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BACKGROUND: Higher doses of opioids, mental health comorbidities, co-prescription of sedatives, lower socioeconomic status and a history of opioid overdose have been reported as risk factors for opioid overdose; however, the magnitude of these associations and their credibility are unclear. We sought to identify predictors of fatal and nonfatal overdose from prescription opioids. METHODS: We systematically searched MEDLINE, Embase, CINAHL, PsycINFO and Web of Science up to Oct. 30, 2022, for observational studies that explored predictors of opioid overdose after their prescription for chronic pain. We performed random-effects meta-analyses for all predictors reported by 2 or more studies using odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Twenty-eight studies (23 963 716 patients) reported the association of 103 predictors with fatal or nonfatal opioid overdose. Moderate- to high-certainty evidence supported large relative associations with history of overdose (OR 5.85, 95% CI 3.78-9.04), higher opioid dose (OR 2.57, 95% CI 2.08-3.18 per 90-mg increment), 3 or more prescribers (OR 4.68, 95% CI 3.57-6.12), 4 or more dispensing pharmacies (OR 4.92, 95% CI 4.35-5.57), prescription of fentanyl (OR 2.80, 95% CI 2.30-3.41), current substance use disorder (OR 2.62, 95% CI 2.09-3.27), any mental health diagnosis (OR 2.12, 95% CI 1.73-2.61), depression (OR 2.22, 95% CI 1.57-3.14), bipolar disorder (OR 2.07, 95% CI 1.77-2.41) or pancreatitis (OR 2.00, 95% CI 1.52-2.64), with absolute risks among patients with the predictor ranging from 2-6 per 1000 for fatal overdose and 4-12 per 1000 for nonfatal overdose. INTERPRETATION: We identified 10 predictors that were strongly associated with opioid overdose. Awareness of these predictors may facilitate shared decision-making regarding prescribing opioids for chronic pain and inform harm-reduction strategies SYSTEMATIC REVIEW REGISTRATION: Open Science Framework (https://osf.io/vznxj/).
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Dolor Crónico , Sobredosis de Droga , Sobredosis de Opiáceos , Humanos , Analgésicos Opioides/uso terapéutico , Dolor Crónico/tratamiento farmacológico , Sobredosis de Droga/tratamiento farmacológico , Sobredosis de Opiáceos/complicaciones , Sobredosis de Opiáceos/tratamiento farmacológico , Prescripciones , Estudios Observacionales como AsuntoRESUMEN
BACKGROUND: The prevalence and intensity of persistent post-surgical pain (PPSP) after breast cancer surgery are uncertain. We conducted a systematic review and meta-analysis to further elucidate this issue. METHODS: We searched MEDLINE, Embase, CINAHL, and PsycINFO, from inception to November 2018, for observational studies reporting persistent pain (≥3 months) after breast cancer surgery. We used random-effects meta-analysis and the Grading of Recommendations, Assessment, Development and Evaluations approach to rate quality of evidence. RESULTS: We included 187 observational studies with 297 612 breast cancer patients. The prevalence of PPSP ranged from 2% to 78%, median 37% (inter-quartile range: 22-48%); the pooled prevalence was 35% (95% confidence interval [CI]: 32-39%). The pooled pain intensity was 3.9 cm on a 10 cm visual analogue scale (95% CI: 3.6-4.2 cm). Moderate-quality evidence supported the subgroup effects of PPSP prevalence for localized pain vs any pain (29% vs 44%), moderate or greater vs any pain (26% vs 44%), clinician-assessed vs patient-reported pain (23% vs 36%), and whether patients underwent sentinel lymph node biopsy vs axillary lymph node dissection (26% vs 43%). The adjusted analysis found that the prevalence of patient-reported PPSP (any severity/location) was 46% (95% CI: 36-56%), and the prevalence of patient-reported moderate-to-severe PPSP at any location was 27% (95% CI: 10-43%). CONCLUSIONS: Moderate-quality evidence suggests that almost half of all women undergoing breast cancer surgery develop persistent post-surgical pain, and about one in four develop moderate-to-severe persistent post-surgical pain; the higher prevalence was associated with axillary lymph node dissection. Future studies should explore whether nerve sparing for axillary procedures reduces persistent post-surgical pain after breast cancer surgery.
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Neoplasias de la Mama/cirugía , Dolor Crónico/epidemiología , Estudios Observacionales como Asunto , Dolor Postoperatorio/epidemiología , Neoplasias de la Mama/epidemiología , Femenino , Humanos , Prevalencia , Índice de Severidad de la EnfermedadRESUMEN
INTRODUCTION: Assessment of cranial dysmorphism in sagittal synostosis is often subjective but objective measures can be applied. These include cephalic index (CI) and midsagittal vector analysis (MSVA). OBJECTIVE: To assess discriminant validity, construct validity, and responsiveness of CI and MSVA measured from computed tomography (CT) in patients with sagittal synostosis. METHODS: Patients with nonsyndromic isolated sagittal synostosis with complete preoperative (n = 30) and postoperative (n = 13) CT data were included. Age-matched control group (n = 24) comprised of normocephalic patients who underwent CT for reasons related to trauma. OUTCOME MEASURES: Retrospective CT evaluation of CI and MSVA was conducted and correlated with a dysmorphism numeric rating scale (D-NRS) that measured surgeon-rated severity of sagittal synostosis. Responsiveness of CI and MSVA was evaluated using dysmorphism global rating of change (D-GRC). RESULTS: Thirty patients with sagittal synostosis were demographically similar to 24 normocephalic patients. The difference in CI and MSVA was statistically significant between normocephalic and scaphocephalic patients. Cephalic index had a good correlation with D-NRS (r = -0.665, ρ = -0.667), but not with MSVA (r = 0.250, ρ = 0.203). Change in CI (r = 0.738, ρ = 0.657) was well correlated with D-GRC, but not with MSVA (r = -0.409, ρ = -0.301). CONCLUSION: Cephalic index appears to quantify the severity of sagittal synostosis better than MSVA. Cephalic index also has better responsiveness than MSVA to measure a reduction in severity of disease; however, MSVA is a better descriptive craniometric measurement. Midsagittal vector analysis was able to quantify the shift in morphology in sagittal synostosis following surgical treatment.
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Cefalometría , Craneosinostosis , Procedimientos de Cirugía Plástica , Craneosinostosis/diagnóstico por imagen , Craneosinostosis/cirugía , Huesos Faciales , Humanos , Lactante , Estudios Retrospectivos , Tomografía Computarizada por Rayos XRESUMEN
Diabetic patients have a twofold to fourfold increased risk of cardiovascular disease. Despite a vast amount of research, the underlying mechanisms that predispose individuals with diabetes to the development of cardiovascular disease are unclear. To further our understanding of how diabetes promotes atherosclerosis, we have established, characterized, and manipulated a new model of hyperglycemia-induced atherosclerosis: the apolipoprotein E-deficient (ApoE(-/-)):Ins2(+/Akita) mouse. All mice were fed a standard chow diet. Male ApoE(-/-):Ins2(+/Akita) mice developed chronic hyperglycemia, which significantly accelerated atherosclerosis. Female ApoE(-/-):Ins2(+/Akita) mice presented hyperglycemia that normalized by 15 weeks of age. Despite the transient hyperglycemia, advanced atherosclerosis was observed at 15 weeks of age compared with ApoE(-/-) females. To better understand these differences, subsets of mice were castrated or ovariectomized at 5 weeks of age. Castrated ApoE(-/-):Ins2(+/Akita) mice showed a reduction in blood glucose levels that correlated with the amelioration of atherosclerosis. Interestingly, castrated normoglycemic ApoE(-/-) mice developed larger atherosclerotic lesions than sham-operated on controls. Ovariectomized ApoE(-/-):Ins2(+/Akita) mice presented chronic hyperglycemia, and atherosclerosis appeared to be advanced. We have characterized the distinctive sex-specific phenotypes exhibited by the ApoE(-/-):Ins2(+/Akita) mouse model and present evidence for the action of sex hormones on pancreatic ß-cell function and the vasculature that affect the regulation of blood glucose levels and the development of atherosclerosis. This model will provide a test bed to further delineate these effects.
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Apolipoproteínas E/metabolismo , Aterosclerosis/etiología , Hiperglucemia/complicaciones , Insulina/metabolismo , Caracteres Sexuales , Animales , Apolipoproteínas E/deficiencia , Castración , Diabetes Mellitus , Modelos Animales de Enfermedad , Femenino , Insulina/genética , Masculino , Ratones , Ratones Endogámicos C57BL , Ratones Noqueados , Ratones Mutantes , OvariectomíaRESUMEN
OBJECTIVE: To establish the prevalence of long-term and serious harms of medical cannabis for chronic pain. DESIGN: Systematic review and meta-analysis. DATA SOURCES: MEDLINE, EMBASE, PsycINFO and CENTRAL from inception to 1 April 2020. STUDY SELECTION: Non-randomised studies reporting on harms of medical cannabis or cannabinoids in adults or children living with chronic pain with ≥4 weeks of follow-up. DATA EXTRACTION AND SYNTHESIS: A parallel guideline panel provided input on the design and interpretation of the systematic review, including selection of adverse events for consideration. Two reviewers, working independently and in duplicate, screened the search results, extracted data and assessed risk of bias. We used random-effects models for all meta-analyses and the Grades of Recommendations, Assessment, Development and Evaluation approach to evaluate the certainty of evidence. RESULTS: We identified 39 eligible studies that enrolled 12 143 adult patients with chronic pain. Very low certainty evidence suggests that adverse events are common (prevalence: 26.0%; 95% CI 13.2% to 41.2%) among users of medical cannabis for chronic pain, particularly any psychiatric adverse events (prevalence: 13.5%; 95% CI 2.6% to 30.6%). Very low certainty evidence, however, indicates serious adverse events, adverse events leading to discontinuation, cognitive adverse events, accidents and injuries, and dependence and withdrawal syndrome are less common and each typically occur in fewer than 1 in 20 patients. We compared studies with <24 weeks and ≥24 weeks of cannabis use and found more adverse events reported among studies with longer follow-up (test for interaction p<0.01). Palmitoylethanolamide was usually associated with few to no adverse events. We found insufficient evidence addressing the harms of medical cannabis compared with other pain management options, such as opioids. CONCLUSIONS: There is very low certainty evidence that adverse events are common among people living with chronic pain who use medical cannabis or cannabinoids, but that few patients experience serious adverse events.
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Cannabinoides , Dolor Crónico , Marihuana Medicinal , Adulto , Analgésicos Opioides , Cannabinoides/efectos adversos , Niño , Dolor Crónico/tratamiento farmacológico , Humanos , Marihuana Medicinal/efectos adversosRESUMEN
OBJECTIVE: To determine the benefits and harms of medical cannabis and cannabinoids for chronic pain. DESIGN: Systematic review and meta-analysis. DATA SOURCES: MEDLINE, EMBASE, AMED, PsycInfo, CENTRAL, CINAHL, PubMed, Web of Science, Cannabis-Med, Epistemonikos, and trial registries up to January 2021. STUDY SELECTION: Randomised clinical trials of medical cannabis or cannabinoids versus any non-cannabis control for chronic pain at ≥1 month follow-up. DATA EXTRACTION AND SYNTHESIS: Paired reviewers independently assessed risk of bias and extracted data. We performed random-effects models meta-analyses and used GRADE to assess the certainty of evidence. RESULTS: A total of 32 trials with 5174 adult patients were included, 29 of which compared medical cannabis or cannabinoids with placebo. Medical cannabis was administered orally (n=30) or topically (n=2). Clinical populations included chronic non-cancer pain (n=28) and cancer related pain (n=4). Length of follow-up ranged from 1 to 5.5 months. Compared with placebo, non-inhaled medical cannabis probably results in a small increase in the proportion of patients experiencing at least the minimally important difference (MID) of 1 cm (on a 10 cm visual analogue scale (VAS)) in pain relief (modelled risk difference (RD) of 10% (95% confidence interval 5% to 15%), based on a weighted mean difference (WMD) of -0.50 cm (95% CI -0.75 to -0.25 cm, moderate certainty)). Medical cannabis taken orally results in a very small improvement in physical functioning (4% modelled RD (0.1% to 8%) for achieving at least the MID of 10 points on the 100-point SF-36 physical functioning scale, WMD of 1.67 points (0.03 to 3.31, high certainty)), and a small improvement in sleep quality (6% modelled RD (2% to 9%) for achieving at least the MID of 1 cm on a 10 cm VAS, WMD of -0.35 cm (-0.55 to -0.14 cm, high certainty)). Medical cannabis taken orally does not improve emotional, role, or social functioning (high certainty). Moderate certainty evidence shows that medical cannabis taken orally probably results in a small increased risk of transient cognitive impairment (RD 2% (0.1% to 6%)), vomiting (RD 3% (0.4% to 6%)), drowsiness (RD 5% (2% to 8%)), impaired attention (RD 3% (1% to 8%)), and nausea (RD 5% (2% to 8%)), but not diarrhoea; while high certainty evidence shows greater increased risk of dizziness (RD 9% (5% to 14%)) for trials with <3 months follow-up versus RD 28% (18% to 43%) for trials with ≥3 months follow-up; interaction test P=0.003; moderate credibility of subgroup effect). CONCLUSIONS: Moderate to high certainty evidence shows that non-inhaled medical cannabis or cannabinoids results in a small to very small improvement in pain relief, physical functioning, and sleep quality among patients with chronic pain, along with several transient adverse side effects, compared with placebo. The accompanying BMJ Rapid Recommendation provides contextualised guidance based on this body of evidence. SYSTEMATIC REVIEW REGISTRATION: https://osf.io/3pwn2.
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Dolor en Cáncer/tratamiento farmacológico , Cannabinoides/efectos adversos , Dolor Crónico/tratamiento farmacológico , Marihuana Medicinal/administración & dosificación , Adulto , Cannabinoides/administración & dosificación , Femenino , Humanos , Masculino , Marihuana Medicinal/efectos adversos , Diferencia Mínima Clínicamente Importante , Dimensión del Dolor , Ensayos Clínicos Controlados Aleatorios como Asunto , Sueño/efectos de los fármacosRESUMEN
OBJECTIVES: Medical three-dimensional (3D) printing, the fabrication of handheld models from medical images, has the potential to become an integral part of otolaryngology-head and neck surgery (Oto-HNS) with broad impact across its subspecialties. We review the basic principles of this technology and provide a comprehensive summary of reported clinical applications in the field. METHODS: Standard bibliographic databases (MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science, and The Cochrane Central Registry for Randomized Trials) were searched from their inception to May 2018 for the terms: "3D printing," "three-dimensional printing," "rapid prototyping," "additive manufacturing," "computer-aided design," "bioprinting," and "biofabrication" in various combinations with the terms: "ptolaryngology," "head and neck surgery," and "otology." Additional articles were identified from the references of retrieved articles. Only studies describing clinical applications of 3D printing were included. RESULTS: Of 5,532 records identified through database searching, 87 articles were included for qualitative synthesis. Widespread implementation of 3D printing in Oto-HNS is still at its infancy. Nonetheless, it is increasingly being utilized across all subspecialties from preoperative planning to design and fabrication of patient-specific implants and surgical guides. An emerging application considered highly valuable is its use as a teaching tool for medical education and surgical training. CONCLUSIONS: As technology and training standards evolve and as healthcare moves toward personalized medicine, 3D printing is emerging as a key technology in patient care in Oto-HNS. Treating physicians and surgeons who wish to stay abreast of these developments will benefit from a fundamental understanding of the principles and applications of this technology. Laryngoscope, 129:2045-2052, 2019.
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Otolaringología/instrumentación , Impresión Tridimensional , Cirugía Asistida por Computador/instrumentación , Materiales Biocompatibles , Bioimpresión , Diseño Asistido por Computadora , Humanos , Modelos Anatómicos , Planificación de Atención al Paciente , Prótesis e ImplantesRESUMEN
INTRODUCTION: Obstructive sleep apnoea (OSA) is caused by complete or partial obstruction of the upper airway resulting in repeated episodes of interrupted or shallow breaths. OSA is associated with significant morbidity and mortality. The prevalence is estimated to range from 3% to 7% in the general population but may be much higher. Several studies show that weight loss or bariatric surgery may have a role in treating OSA. The aim of this systematic review is to assess the safety and efficacy of randomised controlled trials (RCTs) of weight loss surgery for adults with OSA and comorbid obesity. METHODS AND ANALYSIS: A search of the Cochrane Central Register of Controlled Trials, PubMed, EMBASE and two major Chinese biomedical databases will be performed to identify related trials published as of October 2018. This study will include RCTs, comparing different types of weight loss surgery for OSA with obesity or weight loss surgery for OSA with obesity with other upper airway surgeries. The primary outcomes that will be measured are apnoea-hypopnoea index, excess weight loss and in-hospital mortality. The secondary outcomes will include duration of hospital stay, neck circumference, reoperation, waist circumference, body mass index, Epworth Sleepiness Scale score, overt complications (eg, gastric fistula, bleeding, delayed gastric emptying, wound infection), quality of life, quality of sleep and/or functionality. The systematic review will be conducted according to the recommendations as outlined by the Cochrane collaboration. ETHICS AND DISSEMINATION: The systematic review and meta-analysis will include published data available online and thus ethics approval will not be required. The findings will be disseminated and published in a peer-reviewed journal. Review updates will be conducted if there is new evidence that may cause any change in review conclusions. Any changes to the study protocol will be updated in the PROSPERO trial registry accordingly. PROSPERO REGISTRATION NUMBER: CRD42017081743.
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Cirugía Bariátrica , Índice de Masa Corporal , Obesidad , Apnea Obstructiva del Sueño , Pérdida de Peso , Adolescente , Adulto , Anciano , Humanos , Persona de Mediana Edad , Adulto Joven , Mortalidad Hospitalaria , Obesidad/complicaciones , Obesidad/cirugía , Proyectos de Investigación , Sueño , Apnea Obstructiva del Sueño/cirugía , Metaanálisis como Asunto , Revisiones Sistemáticas como AsuntoRESUMEN
BACKGROUND: Ankle sprains occur frequently among young and active people, accounting for almost 2 million injuries per year. Previous reports suggest that acupressure therapy for acute ankle sprains may shorten the recovery time. OBJECTIVE: To evaluate whether acupressure therapy can improve ankle sprain recovery compared with standard RICE (rest, ice, compression, and elevation) treatment. DESIGN: A randomized controlled trial was conducted. The study protocol was registered in the Chinese Clinical Trial Registry with the study registration number: ChiCTR-TRC-14004794. SETTING: Department of Traditional Chinese Medicine Orthopedics, PLA No.60 Center Hospital, Dali, China, and Department of Orthopedics, Xixi Hospital of Hangzhou, Hangzhou China, between June 2014 and January 2016. PATIENTS: A total of 68 patients with acute ankle sprains were assessed for study eligibility, and a total of 62 patients were included in the present study. METHODS: All patients with ankle sprains seen by the Orthopedics Department within 48 hours since the time of injury were identified. Consenting patients were randomized to either (1) standard treatment (ST group), (2) standard treatment + acupressure (AP group), or (3) standard treatment + mock acupressure (mock AP group). MAIN OUTCOME MEASUREMENTS: Outcomes of interest included a volumetric measurement of the foot, ankle, and lower leg), range of ankle movement, and visual analog pain scores. The American Orthopedic Foot and Ankle Score) and SF12v2 scores were used to assess quality of life. RESULTS: Among the 62 randomized patients, the mean (95% confidence interval [CI]) volumetric measurement of the foot, ankle, and lower leg in the AP group decreased from 185.24 (95% CI 142.80-227.67) to 62.14 (95% CI 44.03-80.25) after 3 sessions of acupressure treatment. This was a statistically significant difference (P < .01) compared with the means of ST group (119.00; 95% CI 89.14-148.86) and mock AP group (118.18; 95% CI 83.99-152.37). After the first treatment, the mean range of ankle movement, visual analog pain scores, and American Orthopedic Foot and Ankle Scores of the AP group were 31.67 (95% CI 27.78-35.55), 3.33 (95% CI 2.97-3.70), and 55.86 (95% CI 50.03-61.69), respectively. These scores were statistically better (P < .01) than the mean of the ST and mock AP group scores. In addition, the mean SF12v2 scores of AP group at 4 and 8 weeks were 109.95 (95% CI 107.29-112.62) and 119.67 (95% CI 119.27-120.05), respectively. These scores were also significantly greater than those of the ST group and mock AP groups (P < .01). CONCLUSION: Acupressure therapy may improve recovery after acute ankle sprain injury, yielding shortened time of disability and improved quality of life. LEVEL OF EVIDENCE: I.
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Acupresión/métodos , Traumatismos del Tobillo/terapia , Articulación del Tobillo/fisiopatología , Calidad de Vida , Recuperación de la Función , Esguinces y Distensiones/terapia , Adulto , Traumatismos del Tobillo/fisiopatología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Esguinces y Distensiones/fisiopatología , Resultado del Tratamiento , Adulto JovenRESUMEN
Purpose Breast cancer surgery is associated with unemployment. Identifying high-risk patients could help inform strategies to promote return to work. We systematically reviewed observational studies to explore factors associated with unemployment after breast cancer surgery. Methods We searched MEDLINE, EMBASE, CINAHL, and PsycINFO to identify studies that explored risk factors for unemployment after breast cancer surgery. When possible, we pooled estimates of association for all independent variables reported by more than one study. Results Twenty-six studies (46,927 patients) reported the association of 127 variables with unemployment after breast cancer surgery. Access to universal health care was associated with higher rates of unemployment (26.6% v 15.4%; test of interaction P = .05). High-quality evidence showed that unemployment after breast cancer surgery was associated with high psychological job demands (odds ratio [OR], 4.26; 95% CI, 2.27 to 7.97), childlessness (OR, 1.30; 95% CI, 1.11 to 1.53), lower education level (OR, 1.15; 95% CI, 1.05 to 1.25), lower income level (OR, 1.46; 95% CI, 1.24 to 1.73), cancer stage II, III or IV (OR, 1.43; 95% CI, 1.13 to 1.82), and mastectomy versus breast-conserving surgery (OR, 1.18; 95% CI, 1.07 to 1.30). Moderate-quality evidence suggested an association with high physical job demands (OR, 2.11; 95%CI, 1.52 to 2.93), African-American ethnicity (OR, 1.89; 95% CI, 1.21 to 2.96), and receipt of chemotherapy (OR, 1.95; 95% CI, 1.36 to 2.79). High-quality evidence demonstrated no significant association with part-time hours, blue-collar work, tumor size, positive lymph nodes, or receipt of radiotherapy or endocrine therapy; moderate-quality evidence suggested no association with age, marital status, or axillary lymph node dissection. Conclusion Addressing high physical and psychological job demands may be important in reducing unemployment after breast cancer surgery.
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Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/cirugía , Desempleo/estadística & datos numéricos , Sesgo , Estudios de Casos y Controles , Estudios de Cohortes , Humanos , Estudios Observacionales como Asunto , Prevalencia , Factores SocioeconómicosRESUMEN
Importance: Progression-free survival (PFS) has become a commonly used outcome to assess the efficacy of new cancer drugs. However, it is not clear if delay in progression leads to improved quality of life with or without overall survival benefit. Objective: To evaluate the association between PFS and health-related quality of life (HRQoL) in oncology through a systematic review and quantitative analysis of published randomized clinical trials. Eligible trials addressed oral, intravenous, intraperitoneal, or intrapleural chemotherapy or biological treatments, and reported PFS or health-related quality of life. Data Sources: For this systematic review and quantitative analysis of randomized clinical trials of patients with cancer, we searched Medline, Embase, and the Cochrane Central Register of Controlled Trials from January 1, 2000, through May 4, 2016. Study Selection: Paired reviewers independently screened citations, extracted data, and assessed risk of bias of included studies. Data Extraction and Synthesis: We examined the association of difference in median PFS duration (in months) between treatment groups with difference in global, physical, and emotional HRQoL scores between groups (standardized to a range of 0-100, with higher scores representing better HRQoL) using weighted simple regressions. Main Outcome and Measure: The association between PFS duration and HRQoL. Results: Of 35â¯960 records screened, 52 articles reporting on 38 randomized clinical trials involving 13â¯979 patients across 12 cancer types using 6 different HRQoL instruments were included. The mean (SD) difference in median PFS between the intervention and the control arms was 1.91 (3.35) months. The mean (SD) differences in change of HRQoL adjusted to per-month values were -0.39 (3.59) for the global domain, 0.26 (5.56) for the physical domain, and 1.08 (3.49) for the emotional domain. The slope of the association between the difference in median PFS and the difference in change for global HRQoL (n = 30 trials) was 0.12 (95% CI, -0.27 to 0.52); for physical HRQoL (n = 20 trials) it was -0.20 (95% CI, -0.62 to 0.23); and for emotional HRQoL (n = 13 trials) it was 0.78 (95% CI, -0.05 to 1.60). Conclusions and Relevance: We failed to find a significant association between PFS and HRQoL in cancer clinical trials. These findings raise questions regarding the assumption that interventions prolonging PFS also improve HRQoL in patients with cancer. Therefore, to ensure that patients are truly obtaining important benefit from cancer therapies, clinical trial investigators should measure HRQoL directly and accurately, ensuring adequate duration and follow-up.
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Neoplasias/mortalidad , Supervivencia sin Progresión , Calidad de Vida , Humanos , Neoplasias/fisiopatología , Neoplasias/psicología , Evaluación de Resultado en la Atención de SaludRESUMEN
OBJECT The optimal clinical management of intraventricular hemorrhage (IVH) and posthemorrhagic ventricular dilation (PHVD)/posthemorrhagic hydrocephalus (PHH) in premature infants remains unclear. A common approach involves temporary treatment of hydrocephalus in these patients with a ventriculosubgaleal shunt (VSGS), ventricular access device (VAD), or external ventricular drain (EVD) until it becomes evident that the patient needs and can tolerate permanent CSF diversion (i.e., ventriculoperitoneal shunt). The present systematic review and meta-analysis aimed to provide a robust and comprehensive summary of the published literature regarding the clinical outcomes and complications of these 3 techniques as temporizing measures in the management of prematurity-related PHVD/PHH. METHODS The authors searched MEDLINE, EMBASE, CINAHL, Google Scholar, and the Cochrane Library for studies published through December 2013 on the use of VSGSs, VADs, and/or EVDs as temporizing devices for the treatment of hydrocephalus following IVH in the premature neonate. Data pertaining to patient demographic data, study methods, interventions, and outcomes were extracted from eligible articles. For each of the 3 types of temporizing device, the authors performed meta-analyses examining 6 outcomes of interest, which were rates of 1) obstruction; 2) infection; 3) arrest of hydrocephalus (i.e., permanent shunt independence); 4) mortality; 5) good neurodevelopmental outcome; and 6) revision. RESULTS Thirty-nine studies, representing 1502 patients, met eligibility criteria. All of the included articles were observational studies; 36 were retrospective and 3 were prospective designs. Nine studies (n = 295) examined VSGSs, 24 (n = 962) VADs, and 9 (n = 245) EVDs. Pooled rates of outcome for VSGS, VAD, and EVD, respectively, were 9.6%, 7.3%, and 6.8% for obstruction; 9.2%, 9.5%, and 6.7% for infection; 12.2%, 10.8%, and 47.3% for revision; 13.9%, 17.5%, and 31.8% for arrest of hydrocephalus; 12.1%, 15.3%, and 19.1% for death; and 58.7%, 50.1%, and 56.1% for good neurodevelopmental outcome. CONCLUSIONS This study provides robust estimates of outcomes for the most common temporizing treatments for IVH in premature infants. With few exceptions, the range of outcomes was similar for VSGS, VAD, and EVD.