Evidence map›Paper›PMID 35585571›Full record

ArticleBMC cancer2022

Identifying and handling unbalanced baseline characteristics in a non-randomized, controlled, multicenter social care nurse intervention study for patients in advanced stages of cancer.

Johann Frick, Pimrapat Gebert, Ulrike Grittner, Anne Letsch, Daniel Schindel, Liane Schenk

Abstract readControlled Clinical TrialMulticenter Study
In one paragraph

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. The effect of social care nurses on health related quality of life in patients with advanced cancer: A non-randomized, multicenter, controlled trial.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024
    Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Johann FrickCharité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Medical Sociology and Rehabilitation Science, Charitéplatz 1, 10117, Berlin, Germany.ORCID http://orcid.org/0000-0002-4826-4684
Pimrapat GebertCharité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Medical Sociology and Rehabilitation Science, Charitéplatz 1, 10117, Berlin, Germany.ORCID http://orcid.org/0000-0002-5946-7137
Ulrike GrittnerCharité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Biometry and Clinical Epidemiology, Charitéplatz 1, 10117, Berlin, Germany.ORCID http://orcid.org/0000-0003-2595-0224
Anne LetschDepartment of Medicine II, Hematology and Oncology, University Hospital Schleswig-Holstein, Arnold-Heller-Straße 3, 24105, Kiel, Germany.
Daniel Schindel *Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Medical Sociology and Rehabilitation Science, Charitéplatz 1, 10117, Berlin, Germany. daniel.schindel@charite.de.ORCID http://orcid.org/0000-0003-3351-8378
Liane Schenk *Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Medical Sociology and Rehabilitation Science, Charitéplatz 1, 10117, Berlin, Germany.ORCID http://orcid.org/0000-0002-8514-2846

Funding

Innovation Fund of the Federal Joint Committee (G-BA) 01NVF17016
6 · The paper itself

Abstract

purposeGiven the psychosocial burdens patients in advanced stages of cancer face, innovative care concepts are needed. At the same time, such vulnerable patient groups are difficult to reach for participation in intervention studies and randomized patient inclusion may not be feasible. This article aims to identify systematic biases respectively selection effects occurring during the recruitment phase and to discuss their potential causes based on a non-randomized, multicenter intervention study with patients in advanced stages of cancer.

methodsPatients diagnosed with at least one of 16 predefined cancers were recruited at four hospitals in three German cities. The effect of social care nurses' continuous involvement in acute oncology wards was measured by health-related quality of life (EORTC QLQ-C30), information and participation preferences, decisional conflicts, doctor-patient communication, health literacy and symptom perception. Absolute standardized mean difference was calculated as a standardized effect size to test baseline characteristics balance between the intervention and control groups.

resultsThe study enrolled 362 patients, 150 in the intervention and 212 in the control group. Except for gender, both groups differed in relevant socio-demographic characteristics, e.g. regarding age and educational background. With respect to the distribution of diagnoses, the intervention group showed a higher symptom burden than the control group. Moreover, the control group reported better quality of life at baseline compared to the intervention group (52.6 points (SD 21.7); 47.8 points (SD 22.0), ASMD = 0.218, p = 0.044).

conclusionOverall, the intervention group showed more social and health vulnerability than the control group. Among other factors, the wide range of diagnoses included and structural variation between the recruiting clinics increased the risk for bias. We recommend a close, continuous monitoring of relevant social and health-related characteristics during the recruitment phase as well as the use of appropriate statistical analysis strategies for adjustment, such as propensity score methods.

trial registrationGerman Clinical Trials Register (DRKS-ID: DRKS00013640 ); registered on 29th December 2017.

Indexed as

Health LiteracyNeoplasmsCommunicationHumansQuality of LifeSocial SupportAdvanced cancerIntervention studyNurse supportPatient-reported outcomesQuality of lifeRecruitment phaseSelection effectsStudy participation

Identifiers

PMID35585571
PMCPMC9118792

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.