How completely are randomized controlled trials of non-pharmacological interventions following concussion reported? A systematic review.

PURPOSE: To examine the reporting completeness of randomized controlled trials (RCTs) of non-pharmacological interventions following concussion. METHODS: We searched MEDLINE, Embase, PsycInfo, CINAHL, and Web of Science up to May 2022. Two reviewers independently screened studies and assessed reporting completeness using the Template for Intervention Description and Replication (TIDieR), Consensus on Exercise Reporting Template (CERT), and international Consensus on Therapeutic Exercise aNd Training (i-CONTENT) checklists. Additional information was sought my study authors where reporting was incomplete. Risk of bias (ROB) was assessed with the Cochrane ROB-2 Tool. RCTs examining non-pharmacological interventions following concussion. RESULTS: We included 89 RCTs (n = 53 high ROB) examining 11 different interventions for concussion: sub-symptom threshold aerobic exercise, cervicovestibular therapy, physical/cognitive rest, vision therapy, education, psychotherapy, hyperbaric oxygen therapy, transcranial magnetic stimulation, blue light therapy, osteopathic manipulation, and head/neck cooling. Median scores were: TIDieR 9/12 (75%; interquartile range (IQR) = 5; range: 5-12), CERT 17/19 (89%; IQR = 2; range: 10-19), and i-CONTENT 6/7 (86%; IQR = 1; range: 5-7). Percentage of studies completely reporting all items was TIDieR 35% (31/89), CERT 24% (5/21), and i-CONTENT 10% (2/21). Studies were more completely reported after publication of TIDieR (t87 = 2.08; p = 0.04) and CERT (t19 = 2.72; p = 0.01). Reporting completeness was not strongly associated with journal impact factor (TIDieR: rs = 0.27; p = 0.01; CERT: rs = -0.44; p = 0.06; i-CONTENT: rs = -0.17; p = 0.48) or ROB (TIDieR: rs = 0.11; p = 0.31; CERT: rs = 0.04; p = 0.86; i-CONTENT: rs = 0.12; p = 0.60). CONCLUSION: RCTs of non-pharmacological interventions following concussion demonstrate moderate to good reporting completeness, but are often missing key components, particularly modifications, motivational strategies, and qualified supervisor. Reporting completeness improved after TIDieR and CERT publication, but publication in highly cited journals and low ROB do not guarantee reporting completeness.

Beyond acute concussion assessment to office management: a systematic review informing the development of a Sport Concussion Office Assessment Tool (SCOAT6) for adults and children.

OBJECTIVES: To systematically review the scientific literature regarding the assessment of sport-related concussion (SRC) in the subacute phase (3-30 days) and provide recommendations for developing a Sport Concussion Office Assessment Tool (SCOAT6). DATA SOURCES: MEDLINE, Embase, PsycINFO, Cochrane CENTRAL, CINAHL, SPORTDiscus and Web of Science searched from 2001 to 2022. Data extracted included study design, population, definition of SRC diagnosis, outcome measure(s) and results. ELIGIBILITY CRITERIA: (1) Original research, cohort studies, case-control studies, diagnostic accuracy and case series with samples >10; (2) SRC; (3) screening/technology that assessed SRC in the subacute period and (4) low risk of bias (ROB). ROB was performed using adapted Scottish Intercollegiate Guidelines Network criteria. Quality of evidence was evaluated using the Strength of Recommendation Taxonomy classification. RESULTS: Of 9913 studies screened, 127 met inclusion, assessing 12 overlapping domains. Results were summarised narratively. Studies of acceptable (81) or high (2) quality were used to inform the SCOAT6, finding sufficient evidence for including the assessment of autonomic function, dual gait, vestibular ocular motor screening (VOMS) and mental health screening. CONCLUSION: Current SRC tools have limited utility beyond 72 hours. Incorporation of a multimodal clinical assessment in the subacute phase of SRC may include symptom evaluation, orthostatic hypotension screen, verbal neurocognitive tests, cervical spine evaluation, neurological screen, Modified Balance Error Scoring System, single/dual task tandem gait, modified VOMS and provocative exercise tests. Screens for sleep disturbance, anxiety and depression are recommended. Studies to evaluate the psychometric properties, clinical feasibility in different environments and time frames are needed. PROSPERO REGISTRATION NUMBER: CRD42020154787.

Acute evaluation of sport-related concussion and implications for the Sport Concussion Assessment Tool (SCAT6) for adults, adolescents and children: a systematic review.

OBJECTIVES: To systematically review the scientific literature regarding the acute assessment of sport-related concussion (SRC) and provide recommendations for improving the Sport Concussion Assessment Tool (SCAT6). DATA SOURCES: Systematic searches of seven databases from 2001 to 2022 using key words and controlled vocabulary relevant to concussion, sports, SCAT, and acute evaluation. ELIGIBILITY CRITERIA: (1) Original research articles, cohort studies, case-control studies, and case series with a sample of >10; (2) ≥80% SRC; and (3) studies using a screening tool/technology to assess SRC acutely (<7 days), and/or studies containing psychometric/normative data for common tools used to assess SRC. DATA EXTRACTION: Separate reviews were conducted involving six subdomains: Cognition, Balance/Postural Stability, Oculomotor/Cervical/Vestibular, Emerging Technologies, and Neurological Examination/Autonomic Dysfunction. Paediatric/Child studies were included in each subdomain. Risk of Bias and study quality were rated by coauthors using a modified SIGN (Scottish Intercollegiate Guidelines Network) tool. RESULTS: Out of 12 192 articles screened, 612 were included (189 normative data and 423 SRC assessment studies). Of these, 183 focused on cognition, 126 balance/postural stability, 76 oculomotor/cervical/vestibular, 142 emerging technologies, 13 neurological examination/autonomic dysfunction, and 23 paediatric/child SCAT. The SCAT discriminates between concussed and non-concussed athletes within 72 hours of injury with diminishing utility up to 7 days post injury. Ceiling effects were apparent on the 5-word list learning and concentration subtests. More challenging tests, including the 10-word list, were recommended. Test-retest data revealed limitations in temporal stability. Studies primarily originated in North America with scant data on children. CONCLUSION: Support exists for using the SCAT within the acute phase of injury. Maximal utility occurs within the first 72 hours and then diminishes up to 7 days after injury. The SCAT has limited utility as a return to play tool beyond 7 days. Empirical data are limited in pre-adolescents, women, sport type, geographical and culturally diverse populations and para athletes. PROSPERO REGISTRATION NUMBER: CRD42020154787.

Association of Posttraumatic Headache With Symptom Burden After Concussion in Children.

Importance: Headache is the most common symptom after pediatric concussion. Objectives: To examine whether posttraumatic headache phenotype is associated with symptom burden and quality of life 3 months after concussion. Design, Setting, and Participants: This was a secondary analysis of the Advancing Concussion Assessment in Pediatrics (A-CAP) prospective cohort study, conducted September 2016 to July 2019 at 5 Pediatric Emergency Research Canada (PERC) network emergency departments. Children aged 8.0-16.99 years presenting with acute (<48 hours) concussion or orthopedic injury (OI) were included. Data were analyzed from April to December 2022. Exposure: Posttraumatic headache was classified as migraine or nonmigraine headache, or no headache, using modified International Classification of Headache Disorders, 3rd edition, diagnostic criteria based on self-reported symptoms collected within 10 days of injury. Main Outcomes and Measures: Self-reported postconcussion symptoms and quality-of-life were measured at 3 months after concussion using the validated Health and Behavior Inventory (HBI) and Pediatric Quality of Life Inventory-Version 4.0 (PedsQL-4.0). An initial multiple imputation approach was used to minimize potential biases due to missing data. Multivariable linear regression evaluated the association between headache phenotype and outcomes compared with the Predicting and Preventing Postconcussive Problems in Pediatrics (5P) clinical risk score and other covariates and confounders. Reliable change analyses examined clinical significance of findings. Results: Of 967 enrolled children, 928 (median [IQR] age, 12.2 [10.5 to 14.3] years; 383 [41.3%] female) were included in analyses. HBI total score (adjusted) was significantly higher for children with migraine than children without headache (estimated mean difference [EMD], 3.36; 95% CI, 1.13 to 5.60) and children with OI (EMD, 3.10; 95% CI, 0.75 to 6.62), but not children with nonmigraine headache (EMD, 1.93; 95% CI, -0.33 to 4.19). Children with migraine were more likely to report reliable increases in total symptoms (odds ratio [OR], 2.13; 95% CI, 1.02 to 4.45) and somatic symptoms (OR, 2.70; 95% CI, 1.29 to 5.68) than those without headache. PedsQL-4.0 subscale scores were significantly lower for children with migraine than those without headache only for physical functioning (EMD, -4.67; 95% CI, -7.86 to -1.48). Conclusions and Relevance: In this cohort study of children with concussion or OI, those with posttraumatic migraine symptoms after concussion had higher symptom burden and lower quality of life 3 months after injury than those with nonmigraine headache. Children without posttraumatic headache reported the lowest symptom burden and highest quality of life, comparable with children with OI. Further research is warranted to determine effective treatment strategies that consider headache phenotype.

Return to the Emergency Department Within 3 Months Following Pediatric Acute Concussion.

OBJECTIVE: To determine the proportion of concussed children returning to the emergency department (ED) for a concussion-related reason within 3 months of initial presentation and to determine which clinical composite score (5P or Post-Concussion Symptom Inventory) best predicts a return visit. SETTING, DESIGN, AND PARTICIPANTS: We combined a secondary analysis of data from the prospectively collected 5P study with a retrospective medical record review of children aged 5 to 18 years who returned to the Children's Hospital of Eastern Ontario (CHEO) ED for a concussion-related reason within 3 months of an acutely diagnosed concussion. Among 770 eligible participants, 632 children (median age: 11.8 [interquartile range (IQR), 9.0-14.5] years; 58.9% male) were included in the study. MAIN MEASURES: The primary outcome was the number of patients who returned to CHEO ED for a concussion-related reason within 3 months of an acute concussion diagnosed at CHEO ED. The secondary outcome was number of patients who returned within 14 days. RESULTS: Forty-seven children (7.4%; 95% confidence interval [CI]: 5.6-9.7) had a concussion-related return to the ED within 3 months, the majority of which occurred in the first 14 days (29/47; 61.7%; 95% CI: 47.4-74.2). History of migraines (21.3% vs 9.7%; P = .03) were more common in those with a return visit. Headache was the most frequently reported symptom (87.2%) on revisit. Females aged 13 to 18 years had the highest return rate (survival rate: 85.8% [95% CI: 79.8-92.3]) compared with males and younger age groups. In multivariable Cox hazards regression modeling, inclusion of risk scores improved prognostication (pseudo R2 = 8%). The difference in pseudo R2 between 5P and Post-Concussion Symptom Inventory is small. CONCLUSION: Most children and adolescents do not return to the ED following an acute concussion. Female youth with medium to high 5P scores at the index concussion visit may benefit from early referral to interdisciplinary specialty concussion care to guide treatment in anticipation of prolonged symptoms. By identifying these risk factors at the initial ED visit, healthcare and patient burden may be reduced.

Clinician Perspectives on Providing Concussion Assessment and Management via Telehealth: A Mixed-Methods Study.

OBJECTIVE: To examine clinician perspectives regarding the use of telehealth for concussion assessment and management. SETTING: A Pan-Canadian survey. PARTICIPANTS: Twenty-five purposively sampled multidisciplinary clinician-researchers with concussion expertise (female, n = 21; physician, n = 11; and other health professional, n = 14). DESIGN: Sequential mixed-method design: (1) electronic survey and (2) semistructured interviews with focus groups via videoconference. Qualitative descriptive design. MAIN OUTCOME MEASURES: Survey : A 59-item questionnaire regarding the suitability of telehealth to perform recommended best practice components of concussion assessment and management. Focus groups : 10 open-ended questions explored survey results in more detail. RESULTS: Clinicians strongly agreed that telehealth could be utilized to obtain a clinical history (96%), assess mental status (88%), and convey a diagnosis (83%) on initial assessment; to take a focused clinical history (80%); to monitor functional status (80%) on follow-up; and to manage symptoms using education on rest (92%), planning and pacing (92%), and sleep recommendations (91%); and to refer to a specialist (80%). Conversely, many clinicians believed telehealth was unsuitable to perform a complete neurologic examination (48%), cervical spine (38%) or vestibular assessment (61%), or to provide vestibular therapy (21%) or vision therapy (13%). Key benefits included convenience, provision of care, and patient-centered approach. General and concussion-specific challenges included technology, quality of care, patient and clinician characteristics, and logistics. Strategies to overcome identified challenges are presented. CONCLUSIONS: From the perspective of experienced clinicians, telehealth is suited to manage symptomatic concussion patients presenting without red flags or following an initial in-person assessment, but may have limitations in ruling out serious pathology or providing return-to-sport clearance without an in-person physical examination.

Which psychosocial factors are associated with return to sport following concussion? A systematic review.

BACKGROUND: Psychosocial factors predict recurrent injury and return to preinjury level of performance following orthopedic injury but are poorly understood following concussion. Current management protocols prioritize physical measures of recovery. Therefore, the objective of this study was to describe the psychosocial factors associated with return to sport (RTS) and how they are measured in athletes who sustained a concussion. METHODS: MEDLINE, Embase, APA PsycINFO, CINAHL, and SPORTDiscus were searched through February 2, 2021. Eligible studies included original peer-reviewed publications describing psychosocial factors associated with RTS following a diagnosed concussion. The primary outcome was scales or measures employed and/or key thematic concepts. RESULTS: Of the 3615 studies identified, 10 quantitative cohort studies (Oxford Centre for Evidence-Based Medicine Level-3) representing 2032 athletes (85% male; high-school and collegiate collision/contact athletes) and 4 qualitative studies representing 66 athletes (74% male; 70% American football; aged 9-28 years) were included. We identified 3 overarching themes and 10 outcome measures related to psychosocial factors associated with RTS following concussion: (a) fear (e.g, of recurrent concussion, of RTS, of losing playing status); (b) emotional factors (e.g, depression, anxiety, perceived stress, mental health, disturbance mood); and (c) contextual factors (e.g, social support, pressure, sense of identity). CONCLUSION: Although current medical clearance decisions prioritize physical measures of recovery, evidence suggests diverse psychosocial factors influence RTS following concussion. It remains unclear which psychosocial factors contribute to a successful RTS, including the influence of sex/gender and age. Future studies should evaluate the association of psychological readiness with physical measures of recovery at medical clearance, preinjury level of performance, and risk of recurrent concussion to support RTS clinical decision-making.

Exploring the Factors Involved in Being "Ready" to Return to Sport Following a Concussion.

OBJECTIVE: To explore the factors involved in athletes being ready (or not) to return to sport (RTS) after sport-related concussion (SRC). DESIGN: Qualitative, semistructured interviews.Setting: Videoconference.Participants: Twenty-two sport-injury stakeholders involved in contact and collision sports at various levels of competition (high school, university, professional), including: formerly concussed athletes (n = 4), coaches (n = 5), athletic therapists (n = 5), physiotherapists (n = 4), nurse practitioner (n = 1), and sports medicine physicians (n = 3). INTERVENTIONS: N/A. MAIN OUTCOME MEASURES: We included questions in the interview guide regarding factors participants believed were involved in athletes being ready (or not ready) to RTS after a concussion. RESULTS: Participants described physical (concussion symptoms, return to pre-injury fitness), behavioral (changes in behavior, avoidance, malingering), psychological (individual factors, cognitive appraisals, mental health), and social (isolation, social support, communication, pressure) factors that they believed were involved in athletes being ready to RTS after SRC. CONCLUSIONS: The graduated RTS strategy outlined in the most recent Concussion in Sport Group consensus statement focuses on physical aspects involved in being ready to RTS, which does not address behavioral, psychological, and social factors, which were identified by participants as being related to returning to sport post-SRC. More research is needed to determine whether the additional factors outlined in this study are relevant among larger samples of athletes, coaches, and healthcare professionals.

Sex-Based Differences in Symptoms With Mouthguard Use After Pediatric Sport-Related Concussion.

CONTEXT: Current evidence regarding the protective effect of mouthguard use on symptom severity in children and adolescents who sustain sport-related concussions is insufficient to make clinical recommendations. OBJECTIVE: To compare the association between mouthguard use and symptoms stratified by sex in the first 4 weeks after pediatric sport-related concussion. We hypothesized that mouthguard use would be associated with less severe symptoms. DESIGN: Prospective cohort study. SETTING: Nine Canadian pediatric emergency departments (EDs). PATIENTS OR OTHER PARTICIPANTS: Children aged 5 to 18 years who were assessed within 48 hours of concussions sustained during a collision or contact sport. MAIN OUTCOME MEASURE(S): Injury characteristics were collected using the Acute Concussion Evaluation. The primary outcome measure was symptom score (range = 0-6), measured using age-appropriate versions (5-7, 8-12, or 13-18 years) of the Post-Concussion Symptom Inventory. The independent variable was time postconcussion (initial assessment and 1, 2, and 4 weeks). RESULTS: Of 1019 children (73% male; median [interquartile range] age = 13.43 years [11.01-15.27 years]), 42% wore a mouthguard at the time of injury. No significant group-by-sex-by-time interaction was present for symptoms (\(\def\upalpha{\unicode[Times]{x3B1}}\)\(\def\upbeta{\unicode[Times]{x3B2}}\)\(\def\upgamma{\unicode[Times]{x3B3}}\)\(\def\updelta{\unicode[Times]{x3B4}}\)\(\def\upvarepsilon{\unicode[Times]{x3B5}}\)\(\def\upzeta{\unicode[Times]{x3B6}}\)\(\def\upeta{\unicode[Times]{x3B7}}\)\(\def\uptheta{\unicode[Times]{x3B8}}\)\(\def\upiota{\unicode[Times]{x3B9}}\)\(\def\upkappa{\unicode[Times]{x3BA}}\)\(\def\uplambda{\unicode[Times]{x3BB}}\)\(\def\upmu{\unicode[Times]{x3BC}}\)\(\def\upnu{\unicode[Times]{x3BD}}\)\(\def\upxi{\unicode[Times]{x3BE}}\)\(\def\upomicron{\unicode[Times]{x3BF}}\)\(\def\uppi{\unicode[Times]{x3C0}}\)\(\def\uprho{\unicode[Times]{x3C1}}\)\(\def\upsigma{\unicode[Times]{x3C3}}\)\(\def\uptau{\unicode[Times]{x3C4}}\)\(\def\upupsilon{\unicode[Times]{x3C5}}\)\(\def\upphi{\unicode[Times]{x3C6}}\)\(\def\upchi{\unicode[Times]{x3C7}}\)\(\def\uppsy{\unicode[Times]{x3C8}}\)\(\def\upomega{\unicode[Times]{x3C9}}\)\(\def\bialpha{\boldsymbol{\alpha}}\)\(\def\bibeta{\boldsymbol{\beta}}\)\(\def\bigamma{\boldsymbol{\gamma}}\)\(\def\bidelta{\boldsymbol{\delta}}\)\(\def\bivarepsilon{\boldsymbol{\varepsilon}}\)\(\def\bizeta{\boldsymbol{\zeta}}\)\(\def\bieta{\boldsymbol{\eta}}\)\(\def\bitheta{\boldsymbol{\theta}}\)\(\def\biiota{\boldsymbol{\iota}}\)\(\def\bikappa{\boldsymbol{\kappa}}\)\(\def\bilambda{\boldsymbol{\lambda}}\)\(\def\bimu{\boldsymbol{\mu}}\)\(\def\binu{\boldsymbol{\nu}}\)\(\def\bixi{\boldsymbol{\xi}}\)\(\def\biomicron{\boldsymbol{\micron}}\)\(\def\bipi{\boldsymbol{\pi}}\)\(\def\birho{\boldsymbol{\rho}}\)\(\def\bisigma{\boldsymbol{\sigma}}\)\(\def\bitau{\boldsymbol{\tau}}\)\(\def\biupsilon{\boldsymbol{\upsilon}}\)\(\def\biphi{\boldsymbol{\phi}}\)\(\def\bichi{\boldsymbol{\chi}}\)\(\def\bipsy{\boldsymbol{\psy}}\)\(\def\biomega{\boldsymbol{\omega}}\)\(\def\bupalpha{\bf{\alpha}}\)\(\def\bupbeta{\bf{\beta}}\)\(\def\bupgamma{\bf{\gamma}}\)\(\def\bupdelta{\bf{\delta}}\)\(\def\bupvarepsilon{\bf{\varepsilon}}\)\(\def\bupzeta{\bf{\zeta}}\)\(\def\bupeta{\bf{\eta}}\)\(\def\buptheta{\bf{\theta}}\)\(\def\bupiota{\bf{\iota}}\)\(\def\bupkappa{\bf{\kappa}}\)\(\def\buplambda{\bf{\lambda}}\)\(\def\bupmu{\bf{\mu}}\)\(\def\bupnu{\bf{\nu}}\)\(\def\bupxi{\bf{\xi}}\)\(\def\bupomicron{\bf{\micron}}\)\(\def\buppi{\bf{\pi}}\)\(\def\buprho{\bf{\rho}}\)\(\def\bupsigma{\bf{\sigma}}\)\(\def\buptau{\bf{\tau}}\)\(\def\bupupsilon{\bf{\upsilon}}\)\(\def\bupphi{\bf{\phi}}\)\(\def\bupchi{\bf{\chi}}\)\(\def\buppsy{\bf{\psy}}\)\(\def\bupomega{\bf{\omega}}\)\(\def\bGamma{\bf{\Gamma}}\)\(\def\bDelta{\bf{\Delta}}\)\(\def\bTheta{\bf{\Theta}}\)\(\def\bLambda{\bf{\Lambda}}\)\(\def\bXi{\bf{\Xi}}\)\(\def\bPi{\bf{\Pi}}\)\(\def\bSigma{\bf{\Sigma}}\)\(\def\bPhi{\bf{\Phi}}\)\(\def\bPsi{\bf{\Psi}}\)\(\def\bOmega{\bf{\Omega}}\)\({\rm{\chi }}_3^2\) = 0.27; P = .965). Male mouthguard users reported similar symptom scores in the ED (difference in Post-Concussion Symptom Inventory Δ scores [diff] = -0.07; 95% CI = -0.23, 0.09) and at weeks 1 (diff = -0.02; 95% CI = -0.18, 0.14), 2 (diff = -0.03; 95% CI = -0.19, 0.13), and 4 (diff = -0.13; 95% CI = -0.29, 0.04) compared with males who did not wear a mouthguard. Female mouthguard users described minimally higher symptom scores at week 1 compared with non-mouthguard users (diff = 0.29; 95% CI = 0.01, 0.56). In the ED, symptom scores were not different for females who wore a mouthguard and those who did not (diff = 0.22; 95% CI = -0.04, 0.48) or at weeks 2 (diff = 0.22; 95% CI = -0.06, 0.51) or 4 (diff = 0.08; 95% CI = -0.20, 0.36). CONCLUSIONS: Wearing a mouthguard at the time of injury was not associated with reduced acute or subacute symptoms after sport-related concussion in either males or females who were treated in the ED compared with those who did not wear a mouthguard. Athletes are still encouraged to wear mouthguards during sports because overwhelming evidence supports their use in preventing dental injuries.

What is the risk of recurrent concussion in children and adolescents aged 5-18 years? A systematic review and meta-analysis.

OBJECTIVE: We aimed to examine the risk of concussion in children with a previous history of concussion. DESIGN: Systematic review and meta-analysis. The primary outcome was number of children with and without a previous lifetime history of concussion who sustained a diagnosed concussion within each study period. Risk of bias was assessed using the Newcastle-Ottawa Scale. A random effects model was used to estimate a pooled risk ratio (RR) with corresponding 95% CIs; results were summarised in forest plots. DATA SOURCES: Four electronic databases (MEDLINE, Embase, CINAHL, SPORTDiscus) and selected reference lists were searched (PROSPERO registration No CRD42019135462). ELIGIBILITY CRITERIA: Original English language peer-reviewed publications that compared concussion risk in children aged 5-18 years with and without a previous concussion history in which risk estimates were reported or able to be calculated. RESULTS: Of 732 identified studies, 7 studies representing 23 411 children (risk of bias range, 7-9; maximum possible score=9) were included for meta-analysis. Pooled risk of sustaining a concussion was more than three times greater in children with a previous concussion compared with those with no previous concussion (RR=3.64; 95% CI: 2.68 to 4.96; p<0.0001; I 2=90.55%). Unreported sex-stratified data precluded direct comparison of concussion risk in male versus female athletes. CONCLUSION: Previously concussed children have four times the risk of sustaining a concussion compared with those with no previous concussion history. This should be a consideration for clinicians in return to sport decision-making. Future studies examining subsequent recurrent concussion in youth sports must consider sex differences.

Protocol for the mixed-methods development of a concussion-specific health-related quality of life outcome measure based on the international classification of functioning, disability and health.

INTRODUCTION: Recovery from concussion has traditionally been evaluated by patient-reported symptoms, objective measures such as loss of consciousness, specific dimensions such as depression or fatigue, cognitive status, employment status, level of physical activity and the more complex construct of disability. Increasingly, patient-reported outcome measures of health-related quality of life (HRQOL) are being emphasised as an important end point in patient care, clinical trial and health policy decisions. Currently, no standardised concussion-specific HRQOL outcome measure exists. The process for developing a concussion-specific HRQOL outcome measure based on the international classification of functioning, disability and health is outlined. METHODS AND ANALYSIS: A multistage, patient-centred approach to developing the outcome measure will integrate evidence from systematic reviews, qualitative research and cognitive interviewing into a self-report questionnaire to guide clinical decision-making. The psychometric properties of the questionnaire will be evaluated to assess the inter-rater reliability and construct validity of the measure in individuals with persistent post-concussion symptoms. To date, the systematic review and the clinical expert interviews within the preparatory phase have been completed and work is progressing on the subsequent phases. It is anticipated that the outcome measure will be ready for psychometric testing in September 2018. ETHICS AND DISSEMINATION: Ethical approval was granted by the Ottawa Health Science Network Research Ethics Board (Protocol #20170720-01H) on 31 October 2017 to conduct the patient and clinical expert interviews. Ethical approval for psychometric testing of the outcome measure will be sought by the Ottawa Health Science Network Research Ethics Board in Phase II, after the development of the final HRQOL questionnaire. Results will be disseminated through peer-reviewed journals and professional conferences. PROSPERO REGISTRATION: Phase I systematic review registration number CRD42017075588 (15 June 2017). Phase II systematic review registration number CRD42017075588 (27 September 2017).