Success of a screening protocol for safe spine surgery during the early COVID-19 pandemic in a COVID-free hospital in Mexico

Introduction

COVID-19 pandemic derived in a global temporal suspension of elective surgeries (including spine) during a while globally^1–3. Medical societies decided to differ surgeries based on a priority level related to morbidity and mainly mortality^4–7. Nevertheless, given the severity of symptoms or disability, many patients are urged for treating their spine illnesses even on the risk of COVID-19 contagious⁸. As a solution, some country authorities visualized the possibility to redirect all non-COVID patients to referral centers called “COVID-free hospitals” to provide environments where to provide health-care safety^9,10. In Mexico, our private hospital was a pioneer very early in the pandemic and the only one of its two campuses to non-COVID patients exclusively. Our goal is to describe our experience with the screening protocol that was institutionally delivered and provide a framework for future pandemics during very early stages as was our case in this pandemic.

Methods

The present study is a retrospective cohort on the early days following the starting of the pandemic in Mexico at one of its private hospitals and the only one delivering health care for non-COVID patients exclusively in a COVID-free facility during the period of April to July 2020 (1 month from the starting of the pandemic and highest period of contagious of the first wave). We followed the strengthening the reporting of observational studies in epidemiology guidelines for observational studies.¹¹ In this report, we also followed all the regulations as by our institution and type of research. We submitted this protocol to the Research and Ethics Committee of the ABC Medical Center, receiving approval under the Folio “ABC-20-74”, ensuring that it complies with all human research standards. We reviewed all the medical files of patients undergoing elective spine surgery during this period. We collected data on illness diagnosis, surgical procedure, pre-operative screening protocol (as described below), surgical time, bleeding, need of transfusion, in-hospital stay, and follow up at 15 days. The pre-operative screening protocol conducted in our hospital consisted of a polymerase chain reaction (PCR) detection test, chest computerized tomography (CT)-scan, and a self-filling symptoms-exposure questionnaire within 3 days of admission. We followed patients in medical office and repeated the self-filling symptoms-exposure questionnaire at 15 days for in-hospital contagious or early post-operative contagious as a cause of surgery-related immunocompromise. Patients are required to have a negative both the PCR sample and the chest CT scan on the past 48 h to permit admission and have a low-risk questionnaire (no exposition and no symptoms). Patients at high risk (early recent exposure and/or symptoms) based on the questionnaire were rescheduled.

Statistical analysis

We conducted descriptive statistics on categorical variables, and central dispersion measures were performed for numerical variables. Outcome evaluation consisted of in-hospital and follow-up cases of COVID-19 infection because of symptoms or positive testing. For the outcome variable, we used Kaplan–Meier tables and relative risk ratios as required.

Results

Fifty-nine patients met the inclusion criteria, from those eleven were excluded (18.6%), because of incomplete screening protocol on medical files (absent questionnaire). From the remaining forty-eight patients, thirty were females (62.5%) and eighteen were males (37.5%). Patients’ mean age was 60.77 years (95% confidence interval [CI] 55.72-65.82 standard deviation [SD] 17.38) with no statistically significant difference (p = 0.640) among sex. Patients’ mean body mass index was 24.38 (95% CI 23.33-25.43 SD 3.51; 3 missing values). 27 patients had no comorbidities (56.3%), 15 had one (31.3%), five had two (10.4%), and only one had three comorbidities (2.1%). The most frequent comorbidity was hypertension with thirteen cases (27.1%) followed by diabetes 4 (8.3%). 33 patients (68.8%) smoked while the rest did not. The patient’s diagnosis in order of frequency was spinal stenosis and disc herniation with 11 patients (22.9%) each (45.8%), followed by vertebral fracture 8 (16.7%), listhesis and lumbociatic pain with five patients (10.4%) each, spinal instability 3 (6.3%), adjacent segment disease 2 (4.2%), and subluxation, pseudoarthrosis and prothesic material migration with 1 patient (2.1%) each (6.3%). 25 surgical procedures (72.9%) were performed in the lumbar spine, 5 (10.4%) and two (4.2%) in the cervical and thoracic region, respectively, with two patients (4.2%) were non-classified. Sixteen (33.3%) patients underwent a fixation procedure, 10 (20.8%) discectomy, seven (14.6%) vertebroplasty, six (12.5%) simple decompression, two (4.2%) decompression and fixation, one (2.1%) total disc replacement, and one (2.1%) with five patients missing the specific surgical procedure on medical files. 24 (70.8%) surgical procedures were performed on an elective basis while fourteen (29.2%) were classified as a priority. Mean surgical time was 127 min (95% CI 100.38-153.62, SD 71.30) and mean surgical bleeding was 127.43 (95% CI: 54.11-200.76, SD: 196.37) (18 missing values each). The mean in-hospital stay was 3.23 days (95% CI: 2.73-3.74, SD: 1.36) (eighteen missing values). All the patients had normal chest CT scans with RCP within normal limits and negative pre-operative COVID-19 questionnaires. At 15-day post-operative, none of the patients reported COVID symptoms on follow-up COVID-19 questionnaires. Table 1 shows the patient’s data in full; we could do no Kaplan–Meier table because none of the patients had COVID-19 symptoms.

Discussion

The pandemic developed in a scenario filled with obscure and limited information in the country of the first reported cases^12,13. As a result, many countries did realize the severity of the problem until no major change could have been done to prevent dissemination, and the illness was poorly characterized and underdiagnosed as atypical pneumonia^13,14. Nevertheless, the characterization once realized that we were fighting a new illness developed quickly and promptly thanks to the recent advancement in genetic profiling¹⁵. Soon RNA test was available to detect the virus^16,17 and even to follow the line of serious mutations. Unfortunately, testing was not readily available^16,18 worldwide derived mainly for a lag in production and a greater demand than production could support provided the speed of spread and the high infection rates. Soon we knew that many countries would have hard times in the early months to have sufficient access to test and medical resources to meet demand and fight properly the pandemic¹⁹. Based on this scenario, many organizations tried to limit the spread and to cope with the needs of fighting the pandemic^19–21. Most institutions focused on COVID patients and left aside non-COVID illnesses based on priority levels of morbidity and mortality^22,23. This scenario was very compressible, nevertheless unfair for most patients requiring essential non-COVID attention. Hopefully, not everyone centered its attention on COVID, and a thought analysis was made on thinking on collateral damage for non-COVID patients^3,24,25. Our institution, always looking for excellence on health care as our slogan tells, was pioneer on this situation at opting for dividing our two campuses in a practical distribution, COVID and non-COVID. This was substantiable for a private hospital that was compromised with helping community on the crisis of COVID, but also being a refuge for people requiring non-COVID but indeed essential health care in this hard moment. It is our belief that our administrative and medical authorities hit a homerun on this decision for our population, as we were the only exclusive COVID-free hospital (either private or public) and still is the only one to provide this kind of health care in Mexico at almost 3 years in the pandemic. This was the first aspect, the decision making, but second and outmost important, how to make it possible. Our epidemiologic and infectious experts help administrative personnel to design a screening protocol for this effect, based on the very early information on diagnosis and screening tools, we opted for a triad of standard, specific RNA detection, paraclinical detection on imaging and clinical information, being as accurate as the praxis itself, and combination of decision-making based on clinical, paraclinical, and molecular basis. That was the second measure of success, translating individual clinical praxis to population-based epidemiological containment measures. This screening protocol was also in line with the difficultness we had as a country, a low set of screening test poorly available for “screening” but left for “diagnosis” in most places, scarce availability of personal equipment protection, and a lot of people either patients, physicians, or community afraid of an unknown enemy. It also helped with the early unknown rate of false-negative tests even with PCR sampling for a new virus¹⁷. We also had little if any knowledge of the patterns of affection this virus might had on paraclinical and clinical grounds. Moreover, if it were not enough, we had no knowledge as to how surgery could affect the vulnerability of individuals to contract contagious. We even do not know it now, that’s the core of our study. As a resume, this triad of screening was the perfect multimodal tool to provide a safe environment for surgery, or at least it was our best effort to provide it. Hopefully, as many times in the history, serendipity, luck, divine help, or the majestic of the science, a characteristic of humanity, a result of evolution, or simply the desire of living was on our side, and we had success on this decision and screening protocol. We still do not know if this will suffice to contain the collateral damage this pandemic has done on our society, but we are sure that we made our best at having of possibility to reach that point. Nowadays, we know a bit more of the illness, tests are more readily available, there are most specific and sensitive, CT-scan was given more a prognosis^26–28 value and losing diagnosis value on the gain of specificity of C-reactive protein tests even more for asymptomatic, the elf filling questionnaire is the one losing more specificity; nevertheless, new variants are emerging very promptly and there are making the most infectious virus ever known¹⁵, in almost 2 months, we had an almost global contagious of 50%, fortunately, it was behaving more benign, but we consider this readily available questionnaries everywhere are clinical tools that can help judicious clinicians to take early decision based on illness priority, with new variants hiding from PCR tests, and taking the illness to new edges of dispersion and contagious, we consider this tools should never be left behind, it is the clinical decision the most important in every scenario, or at least that is what we say to the patients; why not to trust on it for epidemiological purposes, at the end they are not but reason-based, thought and logic instruments that are related to judgment and criteria. We hope that the results of this experience can help the world on the new pandemics we will be facing for sure in the years to come, with the overpopulation we have, and with the desire to continue living and evolving as species, or at least, that help us fight new variants on this fight that is far from finished nor even the winner decided.

Conclusions

We demonstrated the value and success of a multimodal screening tool based on a three-tier standard of quality, clinical, paraclinical, and molecular. We have a 100% success rate with this implementation tool with the aid of a facility exclusively dedicated to COVID-free health care. We hope this information in a very early and obscure stage of high contagious in a low to middle income country with high rates of infection and mortality helps other countries and even other institutions in our country to take measures to cope with the pandemic.

Funding

The authors declare that they have not received funding.

Conflicts of interest

The authors declare no conflicts of interest.

Ethical disclosures

Protection of human and animal subjects. The authors declare that no experiments were performed on humans or animals for this study.

Confidentiality of data. The authors declare that they have followed the protocols of their work center on the publication of patient data.

Right to privacy and informed consent. The authors have obtained approval from the Ethics Committee for analysis and publication of routinely acquired clinical data and informed consent was not required for this retrospective observational study.

Use of artificial intelligence for generating text. The authors declare that they have not used any type of generative artificial intelligence for the writing of this manuscript, nor for the creation of images, graphics, tables, or their corresponding captions.