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Optimal Evidence in Difficult Settings: Improving Health Interventions and Decision Making in Disasters

April 24, 2014 Comments off

Optimal Evidence in Difficult Settings: Improving Health Interventions and Decision Making in Disasters
Source: PLoS Medicine

Summary Points

  • As for any type of health care, decisions about interventions in the context of natural disasters, conflict, and other major healthcare emergencies must be guided by the best possible evidence.
  • Disaster health interventions and decision making can benefit from an evidence-based approach.
  • We outline how systematic reviews and methodologically sound research can build a much-needed evidence base.
  • We do this from the standpoint of Evidence Aid, an initiative that aims to improve access to evidence on the effects of interventions, actions, and policies before, during, and after disasters and other humanitarian emergencies, so as to improve health-related outcomes.
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Physicians as Fundraisers: Medical Philanthropy and the Doctor-Patient Relationship

March 17, 2014 Comments off

Physicians as Fundraisers: Medical Philanthropy and the Doctor-Patient Relationship
Source: PLoS Medicine

Summary

+ American medical institutions commonly have “grateful patient” programs that solicit donations from wealthy individuals who receive care. Physicians are often encouraged to assist in these programs.

+ Development efforts have intensified in recent years, and the increasing reliance on physician fundraisers risks blurring the lines between clinical care and fundraising. New changes to the US Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule continue that trend by allowing development officials to access certain types of clinical information without patient consent.

+ The practice of physicians fundraising from their own patients raises three main concerns: (1) undue pressure on patients to contribute, (2) possible expectations of preferential treatment from donors, and (3) concerns about patient confidentiality and trust.

+ We propose that institutions voluntarily adopt development policies that mitigate these risks. Specifically, we recommend that patient consent be secured before development staff access patient information or physicians refer patients to the development office. We also recommend that physicians not directly solicit donations from their own patients.

The concerns discussed here in the context of American grateful patient programs are relevant to similar patient fundraising efforts in other nations.

Active or Passive Exposure to Tobacco Smoking and Allergic Rhinitis, Allergic Dermatitis, and Food Allergy in Adults and Children: A Systematic Review and Meta-Analysis

March 14, 2014 Comments off

Active or Passive Exposure to Tobacco Smoking and Allergic Rhinitis, Allergic Dermatitis, and Food Allergy in Adults and Children: A Systematic Review and Meta-Analysis
Source: PLoS Medicine

Background
Allergic rhinitis, allergic dermatitis, and food allergy are extremely common diseases, especially among children, and are frequently associated to each other and to asthma. Smoking is a potential risk factor for these conditions, but so far, results from individual studies have been conflicting. The objective of this study was to examine the evidence for an association between active smoking (AS) or passive exposure to secondhand smoke and allergic conditions.

Methods and Findings
We retrieved studies published in any language up to June 30th, 2013 by systematically searching Medline, Embase, the five regional bibliographic databases of the World Health Organization, and ISI-Proceedings databases, by manually examining the references of the original articles and reviews retrieved, and by establishing personal contact with clinical researchers. We included cohort, case-control, and cross-sectional studies reporting odds ratio (OR) or relative risk (RR) estimates and confidence intervals of smoking and allergic conditions, first among the general population and then among children.

We retrieved 97 studies on allergic rhinitis, 91 on allergic dermatitis, and eight on food allergy published in 139 different articles. When all studies were analyzed together (showing random effects model results and pooled ORs expressed as RR), allergic rhinitis was not associated with active smoking (pooled RR, 1.02 [95% CI 0.92–1.15]), but was associated with passive smoking (pooled RR 1.10 [95% CI 1.06–1.15]). Allergic dermatitis was associated with both active (pooled RR, 1.21 [95% CI 1.14–1.29]) and passive smoking (pooled RR, 1.07 [95% CI 1.03–1.12]). In children and adolescent, allergic rhinitis was associated with active (pooled RR, 1.40 (95% CI 1.24–1.59) and passive smoking (pooled RR, 1.09 [95% CI 1.04–1.14]). Allergic dermatitis was associated with active (pooled RR, 1.36 [95% CI 1.17–1.46]) and passive smoking (pooled RR, 1.06 [95% CI 1.01–1.11]). Food allergy was associated with SHS (1.43 [1.12–1.83]) when cohort studies only were examined, but not when all studies were combined.

The findings are limited by the potential for confounding and bias given that most of the individual studies used a cross-sectional design. Furthermore, the studies showed a high degree of heterogeneity and the exposure and outcome measures were assessed by self-report, which may increase the potential for misclassification.

Conclusions
We observed very modest associations between smoking and some allergic diseases among adults. Among children and adolescents, both active and passive exposure to SHS were associated with a modest increased risk for allergic diseases, and passive smoking was associated with an increased risk for food allergy. Additional studies with detailed measurement of exposure and better case definition are needed to further explore the role of smoking in allergic diseases.

Cervical Screening at Age 50–64 Years and the Risk of Cervical Cancer at Age 65 Years and Older: Population-Based Case Control Study

January 17, 2014 Comments off

Cervical Screening at Age 50–64 Years and the Risk of Cervical Cancer at Age 65 Years and Older: Population-Based Case Control Study
Source: PLoS Medicine

Background
There is little consensus, and minimal evidence, regarding the age at which to stop cervical screening. We studied the association between screening at age 50–64 y and cervical cancer at age 65–83 y.

Methods and Findings
Cases were women (n = 1,341) diagnosed with cervical cancer at age 65–83 y between 1 April 2007 and 31 March 2012 in England and Wales; age-matched controls (n = 2,646) were randomly selected from population registers. Screening details from 1988 onwards were extracted from national databases. We calculated the odds ratios (OR) for different screening histories and subsequent cervical cancer. Women with adequate negative screening at age 65 y (288 cases, 1,395 controls) were at lowest risk of cervical cancer (20-y risk: 8 cancers per 10,000 women) compared with those (532 cases, 429 controls) not screened at age 50–64 y (20-y risk: 49 cancers per 10,000 women, with OR = 0.16, 95% CI 0.13–0.19). ORs depended on the age mix of women because of the weakening association with time since last screen: OR = 0.11, 95% CI 0.08–0.14 at 2.5 to 7.5 y since last screen; OR = 0.27, 95% CI 0.20–0.36 at 12.5 to 17.5 y since last screen. Screening at least every 5.5 y between the ages 50 and 64 y was associated with a 75% lower risk of cervical cancer between the ages 65 and 79 y (OR = 0.25, 95% CI 0.21–0.30), and the attributable risk was such that in the absence of screening, cervical cancer rates in women aged 65+ would have been 2.4 (95% CI 2.1–2.7) times higher. In women aged 80–83 y the association was weaker (OR = 0.49, 95% CI 0.28–0.83) than in those aged 65–69 y (OR = 0.12, 95% CI 0.09–0.17). This study was limited by an absence of data on confounding factors; additionally, findings based on cytology may not generalise to human papillomavirus testing.

Conclusions
Women with adequate negative screening at age 50–64 y had one-sixth of the risk of cervical cancer at age 65–83 y compared with women who were not screened. Stopping screening between ages 60 and 69 y in women with adequate negative screening seems sensible, but further screening may be justifiable as life expectancy increases.

Associations between Intimate Partner Violence and Termination of Pregnancy: A Systematic Review and Meta-Analysis

January 9, 2014 Comments off

Associations between Intimate Partner Violence and Termination of Pregnancy: A Systematic Review and Meta-Analysis
Source: PLoS Medicine

Background
Intimate partner violence (IPV) and termination of pregnancy (TOP) are global health concerns, but their interaction is undetermined. The aim of this study was to determine whether there is an association between IPV and TOP.

Methods and Findings
A systematic review based on a search of Medline, Embase, PsycINFO, and Ovid Maternity and Infant Care from each database’s inception to 21 September 2013 for peer-reviewed articles of any design and language found 74 studies regarding women who had undergone TOP and had experienced at least one domain (physical, sexual, or emotional) of IPV. Prevalence of IPV and association between IPV and TOP were meta-analysed. Sample sizes ranged from eight to 33,385 participants. Worldwide, rates of IPV in the preceding year in women undergoing TOP ranged from 2.5% to 30%. Lifetime prevalence by meta-analysis was shown to be 24.9% (95% CI 19.9% to 30.6%); heterogeneity was high (I2>90%), and variation was not explained by study design, quality, or size, or country gross national income per capita. IPV, including history of rape, sexual assault, contraceptive sabotage, and coerced decision-making, was associated with TOP, and with repeat TOPs. By meta-analysis, partner not knowing about the TOP was shown to be significantly associated with IPV (pooled odds ratio 2.97, 95% CI 2.39 to 3.69). Women in violent relationships were more likely to have concealed the TOP from their partner than those who were not. Demographic factors including age, ethnicity, education, marital status, income, employment, and drug and alcohol use showed no strong or consistent mediating effect. Few long-term outcomes were studied. Women welcomed the opportunity to disclose IPV and be offered help. Limitations include study heterogeneity, potential underreporting of both IPV and TOP in primary data sources, and inherent difficulties in validation.

Conclusions
IPV is associated with TOP. Novel public health approaches are required to prevent IPV. TOP services provide an opportune health-based setting to design and test interventions.

Burden of Depressive Disorders by Country, Sex, Age, and Year: Findings from the Global Burden of Disease Study 2010

November 7, 2013 Comments off

Burden of Depressive Disorders by Country, Sex, Age, and Year: Findings from the Global Burden of Disease Study 2010
Source: PLoS Medicine

Background
Depressive disorders were a leading cause of burden in the Global Burden of Disease (GBD) 1990 and 2000 studies. Here, we analyze the burden of depressive disorders in GBD 2010 and present severity proportions, burden by country, region, age, sex, and year, as well as burden of depressive disorders as a risk factor for suicide and ischemic heart disease.

Methods and Findings
Burden was calculated for major depressive disorder (MDD) and dysthymia. A systematic review of epidemiological data was conducted. The data were pooled using a Bayesian meta-regression. Disability weights from population survey data quantified the severity of health loss from depressive disorders. These weights were used to calculate years lived with disability (YLDs) and disability adjusted life years (DALYs). Separate DALYs were estimated for suicide and ischemic heart disease attributable to depressive disorders.

Depressive disorders were the second leading cause of YLDs in 2010. MDD accounted for 8.2% (5.9%–10.8%) of global YLDs and dysthymia for 1.4% (0.9%–2.0%). Depressive disorders were a leading cause of DALYs even though no mortality was attributed to them as the underlying cause. MDD accounted for 2.5% (1.9%–3.2%) of global DALYs and dysthymia for 0.5% (0.3%–0.6%). There was more regional variation in burden for MDD than for dysthymia; with higher estimates in females, and adults of working age. Whilst burden increased by 37.5% between 1990 and 2010, this was due to population growth and ageing. MDD explained 16 million suicide DALYs and almost 4 million ischemic heart disease DALYs. This attributable burden would increase the overall burden of depressive disorders from 3.0% (2.2%–3.8%) to 3.8% (3.0%–4.7%) of global DALYs.

Conclusions
GBD 2010 identified depressive disorders as a leading cause of burden. MDD was also a contributor of burden allocated to suicide and ischemic heart disease. These findings emphasize the importance of including depressive disorders as a public-health priority and implementing cost-effective interventions to reduce its burden.

Mortality in Iraq Associated with the 2003–2011 War and Occupation: Findings from a National Cluster Sample Survey by the University Collaborative Iraq Mortality Study

October 16, 2013 Comments off

Mortality in Iraq Associated with the 2003–2011 War and Occupation: Findings from a National Cluster Sample Survey by the University Collaborative Iraq Mortality Study
Source: PLoS Medicine

Background
Previous estimates of mortality in Iraq attributable to the 2003 invasion have been heterogeneous and controversial, and none were produced after 2006. The purpose of this research was to estimate direct and indirect deaths attributable to the war in Iraq between 2003 and 2011.

Methods and Findings
We conducted a survey of 2,000 randomly selected households throughout Iraq, using a two-stage cluster sampling method to ensure the sample of households was nationally representative. We asked every household head about births and deaths since 2001, and all household adults about mortality among their siblings. We used secondary data sources to correct for out-migration. From March 1, 2003, to June 30, 2011, the crude death rate in Iraq was 4.55 per 1,000 person-years (95% uncertainty interval 3.74–5.27), more than 0.5 times higher than the death rate during the 26-mo period preceding the war, resulting in approximately 405,000 (95% uncertainty interval 48,000–751,000) excess deaths attributable to the conflict. Among adults, the risk of death rose 0.7 times higher for women and 2.9 times higher for men between the pre-war period (January 1, 2001, to February 28, 2003) and the peak of the war (2005–2006). We estimate that more than 60% of excess deaths were directly attributable to violence, with the rest associated with the collapse of infrastructure and other indirect, but war-related, causes. We used secondary sources to estimate rates of death among emigrants. Those estimates suggest we missed at least 55,000 deaths that would have been reported by households had the households remained behind in Iraq, but which instead had migrated away. Only 24 households refused to participate in the study. An additional five households were not interviewed because of hostile or threatening behavior, for a 98.55% response rate. The reliance on outdated census data and the long recall period required of participants are limitations of our study.

Conclusions
Beyond expected rates, most mortality increases in Iraq can be attributed to direct violence, but about a third are attributable to indirect causes (such as from failures of health, sanitation, transportation, communication, and other systems). Approximately a half million deaths in Iraq could be attributable to the war.

Acupuncture and Counselling for Depression in Primary Care: A Randomised Controlled Trial

October 15, 2013 Comments off

Acupuncture and Counselling for Depression in Primary Care: A Randomised Controlled Trial
Source: PLoS Medicine

Background
Depression is a significant cause of morbidity. Many patients have communicated an interest in non-pharmacological therapies to their general practitioners. Systematic reviews of acupuncture and counselling for depression in primary care have identified limited evidence. The aim of this study was to evaluate acupuncture versus usual care and counselling versus usual care for patients who continue to experience depression in primary care.

Methods and Findings
In a randomised controlled trial, 755 patients with depression (Beck Depression Inventory BDI-II score ≥20) were recruited from 27 primary care practices in the North of England. Patients were randomised to one of three arms using a ratio of 2:2:1 to acupuncture (302), counselling (302), and usual care alone (151). The primary outcome was the difference in mean Patient Health Questionnaire (PHQ-9) scores at 3 months with secondary analyses over 12 months follow-up. Analysis was by intention-to-treat.

PHQ-9 data were available for 614 patients at 3 months and 572 patients at 12 months. Patients attended a mean of ten sessions for acupuncture and nine sessions for counselling. Compared to usual care, there was a statistically significant reduction in mean PHQ-9 depression scores at 3 months for acupuncture (−2.46, 95% CI −3.72 to −1.21) and counselling (−1.73, 95% CI −3.00 to −0.45), and over 12 months for acupuncture (−1.55, 95% CI −2.41 to −0.70) and counselling (−1.50, 95% CI −2.43 to −0.58). Differences between acupuncture and counselling were not significant. In terms of limitations, the trial was not designed to separate out specific from non-specific effects. No serious treatment-related adverse events were reported.

Conclusions
In this randomised controlled trial of acupuncture and counselling for patients presenting with depression, after having consulted their general practitioner in primary care, both interventions were associated with significantly reduced depression at 3 months when compared to usual care alone.

Trial Registration
Controlled-Trials.com ISRCTN63787732

Pregnancy Weight Gain and Childhood Body Weight: A Within-Family Comparison

October 9, 2013 Comments off

Pregnancy Weight Gain and Childhood Body Weight: A Within-Family Comparison
Source: PLoS Medicine

Background
Excessive pregnancy weight gain is associated with obesity in the offspring, but this relationship may be confounded by genetic and other shared influences. We aimed to examine the association of pregnancy weight gain with body mass index (BMI) in the offspring, using a within-family design to minimize confounding.

Methods and Findings
In this population-based cohort study, we matched records of all live births in Arkansas with state-mandated data on childhood BMI collected in public schools (from August 18, 2003 to June 2, 2011). The cohort included 42,133 women who had more than one singleton pregnancy and their 91,045 offspring. We examined how differences in weight gain that occurred during two or more pregnancies for each woman predicted her children’s BMI and odds ratio (OR) of being overweight or obese (BMI≥85th percentile) at a mean age of 11.9 years, using a within-family design. For every additional kg of pregnancy weight gain, childhood BMI increased by 0.0220 (95% CI 0.0134–0.0306, p<0.0001) and the OR of overweight/obesity increased by 1.007 (CI 1.003–1.012, p = 0.0008). Variations in pregnancy weight gain accounted for a 0.43 kg/m2 difference in childhood BMI. After adjustment for birth weight, the association of pregnancy weight gain with childhood BMI was attenuated but remained statistically significant (0.0143 kg/m2 per kg of pregnancy weight gain, CI 0.0057–0.0229, p = 0.0007).

Conclusions
High pregnancy weight gain is associated with increased body weight of the offspring in childhood, and this effect is only partially mediated through higher birth weight. Translation of these findings to public health obesity prevention requires additional study.

Physician Emigration from Sub-Saharan Africa to the United States: Analysis of the 2011 AMA Physician Masterfile

October 9, 2013 Comments off

Physician Emigration from Sub-Saharan Africa to the United States: Analysis of the 2011 AMA Physician Masterfile
Source: PLoS Medicine

Background
The large-scale emigration of physicians from sub-Saharan Africa (SSA) to high-income nations is a serious development concern. Our objective was to determine current emigration trends of SSA physicians found in the physician workforce of the United States.

Methods and Findings
We analyzed physician data from the World Health Organization (WHO) Global Health Workforce Statistics along with graduation and residency data from the 2011 American Medical Association Physician Masterfile (AMA-PM) on physicians trained or born in SSA countries who currently practice in the US. We estimated emigration proportions, year of US entry, years of practice before emigration, and length of time in the US. According to the 2011 AMA-PM, 10,819 physicians were born or trained in 28 SSA countries. Sixty-eight percent (n = 7,370) were SSA-trained, 20% (n = 2,126) were US-trained, and 12% (n = 1,323) were trained outside both SSA and the US. We estimated active physicians (age ≤70 years) to represent 96% (n = 10,377) of the total. Migration trends among SSA-trained physicians increased from 2002 to 2011 for all but one principal source country; the exception was South Africa whose physician migration to the US decreased by 8% (−156). The increase in last-decade migration was >50% in Nigeria (+1,113) and Ghana (+243), >100% in Ethiopia (+274), and >200% (+244) in Sudan. Liberia was the most affected by migration to the US with 77% (n = 175) of its estimated physicians in the 2011 AMA-PM. On average, SSA-trained physicians have been in the US for 18 years. They practiced for 6.5 years before US entry, and nearly half emigrated during the implementation years (1984–1999) of the structural adjustment programs.

Conclusion
Physician emigration from SSA to the US is increasing for most SSA source countries. Unless far-reaching policies are implemented by the US and SSA countries, the current emigration trends will persist, and the US will remain a leading destination for SSA physicians emigrating from the continent of greatest need.

Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China

September 30, 2013 Comments off

Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China
Source: PLoS Medicine

Medical devices play an increasingly vital role in health care delivery around the world. These technologies are defined in distinction to drugs as an “instrument, apparatus…machine…implant…or other similar or related article…which is…intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease…and which does not achieve its primary intended purposes through chemical action” [1]. In recognition of the importance of medical devices, the World Health Organization established a Medical Device Unit to focus research and policy on prioritizing access to medical devices in low-resource settings, dessemination of innovations, and training of biomedical personnel to support the use of devices worldwide [2]. While medical devices offer opportunities for improved diagnosis and management of disease, they also can carry substantial risks. Governmental regulatory bodies considering new medical device approval balance the goals of expanding therapeutic options with safeguarding public health. Wherever the standard for market authorization is set, questions about a device’s safety and effectiveness will remain after introduction into clinical practice. However, medical devices raise several unique challenges, including operator variability and procedural learning curves, permanent implantation, and the technological complexity of some devices.

After a new medical device is brought to market, the process of postmarket surveillance (PS) provides an ongoing assessment of safety and effectiveness. High-profile international public health crises involving widely used implantable cardioverter-defibrillator leads [3],[4], joint prostheses [5], and breast implants [6] raise questions regarding the strengths and weaknesses of different approaches to device PS worldwide. Though only limited quantitative measures of PS guide policy decisions [7], we evaluated the range of device PS strategies in four important medical device markets—the US, EU, Japan, and China. The US and EU represent large markets that are entertaining substantial reforms to PS practice. Japan and China are, respectively, mature and emerging international markets that have systems that could inform ongoing policy debates in the US and EU and be influenced by their practices in turn. Our goal was to identify “best practices” from among these countries that could support the public health goals of all device regulatory systems.

The Influence of Health Systems on Hypertension Awareness, Treatment, and Control: A Systematic Literature Review

August 7, 2013 Comments off

The Influence of Health Systems on Hypertension Awareness, Treatment, and Control: A Systematic Literature Review
Source: PLoS Medicine
Background
Hypertension (HT) affects an estimated one billion people worldwide, nearly three-quarters of whom live in low- or middle-income countries (LMICs). In both developed and developing countries, only a minority of individuals with HT are adequately treated. The reasons are many but, as with other chronic diseases, they include weaknesses in health systems. We conducted a systematic review of the influence of national or regional health systems on HT awareness, treatment, and control.

Methods and Findings
Eligible studies were those that analyzed the impact of health systems arrangements at the regional or national level on HT awareness, treatment, control, or antihypertensive medication adherence. The following databases were searched on 13th May 2013: Medline, Embase, Global Health, LILACS, Africa-Wide Information, IMSEAR, IMEMR, and WPRIM. There were no date or language restrictions. Two authors independently assessed papers for inclusion, extracted data, and assessed risk of bias. A narrative synthesis of the findings was conducted. Meta-analysis was not conducted due to substantial methodological heterogeneity in included studies. 53 studies were included, 11 of which were carried out in LMICs. Most studies evaluated health system financing and only four evaluated the effect of either human, physical, social, or intellectual resources on HT outcomes. Reduced medication co-payments were associated with improved HT control and treatment adherence, mainly evaluated in US settings. On balance, health insurance coverage was associated with improved outcomes of HT care in US settings. Having a routine place of care or physician was associated with improved HT care.

Conclusions
This review supports the minimization of medication co-payments in health insurance plans, and although studies were largely conducted in the US, the principle is likely to apply more generally. Studies that identify and analyze complexities and links between health systems arrangements and their effects on HT management are required, particularly in LMICs.

Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis

June 13, 2013 Comments off

Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis
Source: PLoS Medicine

Background
Drug manufacturers have developed “evergreening” strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs) on the healthcare system as a whole (“spillover effect”).

Methods and Findings
We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. “Extra costs” were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1) all brand (i.e., initially patented) drugs, (2) all follow-on drugs, or (3) brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community.

Estimated “extra costs” over the study period were €15.9 (95% CI 15.5; 16.2) million for scenario 1, €14.4 (95% CI 14.1; 14.7) million for scenario 2, and €30.3 (95% CI 29.8; 30.8) million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover “extra cost” of €330,300 (95% CI 276,100; 383,800), whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100). Overall we estimated that the RDF resulted in “extra costs” of €503,600 (95% CI 444,500; 563,100).
Conclusions

Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to increased overall healthcare costs by listing follow-on drugs in their RDF. Therefore, healthcare providers and policy makers should be aware of the impact of evergreening strategies.

Comparative Efficacy of Seven Psychotherapeutic Interventions for Patients with Depression: A Network Meta-Analysis

June 10, 2013 Comments off

Comparative Efficacy of Seven Psychotherapeutic Interventions for Patients with Depression: A Network Meta-Analysis

Source: PLoS Medicine

Background

Previous meta-analyses comparing the efficacy of psychotherapeutic interventions for depression were clouded by a limited number of within-study treatment comparisons. This study used network meta-analysis, a novel methodological approach that integrates direct and indirect evidence from randomised controlled studies, to re-examine the comparative efficacy of seven psychotherapeutic interventions for adult depression.

Methods and Findings

We conducted systematic literature searches in PubMed, PsycINFO, and Embase up to November 2012, and identified additional studies through earlier meta-analyses and the references of included studies. We identified 198 studies, including 15,118 adult patients with depression, and coded moderator variables. Each of the seven psychotherapeutic interventions was superior to a waitlist control condition with moderate to large effects (range d = −0.62 to d = −0.92). Relative effects of different psychotherapeutic interventions on depressive symptoms were absent to small (range d = 0.01 to d = −0.30). Interpersonal therapy was significantly more effective than supportive therapy (d = −0.30, 95% credibility interval [CrI] [−0.54 to −0.05]). Moderator analysis showed that patient characteristics had no influence on treatment effects, but identified aspects of study quality and sample size as effect modifiers. Smaller effects were found in studies of at least moderate (Δd = 0.29 [−0.01 to 0.58]; p = 0.063) and large size (Δd = 0.33 [0.08 to 0.61]; p = 0.012) and those that had adequate outcome assessment (Δd = 0.38 [−0.06 to 0.87]; p = 0.100). Stepwise restriction of analyses by sample size showed robust effects for cognitive-behavioural therapy, interpersonal therapy, and problem-solving therapy (all d>0.46) compared to waitlist. Empirical evidence from large studies was unavailable or limited for other psychotherapeutic interventions.

Conclusions

Overall our results are consistent with the notion that different psychotherapeutic interventions for depression have comparable benefits. However, the robustness of the evidence varies considerably between different psychotherapeutic treatments.

Tobacco Company Efforts to Influence the Food and Drug Administration-Commissioned Institute of Medicine Report Clearing the Smoke: An Analysis of Documents Released through Litigation

June 5, 2013 Comments off

Tobacco Company Efforts to Influence the Food and Drug Administration-Commissioned Institute of Medicine Report Clearing the Smoke: An Analysis of Documents Released through Litigation

Source: PLoS Medicine

Background

Spurred by the creation of potential modified risk tobacco products, the US Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to assess the science base for tobacco “harm reduction,” leading to the 2001 IOM report Clearing the Smoke. The objective of this study was to determine how the tobacco industry organized to try to influence the IOM committee that prepared the report.

Methods and Findings

We analyzed previously secret tobacco industry documents in the University of California, San Francisco Legacy Tobacco Documents Library, and IOM public access files. (A limitation of this method includes the fact that the tobacco companies have withheld some possibly relevant documents.) Tobacco companies considered the IOM report to have high-stakes regulatory implications. They developed and implemented strategies with consulting and legal firms to access the IOM proceedings. When the IOM study staff invited the companies to provide information on exposure and disease markers, clinical trial design for safety and efficacy, and implications for initiation and cessation, tobacco company lawyers, consultants, and in-house regulatory staff shaped presentations from company scientists. Although the available evidence does not permit drawing cause-and-effect conclusions, and the IOM may have come to the same conclusions without the influence of the tobacco industry, the companies were pleased with the final report, particularly the recommendations for a tiered claims system (with separate tiers for exposure and risk, which they believed would ease the process of qualifying for a claim) and license to sell products comparable to existing conventional cigarettes (“substantial equivalence”) without prior regulatory approval. Some principles from the IOM report, including elements of the substantial equivalence recommendation, appear in the 2009 Family Smoking Prevention and Tobacco Control Act.

Conclusions

Tobacco companies strategically interacted with the IOM to win several favored scientific and regulatory recommendations.

See: Tobacco companies are not public health stakeholders (EurekAlert!)

Intimate Partner Violence and Incident Depressive Symptoms and Suicide Attempts: A Systematic Review of Longitudinal Studies

May 8, 2013 Comments off

Intimate Partner Violence and Incident Depressive Symptoms and Suicide Attempts: A Systematic Review of Longitudinal Studies

Source: PLoS Medicine

Background

Depression and suicide are responsible for a substantial burden of disease globally. Evidence suggests that intimate partner violence (IPV) experience is associated with increased risk of depression, but also that people with mental disorders are at increased risk of violence. We aimed to investigate the extent to which IPV experience is associated with incident depression and suicide attempts, and vice versa, in both women and men.

Methods and Findings

We conducted a systematic review and meta-analysis of longitudinal studies published before February 1, 2013. More than 22,000 records from 20 databases were searched for studies examining physical and/or sexual intimate partner or dating violence and symptoms of depression, diagnosed major depressive disorder, dysthymia, mild depression, or suicide attempts. Random effects meta-analyses were used to generate pooled odds ratios (ORs). Sixteen studies with 36,163 participants met our inclusion criteria. All studies included female participants; four studies also included male participants. Few controlled for key potential confounders other than demographics. All but one depression study measured only depressive symptoms. For women, there was clear evidence of an association between IPV and incident depressive symptoms, with 12 of 13 studies showing a positive direction of association and 11 reaching statistical significance; pooled OR from six studies = 1.97 (95% CI 1.56–2.48, I2 = 50.4%, pheterogeneity = 0.073). There was also evidence of an association in the reverse direction between depressive symptoms and incident IPV (pooled OR from four studies = 1.93, 95% CI 1.51–2.48, I2 = 0%, p = 0.481). IPV was also associated with incident suicide attempts. For men, evidence suggested that IPV was associated with incident depressive symptoms, but there was no clear evidence of an association between IPV and suicide attempts or depression and incident IPV.

Conclusions

In women, IPV was associated with incident depressive symptoms, and depressive symptoms with incident IPV. IPV was associated with incident suicide attempts. In men, few studies were conducted, but evidence suggested IPV was associated with incident depressive symptoms. There was no clear evidence of association with suicide attempts.

Changing Patterns in Place of Cancer Death in England: A Population-Based Study

March 27, 2013 Comments off

Changing Patterns in Place of Cancer Death in England: A Population-Based Study

Source: PLoS Medicine

Background

Most patients with cancer prefer to die at home or in a hospice, but hospitals remain the most common place of death (PoD).This study aims to explore the changing time trends of PoD and the associated factors, which are essential for end-of-life care improvement.

Methods and Findings

The study analysed all cancer deaths in England collected by the Office for National Statistics during 1993–2010 (n = 2,281,223). Time trends of age- and gender-standardised proportion of deaths in individual PoDs were evaluated using weighted piecewise linear regression. Variables associated with PoD (home or hospice versus hospital) were determined using proportion ratio (PR) derived from the log-binomial regression, adjusting for clustering effects. Hospital remained the most common PoD throughout the study period (48.0%; 95% CI 47.9%–48.0%), followed by home (24.5%; 95% CI 24.4%–24.5%), and hospice (16.4%; 95% CI 16.3%–16.4%). Home and hospice deaths increased since 2005 (0.87%; 95% CI 0.74%–0.99%/year, 0.24%; 95% CI 0.17%–0.32%/year, respectively, p<0.001), while hospital deaths declined (−1.20%; 95% CI −1.41 to −0.99/year, p<0.001). Patients who died from haematological cancer (PRs 0.46–0.52), who were single, widowed, or divorced (PRs 0.75–0.88), and aged over 75 (PRs 0.81–0.84 for 75–84; 0.66–0.72 for 85+) were less likely to die in home or hospice (p<0.001; reference groups: colorectal cancer, married, age 25–54). There was little improvement in patients with lung cancer of dying in home or hospice (PRs 0.87–0.88). Marital status became the second most important factor associated with PoD, after cancer type. Patients from less deprived areas (higher quintile of the deprivation index) were more likely to die at home or in a hospice than those from more deprived areas (lower quintile of the deprivation index; PRs 1.02–1.12). The analysis is limited by a lack of data on individual patients’ preferences for PoD or a clinical indication of the most appropriate PoD.

Conclusions

More efforts are needed to reduce hospital deaths. Health care facilities should be improved and enhanced to support the increased home and hospice deaths. People who are single, widowed, or divorced should be a focus for end-of-life care improvement, along with known at risk groups such as haematological cancer, lung cancer, older age, and deprivation.

Adapting Standards: Ethical Oversight of Participant-Led Health Research

March 18, 2013 Comments off

Adapting Standards: Ethical Oversight of Participant-Led Health Research

Source: PLoS Medicine

Summary Points

  • Online social media and digital technologies have facilitated formation of communities of individuals engaged in establishing and conducting health research projects. The results of such participant-led research (PLR) have already appeared in leading biomedical journals.
  • These projects involve research with human participants. Hence, what are the requirements for ethical oversight? To what extent is standard ethics review also suitable for PLR?
  • A comparison of PLR with standard research reveals six areas that are of potential relevance to ethical oversight: institutionalization, state recognition and support, incentive structures, openness, bottom-up approach, and self-experimentation.
  • The distinctive nature of PLR requires adaptation of ethical oversight standards to the character of such research. These should strike a balance between protecting interests of research participants and achieving promised benefits of PLR.
  • The appropriate form of ethical oversight for PLR projects depends on which of three categories they fall into. If they meet the “institution-plus” criterion, standard ethics review applies. If not, then the appropriate form of oversight depends on the application of a minimal risk criterion.

Tackling Non-Communicable Diseases In Low- and Middle-Income Countries: Is the Evidence from High-Income Countries All We Need?

January 30, 2013 Comments off

Tackling Non-Communicable Diseases In Low- and Middle-Income Countries: Is the Evidence from High-Income Countries All We Need?

Source: PLoS Medicine

Summary Points

  • Applied health research and development for non-communicable diseases (NCDs) in low- and middle-income countries (LMICs) is limited, and despite repeat calls for action, the NCD burden is increasing unchecked.
  • NCD research in high-income countries (HICs) and LMICs can result in mutual advantages in the areas of replication and extending findings; discovering new causes of NCDs; studying health effects of exposures rare or ubiquitous in HICs; and exploring links between infectious diseases and NCDs.
  • Different NCDs are at varying stages of needing research, policy development, and action. These stages range from not knowing the population burden of many NCDs to knowing all we need to take action.
  • Changes in the global and national funding agendas will be required to strengthen the research and health system capacity for NCDs, which should reduce deaths and disability attributable to NCDs and yield economic dividends.

National, Regional, and Global Trends in Infertility Prevalence Since 1990: A Systematic Analysis of 277 Health Surveys

December 19, 2012 Comments off

National, Regional, and Global Trends in Infertility Prevalence Since 1990: A Systematic Analysis of 277 Health Surveys

Source: PLoS Medicine

Background

Global, regional, and national estimates of prevalence of and tends in infertility are needed to target prevention and treatment efforts. By applying a consistent algorithm to demographic and reproductive surveys available from developed and developing countries, we estimate infertility prevalence and trends, 1990 to 2010, by country and region.

Methods and Findings

We accessed and analyzed household survey data from 277 demographic and reproductive health surveys using a consistent algorithm to calculate infertility. We used a demographic infertility measure with live birth as the outcome and a 5-y exposure period based on union status, contraceptive use, and desire for a child. We corrected for biases arising from the use of incomplete information on past union status and contraceptive use. We used a Bayesian hierarchical model to estimate prevalence of and trends in infertility in 190 countries and territories. In 2010, among women 20–44 y of age who were exposed to the risk of pregnancy, 1.9% (95% uncertainty interval 1.7%, 2.2%) were unable to attain a live birth (primary infertility). Out of women who had had at least one live birth and were exposed to the risk of pregnancy, 10.5% (9.5%, 11.7%) were unable to have another child (secondary infertility). Infertility prevalence was highest in South Asia, Sub-Saharan Africa, North Africa/Middle East, and Central/Eastern Europe and Central Asia. Levels of infertility in 2010 were similar to those in 1990 in most world regions, apart from declines in primary and secondary infertility in Sub-Saharan Africa and primary infertility in South Asia (posterior probability [pp] ≥0.99). Although there were no statistically significant changes in the prevalence of infertility in most regions amongst women who were exposed to the risk of pregnancy, reduced child-seeking behavior resulted in a reduction of primary infertility among all women from 1.6% to 1.5% (pp = 0.90) and a reduction of secondary infertility among all women from 3.9% to 3.0% (pp>0.99) from 1990 to 2010. Due to population growth, however, the absolute number of couples affected by infertility increased from 42.0 million (39.6 million, 44.8 million) in 1990 to 48.5 million (45.0 million, 52.6 million) in 2010. Limitations of the study include gaps in survey data for some countries and the use of proxies to determine exposure to pregnancy.

Conclusions

We analyzed demographic and reproductive household survey data to reveal global patterns and trends in infertility. Independent from population growth and worldwide declines in the preferred number of children, we found little evidence of changes in infertility over two decades, apart from in the regions of Sub-Saharan Africa and South Asia. Further research is needed to identify the etiological causes of these patterns and trends.

See: Global Rates of Infertility Remain Unchanged Over Past 2 Decades (Science Daily)

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