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Social Deprivation and Postoperative Mortality

2026년 5월 27일 업데이트: Hospital de Clinicas de Porto Alegre

Assessment of the Impact of Socioeconomic Factors on Perioperative Outcomes

Socioeconomic factors are associated with differences in health outcomes, but their impact on surgical patients is still not well understood, especially in low- and middle-income countries. Social deprivation may affect perioperative outcomes through differences in access to healthcare, burden of comorbidities, timing of care, and hospital resources. However, few studies have evaluated this association in large and diverse surgical populations, and data from Brazil are limited.

This retrospective multicenter cohort study will evaluate the association between socioeconomic deprivation and perioperative outcomes among patients undergoing surgery in Brazil. The study will include patients aged 16 years or older who underwent elective or urgent surgical procedures in participating public and private hospitals between January 1 and December 31, 2024. Patients undergoing ophthalmologic procedures, diagnostic procedures, procedures performed under local anesthesia only, selected transplant procedures, and organ donors after brain death will be excluded.

Socioeconomic deprivation will be assessed using georeferenced area-level indices derived from each patient's residential address, including the Brazilian Deprivation Index, the Social Vulnerability Index, and the Municipal Human Development Index. The researchers will grou patients according to deprivation levels, and analyze the association between deprivation and postoperative outcomes.

The primary outcome will be 30-day in-hospital postoperative mortality. The study will also evaluate demographic, clinical, surgical, and hospital-level factors associated with mortality, including age, sex, ethnicity, American Society of Anesthesiologists physical status classification, surgical urgency, surgical magnitude, surgical specialty, and type of healthcare system. Multivariable logistic regression models will be used to assess whether socioeconomic deprivation is independently associated with postoperative mortality after adjustment for relevant clinical and surgical factors.

The results of this study may improve the understanding of how socioeconomic deprivation influences perioperative risk in Brazil. The findings may help identify vulnerable surgical patients, support risk prediction models that include social determinants of health, and inform strategies to reduce inequities in perioperative care.

연구 개요

상태

아직 모집하지 않음

상세 설명

Socioeconomic deprivation is a multidimensional determinant of health that may influence perioperative outcomes through several pathways, including differences in baseline health status, burden of comorbidities, access to timely healthcare, perioperative optimization, and hospital-level resources. Although previous studies have suggested an association between social deprivation and worse postoperative outcomes, most available evidence comes from high-income countries or from studies focused on specific surgical populations. Data from low- and middle-income countries, including Brazil, remain limited.

This study is a retrospective, multicenter cohort study designed to assess the association between socioeconomic deprivation and perioperative outcomes among surgical patients treated in Brazilian hospitals. Participating centers will include both public and private hospitals from different regions of the country. The study will use routinely collected institutional data from patients who underwent surgical procedures during the 2024 calendar year. No additional contact, intervention, or change in clinical care will occur as part of the study.

The main exposure of interest is socioeconomic deprivation, assessed through georeferenced area-level indicators based on each patient's residential address. Residential addresses will be geocoded to identify the corresponding census tract or human development unit. Socioeconomic deprivation will then be measured using validated Brazilian indices, including the Brazilian Deprivation Index, the Social Vulnerability Index, and the Municipal Human Development Index. These indices capture different dimensions of socioeconomic context, including income, education, household conditions, urban infrastructure, human capital, and vulnerability related to work and income.

The study database will include demographic, clinical, surgical, and structural variables routinely available in hospital electronic records. These variables include age, sex, ethnicity, American Society of Anesthesiologists physical status classification, educational level, occupation, surgical procedure, surgical urgency, date of surgery, date of hospital discharge or in-hospital death, surgical specialty, surgical magnitude, and type of healthcare system. Surgical procedures will be standardized using Brazilian procedural classification systems (Classificação Brasileira Hierarquizada de Procedimentos Médicos -CBHPM). If a patient undergoes more than one eligible surgical procedure during the study period, only the first procedure will be considered for outcome analysis.

Data will be extracted locally by the information technology teams of participating centers using structured database queries. Identifiable patient information will not be included in the analytical dataset. Residential addresses will be used only for geocoding and linkage to area-level socioeconomic indices. After geospatial processing, the final research dataset will exclude full residential addresses and other direct identifiers. Access to study data will be restricted to authorized members of the research team, and data will be stored in a secure institutional environment.

The primary analysis will evaluate whether higher levels of socioeconomic deprivation are associated with 30-day in-hospital postoperative mortality. Deprivation indices will be analyzed in categories, including quintiles, to assess gradients of risk across socioeconomic strata. Baseline characteristics will be summarized across deprivation groups using appropriate descriptive statistics. Multivariable logistic regression models will be used to estimate the association between socioeconomic deprivation and postoperative mortality after adjustment for relevant demographic, clinical, surgical, and hospital-level factors. Planned covariates include age, sex, ethnicity, ASA physical status, surgical urgency, surgical magnitude, surgical specialty, and healthcare system type.

Model performance will be assessed using calibration and discrimination measures. Calibration will be evaluated using the Hosmer-Lemeshow goodness-of-fit test, and discrimination will be assessed using the area under the receiver operating characteristic curve. Results will be reported as odds ratios with 95% confidence intervals. A significance level of 5% will be used for statistical analyses.

The study also aims to explore whether incorporating socioeconomic deprivation into perioperative risk assessment may improve the identification of vulnerable surgical patients. By evaluating social deprivation alongside established clinical and surgical risk factors, this study may contribute to a better understanding of inequities in perioperative care and support future strategies for risk stratification, resource allocation, and quality improvement in both public and private healthcare settings in Brazil.

연구 유형

관찰

등록 (추정된)

45000

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Estado de Bahia
      • Salvador, Estado de Bahia, 브라질, 40110-060
        • Hospital das Clínicas da Universidade Federal da Bahia
        • 연락하다:
    • Maranhão
      • São Luís, Maranhão, 브라질, 65060-645
    • Paraná
      • Curitiba, Paraná, 브라질, 80050-370
        • Hospital São Marcelino Champagnat
        • 연락하다:
    • Rio Grande do Sul
      • Criciuma, Rio Grande do Sul, 브라질, 88.811-500
        • Hospital São José
        • 연락하다:
      • Porto Alegre, Rio Grande do Sul, 브라질, 91350-200
        • Hospital Nossa Senhora da Conceicao
        • 연락하다:
      • Porto Alegre, Rio Grande do Sul, 브라질, 90410-000
        • Hospital de Clinicas de Porto Alegre
        • 연락하다:
    • São Paulo
      • São Paulo, São Paulo, 브라질, 04038-032

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Study participants will be selected from surgical patients treated at participating public and private hospitals in Brazil. The participating centers are Hospital São José in Criciúma, Santa Catarina; Hospital de Clínicas de Porto Alegre and Hospital Nossa Senhora da Conceição in Porto Alegre, Rio Grande do Sul; Hospital São Domingos in São Luís, Maranhão; Hospital Marcelino Champagnat in Curitiba, Paraná; Hospital São Paulo in São Paulo, São Paulo; and Hospital da Universidade Federal da Bahia in Salvador, Bahia.

These hospitals represent different geographic regions of Brazil and include both public and private healthcare settings.

설명

Inclusion Criteria:

  • Patients aged 16 years or older.
  • Patients who underwent an elective or urgent surgical procedure in an operating room at a participating hospital.
  • Surgical procedure performed between January 1, 2024, and December 31, 2024.

Exclusion Criteria:

  • Patients who underwent ophthalmologic surgery, diagnostic procedures only and procedures performed under local anesthesia only.
  • Patients who underwent liver, lung or heart transplantation.
  • Patients diagnosed with brain death who were organ donor candidates.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
2024 Surgical Patients

Patients aged 16 years or older who underwent elective or urgent surgical procedures in participating Brazilian hospitals between January 1 and December 31, 2024. Participating centers will include public and private hospitals. The cohort will be identified retrospectively from routinely collected hospital electronic records.

There will be no study intervention and no change in patient care. The exposure of interest is socioeconomic deprivation, assessed using georeferenced area-level indices derived from each patient's residential address. Patients will be categorized according to levels of socioeconomic deprivation, and perioperative outcomes will be compared across these groups.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
30-day in-hospital postoperative mortality
기간: 30 days
Number of participants who died during the hospital stay within 30 days after the index surgical procedure. Mortality will be assessed using routinely collected hospital electronic records, including the date of surgery, date of hospital discharge, and date of in-hospital death when applicable. Participants discharged alive before 30 days will be considered alive for this outcome. Participants who remain hospitalized beyond 30 days will be assessed up to postoperative day 30 only. This is a binary outcome, reported as death or no death within 30 days after surgery.
30 days

2차 결과 측정

결과 측정
측정값 설명
기간
Admission to intensive care unit or regular ward after surgery
기간: Immediate postoperative destination
Admission to an intensive care unit or to a regular inpatient ward after the index surgical procedure. Postoperative destination will be assessed using routinely collected hospital electronic records. Intensive care unit admission will include admission to an intensive care unit or equivalent critical care unit immediately after surgery. Regular inpatient ward admission will include admission to a standard hospital ward without intensive care support. This is a categorical outcome, reported according to the first postoperative destination after surgery.
Immediate postoperative destination

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Luciana PC Stefani, Md, PhD, Hospital de Clinicas de Porto Alegre

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 15일

기본 완료 (추정된)

2027년 5월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2026년 5월 27일

QC 기준을 충족하는 최초 제출

2026년 5월 27일

처음 게시됨 (실제)

2026년 6월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 27일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2025-0217

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared. This is a retrospective study using routinely collected hospital data from multiple participating centers, including sensitive clinical information and residential address data used for georeferencing. Although the final analytical dataset will be de-identified, sharing individual-level data could pose confidentiality risks and may not be permitted under local ethics approvals and institutional data governance agreements. Study results will be reported only in aggregate form.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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