Abstract Introduction So far, little is known about the overall characteristics of the patients enrolled in studies comparing different treatment groups for negative symptoms of schizophrenia. The aim of this thesis is to examine the differences in the demographic, clinical and study design-related variables in those studies which address negative symptoms in schizophrenia and to compare those variables across five different treatment categories (pharmacological intervention with antipsychotics, other pharmacological agents, brain stimulation, psychological/psychosocial interventions, lifestyle interventions). Methods Mean age, male percentage and illness duration have been considered as clinical/demographic variables. Concerning study design, total sample, attrition bias, study quality, publication year and length of the trial in weeks have been taken into consideration. This pilot study presents the preliminary findings of the trials available up to December 31st, 2013. Results Major between groups differences have been found for the number of patients enrolled in each trial, mean attrition and trial duration. Other variables have shown minor or no significant divergences. Discussion These results have the potential to help the design of future research in the field and to reduce the possible selection bias for the population selected in each treatment category.
Sinossi Introduzione Finora si conosce poco circa le caratteristiche complessive dei pazienti arruolati in studi che comparano differenti gruppi di trattamento per i sintomi negativi della schizofrenia. Lo scopo di questa tesi è di esaminare le differenze in variabili demografiche, cliniche e relative al design dello studio nelle diverse ricerche condotte sui sintomi negativi della schizofrenia e, quindi, di comparare tali variabili in cinque diverse categorie di trattamento (interventi farmacologici con antipsicotici, altri agenti farmacologici, stimolazione cerebrale, interventi psicologici/psicosociali, interventi sullo stile di vita). Metodi Età media, percentuale di maschi e durata della malattia sono state considerate come variabili cliniche/demografiche. Circa il design dello studio, sono state prese in considerazione numerosità campionaria, attrition bias, qualità dello studio, anno di pubblicazione e durata dello studio in settimane. Questo studio pilota presenta i risultati preliminari delle ricerche disponibili fino al 31 Dicembre 2013. Risultati Differenze maggiori tra i gruppi sono state trovate per la numerosità campionaria dei pazienti arruolati in ogni studio, per il tasso di abbandono medio e per la durata degli studi clinici. Altre variabili hanno mostrato differenze minori o non significative. Discussione Questi risultati hanno il potenziale di contribuire al design di ricerche future nel campo e di ridurre il possibile bias di selezione per la popolazione allocata in ogni categoria di trattamento.
Validity of Randomised Clinical Trials for Negative Symptoms in Schizophrenia: a Systematic Review
D'IMPERIO, ALDO
2021/2022
Abstract
Abstract Introduction So far, little is known about the overall characteristics of the patients enrolled in studies comparing different treatment groups for negative symptoms of schizophrenia. The aim of this thesis is to examine the differences in the demographic, clinical and study design-related variables in those studies which address negative symptoms in schizophrenia and to compare those variables across five different treatment categories (pharmacological intervention with antipsychotics, other pharmacological agents, brain stimulation, psychological/psychosocial interventions, lifestyle interventions). Methods Mean age, male percentage and illness duration have been considered as clinical/demographic variables. Concerning study design, total sample, attrition bias, study quality, publication year and length of the trial in weeks have been taken into consideration. This pilot study presents the preliminary findings of the trials available up to December 31st, 2013. Results Major between groups differences have been found for the number of patients enrolled in each trial, mean attrition and trial duration. Other variables have shown minor or no significant divergences. Discussion These results have the potential to help the design of future research in the field and to reduce the possible selection bias for the population selected in each treatment category.È consentito all'utente scaricare e condividere i documenti disponibili a testo pieno in UNITESI UNIPV nel rispetto della licenza Creative Commons del tipo CC BY NC ND.
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https://hdl.handle.net/20.500.14239/14875