Does journal endorsement of reporting guidelines influence the completeness of reporting of health research? A systematic review protocol

Does journal endorsement of reporting guidelines influence the completeness of reporting of health research? A systematic review protocol

Background: Reporting of health research is often inadequate and incomplete. Complete and transparent reporting is imperative to enable readers to assess the validity of research findings for use in healthcare and policy decision-making. To this end, many guidelines, aimed at improving the quality of health research reports, have been developed for reporting a variety of research types. Despite efforts, many reporting guidelines are underused. In order to increase their uptake, evidence of their effectiveness is important and will provide authors, peer reviewers and editors with an important resource for use and implementation of pertinent guidance.....

PLoS ONE: Conflict of Interest Policies for Organizations Producing a Large Number of Clinical Practice Guidelines

PLoS ONE: Conflict of Interest Policies for Organizations Producing a Large Number of Clinical Practice Guidelines

"COI policies among organizations producing a large number of CPGs (clinical practice guidelines) currently do not measure up to IOM standards. Policy-makers, guideline funders, sponsors, and developers, as well as users need to address and demand improvements. Patients and populations need trustworthy CPGs, and the accurate disclosure and subsequent management of COI is essential to achieve that goal."

Ovarian Cancer National Alliance Submits Comments to Government Regarding Ovarian Cancer Screening

Ovarian Cancer National Alliance Submits Comments to Government Regarding Ovarian Cancer Screening:

The Ovarian Cancer National Alliance submitted the following comments in response to the United States Preventive Service Task Force request for comments on draft recommendations for ovarian cancer screening.

Comments to USPSTF re:

Draft Reaffirmation Recommendation Statement

Screening for Ovarian Cancer: U.S. Preventive Services Task Force Reaffirmation Recommendation Statement

As a patient advocacy organization dedicated to promoting the interests of women with ovarian cancer, the Ovarian Cancer National Alliance is pleased to provide comments on the Draft Screening Statement for Ovarian Cancer.
The United States Preventive Services Task Force is to be commended for reviewing the recent scientific publications regarding ovarian cancer screening. As the Task Force correctly noted, the latest studies confirm that the current blood and imaging tests are not useful for population based screening.
However, the Recommendation Statement does not specify that these tools are valid as part of the diagnostic protocol for women suspected of having ovarian cancer, due in large part to the presence of symptoms.
Further, the Task Force did not appear to use the results of studies that indicate more favorable results of using the CA-125 in tailored ways. For example, a study presented at the 2010 American Society of Clinical Oncology Annual Meeting had more than 3,000 post-menopausal women stratified into high, medium and low risk categories based on an algorithm. The women, based on risk, then had different follow up procedures. The practice followed in this study had a low false-positive rate.
While we are by no means arguing that the CA-125 and/or transvaginal ultrasound be recommended as appropriate screening tools, we urge the Task Force to consider all available information when making its recommendations.
We also request that the recommendation include language regarding the symptoms of ovarian cancer (bloating, difficulty eating/feeling full quickly, urinary frequency or urgency, abdominal pain). We encourage the Task Force to also note that if women have symptoms of the disease these screening recommendations do not apply. We suggest: These recommendations apply only to asymptomatic women at average risk (or instead of “at average risk”, “without any hereditary or family history that would put them at an elevated risk”.)
We thank the Committee for noting that this recommendation does not apply to high risk women, including those with a known genetic mutation that puts them at an increased risk of developing ovarian cancer.
About Ovarian Cancer
According to the American Cancer Society, approximately 21,000 American women are diagnosed with ovarian cancer each year, and approximately 15,000 women die from the disease annually. Ovarian cancer is the deadliest gynecologic cancer and the fifth leading cause of cancer death among women in America. Currently, more than half of the women diagnosed with ovarian cancer die within five years.
About the Ovarian Cancer National Alliance
The Ovarian Cancer National Alliance is a survivor-led national umbrella organization with state and local groups representing grassroots activists, women’s health advocates and health care professionals. The Ovarian Cancer National Alliance submits this testimony as a patient advocacy group dedicated to promoting the interests of women with ovarian cancer.

26 APR 2012 - Nutrition and physical activity guidelines for cancer survivors - CA: A Cancer Journal for Clinicians - Wiley Online Library

Nutrition and physical activity guidelines for cancer survivors - CA: A Cancer Journal for Clinicians 

".... After receiving a diagnosis of cancer, survivors soon find there are few clear answers to even the simplest questions, such as: Should I change what I eat? Should I exercise more? Should I gain or lose weight? Should I take dietary supplements? Cancer survivors receive a wide range of advice from many sources about foods they should eat, foods they should avoid, how they should exercise, and what types of supplements they should take, if any. Unfortunately, this advice is often inconsistent and not supported by data...."

Ovarian Cancer

Ovarian cancer is the leading cause of death from gynecologic malignancies in the United States.4 Symptoms tend be nonspecific, making early detection difficult. Consequently, most ovarian cancers are diagnosed at an advanced stage when the prognosis is poor, with an overall 10-year survival rate of 39%.4 The role of lifestyle factors in ovarian cancer prognosis is largely unknown.138, 242 To our knowledge, only 3 studies139, 140, 243 have evaluated the role of dietary factors in ovarian cancer survival. These 3 studies were based on prospective follow-up of the cases participating in case-control studies and evaluated the association between prediagnosis dietary intake and mortality outcomes. One study, conducted in China, focused on the role of green tea and reported that a higher frequency and quantity of green tea intake after diagnosis was associated with better survival.243 The other 2 studies, conducted in Australia140 and the United States,139 suggested that prediagnosis dietary intake may influence the survival experience of patients with ovarian cancer. Both studies tended to support the association of fruit and vegetable consumption with better survival. Dairy food intake was associated with poorer survival in one of the studies,140 while in the other, only milk consumption and not total dairy food consumption was inversely associated with survival.139 Meat consumption was associated with better survival in the Australian study,140 and with lower survival in the study conducted in the United States.139 While these studies controlled for most relevant covariates, they did not include treatment information. In addition, these studies did not evaluate dietary intake after diagnosis. However, they do suggest that dietary intake may influence ovarian cancer survival and warrant further research in this area.

Only one study, also following cases in a case-control study for mortality, has evaluated the role of physical activity in ovarian cancer survival.244 Prediagnosis physical activity was ascertained as hours per week for 3 life periods (childhood, between ages 18-30 years, and in recent years). The study also evaluated the role of changes in physical activity over time. There was not much indication of an association with survival for any of these variables, except for physical activity at aged 18 to 30 years, which seemed to be associated with better survival for women with early stage ovarian cancer and with worse survival for women with an advanced stage of disease at diagnosis.245

The relationship between excess weight and ovarian cancer survival has been evaluated by relatively few studies. Obesity may affect ovarian cancer survival by having a negative impact on optimal surgical and cytotoxic treatment and increasing the likelihood of postoperative complications.246 Overall, the literature evaluating the association between weight/BMI and ovarian cancer survival is limited and inconclusive.76, 242 Cohort studies evaluating the role of prediagnosis obesity obtained at baseline on ovarian cancer mortality have generally found elevated ovarian cancer mortality among obese women.234, 247 Other studies evaluating the role of prediagnosis BMI on ovarian cancer survival by following cases in a case-control study or clinical trial (using baseline data) have offered conflicting results.242 The role of postdiagnosis body size and weight changes on ovarian cancer survival is largely unknown. Only one study has reported on weight changes during chemotherapy and ovarian cancer survival and found that, among patients with advanced ovarian cancer, weight loss during chemotherapy was associated with worse prognosis; however, it is difficult to determine whether this weight loss was involuntary or intentional.248

In summary, while the current evidence is limited and inconclusive, it points to a possible role of dietary factors, physical activity, and body size and weight changes in modulating ovarian cancer survival, and for physical activity in improving the quality of life among ovarian cancer survivors. Further studies are needed before public health recommendations can be made.

open access: G-I-N: Guidelines International Network: Toward International Standards for Clinical Practice Guidelines

 Blogger's Note: this is not specific to ovarian cancer but to guideline development in general (all on the same page, so to speak) hoping that patient care is reflected in a global environment for best care; would be helpful information for patient advocates

Guidelines International Network: Toward International Standards forClinical Practice Guidelines

Guideline development processes vary substantially, and many guidelines do not meet basic quality criteria. Standards for guideline development can help organizations ensure that recommendations are evidence-based and can help users identify high-quality guidelines. Such organizations as the U.S. Institute of Medicine and the United Kingdom's National Institute for Health and Clinical Excellence have developed recommendations to define trustworthy guidelines within their locales. Many groups charged with guideline development find the lengthy list of standards developed by such organizations to be aspirational but infeasible to follow in entirety.
Founded in 2002, the Guidelines International Network (G-I-N) is a network of guideline developers that includes 93 organizations and 89 individual members representing 46 countries. The G-I-N board of trustees recognized the importance of guideline development processes that are both rigorous and feasible even for modestly funded groups to implement and initiated an effort toward consensus about minimum standards for high-quality guidelines. In contrast to other existing standards for guideline development at national or local levels, the key components proposed by G-I-N will represent the consensus of an international, multidisciplinary group of active guideline developers.
This article presents G-I-N's proposed set of key components for guideline development. These key components address panel composition, decision-making process, conflicts of interest, guideline objective, development methods, evidence review, basis of recommendations, ratings of evidence and recommendations, guideline review, updating processes, and funding. It is hoped that this article promotes discussion and eventual agreement on a set of international standards for guideline development.

Medicine Must Allow for Customization: A Lesson for Policy-Makers -- and Regulators - Forbes

Blogger's Note: Hartzband and Groopman article previously posted on blog, try searching blog "Forbes"

Medicine Must Allow for Customization: A Lesson for Policy-Makers -- and Regulators - Forbes

"As appealing as it is – as useful as it is – to imagine that there exists a gold-standard way to practice medicine, and a single-best way to approach most human ailments, the reality is considerably more complex and messy, as Hartzband and Groopman’s (continued) critique of so-called “best practices” makes clear.
The heart of their argument is this: “For patients and experts alike, there is a subjective core to every medical decision. The truth is that, despite many advances, much of medicine still exists in a gray zone where there is not one right answer. No one can say with certainty who will benefit by taking a certain drug and who will not. Nor can we say with certainty what impact a medical condition will have on someone’s life or how they might experience a treatment’s side effects. The path to maintaining or regaining health is not the same for everyone; our preferences really do matter.”
This resonates (see here and here), although I’ve also heard distinguished health policy proponents argue convincingly that even if experts can’t agree what is definitely “right,” there can definitely be agreement about a number of ways of practicing medicine that are clearly “wrong,” yet very common – so that while it may be harmful, and disingenuous, to insist upon a single algorithm or best approach, it could be helpful to at least provide clear guidance so that physicians would know to avoid certain therapeutic approaches.
Not only does Hartzband and Groopman’s argument have implications for the current healthcare debate, it also would seem to have significant implications for the way we view medical product regulation..........

Dr Maurie Markman: Clinical Oncology News - A Provocative Intersection: Rare cancers, “approved” anti-neoplastics and preclinical models

Clinical Oncology News - A Provocative Intersection: Rare cancers, “approved” anti-neoplastics and preclinical models

"Preclinical results describing a novel approach to the treatment of an uncommon malignant condition raise a provocative question: How, in the current increasingly rigid “guideline-based” era of cancer management, can such observations ever leave the realm of the laboratory to be examined in the clinic? And can a rational approach to this highly relevant dilemma be devised?
Primary mucinous tumors comprise a very small proportion (<5%) of morphologic subtypes found in patients with advanced epithelial ovarian cancer......."

"....One might even argue that the outcome of such individual non-investigative experiences be posted in an easily identified, well-organized, condition-specific online database (with absolutely no accompanying patient-specific identifiers), so the oncology community would be aware of any clinically beneficial effects observed if colleagues had previously attempted to employ this novel approach in an individual patient with a metastatic mucinous ovarian cancer.....

open access: Ten problematical issues identified by pathology review for multidisciplinary gynaecological oncology meetings -- McCluggage 65 (4): 293 -- Journal of Clinical Pathology

Ten problematical issues identified by pathology review for multidisciplinary gynaecological oncology meetings

• Accepted 16 August 2011
• Published Online First 19 October 2011   
• J Clin Pathol 2012;65:293-301 doi:10.1136/jclinpath-2011-200352

Take-home message

Pathology review of gynaecological cancer specimens is often carried out as part of the working of gynaecological oncology multidisciplinary team meetings. Some errors are interpretational errors while others are non-interpretational but may result in the incorrect information being relayed to the clinician. Studies have identified more numerous and clinically significant diagnostic discrepancies in the field of gynaecological oncology than in other areas of pathology.

open access: PLoS Medicine: A Comparison of DSM-IV and DSM-5 Panel Members' Financial Associations with Industry: A Pernicious Problem Persists

PLoS Medicine: A Comparison of DSM-IV and DSM-5 Panel Members' Financial Associations with Industry: A Pernicious Problem Persists

 Introduction

All medical subspecialties have been subject to increased scrutiny about the ways by which their financial associations with industry, such as pharmaceutical companies, may influence, or give the appearance of influencing, recommendations in review articles [1] and clinical practice guidelines [2]. Psychiatry has been at the epicenter of these concerns, in part because of high-profile cases involving ghostwriting [3],[4] and failure to report industry-related income [5], and studies highlighting conflicts of interest in promoting psychotropic drugs [6],[7]. The revised Diagnostic and Statistical Manual of Mental Disorders (DSM), scheduled for publication in May 2013 by the American Psychiatric Association (APA), has created a firestorm of controversy because of questions about undue industry influence. Some have questioned whether the inclusion of new disorders (e.g., Attenuated Psychotic Risk Syndrome) and widening of the boundaries of current disorders (e.g., Adjustment Disorder Related to Bereavement) reflects corporate interests [8],[9]. These concerns have been raised because the nomenclature, criteria, and standardization of psychiatric disorders codified in the DSM have a large public impact in a diverse set of areas ranging from insurance claims to jurisprudence. Moreover, through its relationship to the International Classification of Diseases [10], the system used for classification by many countries around the world, the DSM has a global reach.........

Summary Points

• The American Psychiatric Association (APA) instituted a financial conflict of interest disclosure policy for the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
• The new disclosure policy has not been accompanied by a reduction in the financial conflicts of interest of DSM panel members.
• Transparency alone cannot mitigate the potential for bias and is an insufficient solution for protecting the integrity of the revision process.
• Gaps in APA's disclosure policy are identified and recommendations for more stringent safeguards are offered.

Re-operation outcome in patients referred to a gynecologic oncology center with presumed ovarian cancer FIGO I-IIIA after sub-standard initial surgery

Re-operation outcome in patients referred to a gynecologic oncology center with presumed ovarian cancer FIGO I-IIIA after sub-standard initial surgery:

Publication year: 2012

Background 
Surgery is the mainstay of treatment for early ovarian cancer both as therapeutic and comprehensive staging. Only the latter allows appropriate tailoring of systemic treatment. However, the compliance with guidelines for comprehensive staging has been reported to be only moderate and, therefore, re-staging procedures are commonly indicated to avoid undertreatment. The purpose of our study was to evaluate re-operation in a tertiary gynecologic oncology unit after primary operation for presumably ovarian cancer FIGO I-IIIA in general gynecology departments.

Material and methods 
Forty consecutive patients after primary surgery in the outside institutions for presumed early ovarian cancer with assumed tumor spread limited to the pelvis (FIGO I-IIIA) admitted to our department between 1999 and 2007 were included. In 35 cases re-staging surgery in our unit was indicated. The intra- and post-operative results were compared with initial diagnosis and sites of undetected disease were evaluated. Reasons for re-staging and referral pattern were studied. Results 40 patients were enrolled of whom 53% came by self-referral. Only 18% were referred by the primary surgeon and the remaining patients were referred by their home gynecologist. Only 5 patients (13%) were classified as having had a comprehensive staging by surgical records and pathology reports and 35 patients underwent comprehensive re-staging laparotomy after which 20 patients (50%) experienced an upstaging including 13 patients with final diagnosis of FIGO stage IIIC. Most frequent sites of primarily undetected tumor were peritoneum (pelvic 34%, diaphragm 13%, paracolic 8%), lymph nodes (para aortic 32%, pelvic 11%), intestines 24%, and residual omental tissue 18%. The indication for post-operative chemotherapy was modified in 53% of patients.

Conclusion
Comprehensive staging of presumed early ovarian cancer has been described as major problem especially outside gynecologic oncology units. Re-staging results in our department confirmed this deficiency by showing a considerable proportion of upstaging associated with alterations of recommendations for systemic treatment. However, series like this may even underestimate the problem, because incomplete staging is unfortunately accompanied by non-systematic referral practices not reflecting staging quality.

Vignette-Based Study of Ovarian Cancer Screening: Do U.S. Physicians Report Adhering to Evidence-Based Recommendations?

Abstract

"Background: No professional society or group recommends routine ovarian cancer screening, yet physicians' enthusiasm for several cancer screening tests before benefit has been proven suggests that some women may be exposed to potential harms.

Objective: To provide nationally representative estimates of physicians' reported nonadherence to recommendations against ovarian cancer screening.

Design: Cross-sectional survey of physicians offering women's primary care. The 12-page questionnaire contained a woman's annual examination vignette and questions about offers or orders for transvaginal ultrasonography (TVU) and cancer antigen 125 (CA-125).........."

Many Doctors Don’t Follow Ovarian-Cancer Screening Guidelines - Health Blog - WSJ

The study is published in the Annals of Internal Medicine.

open access: Identifying women with suspected ovarian cancer in primary care: derivation and validation of algorithm | BMJ (note reference to recent NICE guidelines)

Objective
To derive and validate an algorithm to estimate the absolute risk of having ovarian cancer in women with and without symptoms.

Main outcome
The primary outcome was incident diagnosis of ovarian cancer recorded in the next two years.

Conclusion
The algorithm has good discrimination and calibration and, after independent validation in an external cohort, could potentially be used to identify those at highest risk of ovarian cancer to facilitate early referral and investigation. Further research is needed to assess how best to implement the algorithm, its cost effectiveness, and whether, on implementation, it has any impact on health outcomes.

.......As there are few established risk factors, targeted screening of asymptomatic patients at risk of developing ovarian cancer is unlikely to be cost effective at present (although further information is likely to become available when the UK ovarian cancer screening trial reports in 2015-6). The challenge presented by ovarian cancer, therefore, is to make the correct diagnosis as early as possible, despite the non-specific nature of symptoms and signs.4 This is particularly the case in primary care, where general practitioners need to differentiate those patients for whom further investigation is warranted from those who require reassurance or a “watch and wait” policy. Moreover, primary care clinicians need to decide which patients require urgent investigation or referral and which require routine tests or referral.........

Summary of key findings

We have developed and validated a new algorithm designed to estimate the absolute risk of having existing but as yet undiagnosed ovarian cancer based on a combination of symptoms and simple variables such as age and family history of ovarian cancer, which the patient is likely to know and which will increase the baseline absolute risk.....
.................................................................................................................................

What is already known on this topic

• Ovarian cancer is the second most common gynaecological cancer and most women are diagnosed with late stage disease, which has a poor survival rate
• Earlier diagnosis could improve with more targeted investigation of symptomatic patients and increased public awareness of symptoms, which is a major challenge given the non-specific nature of some of the symptoms

What this study adds

• An algorithm based on simple clinical variables such as age, family history of ovarian cancer, anaemia, abdominal pain, abdominal distension, rectal bleeding, postmenopausal bleeding, appetite loss, and weight loss, which the patient is likely to know or which are routinely recorded in general practice computer systems, can estimate absolute risk of ovarian cancer in women with and without symptoms in primary care
• The algorithm could be integrated into general practice clinical computer systems and used to assess risk in women presenting with and without symptoms

Medical News: Gene Test Influences Cancer Treatment - in Meeting Coverage, AACR-IASLC from MedPage Today

Action Points

---

• This study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.



• Use of guideline-recommended cancer therapy increased by more than 50% when oncologists included a tumor's gene expression profile in the decision-making process.

......"The changes that oncologists made in response to the test results weren't limited to the choice of chemotherapy," John Hornberger, MD, of Stanford University, said at the Joint Conference on the Molecular Origins of Lung Cancer.
"Some patients had surgery that initially wasn't planned and, in at least one case, the treating oncologist referred a patient to a different oncologist because the test showed the tissue of origin was different from what was indicated by pathology. Referrals to hospice also increased."..........

audio: NCCN Ovarian Cancer Guidelines Update 2011

Blogger's Note: requires registration

full free access: PLoS Medicine: How Industry Uses the ICMJE Guidelines to Manipulate Authorship—And How They Should Be Revised

"The ICMJE guidelines will always be a work in progress, but the adjustments proposed here have the potential to end the self-concealment and authorial misrepresentations that mar industry's contributions to the literature. Furthermore, they have the potential to help industry achieve the enhanced respect its beneficial contributions to medicine deserve. Industry publications will always have a commercial valence alongside their scientific and medical content: this should henceforth be truthfully displayed, and no longer downplayed or concealed."

CDC Releases Infection Prevention Guide to Promote Safe Outpatient Care

abstract: A comparison of international breast cancer guidelines - Do the national guidelines differ in treatment recommendations? USA, Canada, Australia, the UK, and Germany

(USA, Canada, Australia, the UK, and Germany)
 CONCLUDING STATEMENT: Considering that the development of guidelines is a very expensive and resource-intensive task the question arises whether the development of national guidelines in numerous countries is worth the effort since the recommendations differ only marginally.

Canada's Pathologists Issue Guidelines on Investigations into Labs - Press Release - Digital Journal

Note: as specialists key in cancer diagnoses, the number of professional pathologists in Canada is at such a low level that patient care is impacted (negatively)

April 2011: NICE Guidelines - Ovarian cancer: the recognition and initial management of ovarian cancer

The recognition and initial management of ovarian cancer

Description

This clinical guideline offers evidence-based advice on the care and early treatment of women with suspected or confirmed ovarian cancer.
This guidance updates and replaces recommendation 1.7.4 in Referral guidelines for suspected cancer (NICE clinical guideline 27; published 2005).

Guidance documents

• Full guideline PDF format  | MS Word format
• NICE guideline PDF format  | MS Word format
• Quick reference guide PDF format
• NICE guidance written for patients and carers PDF format  | MS Word format
• CG122 Ovarian cancer: guidance (web format)

Implementing this guidance

• Baseline assessment tool
• Clinical audit tool
• Clinical case scenarios
• Costing statement
• Slide set

• CG122 Ovarian cancer: GP podcast
• CG122 Ovarian cancer: SLR podcast

Other information

• Background information

About this guidance

Clinical guidelines CG122

Issued: April 2011
How this guidance was produced

Order printed copies of this guidance

This page was last updated: 27 April 2011