Keywords
scoliosis - waiting lists - spine - adolescent health - Unified Health System - systematic
review
Introduction
Adolescent idiopathic scoliosis (AIS) is a condition that can result in spinal pain
and trunk imbalance. AIS impacts the physical, psychological, and social health of
those affected.[1]
Current guidelines determine the treatment of spinal deformities within the Brazilian
Unified Health System (SUS, Sistema Único de Saúde).[2] Patients who need specialized care are referred via the system's network to accredited
referral centers for high-complexity care. The individuals are then evaluated by the
spine surgeon and, if the surgical procedure is indicated, they are placed on a waiting
list and wait until the treatment can be performed. Surgeries for AIS correction requires
time, experienced staff, technical resources, and expensive implants.[3]
[4]
[5]
[6] Additionally, due to the underfunding of surgeries for spinal deformities in the
public health system patients are subjected to constantly expanding waiting lists.[7]
[8] This long wait until definitive treatment is harmful to patients due to deformity
worsening, increased treatment cost, and negative effects on mental health and quality
of life.[9]
[10]
Rationale
For the cases of AIS requiring surgical correction, the time elapsed between surgical
indication and the proposed treatment may cause progression of the deformity, increase
the risk of complications, and impact the patient's quality of life. Therefore, it
is critical to investigate the effects of the delayed surgical treatment in these
patients and its consequences for SUS from a cost-effectiveness point of view. Since
there are no published systematic reviews or registered protocols on this topic, this
protocol has the novelty quality expected from a systematic review. Improvement of
high-complexity public health actions begins by collecting information on the health
status of a condition.[2] As such, future publications based on this protocol may point out potential priority
criteria to enhance the global health of AIS subjects and the management of Brazilian
public health financial resources.
The main objective of this systematic review is to synthesize the best available evidence
on the impacts of waiting for surgical correction of AIS and its repercussions for
SUS. The secondary objectives are to investigate the effects generated by the SUS
waiting list for AIS surgical correction, considering cost-effectiveness and quality
of life.
Methods
Research Questions
This study will answer the following question: What is the impact of the delayed surgical
correction of AIS considering costs and quality of life? The research question was
designed based on the acronym PICO,[11] in which P is the included population, I is the intervention or exposure, C is the
comparator, and O stands for outcomes. The population consists of subjects with AIS
who were referred to surgery and are on the waiting list for treatment. We will compare
their outcomes regarding treatment costs and quality of life to those presented by
subjects operated on earlier.
Eligibility Criteria
Eligibility criteria followed the research question, defined by the acronym PICO.[11] The articles selected for the systematic review must present a sample of male and
female AIS patients, aged from 10 to 18 years, referred to surgical treatment, and
placed on waiting lists.
Information Sources
Queries will occur in the following databases: MEDLINE (via PubMed), Embase, LILACS,
SciELO, Scopus, Web of Science, LIVIVO, Regional Portal of the Biblioteca Virtual
em Saúde (BVS), and Cochrane Library. A manual query will complement database searches
to include the gray literature and minimize publication bias. This manual query consists
of reading the bibliography of the papers and conducting additional research in the
Brazilian Digital Library of Theses and Dissertations (BDTD, Biblioteca Digital Brasileira
de Teses e Dissertações), Google Scholar, ClinicalTrials.gov, Brazilian Registry of
Clinical Trials (ReBEC, Registro Brasileiro de Ensaios Clínicos), and the OpenGrey
platform.
Search Strategy
The terms used in the search will include the following: waiting time, wait time, waiting list, wait list, delaying surgery, scoliosis, adolescent idiopathic scoliosis, and AIS. There were no limits regarding language and year of publication. Advanced searches
will employ the Boolean operators [OR] and [AND].
Two independent researchers will carry out the queries following the recommendations
of the Peer Review of Electronic Search Strategies (PRESS) protocol.[12] We will record the number of articles found in a Microsoft Excel table (Microsoft
Corp. Redmond, WA, USA), version 15.29.
Data Record
Two independent researchers will select the studies for systematic review. Selection
will occur in two stages. During the first phase, reviewers will choose potentially
relevant studies from titles and abstracts. In a second phase, they will read the
full text of the previously selected studies. Then, they will evaluate these papers
according to the eligibility criteria.
A third party, an expert in the subject, will solve any disagreements by consensus
with the remaining researchers. In addition to that, we will use the Mendeley (Mendeley,
London, UK) reference manager, available as an online application, to avoid duplication
and facilitate file sharing among researchers.
The two evaluators will extract study data in a paired, independent manner. The Rayyan
(Rayyan Systems Inc., Cambridge, MA, USA) systematic review manager, available as
a web application, will allow a better exploration of the findings of the included
studies. The third researcher will analyze any potential disagreement.
The form for data extraction will contain the following:
-
a) general information: title, authors, year of publication, study design, country
of origin;
-
b) demographics: age, gender;
-
c) methodologies used in the study: objectives, randomization, intervention, and control
techniques;
-
d) findings: number of patients, measurement tools, follow-up time, statistical tests,
descriptive information.
If any data is missing, researchers will attempt to contact the authors of the primary
studies to obtain outstanding information for the systematic review. If this is not
possible, researchers will evaluate the data published alone.
Analysis of the Risk of Bias of the Included Studies
Assessment of the risk of bias will include sample representativeness, methods for
participant selection, outcomes measurement, and confounding factors control. Additionally,
we will consider potential conflicts of interest in the included studies.
Data Synthesis
Available evidence will be displayed as a narrative synthesis and meta-analysis, if
possible. Statistical tests will analyze the frequency and association measures of
the studies. Effect or global estimate measures will interpret findings, which will
be displayed in forest plot graphs. This analysis will use the Review Manager (RevMan;
The Cochrane Collaboration, London, UK) software from the Cochrane organization. Heterogeneity
control (I2) will be performed by subgroup and sensitivity analysis.
Evidence Quality Assessment
After completing the critical assessment of the methodological quality of the studies
and synthesizing findings, we will assess the evidence quality for each outcome prioritized
in the systematic review. We will use the Grading of Recommendations Assessment, Development,
and Evaluation (GRADE) system to rank the level of the evidence set for each outcome
as high, moderate, low, or very low.
Register
The systematic review protocol register occurred at the International Prospective
Register of Systematic Reviews (PROSPERO) database from the University of York[13] (CRD42020212134).
Amendments
This protocol does not represent a change to a previously completed or published protocol.
If necessary, we will include protocol amendments documentation on the PROSPERO platform.[13]
