For the past decade, the Harms Study Group has been internationally recognized for producing the highest quality published research on new spinal deformity surgery techniques and has had over 150 peer reviewed publications in scientific journals. The group has achieved this standard by conducting comprehensive, multi-center prospective research studies aimed at answering important clinical questions regarding treatment approach and techniques.
DePuy Spine began formally funding HSG in October of 2000, with a grant that covered an administrative budget for Philadelphia, San Diego, and St. Louis. A data reimbursement budget was included for additional study group sites.
In 2001, under the direction of Peter Newton and Randal Betz, the study group advanced with the development of a multi-user, web-driven, scoliosis database. All of the previous data collected by the study group was imported into this secure, multifaceted, comprehensive database. The ability to collect, manage, and extract data was immediately more efficient, as the new database incorporated digital images of radiographs and clinical photographs. To optimize the utility of the new database, formal prospective study protocols were updated for the two main studies of the group: the “Lenke 1 Curve Study”, which compared three different surgical approaches in thoracic curves and the “Algorithm Study”, which compared approaches for all curve types in order to establish recommended treatment algorithms.
In 2002, both prospective studies were underway and the improvements and growth of the group were apparent with the implementation of standardized data collection practices and the organized dissemination of individual member database mining projects. The administration of the group was split between the Philadelphia and San Diego sites.
In 2003, additional formalization of the study group occurred with extensive database upgrades. The San Diego site assumed the main administrative tasks of the study group; subcontracting with each site and managing the data verification, invoicing, and data reimbursements. The Harms Study Group grew from twelve to sixteen surgeon members, and the database became the largest Adolescent Idiopathic Scoliosis database in existence.
In 2004, the study group continued ongoing prospective data collection and also performed its first multi-center, retrospective study, evaluating the operative management of Scheuermann's Kyphosis. The data for seventy-one patients, including radiographic outcomes, complication tracking, and surgical technique was included. The productivity of the group also grew with a total of nine podium presentations presented at society annual meetings.
In 2005, the prospective study of Scheuermann’s Kyphosis was launched and three multi-center retrospective studies were developed and implemented by the group:
1) Defining the Incidence of Complications and Risk Factors Associated with the Use of Single Lung Ventilation for Thoracoscopic Surgery in Pediatric Spinal Deformity.
2) Retrospective Cerebral Palsy Scoliosis Study: Quantifying Outcomes and Risks.
3) A Multicenter Retrospective Review of the Results of Three Classes of Surgical Treatment for Congenital Scoliosis Due to Hemivertebrae.
The results of the Retrospective Multi-Center Kyphosis Study were presented as a podium presentation in addition to six other podium presentations that year.
In 2006, an additional retrospective study was implemented, comparing severe cases of scoliosis either treated with or without Halo Traction. This study included a peer-to-peer group of surgeons and was facilitated by the HSG. This provided the opportunity for the educational outreach efforts of the HSG to unite with the HSG research endeavors. The HSG also embarked on a medical textbook project relating to the treatment of Idiopathic Scoliosis. In addition, a prospective study of motion preservation following spinal fusion was launched.
In 2007, the HSG research infrastructure was launched to sustain the evolution of the group. The infrastructure would be responsible for centralized digital x-ray measurement and storage, data organization and analysis for individual study group member projects, and data quality assurance for all prospective studies. The productivity of the group grew to fifteen podium presentations. The mechanism for digital image transfer was developed and hardcopy films were scanned into digital images for more than half of the 1500 patients in the HSG database. The “Lenke 1 Curve Study” was completed and the “Algorithm Study” was converted into a long-term Database Registry of AIS, in which operative and non-operative cases were included, with follow-up spanning twenty-five years.
In 2008, the HSG research infrastructure activity benefited the group’s data integrity and productivity by initiating the conversion of all existing manual x-ray measurements to digital measurements and creating a new version of the multi-user web-based database. The mechanisms for multi-center study participation were further strengthened by establishing data collection standardization manuals and improved, revised data collection case report forms. To ensure continual communication with all sites, a HSG web-based central folder was established. This central folder housed up-to-date versions of all HSG documents (protocols, CRFs, and manuals) and allowed all remote access to vital study documents. Monthly site coordinator calls were initiated to facilitate site compliance. Two new studies were launched: “The Prospective Study of Scoliosis in Children with Cerebral Palsy” and “The Retrospective Study of Posterior Vertebral Column Resection in Pediatric Spinal Deformity.”
In 2009, the Harms Study Group infrastructure focused on migrating the AIS data from the original database application into the improved version of the multi-user web-based database and continued converting all manual x-ray measurements into digital measurements. The study group began a new retrospective study on scoliosis correction in Marfan Syndrome.
In 2010, the textbook, Idiopathic Scoliosis: The Harms Study Group Guide to Evaluation and Treatment, was published. It was an immediate best-seller for Thieme Publishers. The Harms Study Group Foundation began fundraising efforts and raised over $100,000 to support HSG research and education outreach.
In 2011, the HSG completed a revised version of "Adolescent Idiopathic Scoliosis: Navigating Your Journey--A Guide for You and Your Family." Twenty-five thousand copies were printed. The group's AIS Database Registry grew to over three thousand patients, and an OREF grant for the Cerebral Palsy in Scoliosis study was awarded, allowing for future funding of this study through 2012.
The members of the HSG conduct a Cerebral Palsy Scoliosis meeting, made possible by the OREF grant. The patient education handbook was translated into Chinese and Spanish. The productivity of the study group soared to twenty-three podium presentations and twenty-seven poster presentations at scientific meetings.
The HSG prospective study of Scheuermann's Kyphosis was completed, as was the prospective study of Post-Operative Motion in AIS, for patients with a two to five year follow-up. The patent education handbook was translated into Turkish and Latin Spanish. The study group's productivity was reflected in twenty-two podium presentations and sixteen poster presentations at annual scientific meetings and conferences.