Heterogeneity of outcome measures in the clinical trials of treatment for oral submucous fibrosis‐ Systematic review

Oral Diseases ◽  
2021 ◽  
Author(s):  
Shailesh M. Gondivkar ◽  
Monal Yuwanati ◽  
Sachin C. Sarode ◽  
Amol R. Gadbail ◽  
Rima S. Gondivkar
2014 ◽  
Vol 15 (6) ◽  
pp. 812-817 ◽  
Author(s):  
Kamran Habib Awan ◽  
Syed Rashid Habib ◽  
Ana Pejcic ◽  
Rosnah Binti Zain

ABSTRACT Oral submucous fibrosis is a chronic, progressive scarring disease associated with both significant morbidity including pain and limited mouth opening and an increased risk for malignancy. This systematic review evaluated the different medicinal (i.e. nonsurgical) interventions available for the management of oral submucous fibrosis. An automated literature searches of online databases from January 1960 to December 2013 were performed and only studies with high level of evidence based on the guidelines of the Oxford Centre for evidence-based medicine were selected. Thirteen studies (3 randomized controlled trials and 10 clinical trials/controlled clinical trials) were included and drugs like steroids, hyaluronidase, human placenta extracts, chymotrypsin and collagenase, pentoxifylline, nylidrin hydrochloride, iron and multivitamin supplements including lycopene were used. There is a clear lack of evidence on the available drug treatment for oral submucous fibrosis and further high quality randomized controlled trials are needed to evaluate the different therapeutic agents. How to cite this article Awan KH, Patil S, Habib SR, Pejcic A, Zain RB. Evaluation of Medicinal Interventions for the Management of Oral Submucous Fibrosis: A Systematic Review of the Literature. J Contemp Dent Pract 2014;15(6):812-817.


BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e018270 ◽  
Author(s):  
Lindsey J Glaspey ◽  
Michael B Roberts ◽  
Anthony Mazzarelli ◽  
Stephen Trzeciak ◽  
Brian W Roberts

IntroductionPost-traumatic stress disorder (PTSD) is being increasingly reported among survivors of critical illness and injury. Previous work has demonstrated that PTSD reduces patient quality of life and ability to return to work, as well as increases healthcare costs. As such, identifying interventions aimed at preventing the development of critical illness-related PTSD could have an important public health impact. The objective of this systematic review is to collate the world’s literature on early interventions aimed at preventing PTSD among survivors of critical illness.Methods and analysisWe will perform a qualitative systematic review of human clinical trials of interventions aimed at preventing or reducing critical illness-related PTSD symptoms. We will methodically search CENTRAL, MEDLINE, Embase and CINAHL. We will also search websites containing details on clinical trials registration (National Library of Medicine’s ClinicalTrials.gov and the WHO’s International Clinical Trials Registry Platform), as well as screen reference lists of the articles we select for inclusion to identify additional studies for potential inclusion. Two authors will independently review all search results. After identification and inclusion of articles, we will use a standardised form for data extraction. We will use tables to describe the study type, populations, interventions tested and timing of interventions, outcome measures and effects of interventions on outcome measures compared with control groups. This review will be completed between 1 August 2017 and 31 August 2017.Ethics and disseminationThe proposed systematic review will not collect individual patient level data and does not require ethical approval. Results of this study will contribute to the understanding of critical illness-related PTSD and help prompt future research aimed at further developing interventions to prevent PTSD symptoms in survivors of critical illness.PROSPERO registration numberThis systematic review is registered in the PROSPERO international prospective register of systematic reviews (registration number CRD42017069672).


2020 ◽  
Vol 6 (4) ◽  
pp. 234-242
Author(s):  
Yang Chen ◽  
Myura Nagendran ◽  
Manuel Gomes ◽  
Peter V Wharton ◽  
Rosalind Raine ◽  
...  

Abstract The aim of this systematic review was to evaluate randomized clinical trials (RCTs) of cardiac catheter ablation (CCA) and to assess the prevalence, characteristics and reporting standards of clinically relevant patient-reported outcome measures (PROMs). Electronic database searches of Medline, Embase, CENTRAL, and the WHO Trial Registry were conducted in March 2019. The study protocol was registered on PROSPERO (CRD42019133086). Of 7125 records identified, 237 RCTs were included for analysis, representing 35 427 patients with a mean age of 59 years. Only 43 RCTs (18%) reported PROMs of which 27 included a generic PROM that measured health-related quality of life (HRQL) necessary to conduct comparative effectiveness research. There was notable under-representation of certain patient groups—only 31% were women and only 8% were of non-Caucasian ethnicity, in trials which reported such data. The reporting standard of PROMs was highly variable with 8–62% adherence against CONSORT PRO-specific items. In summary, PROMs play a crucial role in determining the clinical and cost-effectiveness of treatments which primarily offer symptomatic improvement, such as CCA. Their underuse significantly limits evaluation of the comparative effectiveness of treatments. Using CCA as an exemplar, there are additional issues of infrequent assessment, poor reporting and under-representation of many population groups. Greater use of PROMs, and specifically validated HRQL questionnaires, is paramount in giving patients a voice in studies, generating more meaningful comparisons between treatments and driving better patient-centred clinical and policy-level decision-making.


2021 ◽  
Vol 0 (0) ◽  
pp. 0
Author(s):  
Arpita Rai ◽  
Neeta Kumar ◽  
Shashi Sharma ◽  
Saba Parveen ◽  
Abdur Rasheed

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