External Criterion

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Piotr H. Skarzynski - One of the best experts on this subject based on the ideXlab platform.

  • Clinically important change in tinnitus sensation after stapedotomy.
    Health and quality of life outcomes, 2018
    Co-Authors: Henryk Skarzynski, Beata Dziendziel, Elżbieta Gos, Danuta Raj-koziak, Elżbieta Włodarczyk, Piotr H. Skarzynski
    Abstract:

    When measuring the treatment effect in tinnitus with multi-item outcome instruments, it is crucial for both clinical and research purposes to take into consideration clinical importance of the outcome scores. The aim of the present study is to determine minimal important change (MIC) in tinnitus which is clinically meaningful to patients with otosclerosis. The study population was 95 patients with otosclerosis, suffering from tinnitus. They completed the Tinnitus Functional Index before stapedotomy and 3 months after the surgery. The minimal important change was estimated with the Clinical Global Impression Scale as the External Criterion (anchor). The mean change method and the receiver operating characteristic (ROC) method were used to determine minimal important change in tinnitus sensation. The improvement in tinnitus after stapedotomy was reported by 69.4% of the patients with otosclerosis. Minimal important change in tinnitus was estimated as reduction of 8.8 points in the Tinnitus Functional Index. The anchor-based approach using an External Criterion (anchor) allows to determine change in tinnitus sensation which is meaningful to patients after stapedotomy. The value of 8.8 points in Tinnitus Functional Index could be used as benchmark of stapedotomy effectiveness in otosclerosis patients suffering from tinnitus. Hearing difficulties comorbid with tinnitus could affect the perception of tinnitus change.

Henryk Skarzynski - One of the best experts on this subject based on the ideXlab platform.

  • Clinically important change in tinnitus sensation after stapedotomy.
    Health and quality of life outcomes, 2018
    Co-Authors: Henryk Skarzynski, Beata Dziendziel, Elżbieta Gos, Danuta Raj-koziak, Elżbieta Włodarczyk, Piotr H. Skarzynski
    Abstract:

    When measuring the treatment effect in tinnitus with multi-item outcome instruments, it is crucial for both clinical and research purposes to take into consideration clinical importance of the outcome scores. The aim of the present study is to determine minimal important change (MIC) in tinnitus which is clinically meaningful to patients with otosclerosis. The study population was 95 patients with otosclerosis, suffering from tinnitus. They completed the Tinnitus Functional Index before stapedotomy and 3 months after the surgery. The minimal important change was estimated with the Clinical Global Impression Scale as the External Criterion (anchor). The mean change method and the receiver operating characteristic (ROC) method were used to determine minimal important change in tinnitus sensation. The improvement in tinnitus after stapedotomy was reported by 69.4% of the patients with otosclerosis. Minimal important change in tinnitus was estimated as reduction of 8.8 points in the Tinnitus Functional Index. The anchor-based approach using an External Criterion (anchor) allows to determine change in tinnitus sensation which is meaningful to patients after stapedotomy. The value of 8.8 points in Tinnitus Functional Index could be used as benchmark of stapedotomy effectiveness in otosclerosis patients suffering from tinnitus. Hearing difficulties comorbid with tinnitus could affect the perception of tinnitus change.

Berrie Middel - One of the best experts on this subject based on the ideXlab platform.

  • how to validate clinically important change in health related functional status is the magnitude of the effect size consistently related to magnitude of change as indicated by a global question rating
    Journal of Evaluation in Clinical Practice, 2001
    Co-Authors: Berrie Middel, Roy E Stewart, J Bouma, Eric Van Sonderen, Wim J A Van Den Heuvel
    Abstract:

    Some clinical trials perform repeated measurement over time and estimate clinically relevant change in an instrument's score with global ratings of perceived change or so-called transition questions. The conceptual and methodological difficulties in estimating the magnitude of clinically relevant change over time in health-related functional status (HRFS) are discussed. This paper investigates the concordance between the amount of serially assessed change with effect size estimates (the researcher's perspective) and global ratings of perceived change (the patient's perspective). A total of 217 patients who were scheduled for diagnostic examination were included, and the Minnesota Living with Heart Failure Questionnaire, extended with MOS-20 items, was assessed before and after medical intervention (percutaneous transluminal coronary angioplasty, coronary artery bypass grafting or pharmaco-therapy). Global questions were applied to assess perceived change over time for every item from domains of physical and emotional functioning and used as the External Criterion of relevant change in the analysis of items. Global questions corresponding with overall change in these domains were used in the comparison of change in physical and emotional functioning scales. Two effect size indices were used: (i) ES (mean change/SDpooled) and (ii) ES (mean change/SDchange). A method is described to calculate a value indicating the extent of discordance between the researcher's interpretation of magnitude of change and the External Criterion (the patient's perspective). Findings suggest that effect size (ES) (mean change/SDpooled) was in keeping with the magnitude of change indicated by patients' judgements, or their category of subjective meaning, for all scales. Furthermore, in cases in which the magnitude of change estimated with the SRM (mean change/SDchange) was not confirmed empirically by the External Criterion ratings, the discordance could be interpreted as a trivial discordance.

  • How to validate clinically important change in health‐related functional status. Is the magnitude of the effect size consistently related to magnitude of change as indicated by a global question rating?
    Journal of evaluation in clinical practice, 2001
    Co-Authors: Berrie Middel, Roy E Stewart, J Bouma, Van Eric Sonderen, Van Den Wim Heuvel
    Abstract:

    Some clinical trials perform repeated measurement over time and estimate clinically relevant change in an instrument's score with global ratings of perceived change or so-called transition questions. The conceptual and methodological difficulties in estimating the magnitude of clinically relevant change over time in health-related functional status (HRFS) are discussed. This paper investigates the concordance between the amount of serially assessed change with effect size estimates (the researcher's perspective) and global ratings of perceived change (the patient's perspective). A total of 217 patients who were scheduled for diagnostic examination were included, and the Minnesota Living with Heart Failure Questionnaire, extended with MOS-20 items, was assessed before and after medical intervention (percutaneous transluminal coronary angioplasty, coronary artery bypass grafting or pharmaco-therapy). Global questions were applied to assess perceived change over time for every item from domains of physical and emotional functioning and used as the External Criterion of relevant change in the analysis of items. Global questions corresponding with overall change in these domains were used in the comparison of change in physical and emotional functioning scales. Two effect size indices were used: (i) ES (mean change/SDpooled) and (ii) ES (mean change/SDchange). A method is described to calculate a value indicating the extent of discordance between the researcher's interpretation of magnitude of change and the External Criterion (the patient's perspective). Findings suggest that effect size (ES) (mean change/SDpooled) was in keeping with the magnitude of change indicated by patients' judgements, or their category of subjective meaning, for all scales. Furthermore, in cases in which the magnitude of change estimated with the SRM (mean change/SDchange) was not confirmed empirically by the External Criterion ratings, the discordance could be interpreted as a trivial discordance.

Elżbieta Włodarczyk - One of the best experts on this subject based on the ideXlab platform.

  • Clinically important change in tinnitus sensation after stapedotomy.
    Health and quality of life outcomes, 2018
    Co-Authors: Henryk Skarzynski, Beata Dziendziel, Elżbieta Gos, Danuta Raj-koziak, Elżbieta Włodarczyk, Piotr H. Skarzynski
    Abstract:

    When measuring the treatment effect in tinnitus with multi-item outcome instruments, it is crucial for both clinical and research purposes to take into consideration clinical importance of the outcome scores. The aim of the present study is to determine minimal important change (MIC) in tinnitus which is clinically meaningful to patients with otosclerosis. The study population was 95 patients with otosclerosis, suffering from tinnitus. They completed the Tinnitus Functional Index before stapedotomy and 3 months after the surgery. The minimal important change was estimated with the Clinical Global Impression Scale as the External Criterion (anchor). The mean change method and the receiver operating characteristic (ROC) method were used to determine minimal important change in tinnitus sensation. The improvement in tinnitus after stapedotomy was reported by 69.4% of the patients with otosclerosis. Minimal important change in tinnitus was estimated as reduction of 8.8 points in the Tinnitus Functional Index. The anchor-based approach using an External Criterion (anchor) allows to determine change in tinnitus sensation which is meaningful to patients after stapedotomy. The value of 8.8 points in Tinnitus Functional Index could be used as benchmark of stapedotomy effectiveness in otosclerosis patients suffering from tinnitus. Hearing difficulties comorbid with tinnitus could affect the perception of tinnitus change.

  • Clinically important change in tinnitus sensation after stapedotomy
    BMC, 2018
    Co-Authors: Henryk Skarżyński, Beata Dziendziel, Elżbieta Gos, Danuta Raj-koziak, Elżbieta Włodarczyk, Piotr H. Skarżyński
    Abstract:

    Abstract Background When measuring the treatment effect in tinnitus with multi-item outcome instruments, it is crucial for both clinical and research purposes to take into consideration clinical importance of the outcome scores. The aim of the present study is to determine minimal important change (MIC) in tinnitus which is clinically meaningful to patients with otosclerosis. Methods The study population was 95 patients with otosclerosis, suffering from tinnitus. They completed the Tinnitus Functional Index before stapedotomy and 3 months after the surgery. The minimal important change was estimated with the Clinical Global Impression Scale as the External Criterion (anchor). The mean change method and the receiver operating characteristic (ROC) method were used to determine minimal important change in tinnitus sensation. Results The improvement in tinnitus after stapedotomy was reported by 69.4% of the patients with otosclerosis. Minimal important change in tinnitus was estimated as reduction of 8.8 points in the Tinnitus Functional Index. Conclusions The anchor-based approach using an External Criterion (anchor) allows to determine change in tinnitus sensation which is meaningful to patients after stapedotomy. The value of 8.8 points in Tinnitus Functional Index could be used as benchmark of stapedotomy effectiveness in otosclerosis patients suffering from tinnitus. Hearing difficulties comorbid with tinnitus could affect the perception of tinnitus change

Danuta Raj-koziak - One of the best experts on this subject based on the ideXlab platform.

  • Clinically important change in tinnitus sensation after stapedotomy.
    Health and quality of life outcomes, 2018
    Co-Authors: Henryk Skarzynski, Beata Dziendziel, Elżbieta Gos, Danuta Raj-koziak, Elżbieta Włodarczyk, Piotr H. Skarzynski
    Abstract:

    When measuring the treatment effect in tinnitus with multi-item outcome instruments, it is crucial for both clinical and research purposes to take into consideration clinical importance of the outcome scores. The aim of the present study is to determine minimal important change (MIC) in tinnitus which is clinically meaningful to patients with otosclerosis. The study population was 95 patients with otosclerosis, suffering from tinnitus. They completed the Tinnitus Functional Index before stapedotomy and 3 months after the surgery. The minimal important change was estimated with the Clinical Global Impression Scale as the External Criterion (anchor). The mean change method and the receiver operating characteristic (ROC) method were used to determine minimal important change in tinnitus sensation. The improvement in tinnitus after stapedotomy was reported by 69.4% of the patients with otosclerosis. Minimal important change in tinnitus was estimated as reduction of 8.8 points in the Tinnitus Functional Index. The anchor-based approach using an External Criterion (anchor) allows to determine change in tinnitus sensation which is meaningful to patients after stapedotomy. The value of 8.8 points in Tinnitus Functional Index could be used as benchmark of stapedotomy effectiveness in otosclerosis patients suffering from tinnitus. Hearing difficulties comorbid with tinnitus could affect the perception of tinnitus change.

  • Clinically important change in tinnitus sensation after stapedotomy
    BMC, 2018
    Co-Authors: Henryk Skarżyński, Beata Dziendziel, Elżbieta Gos, Danuta Raj-koziak, Elżbieta Włodarczyk, Piotr H. Skarżyński
    Abstract:

    Abstract Background When measuring the treatment effect in tinnitus with multi-item outcome instruments, it is crucial for both clinical and research purposes to take into consideration clinical importance of the outcome scores. The aim of the present study is to determine minimal important change (MIC) in tinnitus which is clinically meaningful to patients with otosclerosis. Methods The study population was 95 patients with otosclerosis, suffering from tinnitus. They completed the Tinnitus Functional Index before stapedotomy and 3 months after the surgery. The minimal important change was estimated with the Clinical Global Impression Scale as the External Criterion (anchor). The mean change method and the receiver operating characteristic (ROC) method were used to determine minimal important change in tinnitus sensation. Results The improvement in tinnitus after stapedotomy was reported by 69.4% of the patients with otosclerosis. Minimal important change in tinnitus was estimated as reduction of 8.8 points in the Tinnitus Functional Index. Conclusions The anchor-based approach using an External Criterion (anchor) allows to determine change in tinnitus sensation which is meaningful to patients after stapedotomy. The value of 8.8 points in Tinnitus Functional Index could be used as benchmark of stapedotomy effectiveness in otosclerosis patients suffering from tinnitus. Hearing difficulties comorbid with tinnitus could affect the perception of tinnitus change