegziabher, E., Dah, C., Coulibaly, B., Sié, A., Bountogo, M., Ouattara, M., Compaoré, A., Nikiema, M., Tiansi, J. N., Sibiri, N. D., et al. (2023) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.22-0573 · Cited by 19 · see citing works
The use of a synthetic shoulder patch for large and massive rotator cuff tears – a feasibility study
Cowling, P. D., Hackney, R. G., Dube, B., Grainger, A. J., Biglands, J. D., Stanley, M., Song, D., Conaghan, P. G., & Kingsbury, S. R. (2020) · BMC Musculoskeletal Disorders · doi:10.1186/s12891-020-03227-z · Cited by 20 · see citing works
Patients Lost to Follow-up in Shoulder Arthroplasty: Descriptive Characteristics and Reasons
Torrens, C., Martínez, R., & Santana, F. (2022) · Clinics in Orthopedic Surgery · doi:10.4055/cios21034 · Cited by 18 · see citing works
Characteristics and outcomes of patients who did not respond to a national spine surgery registry
Kaur, S., Alhaug, O. K., Dolatowski, F. C., Solberg, T. K., & Lønne, G. (2023) · BMC Musculoskeletal Disorders · doi:10.1186/s12891-023-06267-3 · Cited by 18 · see citing works
- Authors
- Dettori, J.
- Affiliations
- Spectrum Research (United States) (US)
- Corresponding author
- Dettori, Joseph
- ORCID
- Dettori, Joseph
- Venue
- Evidence-Based Spine-Care Journal
- Publisher
- Georg Thieme Verlag KG
- Published
- 2011-02
- Volume
- 2
- Issue
- 01
- Pages
- 7-10
- ISSN
- 1663-7976 (ISSN-L)
- 1869-4136
- PMC
- PMC3427970
- OpenAlex
- W1965730835
- Cited by
- 336
- References
- 1
- Citations by year
- 2026: 16 · 2025: 34 · 2024: 35 · 2023: 28 · 2022: 38 · 2021: 43 · 2020: 37 · 2019: 25 · 2018: 26 · 2017: 20 · 2016: 13 · 2015: 6 · 2014: 7 · 2013: 2 · 2012: 1
- FWCI
- 3.08
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Evidence-Based Spine-Care Journal (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Digital Commons - USU (Utah State University) (submittedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- loss to follow-up, dropout, randomized controlled trials, research validity, bias, cervical myelopathy, spinal surgery outcomes
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