INTRODUCTION: HIP SURVEILLANCE AND ITS RATIONALE Source: http://www.aacpdm.org/care-pathways8 What is the risk to hips in children with CP? The reported rates of hip displacement and hip dislocation in children with CP vary widely and have been reported from 2% to 75%. More recent population studies have identified the rate of hip displacement to be around 30%. Hip displacement and dislocation can lead to pain, reduced function and reduced quality of life. Hip Surveillance in children with CP- WHY IS IT IMPORTANT? Hip surveillance allows for early detection of hip displacement. Early detection enables referral for assessment and/or management. Ongoing Hip surveillance programmes (HSPs) in many countries have proven to be effective in decreasing the salvage surgeries and eliminating hip dislocations on long term follow up. The common thread between all hip surveillance guidelines is that children with more severe cerebral palsy will require more frequent clinical assessments and x-rays. Early identification is an essential part of the strategy for prevention of hip displacement and its sequelae. These early indicators include GMFCS, age, gait classification (WGH IV) and MP. The information gathered from the clinical assessment and radiological review are vital components of hip surveillance and are required to capture often silent displacement of the hip while minimising radiation exposure. Hip surveillance cannot be based on clinical assessment alone. Hip surveillance will assist identification of prognosis for the hip; inform planning for ongoing hip management; support education and assist clear communication. The Hip Surveillance Guidelines document the recommended process for screening, monitoring and triaging to orthopaedic services as part of the overall prevention of hip dislocation. Surgical recommendations and management guidelines do not form part of this study.
Hip Surveillance V/S Screening Hip surveillance is defined as: “The process of monitoring and identifying the critical early indicators of hip displacement.†The term “surveillance†is more appropriate nomenclature to consider in place of screening, because, by definition, it means the close monitoring of someone or something to prevent an adverse outcome. The term surveillance reinforces the concept of periodic physical as well as radiological examinations, if indicated for children with identified risk factors. Hip surveillance is an ongoing process that continues for every child until skeletal maturity or discharge. Hip surveillance should recommence: following the post operative period for any child who has undergone surgery for hip management, following neurosurgical interventions or following an unplanned break in surveillance for any other medical reason.
AACPDM Care Pathways’ Hip Surveillance in CP https://www.aacpdm.org/publications/care-pathways/hip-surveillance AACPDM care pathways include a practical summary, including an algorithm, of evidence informed guidelines or the best evidence for an aspect of care/services for individuals with childhood-onset disabilities to inform clinical practice. An expert committee of seventeen experts in field of CP from around the world formed to develop bottom Line ‘Evidence-Informed’ Recommendations for the Hip Surveillance in Individuals with Cerebral Palsy. AACPDM Care pathways for hip surveillance was published in September, 2017 and is due for review in 2020. As we do not have any standardized hip surveillance protocol for India, for the purpose of this document (WHSP), we have used AACPDM Care pathways for hip surveillance as base. Considering India’s vast geography, a large population with different cultural and socio-economic backgrounds, AACPDM Guidelines Should best fit to the scenario.
OBJECTIVES Primary Objectives 1 To develop a standardized hip surveillance protocol at BJWHC for children with cerebral palsy. 2 To prevent the occurrence of hip dislocation and severe deformities by means of a continuous and standardized surveillance. Secondary Objectives 1. To improve collaboration between various professionals involved in the care of children with CP (Orthopaedic surgeons, Physiotherapists, Neurologists etc.) to ensure early diagnosis of hip displacement and prompt referral. 2. To develop a prospective CP hip registry. MATERIAL AND METHODS Inclusion Criteria: 1. All children between 2 years to skeletal maturity diagnosed with CP or CP like disorder as per accepted definition. Exclusion Criteria: 1. Children / parents who do not consent. 2. Children who have already undergone salvage hip surgeries. Consent / Assent / Dissent Consent The parents/ legal guardians of all patients will be explained the purpose and benefits of enrollment in this programme in the language they understand and will be given opportunity to ask questions. Signed consent will be obtained from parents/ legal guardians of all patients. During any point, parents may ask questions or withdraw their enrollment from WHSP. Assent/ Dissent As per ICMR, 2017 guidelines for children between 7-11 years of age, oral assent will be obtained in the presence of parent/legal guardian with their countersignature confirming that the child’s verbal assent has been taken. For children between 12-18 years of age, written assent will be obtained. If a child becomes 13 years old during the course of the study, then written assent will be obtained in addition to parent/legal guardian consent. Dissent or refusal of a child to participate will be respected. Explanation will be given to ensure that child understands that she/he may withdraw her/his assent at any time during the study.
Study Design Ethical approval will be obtained from the institutional research committee in accordance with the ethical stanÂdards of the 1964 Helsinki declaration. All the children with disorders of movement & posture presenting to our hospital will be assessed by pediatric neurologist or pediatric orthopedist, depending on which department child first presents to. Children presenting to general Pediatric OPD, Physiotherapy or children presenting to Orthopedics OPD with not so clear features of CP will be referred to Neurology department for final diagnosis. All children fulfilling inclusion criteria will undergo Hip Surveillance as per AACPDM Hip Surveillance Guidelines. For the purpose of this document, henceforth it will be called as Wadia Hip Surveillance Protocol (WHSP) for CP.
Patient Enrollment A specialty clinic, Wadia CP Hip Surveillance Clinic, will be conducted weekly (every Saturday 10am to 12pm) in the Department of Pediatric Orthopaedics, BJWHC. This clinic will be staffed by Orthopedic Consultant, Fellows and residents. All children fulfilling inclusion criteria will be reported to this clinic and offered enrollment into WHSP. On enrollment into WHSP, first clinical examination will be performed by the Orthopaedics department team and hip radiographs will be requested, if indicated as per AACPDM guidelines. At this visit a unique ID will be created and a physical folder will be created for each child. This folder will include demographic details, birth & developmental history, clinical & radiological exam findings and a follow-up date schedule as per guideline. On subsequent visits as per schedule, children will be called to CP surveillance clinic. The physiotherapist should refer child before schedule if: · Hip abduction motion is less than 30 degrees · There is deterioration or asymmetry in hip abduction · There is hip pain or decreased function Clinical Examination: includes 1. Classification of type of CP 2. GMFCS of child 3. Gait pattern of child 4. Passive Hip Abduction Angle 5. Any hip pain or fixed deformity 6. Examination of spine to rule out scoliosis Radiological examination: includes 1. Standardized pelvis radiographs following strict positioning protocols. Optimal positioning protocols will be discussed & distributed with radiographers and radiologists at our hospital (Annexure VIII). Senior radiographer will supervise that every hip screening radiograph is performed taking care of positioning protocols. 2. Measurement of migration percentage (MP) from a standardized supine AP pelvis radiograph. This measurement will be done by Orthopaedic department using HipScreen Smartphone App. This App is developed at Shriners Hospitals for Children, Sacramento, California, USA and is available freely on Android/Apple platforms (HipScreen, www.hipscreen.org ). It has been proven to be efficient and reliable mode of measuring MP (Kulkarni et al 2018). For the privacy of patient and data safety, HipScreen app does not store X-rays or data after measurement of MP. While doing MP measurement on X-Ray in HipScreen app, a screenshot will be taken and kept in a password protected Google drive folder of respective ID. Prior to making study measurements, all the consultants, fellows and residents in Orthopaedic department will be briefed on measurement methodology as described by Kulkarni et al. A chart of WHSP will be made available at Orthopaedics, Neurology and Physiotherapy departments. All the consultants and residents of Orthopaedics and Physiotherapy department will download HipScreen App in their smartphones. Both can use it to follow the AACPDM Guidelines and examination schedule. Orthopaedic team will use it additionally for measurement of MP on standardized pelvis radiographs. Surgical recommendations and management guidelines do not form part of this study.
Data Handling, Record keeping and Confidentiality Data will be collected at each visit on Patient record proforma and kept in respective patient folders maintained in locked cabinet in locked office at Department of Pediatric Orthopaedics, Wadia Hospital. Data will also be entered on Excel sheet format and this digital copy of records will be kept on Google Drive folder made for WHSP and it is password protected. While doing MP measurement on X-Ray in HipScreen app, a screenshot will be taken and kept on the Google drive folder with respective case ID. This will help us in keeping X-ray records along with MP measurement values while maintaining patient confidentiality. During data keeping in digital form, only Unique ID No. given to each patient will be used and all personal details will be deidentified. Data with no patient identifiers will be used for analysis. De-identified data will be entered into the online REDCap database by the research coordinator or the principal investigator at the study site. This data collection process will be maintained on a password-protected computer unique to the study site and only the researchers at the study site will have access to their data.
WITHDRAWAL / DROPOUTS Parents may withdraw from WHSP at any time. This will be reported to Principal Investigator. All attempts will be made to contact drop outs and counsel parents so that their treatment can continue.
ETHICAL CONSIDERATIONS This protocol intends to follow well established guidelines for hip surveillance in CP. No added risk exists with following surveillance guidelines as this is purely observational. Clinical exam and radiographs are a part of patients routine care and are not experimental in nature. Data of all patients will be kept with full privacy and confidentiality. Parents are allowed to withdraw at any time.
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