Long-term multimorbidity trajectories in older adults: The role of cancer, demographics, and health behaviors.

BACKGROUND: Multimorbidity is associated with premature mortality and excess health care costs. The burden of multimorbidity is highest among patients with cancer, yet trends and determinants of multimorbidity over time are poorly understood. METHODS: Via Medicare claims linked to Cancer Prevention Study II data, group-based trajectory modeling was used to compare National Cancer Institute comorbidity index score trends for cancer survivors and older adults without a cancer history. Among cancer survivors, multinomial logistic regression analyses evaluated associations between demographics, health behaviors, and comorbidity trajectories. RESULTS: In 82,754 participants (mean age, 71.6 years [SD, 5.1 years]; 56.9% female), cancer survivors (n = 11,265) were more likely than older adults without a cancer history to experience the riskiest comorbidity trajectories: (1) steady, high comorbidity scores (remain high; odds ratio [OR], 1.36; 95% CI, 1.29-1.45), and (2) high scores that increased over time (start high and increase; OR, 1.51; 95% CI, 1.38-1.65). Cancer survivors who were physically active postdiagnosis were less likely to fall into these two trajectories (OR, 0.73; 95% CI, 0.64-0.84, remain high; OR, 0.42; 95% CI, 0.33-0.53, start high and increase) compared to inactive survivors. Cancer survivors with obesity were more likely to have a trajectory that started high and increased (OR, 2.83; 95% CI, 2.32-3.45 vs. normal weight), although being physically active offset some obesity-related risk. Cancer survivors who smoked postdiagnosis were also six times more likely to have trajectories that started high and increased (OR, 6.86; 95% CI, 4.41-10.66 vs. never smokers). CONCLUSIONS: Older cancer survivors are more likely to have multiple comorbidities accumulated at a faster pace than older adults without a history of cancer. Weight management, physical activity, and smoking avoidance postdiagnosis may attenuate that trend.

Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial.

BACKGROUND: New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears. METHODS: We conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Participants and assessors were masked to group assignment. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. The primary outcome was the Oxford Shoulder Score at 12 months. Pre-trial simulations using data from early and late timepoints informed stopping boundaries for two interim analyses. The primary analysis was on a modified intention-to-treat basis, adjusted for the planned interim analysis. The trial was registered with ISRCTN, ISRCTN17825590. FINDINGS: Between June 1, 2018, and July 30, 2020, we assessed 385 people for eligibility, of which 317 were eligible. 249 (79%) people consented for inclusion in the study. 117 participants were randomly allocated to a treatment group, 61 participants to the debridement only group and 56 to the debridement with device group. A predefined stopping boundary was met at the first interim analysis and recruitment stopped with 117 participants randomised. 43% of participants were female, 57% were male. We obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with device group (mean difference adjusted for adaptive design -4·2 [95% CI -8·2 to -0·26];p=0·037) favouring control. There was no difference in adverse events between the two groups. INTERPRETATION: In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears. FUNDING: Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership.

Impact of a pre-existing diagnosis of mental illness on stage of breast cancer diagnosis among older women.

PURPOSE: Having a mental illness increases risk of mortality for women with breast cancer, partly due to barriers to accessing recommended care (e.g., cancer screening). Early detection is one important factor in breast cancer survival. To further understand this disparity in survival, we examined whether older women with mental illness are more likely to be diagnosed with later-staged breast cancers compared to women without mental illnesses. METHODS: We used 2005-2015 SEER-Medicare data to identify AJCC stage I-IV breast cancer patients with and without a history of mental illness prior to cancer diagnosis. We used generalized ordinal regression to examine associations between mental illness diagnoses and stage at diagnosis, controlling for age, race/ethnicity, income, comorbidities, primary care use, rurality, and marital status. RESULTS: Among 96,034 women with breast cancer, 1.7% have a serious mental illness (SMI), 19.9% depression or anxiety, and 7.0% other mental illness. Those with SMI have 40% higher odds of being diagnosed with AJCC Stages II, III than Stage I; women with depression/anxiety have 25% lower odds of being diagnosed with Stage IV cancer than Stage I; and women with other mental illnesses have similar odds of being diagnosed in later stages. CONCLUSION: Women with SMI have higher odds of being diagnosed at later stages, which likely contributes to higher mortality after breast cancer. Surprisingly, women with depression and anxiety have a lower risk of being diagnosed with Stage IV cancer. Earlier breast cancer diagnosis in women with SMI is an important goal for reducing disparities breast cancer survival.

Evaluation of the Completeness of Managed Care Data to Identify Cancer Diagnoses and Treatments for Patients in the SEER-Medicare Data.

BACKGROUND: The utility of codes on Medicare Advantage (MA) data to capture cancer diagnoses and treatment for cancer patients is unknown. OBJECTIVE: This study compared cancer diagnoses and treatments on MA encounter data (MA data) with the Surveillance, Epidemiology, and End-Results (SEER) data. SUBJECTS: Subjects were patients enrolled in either MA or Medicare fee-for-service (MFFS) when diagnosed with incident breast, colorectal, prostate, or lung cancer, 2015-2017, in a SEER cancer registry. MEASURES: MA data, from 2 months before to 12 months following SEER diagnosis, were reviewed to identify cancer diagnoses, surgery, chemotherapy, and radiotherapy (RT). MA data were compared with SEER to determine their sensitivity to capture cancer diagnoses and sensitivity/specificity to identify surgeries. The agreement between SEER and Medicare data regarding receipt of chemotherapy and RT was measured by Kappa statistics. A similar comparison to SEER diagnoses/treatments was made using MFFS claims to provide context for the SEER-MA comparison. RESULTS: The study included 186,449 patients, 38% in MA. MA data had 92%+ sensitivity to identify SEER cancer diagnosis and 90%+ sensitivity for cancer surgery. Specificity for surgery was >84%, except for breast cancer (52%). Kappa statistics for agreement between SEER and MA data regarding chemotherapy varied by cancer, 0.61-0.82, and for receipt of RT exceeded 0.75 for all cancers. Results observed for MFFS claims were similar to those in MA data. CONCLUSION: For 4 common cancers, MA data included most cancer diagnoses and general types of cancer treatment reported in the SEER data. More research is needed to assess additional cancers and detailed treatments.

Effects of ethnic density on the risk of compulsory psychiatric admission for individuals attending secondary care mental health services: evidence from a large-scale study in England.

BACKGROUND: Black, Asian and minority ethnicity groups may experience better health outcomes when living in areas of high own-group ethnic density - the so-called 'ethnic density' hypothesis. We tested this hypothesis for the treatment outcome of compulsory admission. METHODS: Data from the 2010-2011 Mental Health Minimum Dataset (N = 1 053 617) was linked to the 2011 Census and 2010 Index of Multiple Deprivation. Own-group ethnic density was calculated by dividing the number of residents per ethnic group for each lower layer super output area (LSOA) in the Census by the LSOA total population. Multilevel modelling estimated the effect of own-group ethnic density on the risk of compulsory admission by ethnic group (White British, White other, Black, Asian and mixed), accounting for patient characteristics (age and gender), area-level deprivation and population density. RESULTS: Asian and White British patients experienced a reduced risk of compulsory admission when living in the areas of high own-group ethnic density [odds ratios (OR) 0.97, 95% credible interval (CI) 0.95-0.99 and 0.94, 95% CI 0.93-0.95, respectively], whereas White minority patients were at increased risk when living in neighbourhoods of higher own-group ethnic concentration (OR 1.18, 95% CI 1.11-1.26). Higher levels of own-group ethnic density were associated with an increased risk of compulsory admission for mixed-ethnicity patients, but only when deprivation and population density were excluded from the model. Neighbourhood-level concentration of own-group ethnicity for Black patients did not influence the risk of compulsory admission. CONCLUSIONS: We found only minimal support for the ethnic density hypothesis for the treatment outcome of compulsory admission to under the Mental Health Act.

Perception of Telehealth During the COVID-19 Pandemic Among Survivors of Gynecologic Cancer.

Our objective was to assess gynecologic cancer survivor preferences for telehealth cancer care. Gynecologic cancer survivors participating in a prospective cohort study were invited to complete a cross-sectional survey regarding their experience with and preferences for telehealth. Of 188 participants, 48.9% had undergone a telehealth visit since March 2020, and 53.7% reported a preference for exclusively in-person visits for their cancer care and surveillance. Furthermore, 80.5% of participants were satisfied with the telehealth care they received and 54.8% would recommend telehealth services to patients with similar conditions. Most participants thought a physical examination was critical to detecting recurrence, and concern that their provider may miss something during telehealth visits was greater among those who preferred in-person visits. With many gynecologic cancer survivors preferring in-person care, building a future care model that includes telehealth elements will require adaptations, careful evaluation of patient concerns, as well as patient education on telehealth.

Opportunities for personalizing colorectal cancer care: an analysis of SEER-medicare data.

United States clinical practice guidelines for metastatic colorectal cancer recommend use of medications impacted by genetic variants but do not recommend testing. We analyzed real-world treatment using a cancer registry and claims dataset to explore pharmacogenomic (PGx) medication treatment patterns and characterize exposure. In a cohort of 6957 patients, most (86.9%) were exposed to at least one chemotherapy medication with PGx guidelines. In a cohort of 2223 patients with retail pharmacy claims available, most (79.2%) were treated with at least one non-chemotherapy (79.2%) medication with PGx guidelines. PGx-associated chemotherapy exposure was associated with age, race/ethnicity, educational attainment, and rurality. PGx-associated non-chemotherapy exposure was associated with medication use and comorbidities. The potential impact of PGx testing is large and policies aimed at increasing PGx testing at diagnosis may impact treatment decisions for patients with metastatic colorectal cancer as most patients are exposed to medications with pharmacogenomics implications during treatment.

Group sequential designs in pragmatic trials: feasibility and assessment of utility using data from a number of recent surgical RCTs.

BACKGROUND: Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large sample sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions. As a means to assess the potential utility of group sequential designs, we re-analyse data from a number of recent high-profile RCTs and assess whether using such a design would have caused the trial to stop early. METHODS: Many pragmatic RCTs monitor participants at a number of occasions (e.g. at 6, 12 and 24 months after surgery) during follow-up as a means to assess recovery and also to keep participants engaged with the trial process. Conventionally one of the outcomes is selected as the primary (final) outcome, for clinical reasons, with others designated as either early or late outcomes. In such settings, novel group sequential designs that use data from not only the final outcome but also from early outcomes at interim analyses can be used to inform stopping decisions. We describe data from seven recent surgical RCTs (WAT, DRAFFT, WOLLF, FASHION, CSAW, FIXDT, TOPKAT), and outline possible group sequential designs that could plausibly have been proposed at the design stage. We then simulate how these group sequential designs could have proceeded, by using the observed data and dates to replicate how information could have accumulated and decisions been made for each RCT. RESULTS: The results of the simulated group sequential designs showed that for two of the RCTs it was highly likely that they would have stopped for futility at interim analyses, potentially saving considerable time (15 and 23 months) and costs and avoiding patients being exposed to interventions that were either ineffective or no better than standard care. We discuss the characteristics of RCTs that are important in order to use the methodology we describe, particularly the value of early outcomes and the window of opportunity when early stopping decisions can be made and how it is related to the length of recruitment period and follow-up. CONCLUSIONS: The results for five of the RCTs tested showed that group sequential designs using early outcome data would have been feasible and likely to provide designs that were at least as efficient, and possibly more efficient, than the original fixed sample size designs. In general, the amount of information provided by the early outcomes was surprisingly large, due to the strength of correlations with the primary outcome. This suggests that the methods described here are likely to provide benefits more generally across the range of surgical trials and more widely in other application areas where trial designs, outcomes and follow-up patterns are structured and behave similarly.

The influence of the Affordable Care Act-Dependent Care Expansion on insurance coverage among young cancer survivors in California: an updated analysis.

PURPOSE: To assess changes in health insurance coverage for young cancer patients pre- and post- the Affordable Care Act-Dependent Care Expansion (ACA-DCE) implementation in California. Further, we examined differences in insurance coverage by socioeconomic and race/ethnicity. METHODS: Data were obtained from the California Cancer Registry and Medicaid enrollment files, from 2005 to 2014. We conducted difference-in-difference analyses among 7042 cancer patients aged 22-25 years ("intervention group") and 25,269 aged 26-34 years ("control group"). We also examined the independent and combined effects of race/ethnicity and neighborhood socioeconomic status (nSES) on insurance coverage. RESULTS: After the ACA-DCE implementation, we observed a 52.7% reduction in the proportion of uninsured and a 35.7% increase in the proportion of privately insured patients. There was also a 17.3% reduction in Medicaid at cancer diagnosis and a 27.5% reduction in discontinuous Medicaid enrollment. However, these benefits were limited to patients of non-Hispanic White, Hispanic and Asian/Pacific Islander race/ethnicity living in higher nSES, with no differences in insurance enrollment among young adults who lived in low nSES or those of Black race/ethnicity. CONCLUSION: The ACA-DCE broadened insurance coverage for young adults with cancer in California. Yet, only certain subgroups of patients have benefited from this policy.

The New Normal? Patient Satisfaction and Usability of Telemedicine in Breast Cancer Care.

BACKGROUND: Telemedicine was adopted to minimize exposure risks for patients and staff during the coronavirus disease 2019 pandemic. This study measured patient satisfaction and telemedicine usability in breast cancer care. METHODS: Adult breast cancer patients who had a telemedicine visit at a single academic institution (with surgical, radiation, or medical oncology) from 15 June 2020 to 4 September 2020 were surveyed anonymously. Patient and cancer characteristics were collected, and patient satisfaction and telemedicine usability were assessed using a modified Telehealth Usability Questionnaire with a 7-point Likert scale. Associations of satisfaction and usability with patient characteristics were analyzed using Wilcoxon rank-sum and Kruskal-Wallis tests. RESULTS: Of 203 patients who agreed to be contacted, 78 responded, yielding a response rate of 38%. The median age of the respondents was 63 years (range 25-83 years). The majority lived in an urban area (61%), were white (92%), and saw a medical oncologist (62%). The median patient satisfaction score was 5.5 (interquartile range [IQR] 4.25-6.25). The median telemedicine usability score was 5.6 (IQR 4.4-6.2). A strong positive correlation was seen between satisfaction and usability, with a Spearman correlation coefficient (ρ) of 0.80 (p < 0.001). Satisfaction and usability scores did not vary significantly according to patient age, race, location of residence, insurance status, previous visit commute time, oncology specialty seen, prior telemedicine visits, or whether patients were actively receiving cancer treatment. CONCLUSIONS: Breast cancer patients were satisfied with telemedicine and found it usable. Patient satisfaction and telemedicine usability should not limit the use of telemedicine in future post-pandemic breast cancer care.

Racial and ethnic disparities in survival of children with brain and central nervous tumors in the United States.

BACKGROUND: Despite improvements in overall survival for pediatric cancers, treatment disparities remain for racial/ethnic minorities compared to non-Hispanic Whites; however, the impact of race on treatment outcomes for pediatric brain and central nervous system (CNS) tumors in the United States is not well known. METHODS: We included 8713 children aged 0-19 years with newly diagnosed primary brain and CNS tumors between 2000 and 2015 from the Census Tract-level SES and Rurality Database developed by Surveillance, Epidemiology, and End Results (SEER) Program. We used chi-square tests to assess differences in sociodemographic, cancer, and treatment characteristics by race/ethnicity and Kaplan-Meier curves and Cox proportional hazards models to examine differences in 10-year survival, adjusting for these characteristics. RESULTS: Among 8713 patients, 56.75% were non-Hispanic White, 9.59% non-Hispanic Black, 25.46% Hispanic, and 8.19% from "other" racial/ethnic groups. Median unadjusted survival for all pediatric brain tumors was 53 months, but varied significantly by race/ethnicity with a median survival of 62 months for non-Hispanic Whites, 41 months for non-Hispanic Blacks, and 40 months for Hispanic and other. Multivariable analyses demonstrated minority racial groups still had significantly higher hazard of death than non-Hispanic Whites; Hispanic (adjusted hazard ratio [aHR] 1.25 [1.18-1.31]); non-Hispanic Black (aHR 1.12 [1.04-1.21]); other (aHR 1.22 [1.12-1.32]). Results were consistent when stratified by tumor histology. CONCLUSION: We identified disparities in survival among racial/ethnic minorities with pediatric brain and CNS tumors, with Hispanic patients having the highest risk of mortality. Eliminating these disparities requires commitment toward promoting heath equity and personalized cancer treatment.

Impact of insurance type and timing of Medicaid enrollment on survival among adolescents and young adults with cancer.

BACKGROUND: Adolescents and young adults (AYAs) with public or no insurance experience later stage at diagnosis and worse overall survival compared with those with private insurance. However, prior studies have not distinguished the survival impact of continuous Medicaid coverage prior to diagnosis compared with gaining Medicaid coverage at diagnosis. METHODS: We linked a cohort of AYAs aged 15-39 who were diagnosed with 13 common cancers from 2005 to 2014 in the California Cancer Registry with California Medicaid enrollment files to ascertain Medicaid enrollment, with other insurance determined from registry data. We used Cox proportional hazards regression to evaluate the impact of insurance on survival, adjusting for clinical and demographic characteristics. RESULTS: Among 62 218 AYAs, over 65% had private/military insurance, 10% received Medicaid at diagnosis, 13.2% had continuous Medicaid, 4.1% had discontinuous Medicaid, 1.7% had other public insurance, 3% were uninsured, and 2.6% had unknown insurance. Compared with those with private/military insurance, individuals with Medicaid insurance had significantly worse survival regardless of when coverage began (received Medicaid at diagnosis: hazard ratio [95% confidence interval]: 1.51 [1.42-1.61]; continuously Medicaid insured: 1.42 [1.33-1.52]; discontinuous Medicaid: 1.64 [1.49, 1.80]). Analyses of those with Medicaid insurance only demonstrated slightly worse cancer-specific survival among those with discontinuous Medicaid or enrollment at diagnosis compared with those with continuous enrollment, but results were not significant stratified by cancer site. CONCLUSIONS AND RELEVANCE: AYAs with Medicaid insurance experience worse cancer-specific survival compared with those with private/military insurance, yet continuous enrollment demonstrates slight survival improvements, providing potential opportunities for future policy intervention.

Tourniquet use for knee replacement surgery.

BACKGROUND: Many surgeons prefer to perform total knee replacement surgery with the aid of a tourniquet. A tourniquet is an occlusive device that restricts distal blood flow to help create a bloodless field during the procedure. A tourniquet may be associated with increased risk of pain and complications. OBJECTIVES: To determine the benefits and harms of tourniquet use in knee replacement surgery. SEARCH METHODS: We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) up to 26 March 2020. We searched clinicaltrials.gov, the World Health Organization trials portal, and several international registries and joint registries up to March 2020. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing knee replacement with use of a tourniquet versus without use of a tourniquet and non-randomised studies with more than 1000 participants. Major outcomes included pain, function, global assessment of success, health-related quality of life, serious adverse events (including venous thromboembolism, infection, re-operation, and mortality), cognitive function, and survival of the implant. Minor outcomes included blood loss, economic outcomes, implant stability, and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors screened abstracts and full texts, extracted data, performed risk of bias assessments, and assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included 41 RCTs with 2819 participants. Trials included from 20 to 199 participants. Mean age ranged between 58 and 84 years. More than half of the RCTs had unclear risk of selection bias and unclear risk of performance and detection bias due to absence of blinding of participants and surgeons. Major outcomes Pain: at postoperative day 1, pain (on a scale from zero to 10, with higher scores indicating worse pain) was ranked at 4.56 points after surgery without a tourniquet and at 1.25 points (MD) higher (95% CI 0.32 higher to 2.19 higher) with a tourniquet (8 studies; 577 participants), for an absolute difference of 12.5% higher pain scores (95% CI 3.2% higher to 21.9% higher) and a relative difference of 19% higher pain scores (95% CI 3.4% higher to 49% higher) with a tourniquet. Evidence for these findings was of moderate certainty, downgraded due to risk of bias. Knee replacement with a tourniquet probably led to higher postoperative pain scores at day 1, although this difference may or may not be noticeable to patients (based on a minimal clinically important difference (MCID) of 1.0). Function: at 12 months, tourniquet use probably makes little or no difference to function, based on an MCID of 5.3 for Knee Society Score (KSS) and 5.0 for Oxford Knee Score (OKS). Mean function (on a scale from 0 to 100, with higher scores indicating better outcomes) was 90.03 points after surgery without a tourniquet and was 0.29 points worse (95% CI 1.06 worse to 0.48 better) on a 0 to 100 scale, absolute difference was 0.29% worse (1.06% worse to 0.48% better), with a tourniquet (5 studies; 611 participants). This evidence was downgraded to moderate certainty due to risk of bias. Global assessment of success: low-certainty evidence (downgraded due to bias and imprecision) indicates that tourniquet use may have little or no effect on success. At six months, 47 of 50 (or 940 per 1000) reported overall successful treatment after surgery without a tourniquet and 47 of 50 (or 940 per 1000) with a tourniquet (risk ratio (RR) 1.0, 95% CI 0.91 to 1.10) based on one study with 100 participants. Health-related quality of life: at six months, tourniquet may have little or no effect on quality of life. The 12-Item Short Form Survey (SF-12) score (mental component from zero to 100 (100 is best)) was 54.64 after surgery without a tourniquet and 1.53 (MD) better (95% CI 0.85 worse to 3.91 better) with a tourniquet (1 study; 199 participants); absolute difference was 1.53% better (0.85% worse to 3.91% better). Evidence was of low certainty, downgraded due to risk of bias and small number of participants. Serious adverse events: the risk of serious adverse events was probably higher with tourniquet; 26 of 898 (29 per 1000) reported events following surgery without a tourniquet compared to 53 of 901 (59 per 1000) with a tourniquet (RR 1.73, 95% CI 1.10 to 2.73) in 21 studies (1799 participants). Twenty-nine more per 1000 patients (95% CI 3 to 50 more per 1000 patients) had a serious adverse event with a tourniquet. Forty-eight (95% CI 20 to 345) participants would need to have surgery without a tourniquet to avoid one serious adverse event. This evidence was downgraded to moderate certainty due to risk of bias. Cognitive function: one study reported cognitive function as an outcome; however the data were incompletely reported and could not be extracted for analysis. Survival of implant: it is uncertain if tourniquet has an effect on implant survival due to very low certainty evidence (downgraded for bias, and twice due to very low event rates); 2 of 107 (19 per 1000) required revision surgery in the surgery with a tourniquet group compared to 1 of 107 (9 per 1000) without a tourniquet group at up to two years' follow-up (RR 1.44, 95% CI 0.23 to 8.92). This equates to a 0.4% (0.7% lower to 7% more) increased absolute risk in surgery with a tourniquet. AUTHORS' CONCLUSIONS: Moderate certainty evidence shows that knee replacement surgery with a tourniquet is probably associated with an increased risk of serious adverse events. Surgery with a tourniquet is also probably associated with higher postoperative pain, although this difference may or may not be noticeable to patients. Surgery with a tourniquet does not appear to confer any clinically meaningful benefit on function, treatment success or quality of life. Further research is required to explore the effects of tourniquet use on cognitive function and implant survival, to identify any additional harms or benefits. If a tourniquet continues to be used in knee replacement surgery, patients should be informed about the potential increased risk of serious adverse events and postoperative pain.

ANTECEDENTES: Muchos cirujanos prefieren realizar una cirugía de reemplazo total de rodilla con la ayuda de un torniquete. Un torniquete es un dispositivo oclusivo que restringe el flujo sanguíneo distal para ayudar a crear un campo sin sangre durante el procedimiento. El torniquete se puede asociar con un mayor riesgo de dolor y complicaciones. OBJETIVOS: Determinar los efectos beneficiosos y perjudiciales del uso de torniquetes en la cirugía de reemplazo de rodilla. MÉTODOS DE BÚSQUEDA: Se hicieron búsquedas en MEDLINE, Embase y en el Registro Cochrane central de ensayos controlados (CENTRAL) hasta el 26 de marzo de 2020. Se realizaron búsquedas en clinicaltrials.gov, el portal de ensayos de la Organización Mundial de la Salud, y en varios registros internacionales y registros conjuntos hasta marzo de 2020. CRITERIOS DE SELECCIÓN: Se incluyeron los ensayos controlados aleatorizados (ECA) que compararon el reemplazo de rodilla con el uso de un torniquete versus sin el uso de un torniquete y los estudios no aleatorizados con más de 1000 participantes. Los desenlaces principales fueron el dolor, la funcionalidad, la evaluación general del éxito, la calidad de vida relacionada con la salud, los eventos adversos graves (incluido el tromboembolismo venoso, la infección, la reintervención y la mortalidad), la función cognitiva y la supervivencia del implante. Los desenlaces secundarios incluyeron la pérdida de sangre, los desenlaces económicos, la estabilidad del implante y los eventos adversos. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Dos autores de la revisión examinaron los resúmenes y los textos completos, extrajeron los datos, realizaron las evaluaciones del riesgo de sesgo y evaluaron la certeza de la evidencia utilizando el enfoque GRADE. RESULTADOS PRINCIPALES: Se incluyeron 41 ECA con 2819 participantes. Los ensayos incluyeron de 20 a 199 participantes. La media de edad varió entre 58 y 84 años. Más de la mitad de los ECA tenían riesgo incierto de sesgo de selección y riesgo incierto de sesgo de realización y detección debido a la falta de cegamiento de los participantes y los cirujanos. Desenlaces principales Dolor: en el primer día después de la cirugía, el dolor (en una escala de 0 a 10, con puntuaciones mayores que indican un peor dolor) se clasificó en 4,56 puntos después de la cirugía sin torniquete y en 1,25 puntos (DM) mayor (IC del 95%: 0,32 mayor a 2,19 mayor) con un torniquete (ocho estudios; 577 participantes), para una diferencia absoluta de 12,5% de puntuaciones mayores de dolor (IC del 95%: 3,2% mayor a 21,9% mayor) y una diferencia relativa de 19% de puntuaciones mayores de dolor (IC del 95%: 3,4% mayor a 49% mayor) con un torniquete. La evidencia de estos hallazgos fue de certeza moderada, disminuida debido al riesgo de sesgo. El reemplazo de rodilla con un torniquete probablemente dio lugar a mayores puntuaciones de dolor en el primer día después de la cirugía, aunque esta diferencia puede o no ser perceptible para los pacientes (sobre la base de una diferencia mínima clínicamente importante [DMCI] de 1,0). Funcionalidad: a los 12 meses el uso de torniquetes probablemente da lugar a poca o ninguna diferencia en la funcionalidad, según una DMCI de 5,3 en la Knee Society Score (KSS) y de 5,0 en la Oxford Knee Score (OKS). La funcionalidad media (en una escala de 0 a 100, con puntuaciones más altas que indican mejores desenlaces) fue de 90,03 puntos después de la cirugía sin torniquete y fue 0,29 puntos peor (IC del 95%: 1,06 peor a 0,48 mejor) en una escala de 0 a 100, la diferencia absoluta fue 0,29% peor (1,06% peor a 0,48% mejor), con un torniquete (cinco estudios; 611 participantes). Esta evidencia se disminuyó a certeza moderada debido al riesgo de sesgo. Evaluación general del éxito: evidencia de certeza baja (disminuida debido al sesgo y la imprecisión) indica que el uso de torniquetes puede tener poco o ningún efecto en el éxito. A los seis meses, 47 de 50 (o 940 por 1000) informaron de un tratamiento general exitoso después de la cirugía sin torniquete y 47 de 50 (o 940 por 1000) con torniquete (razón de riesgos [RR] 1,0; IC del 95%: 0,91 a 1,10), según un estudio con 100 participantes. Calidad de vida relacionada con la salud: a los seis meses, el torniquete puede tener poco o ningún efecto en la calidad de vida. La puntuación de la 12­Item Short Form Survey (SF­12) (componente mental de 0 a 100 [100 es mejor]) fue de 54,64 después de la cirugía sin torniquete y 1,53 (DM) mejor (IC del 95%: 0,85 peor a 3,91 mejor) con torniquete (un estudio; 199 participantes); la diferencia absoluta fue 1,53% mejor (0,85% peor a 3,91% mejor). La evidencia fue de certeza baja, y se disminuyó debido al riesgo de sesgo y al escaso número de participantes. Eventos adversos graves: el riesgo de eventos adversos graves probablemente fue mayor con el uso de un torniquete; 26 de 898 (29 por 1000) notificaron eventos después de la cirugía sin torniquete en comparación con 53 de 901 (59 por 1000) con un torniquete (RR 1,73; IC del 95%: 1,10 a 2,73) en 21 estudios (1799 participantes). Veintinueve más por cada 1000 pacientes (95% CI 3 a 50 más por 1000 pacientes) presentaron un evento adverso grave con un torniquete. Cuarenta y ocho (IC del 95%: 20 a 345) participantes tendrían que ser operados sin torniquete para evitar un evento adverso grave. Esta evidencia se disminuyó a certeza moderada debido al riesgo de sesgo. Función cognitiva: un estudio informó de la función cognitiva como un desenlace; sin embargo, los datos se informaron de manera incompleta y no se pudieron extraer para el análisis. Supervivencia del implante: no está claro si el torniquete tiene un efecto sobre la supervivencia del implante debido a evidencia de certeza muy baja (disminuida por el sesgo, y dos veces debido a las tasas de eventos muy bajas); dos de 107 (19 por 1000) requirieron cirugía de revisión en el grupo de cirugía con torniquete en comparación con uno de 107 (nueve por 1000) en el grupo sin torniquete hasta los dos años de seguimiento (RR 1,44; IC del 95%: 0,23 a 8,92). Esto equivale a un 0,4% (0,7% menos a 7% más) de aumento del riesgo absoluto en la cirugía con torniquete. CONCLUSIONES DE LOS AUTORES: Evidencia de certeza moderada muestra que la cirugía de reemplazo de rodilla con torniquete probablemente se asocia con un mayor riesgo de eventos adversos graves. La cirugía con torniquete también se asocia probablemente con un mayor dolor posoperatorio, aunque esta diferencia puede o no ser perceptible para los pacientes. La cirugía con torniquete no parece conferir efectos beneficiosos clínicamente significativos en la funcionalidad, el éxito del tratamiento o la calidad de vida. Se necesitan estudios de investigación adicionales para explorar los efectos del uso de torniquetes en la función cognitiva y la supervivencia del implante, para identificar cualquier efecto perjudicial o beneficioso adicional. Si se sigue utilizando un torniquete en la cirugía de reemplazo de rodilla, se debe informar a los pacientes sobre el posible aumento del riesgo de que se produzcan efectos adversos graves y dolor posoperatorio.

Health-related quality of life among US adults with cancer: Potential roles of complementary and alternative medicine for health promotion and well-being.

OBJECTIVES: We estimated prevalence of complementary and alternative medicine (CAM) use by reason for use (treatment, wellness, or both) among non-institutionalized adults with cancer in the United States. We also examined health-related quality of life (HRQOL) outcomes among adults with cancer who used CAM. METHODS: We used data from the 2012 National Health Interview Survey (NHIS), which represents non-institutionalized adults with cancer (n = 2967 unweighted). Using a cross-sectional design with survey sampling techniques, we estimated past year prevalence of CAM use. We ran multivariable logistic regression analyses to investigate the odds of perceived benefits of CAM. RESULTS: In the past 12 months, 35.1% of adults with cancer reported using some form of CAM. Among CAM users, 56.0% used CAM for both treatment and wellness, and 32.4% used CAM for wellness only. Only 11.6% used CAM for treatment only. Regardless of reason for use, the most commonly used CAM types in the past year were herbal therapies (56.8%), chiropractic (27.1%), and massage (24.9%). Among CAM users, those using CAM for wellness only and for a combination of treatment and wellness reported significantly higher odds of "a better sense of controlling health" and "improved overall health and feeling better" compared with treatment only users. Similar patterns were found in other HRQOL outcomes, but they were not statistically different. CONCLUSIONS: CAM is widely used among adults with cancer for wellness only or a combination of treatment and wellness. Given improved HRQOL outcomes, CAM may be a promising approach for enhancing health promotion and well-being among adults with cancer.

Increased clinical trial enrollment among adolescent and young adult cancer patients between 2006 and 2012-2013 in the United States.

BACKGROUND: Stagnant outcomes for adolescents and young adults (AYAs) 15-39 years of age with cancer are partly attributed to poor enrollment onto clinical trials. Initiatives have focused on increasing accrual, but changes at the population-level are unknown. We examined patterns of clinical trial participation over time in AYA patients with cancer. PROCEDURE: We utilized medical record data from AYAs in two population-based National Cancer Institute Patterns of Care Studies identified through the Surveillance, Epidemiology and End Results Program. Among 3135 AYAs diagnosed with non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, acute lymphoblastic leukemia (ALL), and sarcoma, we used multivariate logistic regression to evaluate patient and provider characteristics associated with clinical trial enrollment. Interaction terms evaluated variation in clinical trial enrollment across patient and provider characteristics by year of diagnosis. RESULTS: From 2006 to 2012-2013, clinical trial participation increased from 14.8% to 17.9% (P < 0.01). Adjusting for patient and provider characteristics, we found lower clinical trial enrollment among those who were older at diagnosis, diagnosed with NHL vs ALL, treated by adult hematologist/oncologists only (vs pediatric hematologist/oncologists), and of non-Hispanic Black race/ethnicity (vs non-Hispanic White) (P < 0.05 for all). Interaction analyses indicate improved clinical trial enrollment from 2006 to 2012-2013 among young adults 25-29 years of age and the uninsured. CONCLUSIONS: Although disparities in enrollment onto clinical trials remain for AYAs with cancer, our study identified increasing overall clinical trial participation over time. Further, we identify promising trends in enrollment uptake among AYAs 25-29 years of age and the uninsured.

The association between headache and low back pain: a systematic review.

BACKGROUND: To systematically review studies quantifying the association between primary chronic headaches and persistent low back pain (LBP). MAIN TEXT: We searched five electronic databases. We included case-control, cross-sectional and cohort studies that included a headache and back pain free group, reporting on any association between persistent LBP and primary headache disorders. Methodological quality was assessed using Newcastle-Ottawa Scale. Our primary outcome was the association between primary headache disorders and persistent LBP. Our secondary outcomes were any associations between severity of LBP and severity of headache, and the relationship between specific headache sub-types classified as per International Classification of Headache Disorders (ICHD) criteria and persistent LBP. We included 14 studies. The sizes of the studies ranged from 88 participants to a large international study with 404, 206 participants. Odds ratios for the association were between 1.55 (95% confidence interval (CI) 1.13-2.11) and 8.00 (95% CI 5.3-12.1). Study heterogeneity meant statistical pooling was not possible. Only two studies presented data investigating persistent LBP and chronic headache disorders in accordance with ICDH criteria. CONCLUSIONS: We identified a positive association between persistent LBP and primary headache disorders. The quality of the review findings is limited by diversity of populations, study designs and uncertainly about headache and LBP definitions. TRIAL REGISTRATION: PROSPERO 2018 CRD42018086557 .

Changes in Health Insurance Coverage Associated With the Affordable Care Act Among Adults With and Without a Cancer History: Population-based National Estimates.

BACKGROUND: The Affordable Care Act (ACA) improved health care coverage accessibility by expanding Medicaid eligibility, creating insurance Marketplaces, and subsidizing premiums. We examine coverage changes associated with ACA implementation, comparing adults with and without a cancer history. METHODS: We included nonelderly adults from the 2012 to 2015 National Health Interview Survey. Using information on state Medicaid policies (2013), expansion decisions (2015), family structure, income, insurance offers, and current coverage, we assigned adults in all 4 years to mutually exclusive eligibility categories including: Medicaid-eligible pre-ACA; expansion eligible for Medicaid; and Marketplace premium subsidy eligible. Linear probability regressions estimated pre-post (2012-2013 vs. 2014-2015) coverage changes by eligibility category, stratified by cancer history. RESULTS: The uninsured rate for cancer survivors decreased from 12.4% to 7.7% (P<0.001) pre-post ACA implementation. Relative to income >400% of the federal poverty guideline, the uninsured rate for cancer survivors decreased by an adjusted 8.4 percentage points [95% confidence interval (CI), 1.3-15.6] among pre-ACA Medicaid eligible; 16.7 percentage points (95% CI, 9.0-24.5) among expansion eligible, and 11.3 percentage points (95% CI, -0.8 to 23.5, with a trend P=0.069) for premium subsidy eligible. Decreases in uninsured among expansion-eligible adults without a cancer history [9.7 percentage points (95% CI, 7.4-12.0), were smaller than for cancer survivors (with a trend, P=0.086)]. Despite coverage gains, ∼528,000 cancer survivors and 19.1 million without a cancer history remained uninsured post-ACA, yet over half were eligible for Medicaid or subsidized Marketplace coverage. CONCLUSIONS: ACA implementation was associated with large coverage gains in targeted expansion groups, including cancer survivors, but additional progress is needed.

A realist approach to the evaluation of complex mental health interventions.

Conventional approaches to evidence that prioritise randomised controlled trials appear increasingly inadequate for the evaluation of complex mental health interventions. By focusing on causal mechanisms and understanding the complex interactions between interventions, patients and contexts, realist approaches offer a productive alternative. Although the approaches might be combined, substantial barriers remain.Declaration of interestAll authors had financial support from the National Institute for Health Research Health Services and Delivery Research Programme while completing this work. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the National Health Service, the National Institute for Health Research, the Medical Research Council, Central Commissioning Facility, National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, the Health Services and Delivery Research Programme or the Department of Health. S.P.S. is part funded by Collaboration for Leadership in Applied Health Research and Care West Midlands. K.B. is editor of the British Journal of Psychiatry.

Centralisation of radical cystectomies for bladder cancer in England, a decade on from the 'Improving Outcomes Guidance': the case for super centralisation.

OBJECTIVE: To analyse the impact of centralisation of radical cystectomy (RC) provision for bladder cancer in England, on postoperative mortality, length of stay (LoS), complications and re-intervention rates, from implementation of centralisation from 2003 until 2014. In 2002, UK policymakers introduced the 'Improving Outcomes Guidance' (IOG) for urological cancers after a global cancer surgery commission identified substantial shortcomings in provision of care of RCs. One key recommendation was centralisation of RCs to high-output centres. No study has yet robustly analysed the changes since the introduction of the IOG, to assess a national healthcare system that has mature data on such institutional transformation. PATIENTS AND METHODS: RCs performed for bladder cancer in England between 2003/2004 and 2013/2014 were analysed from Hospital Episode Statistics (HES) data. Outcomes including 30-day, 90-day, and 1-year all-cause postoperative mortality; median LoS; complication and re-intervention rates, were calculated. Multivariable statistical analysis was undertaken to describe the relationship between each surgeon and the providers' annual case volume and mortality. RESULTS: In all, 15 292 RCs were identified. The percentage of RCs performed in discordance with the IOG guidelines reduced from 65% to 12.4%, corresponding with an improvement in 30-day mortality from 2.7% to 1.5% (P = 0.024). Procedures adhering to the IOG guidelines had better 30-day mortality (2.1% vs 2.9%; P = 0.003) than those that did not, and better 1-year mortality (21.5% vs 25.6%; P < 0.001), LoS (14 vs 16 days; P < 0.001), and re- intervention rates (30.0% vs 33.6%; P < 0.001). Each single extra surgery per centre reduced the odds of death at 30 days by 1.5% (odds ratio [OR] 0.985, 95% confidence interval [CI] 0.977-0.992) and 1% at 1 year (OR 0.990, 95% CI 0.988-0.993), and significantly reduced rates of re-intervention. CONCLUSION: Centralisation has been implemented across England since the publication of the IOG guidelines in 2002. The improved outcomes shown, including that a single extra procedure per year per centre can significantly reduce mortality and re-intervention, may serve to offer healthcare planners an evidence base to propose new guidance for further optimisation of surgical provision, and hope for other healthcare systems that such widespread institutional change is achievable and positive.