Open vs. minimally invasive sublay incisional hernia repair. Is there a risk of overtreatment? EVEREG registry analysis.

INTRODUCTION: Incisional hernia (IH) is a very common surgical procedure. Registries provide real world data. The objective is to analyze the open and minimally invasive (MIS) sublay technique (with or without associated components separation [CS]) in IH cases from the EVEREG registry and to evaluate the evolution over time of the techniques. METHODS: All patients in EVEREG from July 2012 to December 2021 were included. The characteristics of the patients, IH, surgical technique, complications and mortality in the first 30 days were collected. We analyzed Group 1 (open sublay vs MIS sublay, without CS), Group 2 (open sublay vs MIS sublay, with CS) and Group 3 where the evolution of open and MIS techniques was evaluated over time. RESULTS: 4867 IH were repaired using a sublay technique. Group 1: 3739 (77%) open surgery, mostly midline hernias combined (P = .016) and 55 (1%) MIS, mostly lateral hernias (LH) (P = .000). Group 2: 1049 (21.5%) open surgery and 24 (0.5%) MIS. A meaningful difference (P = .006) was observed in terms of transverse diameters (5.9 (SD 2.1) cm for the MIS technique and 10.11 (SD 4.8) for the open technique). The LH MIS associated more CS (P = .002). There was an increase in the use of the sublay technique over time (with or without CS). CONCLUSION: Increased use of the sublay technique (open and MIS) over time. For some type of hernia (LH) the MIS sublay technique with associated CS may have represented an overtreatment.

Effects of overtreatment with different attachment positions on maxillary anchorage enhancement with clear aligners: a finite element analysis study.

BACKGROUND: The effect of attachment positions on anchorage has not been fully explored. The aim of the present study is to analyze the effect of overtreatment with different anchorage positions on maxillary anchorage enhancement with clear aligners in extraction cases. METHODS: Models of the maxilla and maxillary dentition were constructed and imported into SOLIDWORKS software to create periodontal ligament (PDL), clear aligners, and attachments. Attachment positions on second premolars included: without attachment (WOA), buccal attachment (BA), and bucco-palatal attachment (BPA). Overtreatment degrees were divided into five groups (0°, 1°, 2°, 3°, 4°) and added on the second premolars. The calculation and analysis of the displacement trends and stress were performed using ANSYS software. RESULTS: Distal tipping and extrusion of the canines, and mesial tipping and intrusion of the posterior teeth occurred during retraction. A strong anchorage was achieved in cases of overtreatment of 2.8° with BA and 2.4° with BPA. Moreover, the BPA showed the best in achieving bodily control of the second premolars. When the overtreatment was performed, the canines and first molars also showed reduced tipping trends with second premolars attachments. And the stress on the PDL and the alveolar bone was significantly relieved and more evenly distributed in the BPA group. CONCLUSIONS: Overtreatment is an effective means for anchorage enhancement. However, the biomechanical effect of overtreatment differs across attachment positions. The BPA design performs at its best for stronger overtreatment effects with fewer adverse effects.

Evidencing general acceptability of open-label placebo use for tackling overtreatment in primary care: a mixed methods study.

BACKGROUND: Overtreatment poses a challenge to healthcare systems due to harmful consequences of avoidable side-effects and costs. This study presents the first account for examining the feasibility of placebo use for reducing overtreatment in primary care, including whether public attitudes support the use of different placebo types in place of inappropriate prescriptions of antibiotics, antidepressants, or analgesics. METHODS: We used a multi-study, mixed-methods design, including patient and public (PPI) consultations, focus groups (Study 1) and two pre-registered online experiments (Studies 2 and 3). RESULTS: Study 1 (N = 16) explored everyday conceptions and practicalities of potential placebo use in the context of respiratory infections. Findings highlighted the importance of trusting doctor-patient relationships and safety-netting. Study 2 employed a randomised experiment with a representative UK sample (N = 980), investigating attitudes towards 5 different treatment options for respiratory infections: (1) blinded + pure placebo, (2) open-label + pure placebo, (3) open-label + impure placebo, (4) antibiotic treatment, and (5) no treatment. Study 2 also examined how attitudes varied based on wording and individual differences. Findings indicated general support (ηp2 = .149, large effect size) for replacing inappropriate antibiotics with open-label + impure placebos, although personal placebo acceptability was lower. Also, older people, individuals suffering from chronic illness or those showing higher levels of health anxiety appeared less amenable to placebo use. Study 3 (N = 1177) compared attitudes towards treatment options across three clinical scenarios: respiratory infection, depression and pain. Findings suggested significant differences in the acceptability of placebo options based on the clinical context. In the infection scenario, options for open-label + pure placebos, open-label + impure placebos and no treatment were rated significantly more acceptable (ηp2 = .116, medium effect size) compared to the depression and pain scenarios. Again, general support for placebos was higher than placebo acceptability for personal use. CONCLUSIONS: Findings from PPI and three studies indicate general support for combatting overprescribing in primary care through clinical placebo use. This is an indicator for wider UK public support for a novel, behavioural strategy to target a long-standing healthcare challenge. General acceptability appears to be highest for the use of open-label + impure placebos in the context of antibiotic overprescribing.

Does the Academy of Breastfeeding Medicine's Clinical Protocol #36 'The Mastitis Spectrum' promote overtreatment and risk worsened outcomes for breastfeeding families? Commentary.

BACKGROUND: In 2022 the Academy of Breastfeeding Medicine (ABM) published Clinical Protocol #36: The Mastitis Spectrum, which aims to update clinical approaches to management of benign lactation-related breast inflammation. The protocol has been timely because of the exponential increase in knowledge about the human milk microbiome over the past decade. This Commentary aims to continue respectful debate amongst clinicians and researchers within the Academy of Breastfeeding Medicine and more broadly, confident that we share a fundamental commitment to promote breastfeeding and support the well-being of lactating women, their infants and their families. ANALYSIS: Although Clinical Protocol #36 offers advances, it does not fulfil the principles of best practice implementation science for translation of evidence into clinical guidelines. Clinical Protocol #36 inaccurately represents studies; misrepresents theoretical models as proven aetiologies; does not consistently attribute sources; does not reliably apply the SORT taxonomy; and relies upon single case reports. As a result, various recommendations in Clinical Protocol #36 lack an evidence-base or credible underlying theoretical model. This includes recommendations to use 'lymphatic drainage' massage, therapeutic ultrasound, and oral lecithin. Similarly, based on a contestable theoretical model which is presented as fact, Clinical Protocol #36 makes the recommendation to either reduce frequency of milk removal or to maintain current frequency of milk removal during an episode of breast inflammation. Although Clinical Protocol #36 limits this advice to cases of 'hyperlactation', the diagnosis 'hyperlactation' itself is undefinable. As a result, this recommendation may put breastfeeding women who present with breast inflammation at risk of worsened inflammation and decreased breast milk production. CONCLUSION: Clinical Protocol #36 offers some advances in the management of breast inflammation. However, Clinical Protocol #36 also exposes clinicians to two international trends in healthcare which undermine health system sustainability: overdiagnosis, including by over-definition, which increases risk of overtreatment; and antibiotic over-use, which worsens the crisis of global antimicrobial resistance. Clinical Protocol #36 also recommends unnecessary or ineffective interventions which may be accessed by affluent patients within advanced economies but are difficult to access for the global majority. The Academy of Breastfeeding Medicine may benefit from a review of processes for development of Clinical Protocols.

Overtreatment of malaria in the Nigerian healthcare setting: prescription practice, rationale and consequences.

Nigeria is one of the countries in the world with the highest burden of malaria, accounting for a quarter of all cases in Africa. According to the Centers for Disease Control and Prevention, microscopic examination remains the gold standard for laboratory confirmation of malaria. However, the policy and practice of presumptive treatment of malaria for all febrile illnesses has been widely advocated in sub-Saharan Africa. Presumptive management of fevers and/or other symptoms of malaria results in over-diagnosis, and consequently overtreatment. This article discusses the overtreatment of malaria as practiced in Nigeria and other African regions against standard treatment guidelines, highlights a wide range of its associated effects on patients and proffers possible solutions to curb the unethical practice of malaria overtreatment.

Reducing hypoglycemia from overtreatment of type 2 diabetes in older adults: The HypoPrevent study.

BACKGROUND: Hypoglycemia from overtreatment is a serious but underrecognized complication among older adults with type 2 diabetes. However, diabetes treatment is seldom deintensified. We assessed the effectiveness of a Clinical Decision Support (CDS) tool and shared decision-making (SDM) in decreasing the number of patients at risk for hypoglycemia and reducing the impact of non-severe hypoglycemic events. METHODS: HypoPrevent was a pre-post, single arm study at a five-site primary care practice. We identified at-risk patients (≥65 years-old, with type 2 diabetes, treated with insulin or sulfonylureas, and HbA1c < 7.0%). During three clinic visits over 6 months, clinicians used the CDS tool and SDM to assess hypoglycemic risk, set individualized HbA1c goals, and adjust use of hypoglycemic agents. We assessed the number of patients setting individualized HbA1c goals or modifying medication use, changes in the population at risk for hypoglycemia, and changes in impact of non-severe hypoglycemic events using a validated patient-reported outcome tool (TRIM-HYPO). RESULTS: We enrolled 94 patients (mean age-74; mean HbA1c (±SD)-6.36% ± 0.43), of whom 94% set an individualized HbA1c goal at either the baseline or first follow-up visit. Ninety patients completed the study. Insulin or sulfonylurea use was decreased or eliminated in 20%. An HbA1c level before and after goal setting was obtained in 53% (N = 50). Among these patients, the mean HbA1c increased 0.53% (p < 0.0001) and the number of patients at-risk decreased by 46% (p < 0.0001). Statistically significant reductions in the impact of hypoglycemia during daily activities occurred in both the total score and each functional domain of TRIM-HYPO. CONCLUSIONS: In a population of older patients at risk for hypoglycemia, the use of a CDS tool and SDM reduced the population at risk and decreased the use of insulin and sulfonylureas. Using a patient-reported outcome tool, we demonstrated significant reductions in the impact of hypoglycemia on daily life.

Is alveolar ridge preservation an overtreatment?

The morphology and dimensions of the postextraction alveolar ridge are important for the surgical and restorative phases of implant treatment. Adequate new bone formation and preservation of alveolar ridge dimensions following extraction will facilitate installation of the implant in a restorative position, while preservation of soft tissue contour and volume is essential for an aesthetic and implant-supported restoration with healthy peri-implant tissues. Alveolar ridge preservation (ARP) refers to any procedure that aims to: (i) limit dimensional changes in the alveolar ridge after extraction facilitating implant placement without additional extensive bone and soft tissue augmentation procedures (ii) promote new bone formation in the healing alveolus, and (iii) promote soft tissue healing at the entrance of the alveolus and preserve the alveolar ridge contour. Although ARP is a clinically validated and safe approach, in certain clinical scenarios, the additional clinical benefit of ARP over unassisted socket healing has been debated and it appears that for some clinicians may represent an overtreatment. The aim of this critical review was to discuss the evidence pertaining to the four key objectives of ARP and to determine where ARP can lead to favorable outcomes when compared to unassisted socket healing.

Ethnoracial Differences in Premenopausal Hysterectomy: The Role of Symptom Severity.

OBJECTIVE: To evaluate whether greater symptom severity can explain higher hysterectomy rates among premenopausal non-Hispanic Black compared with White patients in the U.S. South rather than potential overtreatment of Black patients. METHODS: Using electronic health record data from 1,703 patients who underwent hysterectomy in a large health care system in the U.S. South between 2014 and 2017, we assessed symptom severity to account for differences in hysterectomy rates for noncancerous conditions among premenopausal non-Hispanic Black, non-Hispanic White, and Hispanic patients. We used Poisson generalized linear mixed modeling to estimate symptom severity (greater than the 75th percentile on composite symptom severity scores of bleeding, bulk, or pelvic pain) as a function of race-ethnicity. We calculated prevalence ratios (PRs). We controlled for factors both contra-indicating and contributing to hysterectomy. RESULTS: The overall median age of non-Hispanic White (n=1,050), non-Hispanic Black (n=565), and Hispanic (n=158) patients was 40 years. The White and Black patients were mostly insured (insured greater than 95%), whereas the Hispanic patients were often uninsured (insured 58.9%). White and Black patients were mostly treated outside academic medical centers (nonmedical center: 63.7% and 58.4%, respectively); the opposite was true for Hispanic patients (nonmedical center: 34.2%). Black patients had higher bleeding severity scores compared with Hispanic and White patients (median 8, 7, and 4 respectively) and higher bulk scores (median 3, 1, and 0, respectively), but pain scores differed (median 3, 5, and 4, respectively). Black and Hispanic patients were disproportionately likely to have severe symptoms documented on two or more symptoms (referent: not severe on any symptoms) (adjusted PR [Black vs White] 3.02, 95% CI 2.29-3.99; adjusted PR [Hispanic vs White] 2.61, 95% CI 1.78-3.83). Although Black and Hispanic patients were more likely to experience severe symptoms, we found no racial and ethnic differences in the number of alternative treatments attempted before hysterectomy. CONCLUSION: We did not find evidence of overtreatment of Black patients. Our findings suggest potential undertreatment of Black and Hispanic patients with uterine-sparing alternatives earlier in their disease progression.

Overtreatment "Successes"--What Are the Negative Consequences for Patients, Dentists, and the Profession?

AIMS: To describe how some management practices in the field of orofacial musculoskeletal disorders (also described as temporomandibular disorders [TMDs]) are based on concepts about occlusal relationships, condyle positions, or functional guidance; for some patients, these procedures may be producing successful outcomes in terms of symptom reduction, but in many cases, they can be examples of unnecessary overtreatment. METHODS: The authors discuss the negative consequences of this type of overtreatment for both doctors and patients, as well as the impact on the dental profession itself. Special focus is given to trying to move the dental profession away from the old mechanical paradigms for treating TMDs and forward to the more modern (and generally more conservative) medically based approaches, with emphasis on the biopsychosocial model. RESULTS: The clinical implications of such a discussion are apparent. For example, it can be argued that the routine use of Phase II dental or surgical treatments for managing most orofacial pain cases represents overtreatment, which cannot be defended on the grounds of symptom improvement (ie, "successful" outcomes) alone. Similarly, there is enough clinical evidence to conclude that complex biomechanical approaches focusing on the search for an ideal specific condylar or neuromuscular position for the management of orofacial musculoskeletal disorders are not needed to produce a positive clinical result that is stable over time. CONCLUSION: Typically, overtreatment successes cannot be easily perceived by the patients or the treating dentists because the patients are satisfied and the dentists feel good about those outcomes. However, neither party knows whether an excessive amount of treatment has been provided. Therefore, both the practical and ethical aspects of this discussion about proper treatment vs overtreatment deserve attention.

Examining the factors associated with inpatients' perception of overtreatment in Korea: a cross-sectional study.

BACKGROUND: Patients' perception of receiving overtreatment can cause distrust in medical services. Unlike outpatients, inpatients are highly likely to receive many medical services without fully understanding their medical situation. This information asymmetry could prompt inpatients to perceive treatment as excessive. This study tested the hypothesis that there are systematic patterns in inpatients' perceptions of overtreatment. METHODS: We examined determinant factors of inpatients' perception of overtreatment in a cross-sectional design that used data from the 2017 Korean Health Panel (KHP), a nationally representative survey. For sensitivity analysis, the concept of overtreatment was analyzed by dividing it into a broad meaning (any overtreatment) and a narrow meaning (strict overtreatment). We performed chi-square for descriptive statistics, and multivariate logistic regression with sampling weights employing Andersen's behavioral model. RESULTS: There were 1,742 inpatients from the KHP data set that were included in the analysis. Among them, 347 (19.9%) reported any overtreatment and 77 (4.42%) reported strict overtreatment. Furthermore, we found that the inpatient's perception of overtreatment was associated with gender, marital status, income level, chronic disease, subjective health status, health recovery, and general tertiary hospital. CONCLUSION: Medical institutions should understand factors that contribute to inpatients' perception of overtreatment to mitigate patients' complaints due to information asymmetry. Moreover, based on the result of this study, government agencies, such as the Health Insurance Review and Assessment Service, should create policy-based controls and evaluate overtreatment behavior of the medical providers and intervene in the miscommunication between patients and providers.

Can Molecular Biomarkers Help Reduce the Overtreatment of DCIS?

Ductal carcinoma in situ (DCIS), especially in the era of mammographic screening, is a commonly diagnosed breast tumor. Despite the low breast cancer mortality risk, management with breast conserving surgery (BCS) and radiotherapy (RT) is the prevailing treatment approach in order to reduce the risk of local recurrence (LR), including invasive LR, which carries a subsequent risk of breast cancer mortality. However, reliable and accurate individual risk prediction remains elusive and RT continues to be standardly recommended for most women with DCIS. Three molecular biomarkers have been studied to better estimate LR risk after BCS-Oncotype DX DCIS score, DCISionRT Decision Score and its associated Residual Risk subtypes, and Oncotype 21-gene Recurrence Score. All these molecular biomarkers represent important efforts towards improving predicted risk of LR after BCS. To prove clinical utility, these biomarkers require careful predictive modeling with calibration and external validation, and evidence of benefit to patients; on this front, further research is needed. Most trials do not incorporate molecular biomarkers in evaluating de-escalation of therapy for DCIS; however, one-the Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk DCIS (ELISA) trial-incorporates the Oncotype DX DCIS score in defining a low-risk population and is an important next step in this line of research.

Changing nationwide trends away from overtreatment among patients undergoing radical prostatectomy over the past 25 years.

PURPOSE: The objective of the current study was to assess whether and how preoperative risk group distribution and pathological outcomes have changed in men treated with radical prostatectomy (RP) over the past 25 years. METHODS: 11,071 patients from a large contemporary registry-based nationwide cohort with RP as primary treatment between 1995 and 2019 were included. Preoperative risk stratification, postoperative outcomes, and 10 years other-cause mortality (OCM) were analyzed. RESULTS: After 2005, the proportion of low-risk prostate cancer (PCa) decreased from 39.6% to 25.5% in 2010 and decreased further to 15.5% in 2015, and 9.4% in 2019 (p < 0.001). The proportion of high-risk cases increased from 13.1% in 2005 to 23.1% in 2010 and 36.7% in 2015, and 40.4% in 2019 (p < 0.001). After 2005, the proportion of cases with favorable localized PCa decreased from 37.3% to 24.9% in 2010 and decreased further to 13.9% in 2015, and 1.6% in 2019 (p < 0.001). The overall 10 years OCM was 7.7%. CONCLUSION: The current analysis documents a clear shift in utilization of RP toward higher-risk PCa in men with long life expectancy. Patients with low-risk PCa or favorable localized PCa are rarely operated. This suggests a shift in applying surgery only to patients who may really benefit from RP and the long-standing discussion of overtreatment might become outdated.