Scalability and Sustainability of a Surgical Infection Prevention Program in Low-Income Environments.

Importance: Surgical infections are a major cause of perioperative morbidity and mortality, particularly in low-resource settings. Clean Cut, a 6-month quality improvement program developed by the global nonprofit organization Lifebox, has demonstrated improvements in postoperative infectious complications. However, the pilot program required intense external programmatic and resource support. Objective: To examine the improvement in adherence to infection prevention and control standards and rates of postoperative infections in hospitals in the Clean Cut program after implementation strategies were updated and program execution was refined. Design, Setting, and Participants: This cohort study evaluated and refined the Clean Cut implementation strategy to enhance scalability based on a qualitative study of its pilot phase, including formalizing programmatic and educational materials, building an automated data entry and analysis platform, and reorganizing hospital-based team composition. Clean Cut was introduced from January 1, 2019, to February 28, 2022, in 7 Ethiopian hospitals that had not previously participated in the program. Prospective data initiated on arrival in the operating room were collected, and patients were followed up through hospital discharge and with 30-day follow-up telephone calls. Exposure: Implementation of the refined Clean Cut program. Main Outcomes and Measures: The primary outcome was surgical site infection (SSI); secondary outcomes were adherence to 6 infection prevention standards, mortality, hospital length of stay, and other infectious complications. Results: A total of 3364 patients (mean [SD] age, 26.5 [38.0] years; 2196 [65.3%] female) from 7 Ethiopian hospitals were studied (1575 at baseline and 1789 after intervention). After controlling for confounders, the relative risk of SSIs was reduced by 34.0% after program implementation (relative risk, 0.66; 95% CI, 0.54-0.81; P < .001). Appropriate Surgical Safety Checklist use increased from 16.3% to 43.0% (P < .001), surgeon hand and patient skin antisepsis improved from 46.0% to 66.0% (P < .001), and timely antibiotic administration improved from 17.8% to 39.0% (P < .001). Surgical instrument (38.7% vs 10.2%), linen sterility (35.5% vs 12.8%), and gauze counting (89.2% vs 82.5%; P < .001 for all comparisons) also improved significantly. Conclusions and Relevance: A modified implementation strategy for the Clean Cut program focusing on reduced external resource and programmatic input from Lifebox, structured education and training materials, and wider hospital engagement resulted in outcomes that matched our pilot study, with improved adherence to recognized infection prevention standards resulting in a reduction in SSIs. The demonstration of scalability reinforces the value of this SSI prevention program.

Exploring the Use of a Fit-for-Purpose Surgical Headlight in Sub-Saharan Africa: Mixed Methods Study.

BACKGROUND: High-quality surgical lighting is often lacking in low-resource settings. Commercial surgical headlights are unavailable due to high cost and supply and maintenance challenges. We aimed to understand user needs of a surgical headlight for low-resource settings by evaluating a preselected robust but relatively inexpensive headlight and lighting conditions. METHODS: We observed headlight use by ten surgeons in Ethiopia and six in Liberia. All surgeons completed surveys about their lighting environment and experience using headlight, and were subsequently interviewed. Twelve surgeons completed logbooks on headlight use. We distributed headlights to 48 additional surgeons, and all surgeons were surveyed for feedback. RESULTS: In Ethiopia, five surgeons ranked operating room light quality as poor or very poor; seven delayed or cancelled operations within the last year and five described intraoperative complications due to poor lighting. In Liberia, lighting was rated as "good", however fieldnotes, and interviews noted generator fuel-rationing, and poor lighting conditions. In both countries, the headlight was considered extremely useful. Surgeons recommended nine improvements, including comfort, durability, affordability and availability of multiple rechargeable batteries. Thematic analysis identified factors influencing headlight use, specifications and feedback, and infrastructure challenges. CONCLUSION: Lighting in surveyed operating rooms was poor. Although conditions and need for the headlights differed between Ethiopia and Liberia, headlights were considered highly useful. However, discomfort was a major limiting factor for ongoing use, and the hardest to objectively characterise for specification and engineering purposes. Specific needs for surgical headlights include comfort and durability. Refinement of a fit-for-purpose surgical headlight is ongoing.

Evaluation of an adaptive, multimodal intervention to reduce postoperative infections following cesarean delivery in Ethiopia: study protocol of the CLEAN-CS cluster-randomized stepped wedge interventional trial.

BACKGROUND: We previously developed and pilot tested Clean Cut, a program to prevent postoperative infections by improving compliance with the WHO Surgical Safety Checklist (SSC) and strengthening adherence to infection control practices. This protocol describes the CheckList Expansion for Antisepsis and iNfection Control in Cesarean Section (CLEAN-CS) trial evaluating our program's ability to reduce infections following CS and other obstetric and gynecological operations in Ethiopia. METHODS/DESIGN: CLEAN-CS is a cluster-randomized stepped wedge interventional trial with five clusters (two hospitals per cluster). It aims to assess the impact of Clean Cut on six critical perioperative infection prevention standards including antiseptic practices, antibiotic administration, and routine SCC use. The trial involves baseline data collection followed by Clean Cut training and implementation in each cluster in randomized order. The intervention consists of (1) modifying and implementing the SSC to fit local practices, (2) process mapping each standard, (3) coupling data and processes with site-specific action plans for improvement, and (4) targeted training focused on process gaps. The primary outcome is 30-day CS infection rates; secondary outcomes include other patient-level complications and compliance with standards. Assuming baseline SSI incidence of 12%, an effect size of 25% absolute reduction, and the ability to recruit 80-90 patients per cluster per month, we require a sample of 8100 patients for significance. We will report our study according to CONSORT. DISCUSSION: A cluster-randomized stepped wedge design is well-suited for evaluating this type of surgical safety program. The targeted standards are not in doubt, yet compliance is frequently difficult. Solutions are available and may be recognized by individuals, but teams dedicated to improvement are often lacking. Clean Cut was successfully piloted but requires a more rigorous methodological assessment. We seek to understand the qualities, characteristics, and resources needed to implement the program, the magnitude of effect on processes and outcomes, and to what degree it can enhance compliance with care standards. Challenges include a fraught social and political environment, pandemic travel restrictions, and a limited budget. TRIAL REGISTRATION: ClinicalTrials.gov NCT04812522 (registered on March 23, 2021); Pan-African Clinical Trials Registry PACTR202108717887402 (registered on August 24, 2021).

Perioperative provider safety in the pandemic: Development, implementation and evaluation of an adjunct COVID-19 Surgical Patient Checklist.

The COVID-19 pandemic has strained surgical systems worldwide and placed healthcare providers at risk in their workplace. To protect surgical care providers caring for patients with COVID-19, in May 2020 we developed a COVID-19 Surgical Patient Checklist (C19 SPC), including online training materials, to accompany the World Health Organization Surgical Safety Checklist. In October 2020, an online survey was conducted via partner and social media networks to understand perioperative clinicians' intraoperative practice and perceptions of safety while caring for COVID-19 positive patients and gain feedback on the utility of C19 SPC. Descriptive statistics were used to characterise responses by World Bank income classification. Qualitative analysis was performed to describe respondents' perceptions of C19 SPC and recommended modifications. Respondents included 539 perioperative clinicians from 63 countries. One-third of respondents reported feeling unsafe in their workplace due to COVID-19 with significantly higher proportions in low (39.8%) and lower-middle (33.9%) than higher income countries (15.6%). The most cited concern was the risk of COVID-19 transmission to self, colleagues and family. A large proportion of respondents (65.3%) reported that they had not used C19 SPC, yet 83.8% of these respondents felt it would be useful. Of those who reported that they had used C19 SPC, 62.0% stated feeling safer in the workplace because of its use. Based on survey results, modifications were incorporated into a subsequent version. Our survey findings suggest that perioperative clinicians report feeling unsafe at work during the COVID-19 pandemic. In addition, adjunct tools such as the C19 SPC can help to improve perceived safety.

Factors Associated with Intention to Receive Vaccination against COVID-19 in Puerto Rico: An Online Survey of Adults.

We conducted an online survey among adults in Puerto Rico to identify factors associated with the intention to receive vaccination against COVID-19. Sociodemographic variables were analyzed independently for association with intent to receive vaccination. Significant associations were included in the multivariate logistic regression analysis. A total of 1016 responses were available for analysis. In the bivariate analysis, younger age, higher education, pre-COVID-19 employment, male sex, gay/bisexual identity, and single marital status were associated with increased intent to receive the vaccination. In the multivariate logistic regression, younger, male respondents, and those with higher educational attainment reported higher intent to receive the vaccination. Lower-income and living outside the San Juan metro region were associated with lower intent to receive the vaccination. National and international health organizations were identified as the most reliable sources of information, followed by healthcare professionals. These findings highlight the importance of considering sociodemographic characteristics and using trusted sources of information when designing COVID-19 vaccination public messaging.

Estimates of Alpha/Beta (α/ß) Ratios for Individual Late Rectal Toxicity Endpoints: An Analysis of the CHHiP Trial.

PURPOSE: Changes in fraction size of external beam radiation therapy exert nonlinear effects on subsequent toxicity. Commonly described by the linear-quadratic model, fraction size sensitivity of normal tissues is expressed by the α/ß ratio. We sought to study individual α/ß ratios for different late rectal effects after prostate external beam radiation therapy. METHODS AND MATERIALS: The CHHiP trial (ISRCTN97182923) randomized men with nonmetastatic prostate cancer 1:1:1 to 74 Gy/37 fractions (Fr), 60 Gy/20 Fr, or 57 Gy/19 Fr. Patients in the study had full dosimetric data and zero baseline toxicity. Toxicity scales were amalgamated to 6 bowel endpoints: bleeding, diarrhea, pain, proctitis, sphincter control, and stricture. Lyman-Kutcher-Burman models with or without equivalent dose in 2 Gy/Fr correction were log-likelihood fitted by endpoint, estimating α/ß ratios. The α/ß ratio estimate sensitivity was assessed using sequential inclusion of dose modifying factors (DMFs): age, diabetes, hypertension, inflammatory bowel or diverticular disease (IBD/diverticular), and hemorrhoids. 95% confidence intervals (CIs) were bootstrapped. Likelihood ratio testing of 632 estimator log-likelihoods compared the models. RESULTS: Late rectal α/ß ratio estimates (without DMF) ranged from bleeding (G1 + α/ß = 1.6 Gy; 95% CI, 0.9-2.5 Gy) to sphincter control (G1 + α/ß = 3.1 Gy; 95% CI, 1.4-9.1 Gy). Bowel pain modelled poorly (α/ß, 3.6 Gy; 95% CI, 0.0-840 Gy). Inclusion of IBD/diverticular disease as a DMF significantly improved fits for stool frequency G2+ (P = .00041) and proctitis G1+ (P = .00046). However, the α/ß ratios were similar in these no-DMF versus DMF models for both stool frequency G2+ (α/ß 2.7 Gy vs 2.5 Gy) and proctitis G1+ (α/ß 2.7 Gy vs 2.6 Gy). Frequency-weighted averaging of endpoint α/ß ratios produced: G1 + α/ß ratio = 2.4 Gy; G2 + α/ß ratio = 2.3 Gy. CONCLUSIONS: We estimated α/ß ratios for several common late adverse effects of rectal radiation therapy. When comparing dose-fractionation schedules, we suggest using late a rectal α/ß ratio ≤ 3 Gy.

Derivation of Dose/Volume Constraints for the Anorectum from Clinician- and Patient-Reported Outcomes in the CHHiP Trial of Radiation Therapy Fractionation.

PURPOSE: The CHHiP trial randomized 3216 men with localized prostate cancer (1:1:1) to 3 radiation therapy fractionation schedules: 74 Gy in 37 fractions over 7.4 weeks; 60 Gy in 20 fractions over 4 weeks; and 57 Gy in 19 fractions over 3.8 weeks. Literature-based dose constraints were applied with arithmetic adjustment for the hypofractionated arms. This study aimed to derive anorectal dose constraints using prospectively collected clinician-reported outcomes (CROs) and patient-reported outcomes (PROs) and to assess the added predictive value of spatial dose metrics. METHODS AND MATERIALS: A case-control study design was used; 7 CRO and 5 PRO bowel symptoms were evaluated. Cases experienced a moderate or worse symptom 1 to 5 years after-radiation therapy and did not have the symptom before radiation therapy. Controls did not experience the symptom at baseline or between 1 to 5 years after radiation therapy. The anorectum was recontoured from the anal verge to the rectosigmoid junction; dose/volume parameters were extracted. Univariate logistic regression, atlases of complication indices, and bootstrapped receiver-operating-characteristic analysis (1000 replicates, balanced outcomes) were used to derive dose constraints for the whole cohort (hypofractionated schedules were converted to 2-Gy equivalent schedules using α/ß = 3 Gy) and separate hypofractionated/conventional fractionation cohorts. Only areas under the curve with 95% confidence interval lower limits >0.5 were considered statistically significant. Any constraint derived in <95% to 99% of bootstraps was excluded. RESULTS: Statistically significant dose constraints were derived for CROs but not PROs. Intermediate to high doses were important for rectal bleeding, whereas intermediate doses were important for increased bowel frequency, fecal incontinence, and rectal pain. Spatial dose metrics did not improve prediction of CROs or PROs. A new panel of dose constraints for hypofractionated schedules to 60 Gy or 57 Gy are V20Gy <85%, V30Gy <57%, V40Gy <38%, V50Gy <22%, and V60Gy <0.01%. CONCLUSIONS: Dose constraints differed among symptoms, indicating potentially different pathogenesis of radiation-induced side effects. Derived dose constraints were stricter than those used in CHHiP and may reduce bowel symptoms after radiation therapy.