Prospective External Validation of an Early Prediction Model for Adverse Postoperative Pain Trajectories After Orthopedic Surgery
Single-Center Prospective External Validation Study of an Early Prediction Model for Adverse Postoperative Pain Trajectories After Orthopedic Surgery
This prospective observational study will externally validate a previously developed and locked prediction model for identifying adult patients at risk of adverse postoperative pain trajectories after elective orthopedic surgery. Approximately 400 patients will be consecutively recruited at the First Affiliated Hospital of Chongqing Medical University.
Postoperative pain will be assessed during the first 48 hours after surgery using the 0-10 Numeric Rating Scale. Pain scores will be organized into eight consecutive 6-hour time windows to determine each participant's postoperative pain trajectory according to prespecified rules. Clinical information available at the predefined prediction time point will be entered into the locked prediction model to calculate each participant's predicted probability of an adverse pain trajectory.
The study will evaluate the model's discrimination, calibration, overall prediction performance, and potential clinical utility. The model will not be modified or retrained using data from this validation cohort. Individual prediction results will not be provided to patients or treating clinicians and will not be used to guide treatment during the study.
調査の概要
詳細な説明
This is a single-center, prospective, observational external validation study of an early prediction model for adverse postoperative pain trajectories in adult patients undergoing elective orthopedic surgery at the First Affiliated Hospital of Chongqing Medical University.
Eligible participants will receive routine perioperative care. The study will not assign any experimental treatment or alter the participants' surgical, anesthetic, analgesic, nursing, or rehabilitation management. Study personnel will collect prespecified clinical variables from patient interviews, electronic medical records, anesthesia information systems, nursing records, and standardized postoperative pain assessments.
The end of surgery will be defined as postoperative hour 0. Postoperative pain intensity will be assessed using the 0-10 Numeric Rating Scale during the first 48 hours after surgery. This period will be divided into eight consecutive 6-hour windows: 0-6, 6-12, 12-18, 18-24, 24-30, 30-36, 36-42, and 42-48 hours. When more than one valid pain score is available within a time window, the median value will be used for the primary analysis.
Before enrollment of the first participant, the prediction model, prediction time point, predictor definitions, variable coding, data-processing procedures, missing-data handling rules, model structure, model parameters and hyperparameters, and outcome classification rules will be locked. Data from the external validation cohort will not be used to reselect predictors, retune hyperparameters, redefine cutoffs, or otherwise modify the original model.
After completion of the 48-hour observation period and data verification, each participant's probability of developing an adverse postoperative pain trajectory will be calculated using the locked model. The observed postoperative pain trajectory will be determined independently according to the prespecified trajectory classification and mapping rules.
External model performance will be evaluated using the area under the receiver operating characteristic curve, Brier score, calibration curve, calibration intercept, and calibration slope. Additional analyses will include sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and decision curve analysis at prespecified risk thresholds. Exploratory analyses may describe model performance across major orthopedic surgical categories.
Model predictions will be calculated offline and will not be communicated to participants, surgeons, anesthesiologists, nurses, or other treating clinicians during the study. Prediction results will therefore not influence clinical management.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Lihua Peng
- 電話番号：+86 15823443968
- メール：plhcqmu@163.com
研究場所
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Chongqing、中国
- 募集
- The First Affiliated Hospital of Chongqing Medical University
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コンタクト：
- Lihua Peng
- 電話番号：+86 15823443968
- メール：plhcqmu@163.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adult patients undergoing elective orthopedic surgery at the First Affiliated Hospital of Chongqing Medical University who are expected to remain hospitalized for at least 48 hours after surgery. Eligible procedures include major categories of elective orthopedic surgery, such as spinal surgery, hip or knee arthroplasty, pelvic or extremity fracture fixation, and orthopedic corrective surgery. Participants will be prospectively and consecutively screened and enrolled according to the prespecified eligibility criteria.
説明
Inclusion Criteria:
- Aged 18 to 90 years, regardless of sex.
- Scheduled to undergo an eligible elective orthopedic surgical procedure at the First Affiliated Hospital of Chongqing Medical University.
- Expected to remain hospitalized for at least 48 hours after surgery.
- Conscious before surgery, with sufficient understanding and communication ability to understand and complete the 0-10 Numeric Rating Scale for pain.
- Able and willing to provide written informed consent before any study-specific data collection.
Exclusion Criteria:
- Younger than 18 years or older than 90 years.
- Emergency surgery, unplanned surgery, or a surgical procedure outside the prespecified orthopedic surgical scope of the study.
- Unable to reliably understand the study or complete the Numeric Rating Scale because of impaired consciousness, severe cognitive impairment, psychiatric disorder, persistent deep sedation, mechanical ventilation, severe hearing impairment, language or communication difficulties, or similar conditions.
- Lacks full capacity to provide valid informed consent.
- Concurrent participation in another clinical study that may affect pain assessment, analgesic treatment, or study outcomes.
- Expected discharge or transfer within 48 hours after surgery, or inability to complete the main study observation because of clinical circumstances.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Prospective External Validation Cohort
Adult patients undergoing elective orthopedic surgery at the First Affiliated Hospital of Chongqing Medical University will be prospectively enrolled and followed for 48 hours after surgery. Postoperative pain scores and prespecified clinical variables will be collected according to the study protocol. All participants will receive routine perioperative care, and no treatment will be assigned or modified by the study investigators. The locked prediction model will be applied offline to evaluate the risk of an adverse postoperative pain trajectory. |
Participants will undergo elective orthopedic surgery as part of routine clinical care. The surgical procedure, anesthetic management, postoperative analgesia, nursing care, and rehabilitation plan will be determined by the treating clinical team according to standard practice. The study investigators will not assign, modify, or influence these treatments. The study will prospectively collect prespecified perioperative variables and postoperative pain assessments for external validation of a locked prediction model. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants With an Adverse Postoperative Pain Trajectory
時間枠：From the end of surgery through 48 hours postoperatively
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Participants will be classified as having an adverse or non-adverse postoperative pain trajectory based on pain scores collected during the first 48 hours after surgery and the prespecified, locked trajectory classification and mapping rules. The number and percentage of participants classified as having an adverse postoperative pain trajectory will be reported. |
From the end of surgery through 48 hours postoperatively
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Area Under the Receiver Operating Characteristic Curve (AUC)
時間枠：Through 48 hours postoperatively
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The area under the receiver operating characteristic curve (AUC) will be used to assess the discrimination of the locked prediction model for distinguishing participants with and without an adverse postoperative pain trajectory. The AUC ranges from 0.5, indicating no discrimination, to 1.0, indicating perfect discrimination. The AUC and its 95% confidence interval will be reported. |
Through 48 hours postoperatively
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Brier Score
時間枠：Through 48 hours postoperatively
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The Brier score will be used to evaluate the overall predictive performance of the locked prediction model by comparing predicted probabilities with the observed binary adverse postoperative pain trajectory outcome. Lower values indicate better overall predictive performance. The Brier score and its 95% confidence interval will be reported. |
Through 48 hours postoperatively
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Calibration Intercept
時間枠：Through 48 hours postoperatively
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Calibration intercept will be used to assess systematic overestimation or underestimation of predicted risk by the locked prediction model. A value of 0 indicates ideal calibration. The calibration intercept and its 95% confidence interval will be reported. |
Through 48 hours postoperatively
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Calibration Slope
時間枠：Through 48 hours postoperatively
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Calibration slope will be used to assess the agreement between the spread of predicted probabilities and observed outcomes. A value of 1 indicates ideal calibration. The calibration slope and its 95% confidence interval will be reported. |
Through 48 hours postoperatively
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Calibration Curve
時間枠：Through 48 hours postoperatively
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A calibration curve will be used to visually assess agreement between predicted probabilities of an adverse postoperative pain trajectory and observed outcome frequencies across the range of predicted risk. The calibration curve and its 95% confidence interval will be presented. |
Through 48 hours postoperatively
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Classification Performance at the Prespecified Risk Threshold
時間枠：Through 48 hours postoperatively
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Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the locked prediction model will be evaluated at the prespecified risk threshold and reported with 95% confidence intervals where applicable. The threshold will not be selected or optimized using the external validation cohort. |
Through 48 hours postoperatively
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Decision Curve Analysis
時間枠：Through 48 hours postoperatively
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Decision curve analysis will be used to evaluate the clinical net benefit of the locked prediction model across a prespecified range of clinically relevant risk thresholds, compared with strategies of treating all participants or treating no participants as being at increased risk. |
Through 48 hours postoperatively
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Distribution and Characteristics of Postoperative Pain Trajectory Classes
時間枠：From the end of surgery through 48 hours postoperatively
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The number and percentage of participants assigned to each prespecified postoperative pain trajectory class will be described. Class-specific mean pain trajectories over the first 48 postoperative hours and prespecified indicators of classification uncertainty will also be summarized. |
From the end of surgery through 48 hours postoperatively
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CQMUFAH-PT-EXT-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data (IPD) will not be shared with external researchers because the study involves sensitive patient-level clinical information and is subject to institutional data protection and confidentiality requirements. Study data will be securely stored and accessible only to authorized study personnel. Aggregated, de-identified study findings will be disseminated through peer-reviewed scientific publications. Any future change to the IPD sharing plan will be subject to applicable ethical and institutional approvals.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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