scholarly journals Systematic Review of Percutaneous Lumbar Mechanical Disc Decompression Utilizing Dekompressor

2009 ◽  
Vol 3;12 (3;5) ◽  
pp. 589-599 ◽  
Author(s):  
Vijay Singh
Keyword(s):  
Systematic Review ◽  
Outcome Measures ◽  
Systematic Reviews ◽  
Literature Search ◽  
Lumbar Disc ◽  
Cochrane Library ◽  
Level Of Evidence ◽  
Disc Protrusion ◽  
One Year

Background: In recent years, a number of minimally invasive nuclear decompression techniques for lumbar disc prolapse, protrusion, and/or herniation have been introduced, including the Dekompressor® a device utilizing an Archimedes screw. The primary goal of the surgical treatment of nerve root compression from a disc protrusion continues to be the relief of compression by removing the herniated nuclear material with open discectomy. However, poor results have been reported for contained disc herniations with open surgical interventions. The results with several alternative techniques including the Dekompressor, automated percutaneous discectomy, and laser discectomy have been described, but are not convincing. There is a paucity of evidence for all decompression techniques. Study Design: A systematic review of the mechanical disc decompression with Dekompressor literature. Objective: The objective of this systematic review is to evaluate the clinical effectiveness of the Dekompressor, a high rotation per minute device utilizing an Archimedes screw, used in mechanical lumbar disc decompression. Methods: The literature search was conducted utilizing a comprehensive strategy for mechanical disc decompression utilizing the Dekompressor. A literature search was conducted using only English language literature in a comprehensive search of databases including PubMed, EMBASE, the Cochrane Library, along with systematic reviews, and cross-references from reviews, systematic reviews, and individual articles. The quality of the manuscripts included was evaluated according to Cochrane review criteria for randomized controlled trials (RCTs), and for observational studies with the criteria developed by the Agency for Healthcare Research and Quality (AHRQ). The level of evidence developed by the United States Preventive Services Task Force (USPSTF) was utilized in this review. The evidence was classified as Level I, II, or III with 3 subcategories in Level II for a total of 5 levels of evidence. Outcome Measures: Pain relief was the primary outcome measure. Other outcome measures were functional improvement, improvement of psychological status, opioid intake, and return to work. Short-term effectiveness was defined as one year or less, whereas, long-term effectiveness was defined as greater than one year. Results: Based on USPSTF criteria the indicated level of evidence for the mechanical high RPM device or Dekompressor is Level III for short- and long-term relief. Limitations: Lack of literature, both randomized and observational. Conclusion: This systematic review illustrates Level III evidence for mechanical percutaneous disc decompression procedures with the high RPM device or Dekompressor. Key words: Intervertebral disc disease, chronic low back pain, mechanical disc decompression, disc protrusion, disc extrusion, radiculitis, and mechanical high RPM device, Dekompressor

scholarly journals Percutaneous Lumbar Laser Disc Decompression: A Systematic Review of Current Evidence

2009 ◽  
Vol 3;12 (3;5) ◽  
pp. 573-588
Author(s):  
Vijay Singh
Keyword(s):  
Systematic Review ◽  
Intervertebral Disc ◽  
Outcome Measures ◽  
Disc Herniation ◽  
Systematic Reviews ◽  
Level Of Evidence ◽  
Laser Disc ◽  
Level Ii ◽  
One Year

Background: Since the descriptions by Mixter and Barr of open surgical treatment for rupture of the intervertebral disc in 1934, open surgical procedures have become a common practice. Disc herniations have been reported as being contained and non-contained. The results of open surgical discectomy for contained disc herniation have been poor. Consequently, several alternative techniques have been developed which are minimally invasive including percutaneous laser disc decompression. Study Design: A systematic review of the literature. Objective: The objective of this systematic review is to evaluate the clinical effectiveness of percutaneous laser discectomy in managing radicular pain secondary to contained disc herniation. Methods: A comprehensive evaluation of the literature relating to mechanical disc decompression was performed. The literature was evaluated according to Cochrane review criteria for randomized controlled trials (RCTs), and Agency for Healthcare Research and Quality (AHRQ) criteria was utilized for observational studies. A literature search was conducted by using only the English language literature through PubMed, EMBASE, the Cochrane library, systematic reviews, and cross references from reviews and systematic reviews. The level of evidence was classified as Level I, II, or III with 3 subcategories in Level II based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF). Outcome Measures: Pain relief was the primary outcome measure. Other outcome measures were functional improvement, improvement of psychological status, opioid intake, and return to work. Short-term effectiveness was defined as one year or less, whereas, long-term effectiveness was defined as greater than one year. Results: Based on USPSTF criteria the indicated level of evidence for percutaneous lumbar laser discectomy (PLLD) is II-2 for short- and long-term relief. Limitations: Even though laser discectomy has been in utilization for a number of years and numerous procedures have been performed there continues to be a paucity of literature of randomized clinical trials. Conclusion: This systematic review illustrates Level II-2 evidence for percutaneous laser disc decompression which is equivalent to automated percutaneous lumbar disc decompression. Key words: Intervertebral disc disease, chronic low back pain, disc herniation, disc protrusion, radiculitis, contained disc herniation, mechanical disc decompression, percutaneous lumbar laser discectomy, laser assisted spinal endoscopy

scholarly journals Percutaneous Lumbar Mechanical Disc Decompression Utilizing Dekompressor®: An Update of Current Evidence

2013 ◽  
Vol 2s;16 (2s;4) ◽  
pp. SE1-SE24 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Systematic Review ◽  
Outcome Measures ◽  
Lumbar Disc ◽  
Psychological Status ◽  
Current Evidence ◽  
Secondary Outcome ◽  
Low Back ◽  
Level Of Evidence ◽  
Disc Protrusion ◽  
One Year

Background: The primary goal of the surgical treatment of nerve root compression from a disc protrusion continues to be the relief of compression by removing the herniated nuclear material with open discectomy. However, poor results have been reported for contained disc herniations with open surgical interventions. In recent years, a number of minimally invasive nuclear decompression techniques for lumbar disc prolapse, protrusion, and/or herniation have been introduced, including the Dekompressor®. The efficacy of several alternative techniques, including the Dekompressor, automated percutaneous discectomy, and laser discectomy, has been described, but is not convincing. There is a continued paucity of evidence for all decompression techniques. Objective: The objective of this systematic review is to evaluate and update the literature describing the clinical effectiveness of Dekompressor, a high rotation per minute (RPM) device used in mechanical lumbar disc decompression. Study Design: A systematic review of the literature focusing on mechanical disc decompression with Dekompressor. Methods: The available literature on the use of percutaneous disc decompression (PDD) with Dekompressor to manage chronic low back and lower extremity pain was reviewed using the Cochrane Musculoskeletal Review Group criteria for randomized trials and the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor based on the US Preventive Services Task Force (USPSTF) system for grading the quality of evidence. Data sources included relevant literature identified through PubMed and EMBASE from 1966 through September 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: Pain relief was the primary outcome measure. Secondary outcome measures were functional improvement, improvement of psychological status, opioid intake, and return to work. Short-term effectiveness was defined as one year or less. Long-term effectiveness was defined as greater than one year. Results: Only 5 studies were considered for inclusion. Of those, only 3 of them met inclusion criteria. Based on USPSTF criteria, the level of evidence for PDD with Dekompressor is limited. Limitations: Paucity of high quality literature. Conclusion: This systematic review found limited evidence for PDD with Dekompressor. Key words: Intervertebral disc disease, chronic low back pain, mechanical disc decompression, disc protrusion, disc extrusion, radiculitis, Dekompressor.

scholarly journals Percutaneous Lumbar Laser Disc Decompression: An Update of Current Evidence

2013 ◽  
Vol 2s;16 (2s;4) ◽  
pp. SE229-SE260
Author(s):  
Vijay Singh
Keyword(s):  
Systematic Review ◽  
Intervertebral Disc ◽  
Outcome Measures ◽  
Disc Herniation ◽  
Current Evidence ◽  
Low Back ◽  
Level Of Evidence ◽  
Laser Disc ◽  
One Year

Background: Since the descriptions by Mixter and Barr of surgical treatment for rupture of the intervertebral disc in 1934, open surgical procedures have become a common practice. Disc herniations are often classified as being contained or non-contained. The results of open surgical discectomy for contained disc herniation have been poor. Consequently, several less invasive techniques have been developed including percutaneous lumbar laser disc decompression. Study Design: A systematic review of the literature of percutaneous lumbar laser disc decompression. Objective: The objective of this systematic review is to evaluate and update the clinical effectiveness of percutaneous lumbar laser discectomy in managing radicular pain secondary to contained disc herniation. Methods: The available literature on lumbar laser disc decompression in managing chronic low back and lower extremity pain was reviewed. Quality assessment and clinical relevance of randomized trials were graded according to the Cochrane Musculoskeletal Review Group criteria for interventional techniques, and observational studies according to the Newcastle-Ottawa Scale criteria. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: Pain relief was the primary outcome measure. Other outcome measures were functional improvement, improvement of psychological status, opioid intake, and return-to-work. Short-term effectiveness was defined as effectiveness lasting one year or less, whereas, long-term effectiveness was defined as benefit persisting for greater than one year. Results: Based on USPSTF criteria, the indicated level of evidence for percutaneous lumbar laser disc decompression is limited for short- and long-term relief. Limitations: Although laser discectomy has been utilized for many years, there is a paucity of randomized clinical trials. Conclusion: This systematic review shows limited evidence for percutaneous lumbar laser disc decompression. Key words: Intervertebral disc disease, chronic low back pain, disc herniation, disc protrusion, radiculitis, contained disc herniation, mechanical disc decompression, percutaneous lumbar laser discectomy, laser assisted spinal endoscopy

scholarly journals An Update of the Systematic Assessment of Mechanical Lumbar Disc Decompression with Nucleoplasty

2013 ◽  
Vol 2s;16 (2s;4) ◽  
pp. SE25-SE54 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Systematic Review ◽  
Outcome Measures ◽  
Disc Herniation ◽  
Observational Studies ◽  
Lumbar Disc ◽  
Radicular Pain ◽  
Low Back ◽  
Level Of Evidence ◽  
Alternative Techniques ◽  
One Year

Background: Lumbar disc prolapse, protrusion, and extrusion account for less than 5% of all low back problems, but are the most common causes of nerve root pain and surgical interventions. The primary rationale for any form of surgery for disc prolapse is to relieve nerve root irritation or compression due to herniated disc material. The primary modality of treatment continues to be either open or microdiscectomy, although several alternative techniques are also utilized, including nucleoplasty, automated percutaneous discectomy and laser discectomy. There is a paucity of evidence for all decompression techniques, specifically alternative techniques including nucleoplasty. Study Design: A systematic review of the literature of mechanical lumbar disc decompression with nucleoplasty. Objective: To determine the effectiveness and update the effectiveness of mechanical lumbar disc decompression with nucleoplasty. Methods: The available literature on mechanical lumbar disc decompression with nucleoplasty was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: Pain relief and functional improvement were the primary outcome measures. Other outcome measures were improvement of psychological status, reduction in opioid intake, and return to work. Short-term effectiveness was defined as one year or less, whereas long-term effectiveness was defined as greater than one year. Results: For this systematic review, 37 studies were considered for inclusion. Of these, there was one randomized trial and 14 observational studies meeting inclusion criteria for methodological quality assessment. Based on USPSTF criteria, the level of evidence for nucleoplasty is limited to fair in managing radicular pain due to contained disc herniation. Limitations: A paucity of literature with randomized trials. Conclusion: This systematic review illustrates limited to fair evidence for nucleoplasty in managing radicular pain due to contained disc herniation. Key words: Intervertebral disc disease, chronic low back pain, disc herniation, disc protrusion, radiculitis, contained disc herniation, mechanical disc decompression, nucleoplasty, Coblation technology, nucleotomy

scholarly journals The efficacy of systemic antibiotics as an adjunct to surgical treatment of peri-implantitis: a systematic review

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Malene Øen ◽  
Knut N. Leknes ◽  
Bodil Lund ◽  
Dagmar F. Bunæs
Keyword(s):  
Systematic Review ◽  
Surgical Treatment ◽  
Systematic Reviews ◽  
Randomised Controlled Trials ◽  
Literature Search ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
Systemic Antibiotics

Abstract Background Microbial biofilm accumulation is the main cause of peri-implantitis. The majority of surgical peri-implantitis treatment protocols suggests adjunctive use of systemic antibiotics to target specific putative bacteria. The aim of this systematic review was to critically evaluate the adjunctive use of systemically administered antibiotics in surgical treatment of peri-implantitis by reviewing previously published systematic reviews and primary studies. Methods A systematic literature search was conducted in four electronic databases (MEDLINE, The Cochrane Library, EMBASE, and Web of Science) for randomised controlled trials, cohort studies, case–control studies, and systematic reviews reporting surgical treatment of peri-implantitis with and without adjunctive systemically administered antibiotic therapy. The included systematic reviews and primary studies were qualitatively assessed using AMSTAR and GRADE, respectively. No restrictions were set for date of publication, journal, or language. Results The literature search identified 681 papers. Only seven systematic reviews and two primary studies met the inclusion criteria. Four out of seven included systematic reviews concluded that no evidence exists for use of systemic antibiotics to improve the clinical outcomes in surgical treatment of peri-implantitis. One review did not estimate the level of evidence, one did not clearly state any beneficial effect, whereas one reported a limited adjunctive effect. Further, the two included primary studies did not show a long-term significant benefit of adjunctive use of systemically administrated antibiotics. However, one study reported a short-term adjunctive effect in patients with modified surface implants. Due to heterogeneity in study design, low number of included primary studies, and grade of bias, no meta-analysis was performed. Conclusion The use of systemically administered antibiotics as an adjunct to surgical interventions of peri-implantitis cannot be justified as a part of a standard treatment protocol. A pervasive problem is the lack of uniform diagnosis criteria for peri-implantitis, deficient information about patient characteristics, absence of high quality long-term randomised controlled trials, and authors’ declaration on conflict of interest.

scholarly journals The effect of hemodilution on free flap survival: A systematic review of clinical and experimental studies

2020 ◽  
Vol 75 (4) ◽  
pp. 457-466
Author(s):  
Matteo Amoroso ◽  
Peter Apelgren ◽  
Anna Elander ◽  
Karin Säljö ◽  
Lars Kölby
Keyword(s):  
Systematic Review ◽  
Literature Search ◽  
Experimental Studies ◽  
Free Flaps ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Level Of Evidence ◽  
Grade Scale ◽  
Reconstructive Microsurgery ◽  
The Cochrane Library

BACKGROUND: Acute normovolemic hemodilution (ANH) has been proposed as a microsurgical technique to improve blood flow in free flaps. OBJECTIVE: Here, we present the first systematic review of clinical and experimental studies on the effect of ANH. METHODS: We performed a systematic literature search of PubMed, Medline, the Cochrane Library, Google Scholar, and ClinicalTrials.gov using search strategies and a review process in agreement with the PRISMA statement and the Cochrane Handbook for systematic reviews of interventions. PICO criteria were defined before bibliometric processing of the retrieved articles, which were analyzed with the SYRCLE RoB tool for risk of bias and the GRADE scale for level of evidence. RESULTS: We retrieved 74 articles from the literature search, and after processing according to PICO criteria, only four articles remained, all of which were experimental. The rating for risk of bias was uncertain according to SYRCLE RoB results, and the level of evidence was low according to GRADE evaluation. CONCLUSIONS: There is no clinical evidence for the effect of ANH on microcirculation in free flaps, and experimental studies provide weak evidence supporting the use of hemodilution in reconstructive microsurgery.

scholarly journals Generic Patient-Reported Outcomes and Outcome Measures: A Systematic Review Study Protocol

2021 ◽  
Author(s):  
Yuki Seidler ◽  
Erika Mosor ◽  
Margaret R Andrews ◽  
Carolina Watson ◽  
Nick Bott ◽  
...  
Keyword(s):  
Systematic Review ◽  
Outcome Measures ◽  
Systematic Reviews ◽  
Patient Reported Outcomes ◽  
Outcome Measurement ◽  
Meta Analysis ◽  
Patient Reported Outcome ◽  
Cochrane Library ◽  
Screening Process ◽  
Patient Reported

Background: Patient-reported outcomes (PROs) are an essential part of health outcome measurement and vital to patient-centricity and valued-based care. Several international consortia have developed core outcome sets and many of them include PROs. PROs are measured by patient-reported outcome measures (PROMs). PROs and PROMs can be generic or specific to certain diseases or conditions. While the characteristics of generic PROs and PROMs are well recognised as widely relevant and applicable across different domains, diseases and conditions, there is a lack of knowledge on the types of PROs measured by generic PROMs. We also do not know in which disease areas generic PROs and PROMs are commonly used. To date, there has been no systematic review solely focusing on generic PROMs, what they measure and their areas of application. Objectives: This systematic review will identify core PROs measured by generic PROMs used in adult populations and the areas in which they are applied. Methods: We will conduct a systematic review of reviews. The screening process and the reporting will comply with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) 2020 Statement. We will use four databases, Medline [PubMed], CINHAL [Ebsco], Cochrane [Cochrane Library], and PsycINFO [Ovid], and reports from international consortia. Inclusion criteria are systematic reviews, meta-analysis or patient-reported outcome sets developed by international consortia reporting on generic PROMs in adult populations. Articles primarily focusing on patient-reported experience measures (PREMs), children or adolescents, or those not written in English will be excluded. Risk of bias will be assessed by checking if the included articles comply with established guidelines for systematic reviews such as the PRISMA statement. We will extract generic PROMs and PROs measured by these PROMs, and the areas applied from the selected articles and reports. Extracted data and information will be quantitatively and qualitatively synthesised without statistical interference. The quality of the synthesised evidences will be assessed by clarifying the strengths, limitations and possible biases in our review.

scholarly journals A Systematic Review of Randomized Trials of Long-Term Opioid Management for Chronic Non-Cancer Pain

2011 ◽  
Vol 3;14 (2;3) ◽  
pp. 91-121
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Systematic Review ◽  
Cancer Pain ◽  
Systematic Reviews ◽  
Randomized Trials ◽  
Opioid Therapy ◽  
Functional Improvement ◽  
Controlled Trials ◽  
Chronic Opioid Therapy ◽  
Level Of Evidence

Background: Even though opioids have been used for pain for thousands of years, opioid therapy for chronic non-cancer pain is controversial due to concerns regarding the long-term effectiveness and safety, particularly the risk of tolerance, dependance, or abuse. While the debate continues, the use of chronic opioid therapy for chronic non-cancer pain has increased exponentially. Even though evidence is limited, multiple expert panels have concluded that chronic opioid therapy can be effective therapy for carefully selected and monitored patients with chronic non-cancer pain. Study Design: A systematic review of randomized trials of opioid management for chronic noncancer pain. Objective: The objective of this systematic review is to evaluate the clinical efficacy of opioids in the treatment of chronic non-cancer pain. Methods: A comprehensive evaluation of the literature relating to opioids in chronic non-cancer pain was performed. The literature was evaluated according to Cochrane review criteria for randomized controlled trials (RCTs) and Jadad criteria. A literature search was conducted by using PubMed, EMBASE, Cochrane library, ECRI Institute Library, U.S. Food and Drug Administration (FDA) website, U.S. National Guideline Clearinghouse (NGC), Database of Abstracts of Reviews of Effectiveness (DARE), clinical trials, systematic reviews and cross references from systematic reviews. The level of evidence was classified as good, fair, or poor based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF) and used by other systematic reviews and guidelines. Outcome Measures: Pain relief was the primary outcome measure. Other outcome measures were functional improvement, withdrawals, and adverse effects. Results: Based on the USPSTF criteria, the indicated level of evidence was fair for Tramadol in managing osteoarthritis. For all the drugs assessed, including Tramadol, for all other conditions, the evidence was poor based on either weak positive evidence, indeterminate evidence, or negative evidence. Limitations: A paucity of literature, specifically with follow-up beyond 12 weeks for all types of opioids with controlled trials for various chronic non-cancer pain conditions. Conclusions: This systematic review illustrated fair evidence for Tramadol in managing osteoarthritis with poor evidence for all other drugs and conditions. Thus, recommendations must be based on non-randomized studies. Key words: Chronic non-cancer pain, opioids, opioid efficacy, opioid effectiveness, significant pain relief, functional improvement, adverse effects, morphine, hydrocodone, hydromorphone, fentanyl, tramadol, buprenorphine, methadone, tapentadol, oxycodone, oxymorphone, systematic reviews, randomized trials

Oral Status of Elderly Patients in Long-Term Care Facilities: A Systematic Review

2020 ◽  
Author(s):  
Juan Antonio Ruiz-Roca ◽  
Dora Martin-Fuentes ◽  
Yolanda Martinez-Beneyto ◽  
Ricardo Elias Oñate-Sanchez
Keyword(s):  
Systematic Review ◽  
Health Status ◽  
Oral Health ◽  
Elderly Patients ◽  
Soft Tissues ◽  
Oral Health Status ◽  
Cochrane Library ◽  
Level Of Evidence ◽  
Term Care

Abstract Background: elderly patients who spend long periods hospitalised or those who are in a situation of institutionalisation represent a risk group in this regard, since many of them suffer a degree of dependence and need help to perform the basic personal care tasks. It is therefore important to learn more about the oral health status of this group of patients in order to make a proper assessment of the situation as well as to develop protocols for its management. The purpose of this study was to conduct a systematic review to ascertain the oral health status of elderly patients institutionalised or hospitalised for a long period of time.Methods: a systematic review of the literature published in three different databases (PubMed, Embase and Cochrane Library) was conducted, with 12 different combinations of keywords based on the following selection criteria: studies published in the last 5 years, in English and/or Spanish and/or Portuguese, with samples of ≥30 patients, performed in patients older than 65 years, admitted to any type of institution and/or care centre for at least 7 days and in which the state of hard and/or soft tissues of the oral cavity were assessed in some way. The selected articles were subjected to a thorough analysis.Results: The search strategy covered 1,014 articles: 689 from Pubmed and 325 from Cochrane Library. After applying the eligibility criteria, five articles were selected for our review. The level of evidence of the articles was3, with a sample consisting of 773 patients in which most of them were women with an average age older than 70 years old.Conclusions: the oral health of patients aged more than 65 is worse than that of the rest of the population. Long-term in hospitals or being institutionalised in a retirement home makes this group susceptible to a worsening of their oral health status. It is necessary to develop protocols for the oral health care of these patients, accompanied by training programmes for the personnel.

scholarly journals Patient-Reported Outcome Measures in Cystic Fibrosis: Protocol for a Systematic Review (Preprint)

2019 ◽  
Author(s):  
Irushi Ratnayake ◽  
Susannah Ahern ◽  
Rasa Ruseckaite
Keyword(s):  
Systematic Review ◽  
Cystic Fibrosis ◽  
Outcome Measures ◽  
Systematic Reviews ◽  
Pediatric Patients ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Cochrane Library ◽  
Patient Reported

BACKGROUND Patients with cystic fibrosis (CF) can struggle with burdensome symptoms and treatment regimens that negatively affect every aspect of their life. As physiological parameters can fail to capture these complications, the assessment of health-related quality of life (HRQOL) has gained prominence. HRQOL can be measured using standardized patient questionnaires called patient-reported outcome measures (PROMs). The Australian Cystic Fibrosis Data Registry (ACFDR) collects clinical data on adult and pediatric patients with CF. The incorporation of PROMs into the ACFDR would enable monitoring of HRQOL trends, benchmarking of HRQOL outcomes, and support of HRQOL research in CF. OBJECTIVE Prior to incorporation of a PROM in the ACFDR, this systematic review was planned to evaluate whether any suitable PROMs are currently being used for CF. METHODS This systematic review will be conducted in compliance with the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines. MEDLINE, EMBASE, Scopus, CINAHL (Cumulative Index of Nursing and Allied Health Literature), PsycINFO, and Cochrane Library databases were searched for articles published between January 2009 and February 2019 on the use of PROMs to measure HRQOL in adult and pediatric patients with CF. Study designs such as observational studies, reviews and validation studies were included. Studies describing randomized controlled trials, dissertations, books, guideline statements, and abstracts were excluded. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist was used to assess the methodological quality of included studies. A descriptive synthesis of the results will be undertaken in line with the outcomes of this study. RESULTS As of July 2019, the search has been conducted and 4530 records were screened. After two phases of screening, 97 studies were included in the final review and subjected to data extraction. Reviewers are currently in the process of critical appraisal. CONCLUSIONS This review will identify any PROM(s) that may be used to measure HRQOL in the ACFDR. CLINICALTRIAL PROSPERO International Prospective Register of Systematic Reviews CRD42019126931; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=126931

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