Skip to main content
PLOS One logoLink to PLOS One
. 2025 Jan 24;20(1):e0316827. doi: 10.1371/journal.pone.0316827

Physical measures of physical functioning as prognostic factors in predicting outcomes for neck and thoracic pain: Protocol for a systematic review

Rabea Begum 1,*, Alison Rushton 1, Alaa El Chamaa 1, David Walton 1, Paul Parikh 1
Editor: Cho-Hao Howard Lee2
PMCID: PMC11760039  PMID: 39854374

Abstract

Background

Spinal pain is prevalent and burdensome worldwide. A large proportion of patients with neck and thoracic pain experience chronic symptoms, which can significantly impact their physical functioning. Therefore, it is important to understand factors predicting outcome to inform effective examination and treatment. Knowledge of physical measures of physical functioning as prognostic factors can enhance patient-centered care and aid decision-making. The evidence regarding physical outcome measures as prognostic factors for neck and thoracic pain is unclear. The objective of this study is to summarize the evidence for physical outcome measures of physical functioning as prognostic factors in predicting outcomes in people with neck and thoracic pain.

Methods and analysis

This systematic review follows Cochrane guidelines and aligns with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Included studies will be prospective longitudinal cohort studies in which physical measures of physical functioning are explored as prognostic factors for adults with neck and thoracic pain. A comprehensive search will be performed in key databases (MEDLINE, EMBASE, CINAHL, Scopus, and Web of Science) and the grey literature, with hand searches of key journals, and the reference lists of included studies. Two reviewers will independently perform study selection, data extraction, risk of bias assessment (QUIPS, Quality in Prognostic Studies tool), and quality assessment (Grading of Recommendations Assessment, Development, and Evaluation).

Implications

This systematic review will identify physical measures of physical functioning prognostic factors for neck and thoracic pain populations. Findings will inform researchers about gaps in existing evidence, and clinicians about factors to aid their clinical decisions and to enhance the overall quality of care for individuals with neck and thoracic pain.

Introduction

Spinal pain is a significant public health issue with neck pain which is a prevalent musculoskeletal disorder in adults [1] ranking as the fourth most common cause of years lived with disability [2–4]. According to the latest Global Burden of Disease study, neck pain affected 203 million people in 2020, with peak ages between 45–74 years old, and it will affect 270 million people by 2050 [5]. Thoracic pain is less common than neck and low back pain and its 1-year prevalence is about 15% compared with 32% and 43% for neck and low back pain, respectively [6]. Evidence suggests a significant number of people experience neck pain (70%) [7] and thoracic pain (4–77%) at least once during their lifetime [8]. Research investigating thoracic spine is scarce [9]. While many cases of acute neck pain will resolve, current estimates indicate that the majority (50–85%) will recur or become chronic within 5 years [10, 11]. This burden has a substantial impact on physical functioning [12], health-related quality of life (HRQoL) [12–15], activity limitations, and disability [13, 16] and thus imposes a significant personal and socioeconomic burden [2]. Similarly, thoracic pain can be disabling, and it can cause significant disability [17] and similar burdens on the individual’s life [18] though the burden of thoracic pain has not been adequately established [8]. Compared with the neck and low back, the thoracic spine has received less attention, probably owing to the public health burden of thoracic pain being presumed to be less [19]. Thoracic and cervical impairments often co-exist [20], making the thoracic region a critical component of examination, classification, diagnosis, and management of neck pain, as per clinical practice guidelines [21, 22]. Understanding both conditions together is crucial due to the shared anatomical and biomechanical relationship between the neck and thoracic spine. Dysfunction in cervical spine might affect thoracic spine and vice versa. Dysfunction in thoracic spine is considered a potential contributor which necessitates the need to explore the contribution of thoracic region toward dysfunction in cervical spine [23].

The IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) provides a standardized framework for assessing outcomes in pain management and emphasizes that physical functioning is an important independent outcome domain which is also included in the core outcome set (COS) for a meaningful evaluation of pain [24]. For purposes of this protocol, physical functioning is conceptualized as a multidimensional construct that integrates body structures and function, activity and participation capacity, influenced by both personal and social factors, per the international Classification of Functioning, Disability, and Health (ICF) [25]. Measuring limitation of physical functioning is important because it can affect a person’s quality of life, disability, and health care expenses [26].

Measures of physical functioning evaluate diverse aspects of a participant’s life, including the ability to carry out such daily activities as household chores, walking, work, travel, and self-care, as well as strength and endurance [27]. Physical functioning can be assessed through various methods such as patient-reported outcome measures (PROMs) or physical measures (observable, quantifiable) of impairment, performance, or activity [24, 28–30]. PROMs are standardized tools used to evaluate various aspects of perceived or anticipated physical functioning from the patient’s perspective [31]. Impairments are characterized by dysfunction or structural abnormality of a specific body function or structure [32]. Physical measurement of impairments assess structural or functional limitation, such as limited range of motion (ROM) (measured by a goniometer or inclinometer), and diminished grip strength (measured by a dynamometer) [33]. Physical measures of performance measure can be used to quantify physical function in a standardized environment (e.g., hospital, clinical setting). For these measures, a participant is asked to perform a specific task and performance on the task is evaluating to identify limitations in physical functioning, such as the Timed Up and Go (TUG) test [24], and Functional Capacity Evaluation (FCE) [34] which consists of a series of tests (lifting, pushing, pulling, and other tasks). Physical measures can also be used to provide estimates of physical function in real environments typically captured through technologically advanced measurement devices like accelerometer which is widely used to measure sedentary time, physical activity, and sleep-related behaviors [24, 35]. Physical measures of impairment, performance, and physical measures of activity in a real environment provide different insights into the functioning of the body, and when interpreted together can provide integrated insights into physical function beyond what any one measure can provide in isolation [24]. Many healthcare providers globally, including physiotherapists, extensively utilize physical measures in clinical practice. MacDermid and colleagues [36] have performed an international survey investigating outcome measures used by clinicians for evaluation of neck pain. Physical measures were frequently used, with 44% clinicians using ROM, 44% using segmental joint mobility, and more than 56% using neck muscle strength, along with PROMs. Clinicians also routinely assess joint mobility, tissue extensibility and function using ROM [37], mobility, endurance, and strength measures when evaluating people with thoracic pain [38].

There are several systematic reviews [39–44] that have synthesized physical prognostic factors for individuals with neck pain. They investigated a range of physical prognostic factors, including ROM [39–44], joint position error (JPE) [39–41], altered muscle recruitment [40, 41]. However, cervical motor dysfunctions, such as reduced ROM, disturbed cervical kinesthesia, muscle strength/endurance and altered cervical muscle activity have limited predictive value for long-term (6-month, 1 year, 2 year or 3 year) outcomes [39, 40]. These systematic reviews exclusively focus on acute (<6 weeks) whiplash injuries; however, sub-acute (6 to 12 weeks) [22] and chronic (>12 weeks) symptoms [22] were not explored for other types of neck pain (e.g. radicular pain). The majority included studies only in the English language. Only one systematic review included other languages (German, French and Dutch) along with English [42]. Language restrictions in systematic reviews should be avoided due to language bias [45], particularly with recent innovations in online translation. In addition, the overall risk of bias assessment score of these systematic reviews is high according to AMSTAR-2, (A Measurement Tool to Assess Systematic Reviews) [46]. Key measures for high risk of bias assessments include: risk of bias not assessed for included studies [41, 44], grey literature not included [40–44] and level of evidence not assessed [40, 41]. Only one systematic review [39] used a standard approach (GRADE) for level of evidence. No review included evaluation of performance-based, and activity measures in the natural environment. Most of the systematic reviews investigated prognostic factors for acute (< 6 weeks) whiplash condition. Previous systematic reviews focused psychophysical measures, for example cold pain threshold [40, 41, 43, 44] and pressure pain threshold [43, 44] while investigating physical prognostic factors for neck pain. This emphasis highlights a gap of physical functioning. Therefore, there is a considerable knowledge and methodological gap in the existing literature regarding physical functioning measures for predicting outcomes in neck pain.

Regarding thoracic pain, research investigating prognostic factors is lacking. There are only two systematic reviews [8, 47] that have synthesized different factors for thoracic pain. The first systematic review by Briggs and colleagues [8] studied associated risk factors in the general population and they concluded that the majority of studies included were cross-sectional in design which limiting inferences about prognosis for thoracic pain and they recommend including prospective cohort studies for providing evidence more robust evidence for prognostic factors. The second systematic review [47] did not find any studies investigating prognostic factors for thoracic pain [47]. To date there are no systematic reviews that have investigated physical measures of physical functioning as prognostic factors for thoracic pain population and clinicians face challenges in seeking information about prognostic factors for thoracic pain.

Owing to the methodological issues detailed above, and insufficient inclusion of physical measures in systematic reviews of prognostic factors, a gap in existing evidence exists for neck and thoracic pain population. It is therefore important to systematically determine prognostic factors predicting outcomes following neck and thoracic pain.

Objective

To summarize the evidence for physical measures of physical functioning as prognostic factors for predicting outcomes in individuals with neck and thoracic pain.

Methods

Design

This systematic review protocol is reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 statement [48] (S1 File), the Cochrane Back Review Group guidelines [49] and the Cochrane Handbook [50]. This protocol is registered in the International Prospective Register of Systematic Reviews (PROSPERO) to improve transparency, accountability, and prevent duplication [51], registration ID: CRD42024574473.

Eligibility criteria

The PICOS (Population, Intervention/Exposure, Comparator, Outcome and Study design) framework is used to develop the inclusion criteria [52]. The Comparator component is not applicable due to the nature of this review.

Population (P)

Individuals aged 18 and above with neck and thoracic pain for any duration (acute or chronic) will be included. For the purpose of this review, the anatomical boundaries of neck and thoracic pain will be used as reported in the primary studies.

Exposure (E)

Studies will be included if they use any of the physical measures of physical functioning, including impairment-based physical measures (e.g., strength, ROM) [29], performance-based physical measures (e.g., TUG), and activities in the natural environment (e.g., accelerometry) [24].

Outcome (O)

No limitation will be placed on the types of outcomes evaluated. Including all outcomes provides a more comprehensive understanding of the potential prognostic factors. The scoping search has identified the limited number of studies available on this topic, and restricting the outcomes might result in excluding valuable data. The limited number of studies available emphasized the necessity for a wider range of outcomes in our review. Any time point of outcome assessment will be included.

Study design (S)

Only prospective longitudinal cohort studies will be included as they are the preferred design for establishing a clear temporal sequence between exposure and outcome [53].

No limitation on language and publication year will be applied. For non-English studies, open-source software, specifically ChatGPT (Chat Generative Pre-Trained Transformer) will be used to translate the texts, and bilingual individuals will verify the translation and confirm the accuracy. These individuals will have a background of health sciences, allowing them to identify and correct any errors, particularly with medical terminology.

Exclusion criteria

Studies where pain is a result of a space-occupying lesion (e.g., tumors, cysts), any serious neurological disorders (e.g., spinal cord injury, myelopathy), disc infection, inflammatory disorders (e.g., ankylosing spondylitis), fibromyalgia, any metabolic bone diseases (e.g., osteoporosis), deformities (e.g., congenital scoliosis), spinal dislocation or fracture and other studies related to the non-neuromusculoskeletal origin of pain will be excluded from this review.

Information sources

A comprehensive systematic search will be performed in electronic databases from inception to 31st July 2024 using databases: MEDLINE (Ovid), EMBASE (Ovid), CINAHL, Scopus, and Web of Science. Theses and dissertations will be searched using ProQuest Dissertations and Theses Global and conference proceedings/abstracts in Web of Science and Scopus. Manual (or hand) search will be performed in key journals: Spine, European Spine Journal and The Spine Journal. The reference lists of the studies will also be thoroughly screened.

Search strategy

The search strategy was informed by scoping searches. The search strategy has been developed in MEDLINE (Ovid) in collaboration with a library information specialist, Western University. The MEDLINE search comprised medical subject heading (MESH) terms and text words based on PICOS format, for example populations (individuals with neck and thoracic pain), exposures (physical measures of physical functioning) and study design (prospective longitudinal cohort study). Firstly, the alternative MESH terms and keywords added with OR (Boolean operator) for each concept and after that the three concepts combined with AND (Boolean operator) following Cochrane guideline for searching studies [54]. This search will be adapted in other databases with modifying syntax. The search terms mentioned in the previous systematic reviews [55, 56] and scoping search were used for text words. The MEDLINE (Ovid) search is presented in the S2 File.

Data management

For data management, Covidence, a web-based software platform for systematic reviews will be used [57]. Duplication will be automatically identified and removed by the Covidence software.

Study selection process

Two independent reviewers (RB and AE) will perform the eligibility assessment, initial screening of titles and abstracts, and full-text screening according to eligibility criteria. Excluded studies which do not meet the criteria, will be reported with all reasons for exclusion. The two reviewers will meet and discuss in case of any differences in assessment. Any differences between the two reviewers will be resolved by a third reviewer (P.P) who will act as a mediator. Agreement between reviewers will be evaluated with Cohen’s kappa coefficient where values ≤ 0 as indicating no agreement and 0.01–0.20 as none to slight, 0.21–0.40 as fair, 0.41–0.60 as moderate, 0.61–0.80 as substantial, and 0.81–1.00 as almost perfect agreement [58]. The process of study selection will be reported in the PRISMA flow diagram [59] (Fig 1).

Fig 1. PRISMA 2020 flow diagram.

Fig 1

This diagram reflects the study selection process.

Data extraction process

The CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies (CHARMS) will be used to extract data. CHARMS provides a checklist and background explanation for extracting data for prognostic studies [60]. Two reviewers will extract data independently from selected studies. If disagreement, a third reviewer (P.P) will mediate. The corresponding author of the included studies will be contacted in cases of any data missing or unclear data. A reminder email will be sent after 3 weeks. If there are no responses within a further 3 weeks, we will extract available data.

Data items

Data will be extracted from the included studies based on the CHARMS checklist [60] (Table 1).

Table 1. Summary of data to be extracted from included studies.

Characteristics of study Title, Authors, year of publication, study design, country of study, objective(s) of the study, source of funding
Characteristics of participants Age, gender, history of neck and thoracic pain, characteristics of neck and thoracic pain (e.g., duration, distribution of pain), sample size
Physical measures of physical functioning candidate prognostic factors Name, type (e.g., impairment-based measure), equipment required
Outcome measures Name, type (e.g., PROMs or physical measures), equipment required, time points of assessment of outcome (follow up duration)
Results Analysis method, type of statistical measure, main findings

Outcomes and prioritization

Outcomes will be categorized as impairment-based, performance-based, and activities in a natural environment. The outcome data will be extracted into short-term (< 3 months), medium-term (3 months to 12 months), and long-term (>12 months) [61].

Risk of bias (RoB) of individual studies

Two reviewers will use QUIPS to assess RoB according to Cochrane Prognosis Methods Group recommendations [62]. The QUIPS tool is a standard quality assessment method for included studies in a systematic review and it contains 6 domains. 1) Study participation will assess the representativeness of the study sample and the potential for selection bias. Here we will also consider the information provided on the baseline characteristics of study participants to evaluate the risk of selection bias. 2) Study attrition will evaluate the impact of participant loss on results and the completeness of follow-up. We will investigate the reasons for loss to follow-up and aim to maintain an attrition rate of ≤20%. 3) Prognostic factor measurement will examine the reliability and validity of how prognostic factors are measured. 4) Outcome measurement will focus on the clarity and standardization of outcome definitions and assessments. 5) Study confounding will determine if potential confounding factors are appropriately controlled to isolate effects. 6) Statistical analysis, and reporting will evaluate the appropriateness and transparency of the statistical methods used in the analysis [63]. The different domains contain 3 to 7 prompting items to be rated (yes, partial, no, unsure) and each domain will be rated on a three-graded scale as low, moderate, or high RoB [64]. A low risk of bias will indicate that the findings are reliable, with the true result expected to be close to the estimate. Moderate risk will suggest the true result may vary, requiring careful interpretation. High risk will raise concerns that the true result could significantly differ from the estimate, affecting validity [63, 64]. Before starting the review, two independent reviewers (RB, AE) will undergo calibration exercise using a subset of studies to ensure consistent application of the QUIPS tool. They will provide rationales for any discrepancies and engage in structured discussions based on pre-defined criteria, focusing on study design, participant selection, prognostic factors, and outcome assessment. This process will ensure a consistent, reliable risk of bias assessment and support well-informed decisions. Any disagreements will be discussed between two independent reviewers and if a consensus is not reached, a third reviewer (PP) will mediate. The level of agreement will be evaluated by using Cohen’s kappa coefficient [58].

Data synthesis

The synthesis of data for each prognostic factor will be conducted using either a meta-analysis (quantitative synthesis), such as pooling data through meta-analysis, or a narrative approach (qualitative synthesis), by providing a narrative summary of the findings.

Assessment of heterogeneity

The decision to perform a quantitative synthesis will be based on the assessment of heterogeneity (e.g., clinical heterogeneity, methodological heterogeneity, and statistical heterogeneity) in included studies. The variability in the participants, outcomes, outcome measures, follow-up duration, and prognostic factors will be measured by clinical heterogeneity, the variability in RoB will be assessed as methodological heterogeneity, and statistical heterogeneity will be the differences in the effects of prognostic factors and outcomes due to clinical and methodological differences [65, 66]. The I2 statistic and Cochrane Q test. The Chi2 statistic will be used to test and quantify statistical heterogeneity. The Chi2 test will assess the differences in results across studies, and a low p-value (p<0.05) will suggest a significant heterogeneity. The I2 statistic will calculate the proportion of total variation due to heterogeneity than due to chance. The I2 value ranges from 0–100% and it can be interpreted as 0%-40%: might not be important, 30%-60%: moderate heterogeneity, 50%-90%: substantial heterogeneity, and 75%-100%: considerable heterogeneity [67].

Meta-analysis or quantitative synthesis

If studies are sufficiently homogenous in terms of physical measures of physical functioning prognostic factors or outcomes, a meta-analysis will be performed [67, 68]. The summary measures will depend on the nature of the outcomes. For dichotomous outcomes, risk ratios (RR) or odds ratios (OR) will be calculated. For continuous outcomes, mean differences (MD) or standardized mean differences [69] will be used. A random effect model with 95% confidence intervals (CI) will be performed to estimate the effect across studies. A forest plot will be used to display an overall estimate of the effect [70, 71]. The initial scoping search suggested substantial clinical heterogeneity across existing studies, indicating considerable differences in prognostic factors, or outcomes. This variability limits the feasibility of conducting a meaningful subgroup analysis. The limited number of studies identified in the initial search will also constrain sensitivity analysis in the meta-analysis plan, particularly regarding exploring the influence of our judgment on ROB [72]. The influence of high RoB studies will be carefully considered, and they may be given less weight in the synthesis. Their potential impact on the results will be acknowledged, and they will be considered when assessing the overall quality of evidence in the GRADE evaluation. All statistical analyses will be conducted using R statistical software [73].

Narrative analysis or qualitative synthesis

In the situation of a meta-analysis not being possible (due to methodological and clinical heterogeneity), a systematic narrative or qualitative synthesis will be conducted to summarize findings [68, 74]. We will follow three major steps except the first one (developing a theory of how the intervention works, why and for whom) due to nature of this review. Step 1: the preliminary synthesis of the findings will be conducted by summarizing and organizing of included studies according to populations categories, outcomes, potential physical measures of physical functioning candidate prognostic factors. Step 2: the strength of association of different outcomes based on the point of outcome assessment will be explored to find out the relationships in the data within and between studies. Step 3: to explain differences between and within studies, variability of outcomes, populations, and physical measures will be investigated. We will use the GRADE approach to provide a systematic method to assess the certainty in evidence and a transparent documentation of body of evidence [75]. The narrative synthesis will present text and tables to organize and discuss the data and methodological aspects of the included studies.

Dealing with missing data. We will handle missing data in this stage by attempting to calculate missing statistics manually, where feasible. For example, if a study reports standard errors (SE) without reporting standard deviations (SD), we will estimate the missing standard deviations using the relationship between standard errors and standard deviations (SD=SE+n, where n is the sample size). If manual calculation is not possible, we will follow appropriate statistical methods outlined in the Cochrane Handbook, such as imputation method [76]. In a narrative synthesis, the impact of missing data will be addressed by discussing the impact of missing data on the overall findings which will ensure transparency and reliability of the findings.

Meta-bias(es)

If any protocols are found during our searches, reporting bias will be evaluated by examining the consistency of study protocols and published results.

Confidence in cumulative evidence

Two independent reviewers will use the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach [77] to assess the quality of evidence of included studies. It will be categorized into five domains: risk of bias, inconsistency, indirectness, imprecision, and publication bias [78]. The quality evidence can be upgraded or downgraded [79]. The QUIPS tool will be for risk of bias and rated as having no serious limitation, serious limitation and very serious limitation [80]. The evidence will be downgraded if many studies have high risk of bias. Then, to assess the consistency of different prognostic factors across included studies, I2 value will be used to quantify heterogeneity. It will be downgraded in case of significant unexplained heterogeneity. After that, the evidence will ensure the physical functioning measures and outcomes they predict are directly relevant and it will be downgraded if studies use different populations, outcomes that are not directly applicable. Additionally, the evidence will be considered imprecise if confidence intervals are wide or sample sizes are small, and it will be downgraded if there is high uncertainty around effect estimates. Finally, funnel plots will be used to detect publication bias if possible. It will downgrade the evidence if there is evidence of publication or selective reporting bias [79]. The GRADE approach will specify evidence into four levels of certainty consist of 1) high: very confident that true effect lies close to the estimate of the effect, 2) moderate: moderately confident in the effect estimate, 3) low: confidence in the effect estimate is limited, and 4) very low: very limited confidence in the effect estimate [78]. In three situations, the confidence might increase (rating up)-large effect, dose-response gradient or plausible confounding. The large effect will provide significant differences in outcomes between groups exposed to different prognostic factors, indicating that the observed association is unlikely to be due to bias or confounding factors. A dose-response relationship can occur when changes in exposure, such as muscle strength links to changes in the likelihood of an outcome. The domain plausible confounding will be described the effect of the confounding factor on the estimate [79]. For example, if several high-quality included studies will show a specific physical measure (e.g., ROM) is a strong predictor of neck pain outcomes, with a large effect size (relative risk or RR >2 or <0.5), it could be justified as rating the evidence up. If the included studies show that greater ROM is associated with better neck or thoracic outcomes consistently across multiple studies, it will be considered as the rating up. Finally, if well-designed studies will account for confounding outcome variables (e.g., other health conditions or comorbidities) and find a strong association between physical measures and neck or thoracic pain outcomes and the observed effect will not be due to these confounding factors, in that case, it will suggest the effect is robust and rate the evidence up. Two reviewers will try to solve any disagreements through discussion. A third reviewer will resolve if a consensus cannot be reached. Detailed information and certainty of the evidence will be reported in the ‘Summary of findings’ tables [79].

Ethics and dissemination

Ethics approval is not required due to the nature of the study design and there will be no direct contact with patients. The results of this review will be disseminated through publication in a peer-reviewed journal.

Patient and public involvement

This protocol has been discussed with the spinal pain research Patient Partner Advisory Group in the School of Physical Therapy at Western University. Key feedback included 1) the proposed review protocol was very clear, 2) the advisory group expressed their lived experiences with neck and thoracic pain, and they highlighted the importance of using physical measures alongside patient-reported outcome measures and 3) lastly, their feedback also guided the selection of a broader range of outcomes. Specifically, their feedback emphasized the need to include not only clinical outcomes (e.g., pain, disability) but also those that reflect day-to-day functioning and quality of life, which are highly relevant to individuals living with neck and thoracic pain. The feedback ensured that it would be understandable and usable for both researchers and patients. The Patient Partner Advisory Group did not suggest any modifications to the physical measures which supports the review’s approach.

Discussion

Neck and thoracic spinal pain are prevalent musculoskeletal disorders that can have significant personal and social burdens. People experiencing spinal pain report some consequences on physical functioning, for example- reduced daily activities that can result in substantial costs to society [81]. This pain also affects individuals’ quality of life [47] which is very closely linked to physical functioning. Therefore, physical measures of physical functioning is important to predict outcomes for neck and thoracic populations. The use of physical measures of physical functioning is increasing [36] and these measures are also used in clinical practice guidelines [21, 82].

However, the systematic review on physical measures of physical functioning as candidate prognostic factors for predicting outcomes for neck and thoracic pain is insufficient. Predicting outcomes is crucial for both physicians and patients. Prognostic factor research is a fundamental step in developing accurate prognostic models for that purpose [83]. It is expected that the results of the systematic review would have several benefits. First, this review will address important gaps in the literature by providing a comprehensive overview of physical prognostic factors. Second, by including both conditions in this review, it will allow for a more comprehensive analysis of common and distinct prognostic factors, ultimately offering a more comprehensive understanding of the prognostic factors that impact outcomes in individuals with neck and thoracic pain. Third, this prognostic review can enable early identification of patients at risk for poor outcomes and it can play a vital role in policy and clinical decision-making [84] to improve overall quality of patient care. For example, knowledge of prognostic factors can aid in the implementation of personalized treatment for individuals with neck and thoracic pain who are less likely to respond to any specific treatment [85] that can enhance mobility and functionality, enabling patients to perform daily activities with greater ease, leading to a more active and fulfilling life. Fourth, this systematic review will also provide the best evidence for clinicians and researchers to identify the best physical outcome measures of physical functioning as prognostic factors for neck and thoracic populations. Consequently, it will lower the healthcare cost for patients [86]. Furthermore, providing better understanding of prognostic factors, patients would be aware about their condition which can help them to manage their recovery expectations [53]. These benefits can lead to better prediction models and more personalized treatment plans for patients suffering from neck and thoracic pain that can lead to faster recovery, better pain management, and an overall improvement in health-related quality of life [87]. However, the certainty of the evidence of this systematic review may be limited by the limited number of studies available and the possible low quality of the individual studies.

Supporting information

S1 File. PRISMA-P 2015 checklist.

This file shows the completed PRISMA-P 2015 checklist.

(DOCX)

pone.0316827.s001.docx (27.7KB, docx)
S2 File. MEDLINE (Ovid) search strategy.

This file shows MEDLINE search strategy.

(DOCX)

pone.0316827.s002.docx (18.4KB, docx)

Acknowledgments

Librarian, Western Libraries, Western University, London, Ontario, Canada.

Participants of the Patient Partner Advisory Group (PPAG), Spinal Pain Research in the School of Physical Therapy at Western University.

Data Availability

The research data will be made publicly available when the study is completed and published.

Funding Statement

The author(s) received no specific funding for this work.

References

  • 1.de Luca K, Tavares P, Yang H, Hurwitz EL, Green BN, Dale H, et al. Spinal Pain, Chronic Health Conditions and Health Behaviors: Data from the 2016–2018 National Health Interview Survey. International Journal of Environmental Research and Public Health. 2023;20(7):5369. doi: 10.3390/ijerph20075369 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 2.Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. Bmj. 2017;358. doi: 10.1136/bmj.j3221 [DOI] [PubMed] [Google Scholar]
  • 3.Murray CJ, Atkinson C, Bhalla K, Birbeck G, Burstein R, Chou D, et al. The state of US health, 1990–2010: burden of diseases, injuries, and risk factors. JAMA. 2013;310(6):591–608. doi: 10.1001/jama.2013.13805 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 4.Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. The Lancet. 2012;380(9859):2163–96. doi: 10.1016/S0140-6736(12)61729-2 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 5.Wu A-M, Cross M, Elliott JM, Culbreth GT, Haile LM, Steinmetz JD, et al. Global, regional, and national burden of neck pain, 1990–2020, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. The Lancet Rheumatology. 2024;6(3):e142–e55. doi: 10.1016/S2665-9913(23)00321-1 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 6.Leboeuf-Yde C, Nielsen J, Kyvik KO, Fejer R, Hartvigsen J. Pain in the lumbar, thoracic or cervical regions: do age and gender matter? A population-based study of 34,902 Danish twins 20–71 years of age. BMC Musculoskeletal Disorders. 2009;10(1):39. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 7.Côté P, Cassidy JD, Carroll L. The Saskatchewan health and back pain survey: the prevalence of neck pain and related disability in Saskatchewan adults. Spine. 1998;23(15):1689–98. [DOI] [PubMed] [Google Scholar]
  • 8.Briggs AM, Smith AJ, Straker LM, Bragge P. Thoracic spine pain in the general population: prevalence, incidence and associated factors in children, adolescents and adults. A systematic review. BMC musculoskeletal disorders. 2009;10:1–12. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 9.Heneghan NR, Rushton A. Understanding why the thoracic region is the ‘Cinderella’ region of the spine. Manual Therapy. 2016;21:274–6. [DOI] [PubMed] [Google Scholar]
  • 10.Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, et al. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskeletal Disorders. 2022;23(1). doi: 10.1186/s12891-021-04957-4 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 11.Safiri S, Kolahi A-A, Hoy D, Buchbinder R, Mansournia MA, Bettampadi D, et al. Global, regional, and national burden of neck pain in the general population, 1990–2017: systematic analysis of the Global Burden of Disease Study 2017. BMJ. 2020:m791. doi: 10.1136/bmj.m791 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 12.Aafreen A, Khan AR, Khan A, Ahmad A, Alzahrani AH, Alhusayni AI, et al. Neck Health metrics and quality of life: a comparative study in bike drivers with and without neck pain. Journal of Multidisciplinary Healthcare. 2023:3575–84. doi: 10.2147/JMDH.S437826 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 13.Hey HWD, Lim JXY, Ong JZ, Luo N. Epidemiology of neck pain and its impact on quality-of-life—a population-based, cross sectional study in Singapore. Spine. 2021;46(22):1572–80. doi: 10.1097/BRS.0000000000004071 [DOI] [PubMed] [Google Scholar]
  • 14.Nolet PS, Côté P, Kristman VL, Rezai M, Carroll LJ, Cassidy JD. Is neck pain associated with worse health-related quality of life 6 months later? A population-based cohort study. The Spine Journal. 2015;15(4):675–84. doi: 10.1016/j.spinee.2014.12.009 [DOI] [PubMed] [Google Scholar]
  • 15.Rezai M, Côté P, Cassidy JD, Carroll L. The association between prevalent neck pain and health-related quality of life: a cross-sectional analysis. European Spine Journal. 2009;18(3):371–81. doi: 10.1007/s00586-008-0823-6 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 16.Hogg-Johnson S, van der Velde G, Carroll LJ, Holm LW, Cassidy JD, Guzman J, et al. The burden and determinants of neck pain in the general population: results of the Bone and Joint Decade 2000–2010 Task Force on Neck Pain and Its Associated Disorders. Spine. 2008;33(4S):S39–S51. doi: 10.1097/BRS.0b013e31816454c8 [DOI] [PubMed] [Google Scholar]
  • 17.Kjaer P, Wedderkopp N, Korsholm L, Leboeuf-Yde C. Prevalence and tracking of back pain from childhood to adolescence. BMC Musculoskeletal Disorders. 2011;12(1):98. doi: 10.1186/1471-2474-12-98 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 18.Briggs AM, Bragge P, Smith AJ, Govil D, Straker LM. Prevalence and Associated Factors for Thoracic Spine Pain in the Adult Working Population: A Literature Review. Journal of Occupational Health. 2009;51(3):177–92. doi: 10.1539/joh.k8007 [DOI] [PubMed] [Google Scholar]
  • 19.Briggs AM, Straker LM. Thoracic spine pain in youth: should we be concerned? The Spine Journal. 2009;9(4):338–9. doi: 10.1016/j.spinee.2008.11.013 [DOI] [PubMed] [Google Scholar]
  • 20.Quek J, Pua Y-H, Clark RA, Bryant AL. Effects of thoracic kyphosis and forward head posture on cervical range of motion in older adults. Manual therapy. 2013;18(1):65–71. doi: 10.1016/j.math.2012.07.005 [DOI] [PubMed] [Google Scholar]
  • 21.Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, et al. Neck Pain. Journal of Orthopaedic & Sports Physical Therapy. 2008;38(9):A1–A34. [DOI] [PubMed] [Google Scholar]
  • 22.Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, et al. Clinical practice guidelines linked to the international classification of functioning, disability and health from the orthopaedic section of the American physical therapy association. Journal of Orthopaedic and Sports Physical Therapy. 2017;47(7):A1–A83. [DOI] [PubMed] [Google Scholar]
  • 23.Joshi S, Balthillaya G, Neelapala YVR. Thoracic Posture and Mobility in Mechanical Neck Pain Population: A Review of the Literature. Asian spine j. 2019;13(5):849–60. doi: 10.31616/asj.2018.0302 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 24.Taylor AM, Phillips K, Patel KV, Turk DC, Dworkin RH, Beaton D, et al. Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations. PAIN. 2016;157(9):1836–50. doi: 10.1097/j.pain.0000000000000577 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 25.Organization WH. Towards a common language for functioning, and health: ICF. The international classification of functioning, disability and health. 2002. [Google Scholar]
  • 26.Tomey KM, Sowers MR. Assessment of Physical Functioning: A Conceptual Model Encompassing Environmental Factors and Individual Compensation Strategies. Physical Therapy. 2009;89(7):705–14. doi: 10.2522/ptj.20080213 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 27.Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB, et al. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain. 2003;106(3):337–45. doi: 10.1016/j.pain.2003.08.001 [DOI] [PubMed] [Google Scholar]
  • 28.Alamrani S, Rushton A, Gardner A, Falla D, Heneghan NR. Outcome measures evaluating physical functioning and their measurement properties in adolescent idiopathic scoliosis: a protocol for a systematic review. BMJ Open. 2020;10(4):e034286. doi: 10.1136/bmjopen-2019-034286 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 29.Reiman MP, Manske RC. The assessment of function: How is it measured? A clinical perspective. Journal of Manual & Manipulative Therapy. 2011;19(2):91–9. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 30.Bean JF, Ölveczky DD, Kiely DK, Larose SI, Jette AM. Performance-Based Versus Patient-Reported Physical Function: What Are the Underlying Predictors? Physical Therapy. 2011;91(12):1804–11. doi: 10.2522/ptj.20100417 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 31.Weldring T, Smith SMS. Article Commentary: Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Services Insights. 2013;6:HSI.S11093. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 32.Verbrugge LM, Jette AM. The disablement process. Social science & medicine. 1994;38(1):1–14. doi: 10.1016/0277-9536(94)90294-1 [DOI] [PubMed] [Google Scholar]
  • 33.Hefford C, Abbott JH, Baxter GD, Arnold R. Outcome measurement in clinical practice: practical and theoretical issues for health related quality of life (HRQOL) questionnaires. Physical Therapy Reviews. 2011;16(3):155–67. [Google Scholar]
  • 34.Reneman M, Roelofs M, Preuper HS. Reliability and agreement of neck functional capacity evaluation tests in patients with chronic multifactorial neck pain. Archives of Physical Medicine and Rehabilitation. 2017;98(7):1476–9. doi: 10.1016/j.apmr.2016.12.005 [DOI] [PubMed] [Google Scholar]
  • 35.Migueles JH, Cadenas-Sanchez C, Ekelund U, Delisle Nyström C, Mora-Gonzalez J, Löf M, et al. Accelerometer Data Collection and Processing Criteria to Assess Physical Activity and Other Outcomes: A Systematic Review and Practical Considerations. Sports Medicine. 2017;47(9):1821–45. doi: 10.1007/s40279-017-0716-0 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 36.Macdermid JC. Use of Outcome Measures in Managing Neck Pain: An International Multidisciplinary Survey. The Open Orthopaedics Journal. 2013;7(1):506–20. doi: 10.2174/1874325001307010506 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 37.Gavin D. The effect of joint manipulation techniques on active range of motion in the mid-thoracic spine of asymptomatic subjects. Journal of Manual & Manipulative Therapy. 1999;7(3):114–22. [Google Scholar]
  • 38.Wirth B, Potthoff T, Rosser S, Humphreys BK, de Bruin ED. Physical risk factors for adolescent neck and mid back pain: a systematic review. Chiropractic & manual therapies. 2018;26:1–10. doi: 10.1186/s12998-018-0206-y [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 39.Alalawi A, Mazaheri M, Gallina A, Luque-Suarez A, Sterling M, Falla D. Are measures of physical function of the neck region associated with poor prognosis following a whiplash trauma?: A systematic review. The Clinical journal of pain. 2022;38(3):208–21. [DOI] [PubMed] [Google Scholar]
  • 40.Daenen L, Nijs J, Raadsen B, Roussel N, Cras P, Dankaerts W. Cervical motor dysfunction and its predictive value for long-term recovery in patients with acute whiplash-associated disorders: a systematic review. Journal of rehabilitation medicine-Basingstoke. 2013;45(2):113–22. doi: 10.2340/16501977-1091 [DOI] [PubMed] [Google Scholar]
  • 41.Kamper SJ, Rebbeck TJ, Maher CG, McAuley JH, Sterling M. Course and prognostic factors of whiplash: a systematic review and meta-analysis. Pain. 2008;138(3):617–29. doi: 10.1016/j.pain.2008.02.019 [DOI] [PubMed] [Google Scholar]
  • 42.Scholten-Peeters GG, Verhagen AP, Bekkering GE, van der Windt DA, Barnsley L, Oostendorp RA, et al. Prognostic factors of whiplash-associated disorders: a systematic review of prospective cohort studies. Pain. 2003;104(1–2):303–22. doi: 10.1016/s0304-3959(03)00050-2 [DOI] [PubMed] [Google Scholar]
  • 43.Shearer HM, Carroll LJ, Côté P, Randhawa K, Southerst D, Varatharajan S, et al. The course and factors associated with recovery of whiplash-associated disorders: an updated systematic review by the Ontario protocol for traffic injury management (OPTIMa) collaboration. European Journal of Physiotherapy. 2021;23(5):279–94. [Google Scholar]
  • 44.Williams M, Williamson E, Gates S, Lamb S, Cooke M. A systematic literature review of physical prognostic factors for the development of Late Whiplash Syndrome. Spine. 2007;32(25):E764–E80. doi: 10.1097/BRS.0b013e31815b6565 [DOI] [PubMed] [Google Scholar]
  • 45.Pieper D. Language restrictions in systematic reviews should not be imposed in the search strategy but in the eligibility criteria if necessary. Journal of clinical epidemiology. 2021;132:146. doi: 10.1016/j.jclinepi.2020.12.027 [DOI] [PubMed] [Google Scholar]
  • 46.Shea BJ, Reeves BC, Wells G, Thuku M, Hamel C, Moran J, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. BMJ. 2017:j4008. doi: 10.1136/bmj.j4008 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 47.Johansson MS, Jensen Stochkendahl M, Hartvigsen J, Boyle E, Cassidy JD. Incidence and prognosis of mid‐back pain in the general population: A systematic review. European Journal of Pain. 2017;21(1):20–8. doi: 10.1002/ejp.884 [DOI] [PubMed] [Google Scholar]
  • 48.Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4(1):1–9. doi: 10.1186/2046-4053-4-1 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 49.Furlan AD, Pennick V, Bombardier C, van Tulder M. 2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine. 2009;34(18):1929–41. doi: 10.1097/BRS.0b013e3181b1c99f [DOI] [PubMed] [Google Scholar]
  • 50.Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al. Cochrane Handbook for Systematic Reviews of Interventions version 6.5 (updated August 2024). Cochrane, 2024. Available from: www.training.cochrane.org/handbook. [Google Scholar]
  • 51.Schiavo JH. PROSPERO: An international register of systematic review protocols. Medical reference services quarterly. 2019;38(2):171–80. doi: 10.1080/02763869.2019.1588072 [DOI] [PubMed] [Google Scholar]
  • 52.Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group* t. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Annals of internal medicine. 2009;151(4):264–9. doi: 10.7326/0003-4819-151-4-200908180-00135 [DOI] [PubMed] [Google Scholar]
  • 53.Kent P, Cancelliere C, Boyle E, Cassidy JD, Kongsted A. A conceptual framework for prognostic research. BMC Medical Research Methodology. 2020;20(1). doi: 10.1186/s12874-020-01050-7 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 54.Lefebvre C GJ, Briscoe S, Featherstone R, Littlewood A, Metzendorf M-I, Noel-Storr A, et al. Chapter 4: Searching for and selecting studies [last updated September 2024]. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.5. Cochrane, 2024. Available from: www.training.cochrane.org/handbook. [Google Scholar]
  • 55.Kowalski KL, Lukacs MJ, Mistry J, Goodman M, Rushton AB. Physical functioning outcome measures in the lumbar spinal surgery population and measurement properties of the physical outcome measures: protocol for a systematic review. BMJ Open. 2022;12(6):e060950. doi: 10.1136/bmjopen-2022-060950 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 56.Rashed R, Kowalski K, Walton D, Niazigharemakhe A, Rushton A. Physical measures of physical functioning as prognostic factors to predict outcomes in low back pain: Protocol for a systematic review. PLOS ONE. 2023;18(12):e0295761. doi: 10.1371/journal.pone.0295761 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 57.Babineau J. Product review: Covidence (systematic review software). Journal of the Canadian Health Libraries Association/Journal de l’Association des bibliothèques de la santé du Canada. 2014;35(2):68–71. [Google Scholar]
  • 58.Cohen J. A coefficient of agreement for nominal scales. Educational and psychological measurement. 1960;20(1):37–46. [Google Scholar]
  • 59.Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021:n71. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 60.Moons KGM, De Groot JAH, Bouwmeester W, Vergouwe Y, Mallett S, Altman DG, et al. Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies: The CHARMS Checklist. PLoS Medicine. 2014;11(10):e1001744. doi: 10.1371/journal.pmed.1001744 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 61.Bohman T, Bottai M, Björklund M. Predictive models for short-term and long-term improvement in women under physiotherapy for chronic disabling neck pain: a longitudinal cohort study. BMJ open. 2019;9(4):e024557. doi: 10.1136/bmjopen-2018-024557 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 62.Hayden JA, van der Windt DA, Cartwright JL, Côté P, Bombardier C. Assessing bias in studies of prognostic factors. Annals of internal medicine. 2013;158(4):280–6. doi: 10.7326/0003-4819-158-4-201302190-00009 [DOI] [PubMed] [Google Scholar]
  • 63.Hayden JA, Côté P, Bombardier C. Evaluation of the quality of prognosis studies in systematic reviews. Annals of internal medicine. 2006;144(6):427–37. doi: 10.7326/0003-4819-144-6-200603210-00010 [DOI] [PubMed] [Google Scholar]
  • 64.Grooten WJA, Tseli E, Äng BO, Boersma K, Stålnacke B-M, Gerdle B, et al. Elaborating on the assessment of the risk of bias in prognostic studies in pain rehabilitation using QUIPS—aspects of interrater agreement. Diagnostic and Prognostic Research. 2019;3(1). [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 65.Gagnier JJ, Moher D, Boon H, Beyene J, Bombardier C. Investigating clinical heterogeneity in systematic reviews: a methodologic review of guidance in the literature. BMC medical research methodology. 2012;12:1–15. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 66.Higgins JPT GSe. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]: The Cochrane Collaboration, 2011. [Google Scholar]
  • 67.Deeks JJ HJ, Altman DG (editors). Chapter 10: Analysing data and undertaking meta-analyses. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane; 2023. Available from: www.training.cochrane.org/handbook. [Google Scholar]
  • 68.Glisic M, Raguindin PF, Gemperli A, Taneri PE, Salvador D Jr, Voortman T, et al. A 7-Step Guideline for Qualitative Synthesis and Meta-Analysis of Observational Studies in Health Sciences. Public health reviews. 2023;44:1605454. doi: 10.3389/phrs.2023.1605454 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 69.Ayres Pereira Harry Leite MIB, Alves SAF, Reinas RPV, Rodrigues MG, Garrido A, da Cunha OP, et al. Sudden Onset of Severe Cervical Pain in an Adolescent Girl: Case Report and Review of Literature. Pediatr Emerg Care. 2019;35(12):e248–e51. doi: 10.1097/PEC.0000000000001437 [DOI] [PubMed] [Google Scholar]
  • 70.Deeks JJ HJ, Altman DG (editors). Chapter 10: Analysing data and undertaking meta-analyses. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions. Cochrane, 2023. [Google Scholar]
  • 71.Dettori JR, Norvell DC, Chapman JR. Seeing the forest by looking at the trees: how to interpret a meta-analysis forest plot. Global spine journal. 2021;11(4):614–6. doi: 10.1177/21925682211003889 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 72.Katikireddi SV, Egan M, Petticrew M. How do systematic reviews incorporate risk of bias assessments into the synthesis of evidence? A methodological study. Journal of Epidemiology and Community Health. 2015;69(2):189–95. doi: 10.1136/jech-2014-204711 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 73.Balduzzi S, Rücker G, Schwarzer G. How to perform a meta-analysis with R: a practical tutorial. Evidence Based Mental Health. 2019;22(4):153–60. doi: 10.1136/ebmental-2019-300117 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 74.Ryan R. Cochrane Consumers and Communication Review Group: data synthesis and analysis. Cochrane Consumers and Communication Review Group. 2013;2013:216–20. [DOI] [PubMed] [Google Scholar]
  • 75.Murad MH, Mustafa RA, Schünemann HJ, Sultan S, Santesso N. Rating the certainty in evidence in the absence of a single estimate of effect. BMJ Evidence-Based Medicine. 2017. doi: 10.1136/ebmed-2017-110668 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 76.Higgins JPT LT, Deeks JJ (editors). Chapter 6: Choosing effect measures and computing estimates of effect [last updated August 2023]. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.5 Cochrane, 2024. Available from: www.training.cochrane.org/handbook. [Google Scholar]
  • 77.Guyatt GH, Oxman AD, Schünemann HJ, Tugwell P, Knottnerus A. GRADE guidelines: A new series of articles in the Journal of Clinical Epidemiology. Journal of Clinical Epidemiology. 2011;64(4):380–2. doi: 10.1016/j.jclinepi.2010.09.011 [DOI] [PubMed] [Google Scholar]
  • 78.Balshem H, Helfand M, Schünemann HJ, Oxman AD, Kunz R, Brozek J, et al. GRADE guidelines: 3. Rating the quality of evidence. Journal of Clinical Epidemiology. 2011;64(4):401–6. doi: 10.1016/j.jclinepi.2010.07.015 [DOI] [PubMed] [Google Scholar]
  • 79.Schünemann HJ HJ, Vist GE, Glasziou P, Akl EA, Skoetz N, Guyatt GH. Chapter 14: Completing ‘Summary of findings’ tables and grading the certainty of the evidence [last updated August 2023]. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.5. Cochrane, 2024. Available from: www.training.cochrane.org/handbook. [Google Scholar]
  • 80.Guyatt GH, Oxman AD, Vist G, Kunz R, Brozek J, Alonso-Coello P, et al. GRADE guidelines: 4. Rating the quality of evidence—study limitations (risk of bias). Journal of Clinical Epidemiology. 2011;64(4):407–15. doi: 10.1016/j.jclinepi.2010.07.017 [DOI] [PubMed] [Google Scholar]
  • 81.Leboeuf-Yde C, Fejer R, Nielsen J, Kyvik KO, Hartvigsen J. Consequences of spinal pain: do age and gender matter? A Danish cross-sectional population-based study of 34,902 individuals 20–71 years of age. BMC musculoskeletal disorders. 2011;12:1–13. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 82.Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, et al. Neck Pain: Revision 2017. Journal of Orthopaedic & Sports Physical Therapy. 2017;47(7):A1–A83. doi: 10.2519/jospt.2017.0302 [DOI] [PubMed] [Google Scholar]
  • 83.Steyerberg EW, Moons KGM, Van Der Windt DA, Hayden JA, Perel P, Schroter S, et al. Prognosis Research Strategy (PROGRESS) 3: Prognostic Model Research. PLoS Medicine. 2013;10(2):e1001381. doi: 10.1371/journal.pmed.1001381 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 84.Chorti AG, Chortis AG, Strimpakos N, McCarthy CJ, Lamb SE. The prognostic value of symptom responses in the conservative management of spinal pain: a systematic review. Spine. 2009;34(24):2686–99. doi: 10.1097/BRS.0b013e3181b43a41 [DOI] [PubMed] [Google Scholar]
  • 85.Weigl M, Letzel J, Angst F. Prognostic factors for the improvement of pain and disability following multidisciplinary rehabilitation in patients with chronic neck pain. BMC musculoskeletal disorders. 2021;22:1–11. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 86.Killingmo RM, Tveter AT, Pripp AH, Tingulstad A, Maas E, Rysstad T, et al. Modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders: findings from an occupational cohort study. BMJ Open. 2024;14(3):e080567. doi: 10.1136/bmjopen-2023-080567 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 87.Tousignant-Laflamme Y, Houle C, Cook C, Naye F, Leblanc A, Décary S. Mastering Prognostic Tools: An Opportunity to Enhance Personalized Care and to Optimize Clinical Outcomes in Physical Therapy. Physical Therapy. 2022;102(5). doi: 10.1093/ptj/pzac023 [DOI] [PMC free article] [PubMed] [Google Scholar]

Decision Letter 0

Cho-Hao Howard Lee

29 Sep 2024

PONE-D-24-34920Physical measures of physical functioning as prognostic factors in predicting outcomes for neck and thoracic pain: protocol for a systematic reviewPLOS ONE

Dear Dr. Begum, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by Nov 13 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

  • A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.

  • A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.

  • An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Cho-Hao Howard Lee, M.D.

Academic Editor

PLOS ONE

Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Please include a separate caption for each figure in your manuscript. 3. Please include your tables as part of your main manuscript and remove the individual files. Please note that supplementary tables (should remain/ be uploaded) as separate ""supporting information"" files 4. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. 5. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. 6. As required by our policy on Data Availability, please ensure your manuscript or supplementary information includes the following:  A numbered table of all studies identified in the literature search, including those that were excluded from the analyses.   For every excluded study, the table should list the reason(s) for exclusion.   If any of the included studies are unpublished, include a link (URL) to the primary source or detailed information about how the content can be accessed.  A table of all data extracted from the primary research sources for the systematic review and/or meta-analysis. The table must include the following information for each study:  Name of data extractors and date of data extraction  Confirmation that the study was eligible to be included in the review.   All data extracted from each study for the reported systematic review and/or meta-analysis that would be needed to replicate your analyses.  If data or supporting information were obtained from another source (e.g. correspondence with the author of the original research article), please provide the source of data and dates on which the data/information were obtained by your research group.  If applicable for your analysis, a table showing the completed risk of bias and quality/certainty assessments for each study or outcome.  Please ensure this is provided for each domain or parameter assessed. For example, if you used the Cochrane risk-of-bias tool for randomized trials, provide answers to each of the signalling questions for each study. If you used GRADE to assess certainty of evidence, provide judgements about each of the quality of evidence factor. This should be provided for each outcome.   An explanation of how missing data were handled.  This information can be included in the main text, supplementary information, or relevant data repository. Please note that providing these underlying data is a requirement for publication in this journal, and if these data are not provided your manuscript might be rejected. 

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Partly

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Partly

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Partly

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Decision: Major Revision

Thank you for submitting this protocol on a very relevant and timely topic. The systematic review you propose has the potential to fill significant gaps in the literature regarding the role of physical measures as prognostic factors for neck and thoracic pain. While the protocol demonstrates thoughtful planning, there are a few key areas that require more substantial clarification and revision to ensure the review's rigor and applicability.

Merits:

Important Research Focus: Addressing the prognostic value of physical measures for neck and thoracic pain is both necessary and valuable. These conditions have a significant impact on patients' quality of life, and better understanding the predictive factors for outcomes could greatly improve patient care and treatment planning.

Comprehensive Search Strategy: I appreciate the extensive search plan that includes multiple databases and the inclusion of non-English studies, which helps to minimize bias. This is a major strength of the review and will ensure that a broad spectrum of evidence is captured.

Patient Involvement: Including input from the Patient Partner Advisory Group is a commendable effort to incorporate patient perspectives, ensuring the relevance and applicability of the findings to real-world practice.

Aspects Requiring Major Revision:

Inconsistencies in Terminology and Conceptual Framework: There is a lack of clarity in how you define and differentiate between the types of physical measures you will analyze. Terms like "impairment-based," "performance-based," and "activity measures in a natural environment" are used, but the definitions and distinctions between these categories need further elaboration. Additionally, how these measures will be interpreted or weighted during the synthesis of the findings remains vague. Providing a clear conceptual framework for how these different measures will be assessed and categorized is critical for readers to fully understand your approach.

Ambiguity Regarding Outcome Measures: Although the protocol outlines that "no limitation will be placed on the types of outcomes evaluated," this may lead to an overly broad and unfocused review. Consider narrowing the scope to focus on specific, clinically relevant outcomes (e.g., pain, functional mobility, quality of life) that align with the prognostic factors under investigation. This will help ensure that your results are applicable to clinical practice and not overly diluted by including less relevant outcomes.

Lack of Specificity in Data Synthesis and Meta-Analysis Plans: The manuscript would benefit from a much more detailed explanation of how you plan to handle heterogeneity, particularly statistical heterogeneity. While the I² and Chi² tests are mentioned, there’s no clear plan for how different types of heterogeneity will be managed in practice. Will you conduct subgroup analyses? If so, based on which variables? Providing a more structured approach to data synthesis and interpretation is essential, particularly for a systematic review protocol. A clearer decision tree for when you will use a quantitative meta-analysis versus a narrative synthesis would also strengthen the protocol.

Handling of Bias and Quality Assessment: While QUIPS and GRADE are mentioned for assessing the risk of bias and evidence quality, the protocol doesn’t adequately explain how these tools will be applied in practice. Will you exclude studies with high risk of bias, or will they be weighted differently in the analysis? Further detail on how these assessments will impact the inclusion or exclusion of studies is necessary. Additionally, it would be useful to specify any plans for sensitivity analysis to assess the impact of studies with high risk of bias.

Translation and Use of Automated Tools: The use of ChatGPT for translating non-English studies is innovative but comes with risks regarding the accuracy and nuance of translations. While the manuscript mentions human verification of translations, it would benefit from a more detailed explanation of how you plan to ensure that essential details, such as medical terminology, are correctly interpreted. This is particularly important given the technical nature of the studies you are including.

Ethics and Patient Involvement: While the manuscript includes a section on patient involvement, it does not sufficiently elaborate on how patients contributed to the design or methodology of the study. A more detailed account of how patient perspectives shaped the review’s focus or design, beyond simply validating it, would add depth to the protocol and ensure that it aligns with patient-centered research principles.

Conclusion:

This manuscript has significant potential but requires substantial revision before it can move forward. The key areas that need attention include clarifying your conceptual framework and definitions of physical measures, providing more detail on how you will handle heterogeneity and bias, and refining the scope of outcome measures to ensure a focused and clinically relevant review. Additionally, the use of automated tools for translation requires careful oversight to avoid inaccuracies. With these major revisions, the manuscript will be much better positioned to provide robust and actionable insights for clinicians and researchers.

I recommend major revisions to address the concerns outlined above.

Thank you for your work, and I look forward to reviewing the revised manuscript.

Reviewer #2: This protocol outlines a systematic review aimed at summarizing evidence for physical measures of physical functioning as prognostic factors for outcomes in individuals with neck and thoracic pain. The authors propose a comprehensive search strategy across multiple databases, including grey literature, to identify prospective longitudinal cohort studies. They plan to assess risk of bias using the QUIPS tool and evaluate the quality of evidence using the GRADE approach. The review aims to address an important gap in the literature by providing a comprehensive overview of physical prognostic factors for neck and thoracic pain, which could inform clinical decision-making and patient care.

Limited discussion on handling of missing data: The protocol does not adequately address how missing data will be handled, which is crucial in prognostic studies. This omission could affect the quality and reliability of the review's findings. For example: If studies report standard errors without reporting standard deviations, will you attempt to estimate the missing standard deviations using appropriate statistical tools and calculators?

Despite this limitation, this systematic review protocol addresses an important gap in the literature and has the potential to provide valuable insights into physical prognostic factors for neck and thoracic pain outcomes.

Reviewer #3: This manuscript presents a well-structured protocol for a systematic review aimed at summarizing evidence regarding physical measures of physical functioning as prognostic factors in individuals with neck and thoracic pain. The topic is relevant, as neck and thoracic pain are significant public health concerns, and identifying prognostic factors could help improve patient outcomes and clinical decision-making. The methodology appears rigorous, and the authors have followed recognized guidelines such as PRISMA-P, which strengthens the validity of their approach. However, there are a few areas need improvements.

Major Points:

1. The manuscript does an excellent job highlighting the gap in the literature, particularly the need for a review that covers both neck and thoracic pain. However, the rationale for the inclusion of thoracic pain in this review could be further elaborated. Since thoracic pain is less studied compared to neck pain, an explicit discussion about how insights from thoracic pain will be combined with those from neck pain would strengthen the introduction. Will these two conditions be analyzed separately or together?

2. The manuscript mentions categorizing outcomes into impairment-based, performance-based, and activity measures. While this is an appropriate approach, more information is needed on how the authors will handle studies that assess these measures using different instruments. Will they attempt to standardize or pool data from different measurement tools, and if so, how? Additionally, it would be useful to include examples of specific outcome measures under each category to give readers a clearer sense of what is included.

3. The criteria for excluding studies based on non-neuromusculoskeletal origins of pain are appropriate, but the exclusion criteria regarding metabolic bone diseases such as osteoporosis could be reconsidered. Given that osteoporosis is common in older adults, and that neck and thoracic pain are also prevalent in this population, the exclusion may inadvertently omit relevant studies. The authors should either justify this decision more explicitly or consider including such studies with careful adjustment for confounding variables.

4. The authors have selected appropriate tools (QUIPS, GRADE) for assessing the risk of bias and quality of evidence. It would be beneficial to describe in more detail how the authors plan to integrate the findings from the QUIPS tool into the overall analysis. For example, will high-risk studies be excluded from the meta-analysis, or will they be included with sensitivity analyses?

Reviewer #4: The manuscript outlines a protocol for a systematic review investigating the use of physical measures of physical functioning as prognostic factors in predicting outcomes in individuals with neck and thoracic pain. The protocol is well-structured, and the methodology is clearly defined and aligned with best practices for systematic reviews. However, there are areas that require clarification and improvement to strengthen the protocol and ensure robust results.

1. The QUIPS tool is appropriately selected for risk of bias assessment. However, the manuscript should clarify how discrepancies in bias assessments will be handled between the two reviewers beyond consulting a third reviewer. A more structured approach, such as predefined criteria for resolving differences in bias ratings, could improve consistency and reduce potential reviewer bias.

2. The protocol plans to include studies in multiple languages and use tools like ChatGPT for translation. While this is commendable, it is important to ensure the accuracy of translations in technical and clinical terminology. It is recommended to provide more details on the verification process for translated studies, especially how bilingual reviewers will be selected and how translation accuracy will be validated.

3. While the manuscript states that a meta-analysis will be performed if studies show homogeneity, it would benefit from a clearer explanation of how the authors will determine whether studies are sufficiently homogenous. For instance, more information on the thresholds for heterogeneity that will guide decisions to pool data would be useful. Additionally, the narrative synthesis section should be expanded to clarify how qualitative data will be synthesized, categorized, and presented if a meta-analysis is not possible.

4. The manuscript states that authors will be contacted for missing or unclear data, but it does not sufficiently explain how missing data will be handled if authors do not respond. A more detailed description of the imputation methods or sensitivity analyses for handling missing data would strengthen the robustness of the review.

5. While the protocol defines short-, medium-, and long-term follow-up periods, it does not specify how these timeframes will be standardized across different studies that may use varying definitions for follow-up. Including a more detailed strategy for dealing with differing follow-up periods, or defining a minimum acceptable follow-up length, would enhance comparability across studies.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Xiaoyi Zhang

Reviewer #2: No

Reviewer #3: No

Reviewer #4: Yes: Yuhang Liu

**********

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

PLoS One. 2025 Jan 24;20(1):e0316827. doi: 10.1371/journal.pone.0316827.r002

Author response to Decision Letter 0


10 Nov 2024

Rebuttal Letter

To,

The Editor, Reviewers,

PLOS ONE

Date: November 10, 2024

Subject: Addressing Editor and Reviewer Comments for PONE-D-24-34920.

Dear Editor and Reviewers,

We are pleased to have an opportunity to revise our manuscript titled “Physical measures of physical functioning as prognostic factors in predicting outcomes for neck and thoracic pain: protocol for a systematic review”. In our revised manuscript, we have carefully considered the editor’s and reviewers’ suggestions, to address all your concerns to the best of our abilities. We provide our responses to the suggestions below. Comments from Editor and Reviewers are colored in red, and our responses are highlighted in black. We have also updated our S1 file that shows the PRISMA-P checklist.

All feedback on our manuscript were very helpful, and we greatly appreciate your constructive feedback on our original submission. After addressing the issues raised, we feel the quality of the manuscript is much improved.

Sincerely,

Rabea Begum

On behalf of authors of PONE-D-24-34920

Response to Editor

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled ‘Response to Reviewers’.

o Included

• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled ‘Revised Manuscript with Track Changes’.

o Included

• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled ‘Manuscript’.

o Included

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE’s style requirements, including those for file naming. The PLOS ONE style templates can be found at

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

Action(s) performed: We made changes to the new version of the manuscript according to the submission guidelines and PLOS ONE’s style requirements (lines 13,14) including those for file naming. We would like to inform you that we also used the tab key for paragraph indentation during the editing process.

2. Please include a separate caption for each figure in your manuscript.

Action(s) performed: We formatted in-text figure caption as “Fig 1” in our manuscript (line 221) according to PLOS ONE’s requirements in. We also included a figure caption with legend as “Fig 1. PRISMA 2020 flow diagram. This diagram reflects the study selection process” (line 222). In addition, we changed the separate Fig 1 file as “Fig 1.tiff”.

3. Please include your tables as part of your main manuscript and remove the individual files. Please note that supplementary tables (should remain/ be uploaded) as separate “supporting information” files

Action(s) performed: We removed the individual file, and the manuscript was adjusted accordingly with adding Table 1 (lines 234, 235).

4. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.

Action(s) performed: We added supporting information files at the end of our revised manuscript (lines 657 to 660). We updated our revised manuscript with an in-text S1 file (line 150). We also renamed separate supporting information files as S1_file.docx and S2_file.docx.

5. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Action(s) performed: We have updated our reference list.

6. As required by our policy on Data Availability, please ensure your manuscript or supplementary information includes the following:

A numbered table of all studies identified in the literature search, including those that were excluded from the analyses.

For every excluded study, the table should list the reason(s) for exclusion.

If any of the included studies are unpublished, include a link (URL) to the primary source or detailed information about how the content can be accessed.

A table of all data extracted from the primary research sources for the systematic review and/or meta-analysis. The table must include the following information for each study:

Name of data extractors and date of data extraction

Confirmation that the study was eligible to be included in the review.

All data extracted from each study for the reported systematic review and/or meta-analysis that would be needed to replicate your analyses.

If data or supporting information were obtained from another source (e.g. correspondence with the author of the original research article), please provide the source of data and dates on which the data/information were obtained by your research group.

If applicable for your analysis, a table showing the completed risk of bias and quality/certainty assessments for each study or outcome. Please ensure this is provided for each domain or parameter assessed. For example, if you used the Cochrane risk-of-bias tool for randomized trials, provide answers to each of the signaling questions for each study. If you used GRADE to assess certainty of evidence, provide judgements about each of the quality of evidence factor. This should be provided for each outcome.

An explanation of how missing data were handled.

This information can be included in the main text, supplementary information, or relevant data repository. Please note that providing these underlying data is a requirement for publication in this journal, and if these data are not provided your manuscript might be rejected.

Action(s) performed: None as the above points are not relevant to a protocol manuscript except dealing with missing data. We updated our manuscript (lines 317-325).

Responses to Reviewer 1

Inconsistencies in Terminology and Conceptual Framework: There is a lack of clarity in how you define and differentiate between the types of physical measures you will analyze. Terms like "impairment-based," "performance-based," and "activity measures in a natural environment" are used, but the definitions and distinctions between these categories need further elaboration. Additionally, how these measures will be interpreted or weighted during the synthesis of the findings remains vague. Providing a clear conceptual framework for how these different measures will be assessed and categorized is critical for readers to fully understand your approach.

Action(s) performed: Thank you for your feedback regarding the clarity of terminology and the conceptual framework in our review. We appreciate your emphasis on the need for well-defined categories. We have elaborated on the categories of physical measures, including impairment-based, performance-based, and activity measures in a natural environment, ensuring comprehensive coverage in the protocol. We have revised the relevant paragraph (lines 77 to 96).

Ambiguity Regarding Outcome Measures: Although the protocol outlines that "no limitation will be placed on the types of outcomes evaluated," this may lead to an overly broad and unfocused review. Consider narrowing the scope to focus on specific, clinically relevant outcomes (e.g., pain, functional mobility, quality of life) that align with the prognostic factors under investigation. This will help ensure that your results are applicable to clinical practice and not overly diluted by including less relevant outcomes.

Action(s) performed: We appreciate your insightful feedback regarding the outcome measures in our systematic review protocol. We acknowledge the concern about potential ambiguity and dilution of focus due to the inclusion of a broad range of outcomes. However, we believe that including all types of outcomes is essential for our review. From our scoping searches exploring the potential value of this review, we know that the number of studies on neck pain is relatively low compared to other musculoskeletal conditions (e.g., low back pain). There is a significant gap in literature concerning neck and thoracic pain and its prognostic factors. The scarcity of studies limits our understanding of how various factors influence outcomes in this population. Owing to the low number of studies exist, a broad scope in our review was necessary and one way in which this was enabled was through no limitation on outcomes. We have provided further rationale for selecting a broader range of outcomes (lines 171, 172).

Lack of Specificity in Data Synthesis and Meta-Analysis Plans: The manuscript would benefit from a much more detailed explanation of how you plan to handle heterogeneity, particularly statistical heterogeneity. While the I² and Chi² tests are mentioned, there’s no clear plan for how different types of heterogeneity will be managed in practice. Will you conduct subgroup analyses? If so, based on which variables? Providing a more structured approach to data synthesis and interpretation is essential, particularly for a systematic review protocol. A clearer decision tree for when you will use a quantitative meta-analysis versus a narrative synthesis would also strengthen the protocol.

Action(s) performed: We appreciate your thoughtful criticism of our Data Synthesis and Meta-Analysis Plans. In our manuscript, we have mentioned a comprehensive and structured approach to data synthesis that incorporates the potential for both quantitative and qualitative analyses. We have further defined the assessment of heterogeneity. Based on our initial scoping search the subgroup analysis might not be appropriate. We updated the data synthesis part (lines 271 to 325).

Handling of Bias and Quality Assessment: While QUIPS and GRADE are mentioned for assessing the risk of bias and evidence quality, the protocol doesn’t adequately explain how these tools will be applied in practice. Will you exclude studies with high risk of bias, or will they be weighted differently in the analysis? Further detail on how these assessments will impact the inclusion or exclusion of studies is necessary. Additionally, it would be useful to specify any plans for sensitivity analysis to assess the impact of studies with high risk of bias.

Action(s) performed: We appreciate your valuable feedback. We understand your concern regarding risk of bias and quality assessment. We have elaborated on the use of the QUIPS tool for assessing the risk of bias in individual studies based on your suggestion (lines 243 to 264). Studies with a high RoB will not be excluded solely based on their risk rating; however, their influence will be carefully considered. Studies rated as having a high RoB in critical domains may be given less weight in the synthesis of evidence, ensuring that the final conclusions are based on more robust findings. We will also assess whether studies with a higher RoB contribute to downgrading the overall quality of evidence during the GRADE assessment. We might not perform sensitivity analysis due to limited number of studies identified in our scoping searches. We have updated our manuscript (295 to 300).

Translation and Use of Automated Tools: The use of ChatGPT for translating non-English studies is innovative but comes with risks regarding the accuracy and nuance of translations. While the manuscript mentions human verification of translations, it would benefit from a more detailed explanation of how you plan to ensure that essential details, such as medical terminology, are correctly interpreted. This is particularly important given the technical nature of the studies you are including.

Action(s) performed: Thank you for raising the important concern regarding the use of ChatGPT for translating non-English studies, especially considering the technical nature of the studies included in our review. We fully acknowledge the limitations and potential risks associated with automated translation tools, particularly in the context of medical and scientific terminology. To address this, after the automated translation, bilingual experts with proficiency in both the source language and English will carefully review the translated material. These individuals will have a background in medical or health sciences, allowing them to identify and correct any errors or ambiguities, particularly with technical or field-specific terminology. We have elaborated in detail in the study design section (lines 180, 181).

Ethics and Patient Involvement: While the manuscript includes a section on patient involvement, it does not sufficiently elaborate on how patients contributed to the design or methodology of the study. A more detailed account of how patient perspectives shaped the review’s focus or design, beyond simply validating it, would add depth to the protocol and ensure that it aligns with patient-centered research principles.

Action(s) performed: Thank you for your valuable feedback. We acknowledge the importance of patient involvement in ensuring the study aligns with patient-centered research principles. In response to your comment, we would like to clarify that the advisory groups expressed their lived experiences with neck and thoracic pain, and they highlighted the importance of this protocol which ensured that it would be understandable and usable for both researchers and patients. Their feedback also guided the selection and inclusion of outcomes that reflect a broader range of experiences with spinal pain. Specifically, their feedback highlighted the need to include not only traditional clinical outcomes (e.g., pain, disability) but also those that reflect day-to-day functioning and quality of life, which are highly relevant to individuals living with neck and thoracic pain. This is another justification we have made efforts to include a diverse set of outcomes. While they found no need for modifications to the protocol, their feedback reassured us that the methodology and design resonated with their experiences. We adjusted our manuscript (lines 368 to 377).

Responses to Reviewer 2

Limited discussion on handling of missing data: The protocol does not adequately address how missing data will be handled, which is crucial in prognostic studies. This omission could affect the quality and reliability of the review's findings. For example: If studies report standard errors without reporting standard deviations, will you attempt to estimate the missing standard deviations using appropriate statistical tools and calculators?

Action(s) performed: Thank you for your valuable feedback regarding the handling of missing data in our systematic review protocol. We have added a separate paragraph on how we will handle missing data (lines 317 to 325). By implementing this process, we aim to minimize the impact of missing data on our review. We believe this method ensures thoroughness and transparency, allowing us to clearly report on the extent of missing data and its implications for our conclusions.

Responses to Reviewer 3

Major Points:

1. The manuscript does an excellent job highlighting the gap in the literature, particularly the need for a review that covers both neck and thoracic pain. However, the rationale for the inclusion of thoracic pain in this review could be further elaborated. Since thoracic pain is less studied compared to neck pain, an explicit discussion about how insights from thoracic pain will be combined with those from neck pain would strengthen the introduction. Will these two conditions be analyzed separately or together?

Ac

Attachment

Submitted filename: Response to Reviewers.docx

pone.0316827.s003.docx (36.2KB, docx)

Decision Letter 1

Cho-Hao Howard Lee

18 Dec 2024

Physical measures of physical functioning as prognostic factors in predicting outcomes for neck and thoracic pain: protocol for a systematic review

PONE-D-24-34920R1

Dear Dr. Rabea Begum,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Cho-Hao Howard Lee, M.D.

Academic Editor

PLOS ONE

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Partly

Reviewer #2: Yes

Reviewer #3: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Partly

Reviewer #2: Yes

Reviewer #3: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Merits

1. Relevance and Timeliness: This protocol addresses a critical need for systematic evidence regarding physical functioning measures, providing insights applicable to a wide range of musculoskeletal conditions.

2. Rigorous Methodology: The adherence to Cochrane guidelines and the PRISMA-P framework ensures transparency and reliability, making this protocol a strong foundation for the planned systematic review.

3. Practical Implications: By examining prognostic factors for neck and thoracic pain, the study has the potential to inform clinical guidelines and improve the management of a widespread and burdensome condition.

Minor Suggestions for Revision

1. Clarify Conceptual Framework for Physical Measures: The manuscript discusses impairment-based, performance-based, and activity measures but could benefit from a more explicit conceptual framework. A schematic or brief table summarizing these categories, including examples and their relevance to outcomes, would aid reader understanding.

2. Expand on Clinical Implications: While the importance of understanding prognostic factors is noted, the discussion could be enhanced by outlining specific ways clinicians might use this information in practice (e.g., tailoring rehabilitation programs based on predictive physical measures).

3. Strengthen the Patient Involvement Section: The inclusion of patient advisory feedback is commendable. Providing more detail on how this input shaped the design, particularly regarding outcome selection and applicability, would align with patient-centered research principles.

4. Refine the Approach to Missing Data: The plan for handling missing data is sound but could be made more robust by outlining contingency strategies if significant data remain unavailable (e.g., exclusion of studies with critical gaps).

Recommendation: Minor Revision

This manuscript is well-prepared and addresses an important topic in musculoskeletal research. The suggested revisions aim to clarify certain aspects and enhance the overall impact of the protocol. Thank you for your thoughtful work, and I look forward to seeing the results of this review!

Reviewer #2: this systematic review protocol addresses an important gap in the literature and has the potential to provide valuable insights into physical prognostic factors for neck and thoracic pain outcomes. I don't have extra comments.

Reviewer #3: The authors have adequately addressed all of my concerns. I support the publication of this manuscript. Best of luck!

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Xiaoyi Zhang

Reviewer #2: No

Reviewer #3: No

**********

Acceptance letter

Cho-Hao Howard Lee

10 Jan 2025

PONE-D-24-34920R1

PLOS ONE

Dear Dr. Begum,

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team.

At this stage, our production department will prepare your paper for publication. This includes ensuring the following:

* All references, tables, and figures are properly cited

* All relevant supporting information is included in the manuscript submission,

* There are no issues that prevent the paper from being properly typeset

If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps.

Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

If we can help with anything else, please email us at customercare@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Cho-Hao Howard Lee

Academic Editor

PLOS ONE

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 File. PRISMA-P 2015 checklist.

    This file shows the completed PRISMA-P 2015 checklist.

    (DOCX)

    pone.0316827.s001.docx (27.7KB, docx)
    S2 File. MEDLINE (Ovid) search strategy.

    This file shows MEDLINE search strategy.

    (DOCX)

    pone.0316827.s002.docx (18.4KB, docx)
    Attachment

    Submitted filename: Response to Reviewers.docx

    pone.0316827.s003.docx (36.2KB, docx)

    Data Availability Statement

    The research data will be made publicly available when the study is completed and published.


    Articles from PLOS ONE are provided here courtesy of PLOS

    RESOURCES