Hip Hope Network Research Pillar Newsletter

Vol 1 | March 2023

www.hiphopenetwork.org

UPCOMING EVENTS

CALL FOR INTERESTED INVESTIGATORS

FEATURE ARTICLE

Follow-up Strategies in Longitudinal Research

By: Dr. Woody Sankar

Need for improved patient retention

It is critical for any orthopaedic study evaluating the long-term outcome of a disease (treated or untreated) to have high follow-up rates. When large numbers of participants are lost to follow-up, the study power is reduced, generalizability may become limited, and bias can be introduced if those lost differ from those that remain in the study. Zelle et al determined that in more than one-quarter of fifty simulated orthopaedic trials, the results switched from significant to non-significant when loss to follow-up rates were 20%. The authors recommended that researchers aim to achieve at least 80% follow-up rates in any long-term study. Reaching this mark, however, can be a significant challenge, especially in younger patients who are notably transient, often relocating for higher education or vocation during the study period. These challenges transcend the particular pediatric hip disease in question. As such, improving follow-up rates should be a common goal amongst all study groups within the Hip Hope Network.

Experience from other large multi-center study groups in adult orthopaedic surgery, especially the Multicenter Orthopaedic Outcomes Network (MOON) study of ACL reconstruction, can offer important lessons for how best to improve follow-up rates. Clear from all of these studies is the need for a coordinated and organized protocol for achieving patient retention.

Opportunities to improve follow-up

The first opportunity to improve long-term follow-up rates actually occurs at the time of initial enrollment. The more the treating physician touts the importance of the study at the outset—describing its rationale in context, how critical follow-up information is, and how it can help children and adolescents in the future—the more likely the patient/family is to “buy in” and feel like they are a part of something bigger.

Although they run the risk of adding to “oversaturation”, regular study updates or newsletters through email or social media can help maintain study interest as years pass—a strategy well-employed by the famous Framingham Heart Study. Initial enrollment is also the time to collect as much contact information as possible under the particular study’s ethics/IRB approval including email addresses and cell phone numbers of patients (if applicable) and family members when possible. More permanent email addresses (Gmail, Yahoo., etc) are preferred over email addresses tied to schools, as the latter are more likely to become obsolete.

Regular monitoring is key

Regular monitoring by either the local or central coordinating site can help identify patients who have recently missed follow-up appointments and are therefore at risk for being lost to follow-up. Many of these patients can be recaptured easily through early identification and direct contact by the local site’s scheduling team. For patients with larger gaps in follow-up, MOON and other adult studies have found that central site follow-up coordination is preferred over local site at least to start. Most local sites have research assistants and coordinators that may turn-over at higher frequency than central sites, which tend to have more stable study teams. However, the feasibility of this approach may be limited, particularly in truly global collaborations, where vast differences in local clinical procedures, customs and languages is likely.

Use an algorithm for patient contact

Regardless, a clear algorithm for how to contact missing patients is critical, as is an explicit definition for when a patient is truly deemed to be officially “lost”. These algorithms typically include attempts at contact (via email or phone) at regular intervals (e.g., once a week) a predetermined number of times, and logging these attempts to avoid confusion. Phone contact should be attempted at different times of the day (including weekends) with caller IDs associated with the health care center rather than unknown or blocked numbers which are less likely to be answered. Whenever a patient is reached, contact information should be updated and any shorter questionnaires should be administered at that time in case the patient doesn’t respond in the future. If the patient fails to respond to a number of attempts, “escalating” the caller/emailer from a central research coordinator, to the local (and hopefully familiar) advanced practice provider, and eventually to the surgeon him or herself can be extremely helpful. Even the most preoccupied patient is unlikely to ignore a phone call or an email from their treating physician. However, it is important to obtain all necessary ethical approval prior to implementing each of these approaches.

Additional opportunities

Ultimately, tracking down individual patients in order to get in-person clinical exams and written surveys is expensive from both a cost and labor standpoint. When feasible, telemedicine offers improving opportunities to follow-up with patients who may have moved beyond the local area or who are otherwise unable to easily travel back for an appointment. Radiographs, when necessary, can be obtained locally and uploaded through a number of different platforms which interface with most centers’ EMR and PACS systems. Moving forward, long-term studies should focus on outcomes that can easily be obtained through automated email surveys, text-based queries, or brief telephone questionnaires, rather than detailed clinical visits.

References

Booker et al. A systematic review of the effect of retention methods in population-based cohort studies. BMC Public Health. 2011;11:249. https://doi.org/10.1186/1471-2458-11-249

Madden et al. Predicting and preventing loss to follow-up of adult trauma patients in randomized controlled trials: An example from the FLOW trial. J Bone Joint Surg Am. 2017;99:1086-1092. DOI: 10.2106/JBJS.16.00900

Marx et al. MOON’s strategy for obtaining over eighty percent follow-up at 10 years following ACL reconstruction. J Bone Joint Surg Am. 2022:104:e7(1-6). DOI: 10.2106/JBJS.21.00166

Zelle et al. Loss of follow-up in orthopaedic trauma: is 80% follow-up still acceptable? J Orthop Trauma. 2013;27(3):1771-81. DOI: 10.1097/BOT.0b013e31825cf367

LITERATURE HIGHLIGHT

The contralateral hip in slipped capital femoral epiphysis: Is there an easy-to-use algorithm to support a decision for prophylactic fixation?

The purpose of this study was to identify a specific factor or factors that could support decision-making regarding prophylactic fixation of the contralateral hip in unilateral SCFE. This was a retrospective review of the Swedish Pediatric Orthopaedic Quality Register for all patients diagnosed with unilateral SCFE at the time of initial diagnosis over a six-year period. Patient demographics, slip severity and stability were utilized in a regression analysis to identify risk factors for a contralateral slip.

A total of 379 children were identified with a diagnosis of SCFE: 27 with primary bilateral SCFE, 151 with a primary unilateral SCFE who received a concomitant prophylactic fixation, and 201 with a primary unilateral SCFE whose contralateral hip was observed. Of the 201 children with primary unilateral SCFE, 43 went on to develop a slip on the contralateral side. Univariate and multivariate analysis revealed lower chronological age to be the only significantly associated factor with contralateral slip. After 13 years of age, only 1/15 girls and 3/65 boys developed a contralateral slip. Therefore, the authors suggest prophylactic fixation for children under 13 years of age diagnosed with unilateral SCFE.

Read More | DOI: 10.1177/18632521221107748

JOIN US ON DOCMATTER FOR CLINICAL DISCUSSION

GLOBAL REGISTRY HIGHLIGHTS

International Perthes Study Group (IPSG)

IPSG was started in 2012 by an international group of pediatric orthopaedic surgeons and researchers who recognized the need to improve care and treatment outcomes for patients with Perthes’ disease. In formation, over 40 surgeons came together to openly discuss and form consensus on the existing medical evidence, and identify areas to be addressed through a collaborative research program. IPSG’s mission is to advance knowledge of Pethes’ disease and to disseminate objective, evidence-based information to patients, families and the medical community.

Today, IPSG has 49 members – doctors and scientists worldwide, and four active research projects with more than 750 participants. These studies are organized based on age of onset of Perthes’, since treatment options vary according to age.

1. 6-8 year age group:

Study Question: Do surgical treatments produce better outcomes at 2 and 5 years post-treatment than non-surgical treatments?

2. 8-11 year age group:

Study Question: Does a longer duration of non-weightbearing after hip surgery (using crutches and wheelchair for 6 weeks compared to 6 months) make a difference to the femoral head shape and outcome at 2 and 5 years?

3. >11 year age group:

Study Question: Which of 3 treatments (multiple epiphyseal drilling +/- arthrodiastasis, non-surgical treatment) produce better femoral head shape and outcomes at 2 and 5 years?

4. Value of MRI:

Study Question: Can perfusion MRI provide early information about how well the patient will do?

At the 2022 POSNA Annual Meeting in Vancouver, Canada, IPSG Founder Dr. Harry Kim also presented the patient-reported outcomes of a survey of over 900 adults who had childhood Perthes’ disease.

Are you interested in learning more about IPSG or becoming a member? 

Visit Website

Funding Announcement: CIHR Project Grant Received to Support GHDR-Based RCT

The Canadian Institute for Health Research (CIHR) has recently announced project grant funding in the amount of 1.09 million dollars to support a GHDR-based, international, multi-centre, non-inferiority, randomized control trial titled: Bracing versus observation for the treatment of radiologic dysplasia: A non-inferiority RCT.

The project, which is the registry's inaugural RCT, will look at whether careful monitoring of an infant's hips can be just as good as bracing to ensure their hips improve for babies diagnosed with mild DDH under three months of age. If that is the case, then unnecessary treatment can be avoided, especially during that newborn bonding period.

This will be the first study to look at this question, with babies being treated at fourteen different hospitals in seven different countries, so the results will make an impact on children and families worldwide.

ACCEPTED PODIUM ABSTRACTS

PUBLICATION HIGHLIGHTS

Upasani VV, Bomar JD, Fitzgerald RE, Schupper AJ, Kelley SP; International Hip Dysplasia Registry. Prolonged Brace Treatment Does Not Result in Improved Acetabular Indices in Infantile Dislocated Hips. J Pediatr Orthop. 2022 May-Jun 01;42(5):e409-e413. doi: 10.1097/BPO.0000000000002110. PMID: 35200217.

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