647 e-Letters

  • Process Evaluation: Unlikely

    Dear Editors and Authors,

    I am astonished the article and the methodology are titled as a 'process evaluation'? None of what the article describe's in its methodology lends itself to a process evaluation framework. A proper evaluation process involves assessment of the program objectives and how the program activities are tracking towards the objectives. In addition, sophisticated versions of process evaluation assess the theory behind the implementation and if the participants are receiving the benefits stated in the objectives. From what I read in the article, there isn't any of this nor a program logic: textual or illustrated. It is a really poor form to have titled this article as a program evaluation, while it is nothing but a qualitative data collection.

    Sincerely yours,
    Dr Sandeep Reddy

  • A call for more adherence to guidelines for creatinine and potassium monitoring and discontinuation following renin–angiotensin system blockade.

    Schmidt et al examined the adherence to serum creatinine and potassium monitoring and discontinuation guidelines following initiation of treatment with ACE inhibitors (ACEI) or angiotensin receptor blockers (ARBs) in a general practice-based cohort study using electronic health records from the UK Clinical Practice Research Datalink and Hospital Episode Statistics.; and whether high-risk patients were monitored.1 223,814 new ACEI/ARB users were investigated.1 Only 10% of patients had neither baseline nor follow-up monitoring of creatinine within 12 months before and 2 months after initiation of an ACEI/ARB, 28% had monitoring only at baseline, 15% only at follow-up, and 47% both at baseline and follow-up.1 The median period between the most recent baseline monitoring and drug initiation was 40 days (IQR 12–125 days). 34% of patients had baseline creatinine monitoring within 1 month before initiating therapy, but <10% also had the guideline-recommended follow-up test recorded within 2 weeks. Among patients experiencing a creatinine increase ≥30% (n=567, 1.2%) or potassium level >6 mmol/L (n=191, 0.4%), 80% continued treatment.1 Although patients with prior myocardial infarction, hypertension or baseline potassium >5 mmol/L were at high risk of ≥30% increase in creatinine after ACEI/ARB initiation, there was no evidence that they were more frequently monitored.1

    In our opinion, it is indeed disheartening and most disappointing that healthcare providers contin...

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    Leprosy Post-Exposure Prophylaxis (LPEP) programmes is a good initiative for tropical stigmatized disease leprosy.
    A single dose of rifampicin given to contacts of new patients with leprosy was found to be 57% effective in preventing the development of clinical leprosy after two years.1 The findings of the study helps to use single dose rifampicin as a cheap and practical preventive intervention for contacts of patients with leprosy control programmes but implementing in the field is a promising act.
    The protocol of LPEP is designed nicely for evaluating the feasibility and its impact on case detection rates by contact tracing and administration of single dose rifampicin for consented contacts. There are few more points to be considered when it is implemented in the practical set up or in the field. A note or information regarding the adverse effects or flu like syndrome should be noted in the protocol. Even though the side effects/adverse events are rarely seen in a single dose it is mandate to note the possible adverse events/effects due to rifampicin.
    It was found that approximately 5063 were females in rifampicin received group in the study by Moet et al1. As the protocol clearly mentioned regarding the age restrictions in pediatrics and pregnancy status as an exclusion criteria, the reproductive age group especially women should be interviewed properly regarding her plan for pregnancy or plan for postponement of pregnancy by means of any drugs or bar...

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  • Nutrition-focused policies don't work due to bad dietary advice

    Current "nutrition-focused policies" are based on dietary dogmas that lack scientific veracity. For example, in 1977, with the best of intentions, no doubt, saturated fat was designated a nutrient of concern. This was the so-called evidence linking saturated fat to heart disease at the time the United States government declared saturated fats a health hazard.

    "The level of saturated fat in the diet is of concern because it has been directly linked to excessive levels of cholesterol in the blood and therefore to an increased risk of heart disease. Feeding studies in animals in the early 1900's linked high cholesterol intake to atherosclerosis. Evidence that cholesterol could affect the same arterial lesions in man came from Scandanavian countries where atherosclerotic diseases appeared to decline during the war years when consumption of calories and animal fat declined." (Dietary Goals for the United States, Second Edition, Page 39)

    On March 14, 2015, in comments submitted to USDA and HHS, the Academy of Nutrition and Dietetics said this about saturated fat:

    "The Academy supports the DGAC in its decision to drop dietary cholesterol from the nutrients of concern list and recommends it deemphasize saturated fat from nutrients of concern, given the lack of evidence connecting it with cardiovascular disease."...

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  • Satisfaction of Dupuytren's disease with treatment with collagenase

    Dear Editor,
    Recently published in your journal, Lauritzson & Atroshi1 used a dichotomic question for the assessment of patient satisfaction in Dupuytren Disease (DD) treated with collagenase Clostridium hystolyticum (CCH). This satisfaction was correlated with the 11-item disabilities of the arm, shoulder and hand (QuickDASH) scale. Follow up was made initially at 5 weeks and at 2 years, answering the patients to both questionnaires.
    This way of proceeding is adequate. To contemplate the level of satisfaction of patients with their clinical results achieved or about the therapeutic process applied must be done2. However the way to measure satisfaction is not the best. Satisfaction is a multidimensional concept and it is not possible to valuate only with a dichotomic question. The expectation that the patient has about the care, staff or hospital in which he or she has been treated is a fundamental element to know this satisfaction. It has long been considered that satisfaction has between three to ten dimensions, mainly: cognitive (quantity, type and quality of information given by the doctor); affective (interest and understanding that shows); and behavioral (on the abilities and clinical competences of the physician).
    Measurement satisfaction in this article has important bias of selection and information. There may be both a Hawthorne bias (by questions asked directly by a therapist) as well as a recall bias (by the time elapsed and the advanced a...

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  • Correction to link to FDA reviews

    There was a typographical error in the link provided to where one can access the reviews.
    The article states, "The reader may access these reviews at http://doi.org/10.6083.M4H9949P ".
    That is incorrect--it should read, "The reader may access these reviews at http://doi.org/10.6083/M4H9949P ".
    We apologize for the error.

  • Sharing of information in objective structured clinical examinations -- does no evidence of difference mean evidence of no difference?

    Recently, the University of Glasgow medical school had to ask all medical students to retake their Objective Structured Clinical Examinations (OSCE) because of leaking of exam details online.<1> In contrary, this study here suggested that quarantining students to prevent collusion is unnecessary.<2> When I studied medicine at the University of Birmingham, I was also told that knowing the OSCE questions prior to the exam make no difference in the scores. I always find these data counter-intuitive, as I cannot explain why knowing the exam questions beforehand would not give candidates an advantage. I am aware that other students are similarly concerned about the fairness of OSCEs when information is colluded, but are told that the data suggest otherwise.<3> I would like to comment on the validity of these data here.

    First of all, all medical students and graduates must have heard of the phrase ‘no evidence of difference does not mean evidence of no difference’ during their epidemiology and research modules. As an analogy, if I don’t hate you, it doesn’t mean I love you. When a study fails to detect statistical significance among groups, it could be due to a Type II error, meaning failure to detect a difference when there is indeed a difference. Although the authors of the current study stated that other studies also failed to show inter-day difference in students’ OSCE performance, researchers cannot declare no difference between groups -- they must...

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  • Why clozapine therapy, long acting injectable antipsychotics and community treatment orders may be effective in clinical practice, but not in research trials

    In their cross sectional examination of a large sample of people with psychosis, Rashmi Patel and colleagues point out that patients who are approached to participate in research have better HoNOS scores and fewer inpatient days, and are less likely to have been compulsorily hospitalised (1). This may produce a potential selection bias towards less unwell patients, resulting in false negative outcomes in studies aimed at evaluating interventions for patients with more severe conditions, such as clozapine therapy (2), long acting injectable antipsychotics (3) and community treatment orders (4,5).
    Clinical research trials that fail to recruit patients with severe psychosis can result in flawed outcomes, potentially misleading clinicians and policy makers and causing harm to patients, not to mention the waste of increasingly scarce research resources. Academics, clinicians, ethics committees and patient groups should work together to resolve this problem.
    1. Patel R, Oduola S, Callard F, et al. What proportion of patients with psychosis is willing to take part in research? A mental health electronic case register analysis. BMJ Open 2017;7(3):e013113.
    2. Taylor DM. Clozapine for treatment-resistant schizophrenia: still the gold standard? CNS Drugs 2017;31(3):177-180.
    3. Kane JM, Kishimoto T, Correll CU. Assessing the comparative effectiveness of long-acting injectable vs oral antipsychotic medications in the prevention of relapse provi...

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  • Comment on Abraha, I., Rimland, J.M., Trotta, F.M. et al. (2017), "Systematic review of systematic reviews of non-pharmacologic interventions to treat behavioural disturbances in older patients with dementia. The SENATOR-OnTop series".

    March 31th, 2017

    Dear authors and concerned readers,

    We are writing in reference to Abraha, I., Rimland, J.M., Trotta, F.M., et al. (2017), “Systematic review of systematic reviews of non-pharmacologic interventions to treat behavioural disturbances in older patients with dementia. The SENATOR-OnTop series”. The authors are to be commended for their effort to summarize the results of 38 systematic reviews and 142 primary studies.

    In addition to summarizing the results of these studies the authors also, very usefully proposed a categorization of these studies. Unfortunately, at least for the first two categories of non-pharmacologic interventions, the categorizations presented in the abstract differ from the categorizations presented in the text. These differences raise questions about the number of systematic reviews and associated primary studies reported for each category in the abstract and cloud scientific efforts to report on the results of this important scientific project.

    Specifically, the abstract states in part in the Results, “38 SR’s [systematic reviews] and 142 primary studies were identified, comprising the following categories of non-pharmacological interventions: (1) sensory stimulation interventions (12 SR’s, 27 primary studies) that encompassed: acupressure, aromatherapy, massage/touch therapy, light therapy and sensory gardens; (2) cognitive/emotion-oriented interventions ( 33 SR’s; 70 primary studies) that included cognitiv...

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  • Note from Production

    The quotation marks should not be present in the sentence:
    "However, since the early 1990s, interest has progressed to ‘multimorbidity’, commonly defined as the “co-occurrence of two or more diseases within one person without defining an index disease.”2"

    This should read:
    "However, since the early 1990s, interest has progressed to ‘multimorbidity’, commonly defined as the co-occurrence of two or more diseases within one person without defining an index disease.2"