Optimizing radiation safety in dentistry: Clinical recommendations and regulatory considerations.

BACKGROUND: The value of dental radiographs to oral health care decision making must be balanced with radiation safety to minimize patient exposure and occupational risk of oral health care providers. This review summarizes recommendations and regulatory guidance regarding dental radiography and cone-beam computed tomography. An expert panel presents recommendations on radiation safety, appropriate imaging practices, and reducing radiation exposure. TYPES OF STUDIES REVIEWED: A systematic search run in Ovid MEDLINE, Embase, and Cochrane Database of Systematic Reviews identified relevant topical systematic reviews, organizational guidelines, and regulatory reviews published in the peer-reviewed literature since 2010. A supplemental search of the gray literature (eg, technical reports, standards, and regulations) identified topical nonindexed publications. Inclusion criteria required relevance to primary oral health care (ie, general or pediatric dentistry). RESULTS: A total of 95 articles, guidance documents, and regulations met the inclusion criteria. Resources were characterized as applicable to all modalities, operator and occupational protection, dose reduction and optimization, and quality assurance and control. PRACTICAL IMPLICATIONS: Understanding factors affecting imaging safety and applying fundamental principles of radiation protection consistent with federal, state, and local requirements are essential for limiting patient ionizing radiation exposure, in conjunction with implementing optimal imaging procedures to support prudent use of dental radiographs and cone-beam computed tomographic imaging. The regulatory guidance and best practice recommendations summarized in this article should be followed by dentists and other oral health care providers.

Effect of preradiation dental intervention on incidence of osteoradionecrosis in patients with head and neck cancer: A systematic review and meta-analysis.

BACKGROUND: The purpose of this systematic review was to examine whether dental intervention involving bone or soft-tissue manipulation preradiotherapy (pre-RT) is associated with lower rates of osteoradionecrosis of the jaw (ORNJ) in patients with head and neck cancer (HNC). TYPES OF STUDIES REVIEWED: The authors included relevant studies from MEDLINE, Embase, and Cochrane Library, including observational studies published from 2007 through 2021 and involving adults who underwent dental intervention pre-RT for HNC. Authors assessed evidence certainty by using the Grading of Recommendations Assessment, Development, and Evaluation approach. Random-effects models were used to calculate pooled relative risk estimates and hazard ratios. When meta-analysis was not possible, study-level measures of association and narrative summaries of the evidence were reported. RESULTS: Twenty-two studies were included. From the pooled, unadjusted analysis, patients undergoing pre-RT extractions may have a 55% increased risk of experiencing ORNJ (relative risk, 1.55; 95% CI, 0.85 to 2.86; very low certainty); the unadjusted pooled hazard ratio was 3.19 (95% CI, 0.99 to 10.31; very low certainty), corresponding to a possible increased hazard of developing ORNJ (very low certainty). Findings for other pre-RT procedures manipulating bone or tissue relied on limited, observational studies with low or very low certainty evidence. CONCLUSIONS: Mostly very low certainty evidence suggests that patients with HNC who need pre-RT dental intervention may have an increased risk of developing ORNJ compared with those who do not. PRACTICAL IMPLICATIONS: Maintaining optimal oral health may help reduce the need for urgent pre-RT dental treatment, potentially reducing ORNJ risk and minimizing delay of oncologic treatment in patients with HNC.

Benefits and harms associated with analgesic medications used in the management of acute dental pain: An overview of systematic reviews.

BACKGROUND: Effective pain management is a priority in dental practice. Government and private agencies highlight the need to provide optimal pain relief, balancing potential benefits and harms of both opioid and nonopioid analgesic agents. The purpose of this study is to summarize the available evidence on the benefits and harms of analgesic agents, focusing on preexisting systematic reviews. TYPES OF STUDIES REVIEWED: An overview of systematic reviews was conducted to evaluate the efficacy or reported adverse events associated with orally administered medication or medication combinations for relief of acute pain. Reviews were inclusive of all age populations but were limited to those that evaluated medication and medication combinations marketed in the United States and had moderate or high methodological quality according to the A MeaSurement Tool to Assess systematic Reviews (AMSTAR) 2 tool. RESULTS: Five reviews were found eligible for inclusion. The data identified combinations of ibuprofen and acetaminophen as having the highest association with treatment benefit in adult patients and the highest proportion of adult patients who experienced maximum pain relief. Diflunisal, acetaminophen, and oxycodone were found to have the longest duration of action in adult patients. Medication and medication combinations that included opioids were among those associated most frequently with acute adverse events in both child and adult-aged patient populations. PRACTICAL IMPLICATIONS: The best available data suggested that the use of nonsteroidal medications, with or without acetaminophen, offered the most favorable balance between benefits and harms, optimizing efficacy while minimizing acute adverse events.

HER2 testing to manage patients with breast cancer or other solid tumors.

OBJECTIVES: Systematic review of trastuzumab outcomes among breast cancer patients who have negative, equivocal, or discordant HER2 assay results; use of HER2 assay results to predict outcomes of chemotherapy or hormonal therapy regimen for breast cancer; use of serum HER2 to monitor treatment response or disease progression in breast cancer patients; and use of HER2 testing to manage patients with lung, ovarian, prostate, or head and neck tumors. Also, narrative review of concordance of HER2 assays. DATA SOURCES: We abstracted data from: three articles plus one conference abstract on negative, equivocal, or discordant HER2 results; 26 studies on selection of chemotherapy or hormonal therapy; 15 studies on serum HER2; and 26 studies on ovarian, lung, prostate, or head and neck tumors. Foreign-language studies were included. REVIEW METHODS: We sought randomized trials or single-arm series (prospective or retrospective) of identically treated patients that presented relevant outcome data associated with HER2 status. RESULTS: HER2 assay results are influenced by multiple biologic, technical, and performance factors. Many aspects of HER2 assays were standardized only recently, so inconsistencies confound the literature comparing different methods. The evidence is weak on outcomes of trastuzumab added to chemotherapy for HER2-equivocal, -discordant, or -negative patients. Evidence comparing chemotherapy outcomes in HER2-positive and HER2-negative patient subgroups may generate hypotheses, but is too weak to test hypotheses. Only a rigorous test can resolve whether HER2-positive patients (but not HER2-negative patients) benefit from an anthracycline regimen. Evidence is available only from uncontrolled series on whether HER2 status predicts complete pathologic response to neoadjuvant chemotherapy. Evidence also is weak regarding differences by HER2 status for outcomes of chemotherapy for advanced or metastatic disease; with most studies lacking statistical power. Data from studies of tamoxifen and aromatase inhibitors suggest that future studies should examine whether HER2 status predicts response to specific hormonal therapies among estrogen-receptor-positive patients. The evidence is weak on whether serum HER2 predicts outcome after treatment with any regimens in any setting, as is the evidence on use of serum or tissue HER2 testing for malignancies of lung, ovary, head and neck, or prostate. CONCLUSIONS: Overall, few studies directly investigated the key questions of this systematic review. Going forward, cancer therapy trial protocols should incorporate elements to facilitate robust analyses of the use of HER2 status and other biomarkers for managing treatment.

Treatment of primary and secondary osteoarthritis of the knee.

OBJECTIVES: Systematic review of outcomes of three treatments for osteoarthritis (OA) of the knee: intra-articular viscosupplementation; oral glucosamine, chondroitin or the combination; and arthroscopic lavage or debridement. DATA SOURCES: We abstracted data from: 42 randomized, controlled trials (RCTs) of viscosupplementation, all but one synthesized among six meta-analyses; 21 RCTs of glucosamine/chondroitin, 16 synthesized among 6 meta-analyses; and 23 articles on arthroscopy. The search included foreign-language studies and relevant conference proceedings. REVIEW METHODS: The review methods were defined prospectively in a written protocol. We sought systematic reviews, meta-analyses, and RCTs published in full or in abstract. Where randomized trials were few, we sought other study designs. We independently assessed the quality of all primary studies. RESULTS: Viscosupplementation trials generally report positive effects on pain and function scores compared to placebo, but the evidence on clinical benefit is uncertain, due to variable trial quality, potential publication bias, and unclear clinical significance of the changes reported. The Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT), a large (n=1,583), high-quality, National Institutes of Health-funded, multicenter RCT showed no significant difference compared to placebo. Glucosamine sulfate has been reported to be more effective than glucosamine hydrochloride, which was used in GAIT, but the evidence is not sufficient to draw conclusions. Clinical studies of glucosamine effect on glucose metabolism are short term, or if longer (e.g., 3 years), excluded patients with metabolic disorders. The best available evidence for arthroscopy, a single sham-controlled RCT (n=180), showed that arthroscopic lavage with or without debridement was equivalent to placebo. The main limitations of this trial are the use of a single surgeon and enrollment of patients at a single Veterans Affairs Medical Center. No studies reported separately on patients with secondary OA of the knee. The only comparative study was an underpowered, poor-quality trial comparing viscosupplementation to arthroscopy with debridement. CONCLUSIONS: Osteoarthritis of the knee is a common condition. The three interventions reviewed in this report are widely used in the treatment of OA of the knee, yet the best available evidence does not clearly demonstrate clinical benefit. Uncertainty regarding clinical benefit can be resolved only by rigorous, multicenter RCTs. In addition, given the public health impact of OA of the knee, research on new approaches to prevention and treatment should be given high priority.

Evidence for management of small cell lung cancer: ACCP evidence-based clinical practice guidelines (2nd edition).

PURPOSES: This systematic review addressed the following key questions on managing small cell lung cancer (SCLC): the sequence, timing, and dosing characteristics of primary thoracic radiotherapy (TRTx) for limited-stage disease; primary TRTx for extensive-stage disease; effect of prophylactic cranial irradiation (PCI); positron emission tomography (PET) for staging; treatment of mixed histology tumors; surgery; and second-line and subsequent-line treatment for relapsed/progressive disease. METHODS: The review methods were defined prospectively in a written protocol. We primarily sought randomized controlled trials that compared the interventions of interest. RESULTS: Robust evidence was lacking for all questions except PCI, for which a patient-level metaanalysis showed that PCI improves survival of SCLC patients who achieved complete response after primary therapy from 15.3 to 20.7% (p = 0.01). The case for concurrent over sequential radiation delivery rests largely on a single multicenter trial. Support for early concurrent therapy comes from one multicenter trial, but two other multicenter trials found no advantage. Metaanalysis did not find significant reductions in 2-year and 3-year mortality rates for early TRTx. Favorable results from a single-center trial on TRTx for extensive stage disease need replication in a multicenter setting. Relevant comparative studies were nonexistent for management of mixed histology disease and surgery for early limited SCLC. PET may be more sensitive in detecting extracranial disease than conventional staging modalities, but studies were of poor quality. CONCLUSIONS: PCI improves survival among those with a complete remission to primary therapy. A research agenda is needed to optimize the effectiveness of TRTx and its components.

Management of small cell lung cancer.

OBJECTIVES: This is a systematic review of evidence on issues in managing small cell lung cancer (SCLC). Key questions addressed are: the sequence, timing, and dosing characteristics of primary thoracic radiotherapy (TRTx) for limited-stage disease; primary TRTx for extensive-stage disease; effect of prophylactic cranial irradiation (PCI); positron emission tomography (PET) for staging; treatment of mixed histology tumors; surgery; and second- and subsequent-line treatment for relapsed/progressive disease. DATA SOURCES: MEDLINE, EMBASE, and the Cochrane Register REVIEW METHODS: The review methods were defined prospectively in a written protocol. We sought randomized controlled trials that compared the interventions of interest. Where randomized trials were limited or nonexistent, we sought additional studies. We performed meta-analysis of studies that compared early and late TRTx. RESULTS: The strongest evidence available for this report is a patient-level meta-analysis showing that PCI improves survival of SCLC patients who achieved complete response following primary therapy from 15.3 percent to 20.7 percent (p=0.01). No other question yielded evidence so robust. The case for concurrent over sequential radiation delivery rests largely on a single multicenter trial. Support for early concurrent therapy comes from one multicenter trial, but two other multicenter trials found no advantage. Our meta-analysis did not find significant reductions in 2- and 3-year mortality for early TRTx. Favorable results from a single-center trial on TRTx for extensive stage disease need replication in a multicenter setting. For other questions (i.e., management of mixed histology disease; surgery for early limited SCLC), relevant comparative studies were nonexistent. PET may be more sensitive in detecting disease outside the brain than conventional staging modalities, but studies were of poor quality and reliable estimates of performance are not possible. CONCLUSIONS: PCI improves survival among those with a complete response to primary therapy. A research agenda is needed to optimize the effectiveness of TRTx and its components. PET for staging may be useful, but its role awaits clarification by rigorous studies. No relevant evidence was available to address management of mixed histology disease or surgery for early limited SCLC.

Technology evaluation center assessment synopsis: full-field digital mammography.

Full-field digital mammography (FFDM) is proposed as an alternative to screen-film mammography (SFM). The ability to separate and optimize the acquisition, storage, and display of images may allow greater visualization of breast cancers at equal or lower radiation doses, especially in younger women and those with denser breasts. This is a synopsis of a systematic review by the Blue Cross Blue Shield Association Technology Evaluation Center. This updated systematic review primarily incorporated the results of the ACR Imaging Network(R) Digital Mammographic Imaging Screening Trial (DMIST), which provided results on 42,760 asymptomatic women who underwent both FFDM and SFM and showed with reasonable certainty that there was no difference in the accuracy of the 2 modalities for asymptomatic women in general, with some advantages of FFDM in certain subgroups. There were no strong, new studies on the use of digital mammography compared with film mammography in a diagnostic population. However, the DMIST results indicated that tumors detected by FFDM, but not by SFM, were likely to be invasive carcinomas or medium-grade to high-grade ductal carcinoma in situ. On the basis of the suppositions that these are the cancers of greatest interest and the ones more likely to be found in a diagnostic population and that the diagnostic population may be younger on average than the screening population, it was concluded that there is sufficient evidence to support the use of FFDM for diagnostic purposes.

The Blue Cross Blue Shield Association Technology Evaluation Center: how we evaluate radiology technologies.

Evidence-based technology assessment can help answer critical questions concerning the safety, effectiveness, and appropriate uses of medical technologies. This practice can be used to avoid the promotion of ineffective technologies and the premature diffusion of technologies that have not been demonstrated to improve patient-oriented health outcomes, both of which draw resources from effective and appropriate medical care. This article describes the process of such evaluation as undertaken by the Blue Cross Blue Shield Association Technology Evaluation Center. The key components of the assessment process are described, including the problem formulation and evaluation of study quality, as well as the process by which the available evidence is judged against the five Technology Evaluation Center criteria.

Technology Evaluation Center assessment synopsis: use of magnetic resonance imaging to avoid a biopsy in women with suspicious primary breast lesions.

Imaging technologies (e.g., magnetic resonance imaging [MRI]) have been proposed as noninvasive alternatives to surgical biopsy techniques in the follow-up of women with suspicious primary breast lesions. This article is a synopsis of a systematic review by the Blue Cross and Blue Shield Association Technology Evaluation Center. According to the best available evidence, the sensitivity and specificity of MRI ranged from 91% to 99% and from 31% to 91%, respectively. Predictive values were calculated by using three likely scenarios of diagnostic performance and disease prevalence. The potential harm of failing to diagnose or delaying diagnosis of breast cancer in patients with false-negative MRI results is of significant concern. We conclude that the potential benefit of sparing some patients from unnecessary biopsy by using noninvasive imaging does not outweigh the potential harm of a missed or delayed diagnosis of breast cancer.

Wireless capsule endoscopy in patients with obscure small-intestinal bleeding.

Wireless capsule endoscopy is proposed in the management of patients with obscure gastrointestinal (GI) bleeding, defined as persistent or recurrent GI bleeding without a cause identified on routine endoscopy. Obscure GI bleeding often originates from a small-intestinal abnormality, which presents diagnostic and therapeutic challenges because the small intestine is not easily visualized on conventional workup. This is a synopsis of a systematic review by the Blue Cross Blue Shield Association Technology Evaluation Center. Limited evidence shows that capsule endoscopy identified small-bowel lesions generally beyond the reach of push enteroscopy in 25% to 50% of patients and revealed additional diagnostic findings in 25% of patients compared with small-bowel barium radiographic studies. The authors conclude that in some cases, the information provided by capsule endoscopy in this specific patient population with obscure GI bleeding not diagnosed via conventional workup can lead to changes in management that would improve net health outcome.