Key Performance Indicators for the Assessment of NSCLC Patients Pathway

NCT04676321 | Completed

• 1 other identifier: IRST 162.13
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multicenter, observational study involving a retrospective collection of data. A total of potential 16 key performance indicators (KPIs) had been developed from a panel of experts (clinicians, IT experts, etc..) to investigate the appropriateness of care in NSCLC patients, with a special focus on the use of immunotherapy. The eligible population and data will be gathered retrospectively using an algorithm. Administrative databases will be used as unique resource: to identify target population and to collect patient's data with which measure KPIs.

Conditions

Non Small Cell Lung Cancer

Keywords

lung cancer; NSCLC; Administrative databases; Algorithm

Outcome Measures

Primary Outcomes (1)

• Key Performance indicators

  To measure a set of potential indicators (KPIs) derived from administrative database in order to investigate the appropriateness and quality of NSCLC care among participating sites.

  six months

Secondary Outcomes (1)

• Algorithm evaluatation

  two month

Interventions

Patient pathway OTHER

Investigation on the appropriateness and quality of NSCLC care among participating sites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consisted of all adult patients (aged ≥ 18 years) residing in Emilia-Romagna region, identified in the Hospital discharge card, who has been discharged in any one of the participating sites (hospitals of Modena, Reggio-Emilia and Forlì-Cesena provinces) with a newly diagnosis of Non small cell lung cancer between January and December 2017.

You may qualify if:

• \- patients identified from hospital administrative databases of Emilia-Romagna region using a case selection algorithm for identifying Non small cell lung cancer

You may not qualify if:

• patients not residing in Emilia Romagna region (due to the difficulty in obtaining the medical data).

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead
• Azienda USL Reggio Emilia - IRCCS: collaborator
• Azienda Ospedaliera Universitaria Policlinico: collaborator

Study Sites (3)

IRST

Meldola, Forlì-Cesena, 47014, Italy

Location

IRCCS Arcispedale S.Maria Nuova

Reggio Emilia, RE, 42123, Italy

Location

Policlinico of Modena

Modena, 41125, Italy

Location

Related Publications (1)

• Balzi W, Roncadori A, Danesi V, Massa I, Manunta S, Gentili N, Delmonte A, Crino L, Altini M. How to discriminate non-small cell lung cancer (NSCLC) cases from an Italian administrative database? A retrospective, secondary data use study for evaluating a novel algorithm performance. BMJ Open. 2021 Sep 24;11(9):e048188. doi: 10.1136/bmjopen-2020-048188.

  PMID: 34561258 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mattia Altini, Master

  IRST

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biostatician

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: October 1, 2020
• Primary Completion: October 15, 2020
• Study Completion: November 15, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

IT (3)