Displaying 11-20 letters out of 172 published
Re:Authors' Reply to responses on BMJ Open to Bed sharing when parents do not smoke: Is there a risk of SIDS? An individual level analysis of five major cases-control studies.
Language in and of itself has no meaning . Only people have meaning. For example:
Through the Looking Glass, by Lewis Carroll
'I don't know what you mean by "glory",' Alice said.
Humpty Dumpty smiled contemptuously. 'Of course you don't --till I tell you. I meant "there's a nice knock-down argument for you!"'
'But "glory" doesn't mean "a nice knock-down argument",' Alice objected.
'When I use a word,' Humpty Dumpty said, in rather a scornful tone, it means just what I choose it to mean -neither more nor less.'
'The question is,' said Alice, 'whether you can make words mean so many different things.'
'The question is,' said Humpty Dumpty, 'which is to be master -- that's all.'
With that in mind , and amending 'Dr.' to 'Mr.', the opening paragraph of the authors' response reads as follows :
Dr. O'Hagan's suggestion that SIDS may be due to maternal vitamin C deficiency seems unlikely because baby formula milk includes vitamin C supplement. We would therefore expect on his hypothesis that bottle fed babies would, if anything, be at lower risk than breast fed infants, which is not the case(1,2).
Comment: The above statement advisedly merits re- examination by its author(s) with a view to either its deletion or by their acknowledgement that what it concludes is totally in the realm of the non sequitur... and that's putting it mildly !
The Vennemann et al study (1) was structured to compare the two types of infant feeding and the totals of the diagnoses of SIDS respectively. However, neither it nor Dr. Carpenter's report (2), can be cited to support such an entirely erroneously based and thoroughly misleading conclusion.
Note that the implied objective of the response was to refute the " ...suggestion that SIDS may be due to maternal vitamin C deficiency ...". Accordingly, and inasmuch as the terms 'breast fed infants' and 'bottle fed babies' have been employed absent further qualification, they ambiguusly ... and need it be said , most conveniently... provide complete disregard of the the requirement of distinguishing between their employment in (1) and (2), and similarly nourished infants/ babies, who from the moment of their births are deficient in vitamin C.
In other words, Carpenter et al would have been well-advised to 'measure twice prior to cutting once'. Paradoxically, the direct opposite is what they should 'expect' if they were to give a ittle more thought to it ; namely, that vitamin C deficient "... bottle fed babies would, if anything, be at lower risk than breast fed infants ".
Conflict of Interest:
Response from the European Medicines Agency
The European Medicines Agency (EMA) welcomes the research on the usability of the summaries of the European Public Assessment reports (EPAR summaries) by Professor David K Raynor and David Bryant recently published on the BMJ Open website.
The EMA had first become aware of the results of this user-testing study in 2011 while the Agency was already consulting stakeholders on improving the EPAR summaries, aiming at making them easier to read by a lay audience. Although the limitations of the study pointed out by the peer reviewers (such as the suitability of the questions, the representativeness of the participants and the fact that only one summary was user tested) reduced its applicability, the EMA included the results as input to this process.
Using feedback from various stakeholders, but particularly patients and healthcare professionals, the format and content of EPAR summaries were updated in 2012 and this standard is now being used for all new summaries and to gradually update old summaries on the EMA website. The study by Raynor and Bryant used an EPAR summary prepared in 2009, which precedes these extensive changes. Although the changes introduced during the update in 2012 went beyond the scope of the authors' user-testing, the EMA believes that the results of the study are addressed by the current EPAR summary template.
The EMA continues to encourage research in the area of public communication, particularly on the use of lay-language documents, and thanks the authors for conducting this important research.
Conflict of Interest:
The European Medicines Agency is the owner of the EPAR summary documents
Re:Response to 'Does contact with a podiatrist prevent the occurrence of a lower extremity amputation in people with diabetes? A systematic review and meta-analysis.' CM Buckley, IJ Perry, CP Bradley, PM Kearney
Many thanks to the College of Podiatry and the Society of Chiropodists and Podiatrists for your response to our systematic review examining the published evidence for the effect of contact with a podiatrist on the occurrence of a lower extremity amputation in people with diabetes. We agree wholeheartedly that this review does not provide proof that podiatric intervention has no effect on amputation rates. Rather, it highlights the paucity of research in this area.
At the time of designing this study, a question regarding the contribution of podiatrists (as health professionals) to amputation prevention in patients with diabetes had been raised in order to try and inform a policy decision about employing more podiatrists in the Irish healthcare system. Given that teams already existed and had already undertaken some footcare work we were, initially, keen to see if the specific contribution of podiatry could be identified (albeit isolated from other effects on foot health of other members of a footcare team). In the event, it was apparent that the literature did now allow us to answer this question.
Now having reviewed the literature, we recognise that the literature may never be able to answer this question because it is no longer possible to envisage foot care teams without a podiatrist where teams with one have been shown to be effective. As mentioned in your response, many centres have demonstrated reduced amputation risk in people with diabetes coinciding with the introduction of multidisciplinary footcare teams [1- 5]. As you also correctly highlight 'podiatrists do not work in isolation and always seek to work as part of a multidisciplinary team for those patients who are at risk of amputation'. Thus, we concluded that looking at one service in isolation could be flawed as services are seldom delivered in isolation and recommended a systematic review of the literature looking at the effectiveness of multidisciplinary teams which include contact with a podiatrist.
It was most definitely not our intention to 'give the impression that podiatry has at best a benign effect upon those with diabetes'. We wished to highlight this as an area worthy of further research. As you accurately state 'research has not been undertaken to show that a podiatrist working in isolation can influence amputation rates.' However, research has been conducted showing that a podiatrist working as part of a multidisciplinary footcare team can influence amputation rates. This is where future research should be focused.
1. Canavan RJ, Unwin NC, Kelly WF, Connolly VM. Diabetes- and Nondiabetes-Related Lower Extremity Amputation Incidence Before and After the Introduction of Better Organized Diabetes Foot Care. Diabetes Care 2008;31(3):459-63
2. Krishnan S, Nash F, Baker N, Fowler D, Rayman G. Reduction in Diabetic Amputations Over 11 Years in a Defined U.K. Population. Diabetes Care 2008;31(1):99-101
3. Driver VR, Madsen J, Goodman RA. Reducing Amputation Rates in Patients With Diabetes at a Military Medical Center. Diabetes Care 2005;28(2):248-53
4. Larsson J, Apelqvist J, Agardh CD, Stenstrom A. Decreasing incidence of major amputation in diabetic patients: a consequence of a multidisciplinary foot care team approach? Diabet Med 1995;12(9):770-6
5. Meltzer DD, Pels S, Payne WG, et al. Decreasing amputation rates in patients with diabetes mellitus. An outcome study. Journal of the American Podiatric Medical Association 2002;92(8):425-28
Conflict of Interest:
Re:The mortality and cancer experience of New Zealand Vietnam war veterans: a cohort study
Roy, If we saw worse mortality in this group, we would have a problem. We don't, we see the 'healthy soldier' effect. This probably means that the Maori men in our sample were as healthy as anyone else.
Conflict of Interest:
Response to "Specificity and sensitivity of transcranial sonography of the substantia nigra in the diagnosis of Parkinson's disease: prospective cohort study in 196 patients"
The study by Bouwmans and colleagues seems to be well designed and thoroughly executed , but the primary results are surprising regarding both the transcranial sonography (TCS) and dopamine transporters - single- photon emission computed tomography (DAT-SPECT) results. According to large scale prospective studies, DAT-SPECT should have a specificity close to 100% in differentiating neurodegenerative parkinsonian syndromes such as Parkinson's disease (PD) and atypical parkinsonian disorders (APD) based on the underlying nigrostriatal dopaminergic depletion versus other conditions without nigrostriatal denervation [2,3]. In this study specificity for PD was 68% and if merging the conditions which should not be associated with nigrostriatal denervation (i.e. the groups essential tremor, vascular parkinsonism, drug induced parkinsonism, and no parkinsonism) it still was only 84%. Sensitivity of DAT-SPECT to diagnose neurodegenerative parkinsonism was 88% for PD and 84% for neurodegenerative parkinsonism (i.e. merging the groups PD, multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and corticobasal degeneration) which is the range of the reported sensitivity in literature. However, considering that DAT-SPECT should detect neurodegenerative parkinsonian disorders in general, the negative predictive value was only 74% due the high false negative rate misclassifying subjects with a neurodegenerative process as having one of the other conditions. Such diagnostic accuracy data suggest not to use DAT -SPECT in the diagnostic work-up of patients presenting with a parkinsonian syndrome of recent onset which is against current recommendations [4,5]. Similarly, the TCS data in this study have determined suboptimal diagnostic accuracy in detecting PD. Up to now several independent studies by various groups have detected substantia nigra (SN) hyperechogenicity in 80-90% of patients with PD [6-13]. Depending on the cut-off, approximately 10% of healthy adult controls and patients with APDs and a slightly higher number of patients with ET have been reported to show SN hyperechogenicity [6,14-17]. It is unclear, why both the TCS and DAT-SPECT results in this study were surprisingly disappointing. Regarding the TCS data, one has to consider that insufficient technical equipment may have played a role; the authors used the Sonos 5500 Philips machine, which they had judged to be insufficient to display SN- hyperechogenicity in an earlier analysis of the baseline data ("Fourthly, the quality of the ultrasound system is a non-neglectable variable, since in our pilot examinations, we found that the newest ultrasound systems will reveal hyperechointensity of the SN in more patients...") . However, the Sonos 5500 Philips machine has also been used by other groups, yielding useful images suitable for further statistical analysis. It is well known that the way settings are adjusted do play a major role for the visibility of structures under investigation. It cannot be estimated why the authors had more problems in scanning with this machine than other groups. Still, it needs to be acknowledged, that they realized themselves, that they would have done better with another device . The main reason given by the authors for their discrepant results to the literature is that they postulate that their study is the second prospective after the study by Gaenslen et al. . However, there are several other prospective studies in this field, showing the diagnostic utility of TCS in PD, APDs and essential tremor [6,17,22-24]and in the assessment of PD risk in rapid eye movement sleep behaviour disorder patients as well as the general population . Also recent guidelines from the EFNS/MDS-ES recommend TCS for the differential diagnosis of PD from APS and secondary parkinsonian syndromes, for the early diagnosis of PD, and for the detection of subjects at risk for PD . As DAT-SPECT data are not in accordance with the clinical data, clinical classification of the patients might have been suboptimal. Other studies used DAT-imaging in addition to the clinical information to reach a final diagnosis and it would be interesting to know the diagnostic accuracy of TCS in the subjects, whose final clinical diagnosis was also supported by their DAT-Scan. Taken together, this study proves the importance of a good gold standard for diagnosis of all disease entities investigated in studies trying to validate other diagnostic instruments. Moreover, careful consideration should be given to the devices used and to the way methods are applied and data are analysed.
Affiliations: Department of Neurology, Innsbruck Medical University (Philipp Mahlknecht and Klaus Seppi) Center of Neurology, Department of Neurodegeneration and Hertie Institute for Clinical Brain Research, University of Tuebingen, Tuebingen, Germany; German Center for Neurodegenerative Diseases, University of Tuebingen, Tuebingen, Germany (Daniela Berg)
References 1. Bouwmans AE, Vlaar AM, Mess WH, Kessels A, Weber WE. Specificity and sensitivity of transcranial sonography of the substantia nigra in the diagnosis of Parkinson's disease: prospective cohort study in 196 patients. BMJ Open 2013;3. doi:pii: e002613. 10.1136/bmjopen-2013-002613. 2. Marshall VL, Reininger CB, Marquardt M. Parkinson's disease is overdiagnosed clinically at baseline in diagnostically uncertain cases: a 3-year European multicenter study with repeat [123I]FP-CIT SPECT. Mov Disord 2009;24:500-8. 3. Jennings DL, Seibyl JP, Oakes D, Eberly S, Murphy J, Marek K. (123I) beta-CIT and single-photon emission computed tomographic imaging vs clinical evaluation in Parkinsonian syndrome: unmasking an early diagnosis. Arch Neurol 2004;61:1224-9. 4. Suchowersky O, Reich S, Perlmutter J, Zesiewicz T, Gronseth G, Weiner WJ. Practice parameter: diagnosis and prognosis of new onset Parkinson disease (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2006;66:968- 75. 5. Pahwa R, Lyons KE. Early diagnosis of Parkinson's disease: recommendations from diagnostic clinical guidelines. Am J Manag Care 2010;16 Suppl:94-9. 6. Stockner H, Sojer M, Seppi K. Midbrain sonography in patients with essential tremor. Mov Disord 2007;22:414-7. 7. Ressner P, Skoloudik D, Hlustik P, Kanovsky P. Hyperechogenicity of the substantia nigra in Parkinson's disease. J Neuroimaging 2007;17:164-7. 8. Huang YW, Jeng JS, Tsai CF, Chen LL, Wu RM.Transcranial imaging of substantia nigra hyperechogenicity in a Taiwanese cohort of Parkinson's disease. Mov Disord 2007;22:550-5. 9. Walter U, Wittstock M, Benecke R, Dressler D. Substantia nigra echogenicity is normal in non-extrapyramidal cerebral disorders but increased in Parkinson's disease. J Neural Transm 2002;109:191-6. 10. Berg D, Siefker C, Becker G. Echogenicity of the substantia nigra in Parkinson's disease and its relation to clinical findings. J Neurol 2001;248:684-9. 11. Kolevski G, Petrov I, Petrova V. Transcranial sonography in the evaluation of Parkinson disease. J Ultrasound Med 2007;26:509-12. 12. Kim JY, Kim ST, Jeon SH, Lee WY. Midbrain transcranial sonography in Korean patients with Parkinson's disease. Mov Disord 2007;22:1922-6. 13. Okawa M, Miwa H, Kajimoto Y, et al. Transcranial sonography of the substantia nigra in Japanese patients with Parkinson's disease or atypical parkinsonism: clinical potential and limitations. Intern Med 2007;46:1527- 31. 14. Berg D, Becker G, Zeiler B, et al. Vulnerability of the nigrostriatal system as detected by transcranial ultrasound. Neurology 1999;53:1026-31. 15. Berg D, Behnke S, Walter U. Application of transcranial sonography in extrapyramidal disorders: updated recommendations. Ultraschall Med 2006;27:12-9. 16. Berg D. Transcranial sonography in the early and differential diagnosis of Parkinson's disease. J Neural Transm Suppl 2006;249-54. 17. Mahlknecht P, Seppi K, Stockner H. Substantia Nigra Hyperechogenicity as a Marker for Parkinson's Disease: A Population-Based Study. Neurodegener Dis 2013;18. [Epub ahead of print] 18. Vlaar AM, de Nijs T, van Kroonenburgh MJ et al. The predictive value of transcranial duplex sonography for the clinical diagnosis in undiagnosed parkinsonian syndromes: comparison with SPECT scans. BMC Neurol 2008;8:42. 19. Hagenah J, K?nig IR, Sperner J et al. Life-long increase of substantia nigra hyperechogenicity in transcranial sonography. Neuroimage 2010;51:28- 32. 20. Mehnert S, Reuter I, Schepp K et al. Transcranial sonography for diagnosis of Parkinson's disease. BMC Neurol 2010;10:9. 21. Gaenslen A, Unmuth B, Godau J, et al. The specificity and sensitivity of transcranial ultrasound in the differential diagnosis of Parkinson's disease: a prospective blinded study. Lancet Neurol 2008;7:417-24. 22. Walter U, Dressler D, Wolters A, Probst T, Grossmann A, Benecke R. Sonographic discrimination of corticobasal degeneration vs progressive supranuclear palsy. Neurology 2004;63:504-9. 23. Walter U, Dressler D, Probst T, et al. Transcranial brain sonography findings in discriminating between parkinsonism and idiopathic Parkinson disease. Arch Neurol 2007;64:1635-40. 24. Behnke S, Hellwig D, B?rmann J, et al. Evaluation of transcranial sonographic findings and MIBG cardiac scintigraphy in the diagnosis of idiopathic Parkinson's disease. Parkinsonism Relat Disord 2013 Jul 20. [Epub ahead of print]. 25. Iranzo A, Lome?a F, Stockner H, et al. Decreased striatal dopamine transporter uptake and substantia nigra hyperechogenicity as risk markers of synucleinopathy in patients with idiopathic rapid-eye-movement sleep behaviour disorder: a prospective study. Lancet Neurol 2010;9:1070-7. 26. Enlarged substantia nigra hyperechogenicity and risk for Parkinson disease: a 37-month 3-center study of 1847 older persons. Berg D, Seppi K, Behnke S, et al. Arch Neurol 2011;68:932-7. 27. Berardelli A, Wenning GK, Antonini A, et al. EFNS/MDS-ES/ENS [corrected] recommendations for the diagnosis of Parkinson's disease. Eur J Neurol 2013;20:16-34.
Conflict of Interest:
Complementary and alternative asthma treatments and their association with asthma control: a population-based study: Letter to Editor
The use of complementary and alternative treatment in asthmatic patients was very well described by Chen et al. It is indeed a good piece of research wherein relationship of different types of CAM is done with asthma severity and treatment by conventional medications. However, it is also important to estimate the therapeutic-toxicologic safety profile (risk-benefit ratio) of various CAM interventions for asthma 1. Also, a study done by Blanc et al revealed that there was increase incidence of hospitalization with the use of herbal medicines, attributed to lack of control of airway inflammation in herbal medicine 2.Similarly, Mizushima and Kobayashi published a series of 24 cases of interstitial pneumonitis induced by herbal remedies 3.Thus, it is important to assess via questionnaire history of such episodes and the patients must be counseled about potential benefits and harmful effects of the therapy they use. Lastly, this study would have been more comprehensive if children were also included in it.There has been tremendous rise in asthma in children both in number and severity.This may be due to early exposure, immature immunity or genetic factors 4. It is seen that many parents are opting for CAM as a treatment modality for children due to concerns about the long term treatment with conventional medicines 5. This study indeed opens avenue for future investigators to look upon the above mentioned factors for devising a better approach for preventing and treating asthmatic patients.
REFERENCES: 1. L. Bielory, J. Russin, and G. B. Zuckerman, "Clinical efficacy, mechanisms of action, and adverse effects of complementary and alternative medicine therapies for asthma," Allergy and Asthma Proceedings, vol. 25, no. 5, pp. 283-291, 2004 2. Marino LA, shen, Joannie. Characteristics of complementary and alternative medicine use among adults with current asthma. Journal of Asthma : 47;5; 2010: 521-525. 3. Sonibare MA, Gbile ZO. Ethnobotanical survey of anti- asthma plants in south western Nigeria. Afr. J. trad. CAM 2008:5;340-345. 4. O'Connell EJ. The burden of atopy and asthma in children. Allergy. 2004 Aug;59 Suppl 78:7-11. 5. Helen Kopnina, "Alternative Treatment for Asthma: Case Study of Success of Traditional Chinese Medicine Treatment of Children from Urban Areas with Different Levels of Environmental Pollution,"ISRN Allergy, vol. 2012, Article ID 547534, 6 pages, 2012.
Conflict of Interest:
Differences between RCTs and observational studies of hormone therapy effects have not been definitely reconciled
Rossouw et al. addressed only the comparisons of results from randomized controlled trials (RCTs) and observational studies (OSs). They did not consider analyses that compared outcomes of participants who had the same treatment but were in different studies. These analyses found that adjusting for the WHI risk factors was not sufficient to account for unmeasured risk differences between subjects in different studies. The differences between studies due to unexplained confounding were sometimes larger then the effects of HT on either MI or stroke in the RCTs. For example, after adjusting for risk factors measured by the WHI, participants in the RCT of E-alone had a 37% higher rate of an MI (p<0.0001) than participants in the WHI OS if both sets of participants were not taking any HT and a 44% higher rate of an MI (p<0.0001) if both sets of participants were taking E-alone. Explanations other than unmeasured confounders are unlikely to account for differences in outcomes among the studies.
These findings are important because comparisons of subjects in different studies are closely related to OS comparisons of subjects on different treatments. It is therefore likely that unmeasured confounders may in some cases greatly distort apparent treatment effects in OSs even after adjusting for WHI variables.
Below we summarized and responded to the Rossouw et al. critiques of our OS/RCT comparisons.
1. THE DIFFERENCES BETWEEN OBSERVATIONAL STUDIES (OSS) AND RANDOMIZED CONTROLLED TRIALS (RCTS) IN THE WHI CAN BE EXPLAINED BY TAKING INTO ACCOUNT TIME SINCE INITIATION OF CURRENT REGIMEN OF HORMONE THERAPY (HT) AND TIME SINCE MENOPAUSE.
This explanation depends on two beliefs: a) HT increases adverse outcomes soon after it is initiated, and this effect disappears after two years of continuing HT; b) HT increases adverse outcomes more for persons who are older or more years past menopause. If these beliefs are true, then associations between HT and adverse outcomes will be weaker for OS participants because they have been on HT for considerable time before the study and will be stronger for RCT participants who are older at the time they are put on HT. The first belief was supported by our analysis of the RCT of estrogen plus progestin (E+P). This analysis found HT increased the MI rate during the first three years of the study but not subsequently. However, the following findings from our analysis challenged these beliefs.
a. In the RCT of estrogen alone (E-alone) there was no evidence that HT increased the risk of MI either soon after beginning HT or subsequently.
b. In the RCTs of E+P and of E-alone the associations between HT and stroke remained constant over time, i.e., there was no effect of time since initiation of therapy.
c. In the OSs there was a protective effect of HT for MI and no effect of HT on stroke. Regardless of time since initiation the RCTs never show a protective effect of HT and always showed an effect of HT on stroke . In other words, time since initiation does not seem to account for the differences between the OS and RCTs. d. OS participants who began HT after the start date of the OS should show increased risk according to the Rossouw et al. explanation, but instead there was a statistically significant protective effect of HT.
e. In contrast to the Rossouw et al. analysis, neither years since menopause nor age at study baseline significantly modulated the effect of HT on outcome in any of numerous analyses (some reported and most not reported) in the present study. It is possible that Rossouw et al. had a particularly fortuitous way of analyzing the data and slight changes in their analysis might give results that do not show that the HT effect was significantly altered by effects of age or years since menopause.
2. RESULTS FROM THE PRESENT STUDY WERE INVALID BECAUSE WE USED THE WRONG FOLLOW-UP MEASURES AND USED MI INSTEAD OF CHD AS AN OUTCOME MEASURE.
We have two responses to this criticism. The first is that it was irrelevant to our research question, i.e., to determine whether OS results were reliably valid. It has already been well established that OS and RCT results can be similar. It makes no difference whether OS and RCT results are similar for some follow-up times and some outcomes. If OS results are reliably valid, they should be reliably valid for all modifications of the research question. Our second response is that all analyses reported were also performed for different follow-up periods and definitions of CHD as close as we could make it to the Rossouw definition. These additional results were not reported, but they were qualitatively the same as those we did report.
3. THE INCLUSION OF HYSTERECTOMY STATUS WAS UNCLEAR. All of our analyses were done for three data sets: the RCT of E+P (given only to participants without a hysterectomy), the RCT of E-alone (given only to participants with a hysterectomy), and the combined RCT data sets. All three results were report for MI, but only the combined results were reported for stroke because E+P and E-alone results were similar for stroke, the confidence intervals for hazard ratios for stroke were very wide in the individual RCTS, and the estimate for the combined dataset was essentially the average of the estimates in the individual RCTs. OS participants taking HT were also divided into those taking E+P and those taking E-alone. OS participants not taking HT were not divided into those who had or didn't have a hysterectomy because hysterectomy status was unrelated to either subsequent MI or stroke after adjusting for the other risk factors considered. It is unclear how we could have done a better job managing hysterectomy status.
4. THE RCT DATA SHOULD HAVE BEEN DICHOTOMIZED BY A 2 YEAR INSTEAD OF A 3 YEAR PERIOD SINCE ENROLLMENT.
We found no evidence that third year RCT results differed from second year RCT results, and results based on our dichotomization were similar to studies that dichotomized at 2 years. In addition, after delaying follow -up for three years, the RCT results should have looked like the OS results (i.e., HT should have been protective), but they did not.
5. WE WOULD HAVE BEEN WISE TO REQUEST THAT THE ANALYTIC PLAN BE REVIEWED THROUGH THE USUAL WHI PUBLICATIONS PROCESS.
I do not know what the usual WHI publication process is. However, many requests to WHI investigators and even a Nurses' Study Investigator to collaborate on manuscripts, review manuscripts, or allow presentations of this study were declined. I do not know how we could have obtained a review.
With the currently available evidence it is premature to conclude that the WHI data set was adequate to remove confounding. This is not a criticism of the WHI data set, which is universally considered to be outstanding. It is a criticism of the repeated claims that differences between OS and RCT results of HT studies have been resolved. I wish this were the case and that we could be confident of results in well done OSs. Unfortunately, reliably valid OSs are still awaiting methodological improvements.
Conflict of Interest:
The mortality and cancer experience of New Zealand Vietnam war veterans: a cohort study
The Maori population of New Zealand was about 12% at the time of the Vietnam war. The New Zealand Vietnam veterans have a Maori participation of 30%+ over double the percentage of Maori in the general population.
Statistics NZ tell us that Maori males die at twice the rate of Caucasians, mainly cancers, diabetes and heart attacks. By their late fifties Maori male mortality is two and a half times that of Caucasians so using the general population to measure mortality or disease is as futile as it is pointless.
Conflict of Interest:
Family Links response to; Effectiveness and cost effectivenesss of a universal parenting skills programme in deprived communities: multicentre randomised controlled trial - Simkiss et al.
Family Links, is a charity responsible for developing the Nurturing Programme and training practitioners in the UK. We welcomed the opportunity to be one of the very few widely used parenting programmes in the UK to undergo an RCT, although our involvement was for the most part indirect. The study was conducted independently in South Wales' communities by Simkiss and colleagues and was unusual in that the programme was offered universally, rather than to parents on a waiting list for intervention.
We are, of course, disappointed that the results were inconclusive, neither the 'treatment allocated' nor 'per protocol' analyses conducted by Simkiss and colleagues yielding statistically significant results, even though they tended to favour the Nurturing Programme over the control group. The RCT experienced recruitment and contamination issues similar to those that have affected other community-based trials (for example, Hiscock and others, 2008; Losel and others, 2006; Little and others, 2012).
We hope the following may be useful to others contemplating such trials:
1. In the context of the 34 per cent 'no show' rate among parents allocated to take part in the programme the time-lapse between recruitment by the researchers and the start of courses was considerably longer than occurs in everyday settings.
2. In terms of contamination around a fifth of the control group in South Wales received the Family Links Nurturing Programme or another parenting support programme before the end of the trial. We would point out that the trial took place in four areas where the programme was already well-established as an apparently popular part of the Welsh Government's Flying Start initiative. As the researchers have reported elsewhere (Stewart-Brown et al, 2012), there was an inherent danger that parents who felt most in need of the programme - with the greatest potential to change their parenting practices - would decline to be part of an RCT rather than risk being allocated to the control group. This was even more likely to be the case where staff counselled them against participation.
Also the normal recruitment to FLNP includes both targeted parents and self-referrals, in the trial areas those with greatest need (and therefore likely to show greatest benefit) were discouraged by practitioners from taking part. The researchers acknowledge that, "the parents who consented to randomisation may have been different from those who would normally sign up for the FLNP in that some parents did not recognise a need for the programme for themselves and their families. They may therefore have been less ready to change and indeed had less need to change than those who attend the FLNP in the absence of a trial. Together, these factors undoubtedly reduced the study's power to detect any impact of the FLNP." It is encouraging that the Family Links Nurturing Programme continues to be widely used throughout Wales, recognising the limitations of the trial and using other evidence of positive outcomes. The Welsh government published its Flying Start review of parenting support in May 2013 (Kendall & Moller, 2013) and noted:
"FLNP was delivered in a number of Flying Start Partnerships where staff report positively on its effectiveness. The review highlighted the recent RCT and inconclusive results, but, there was other evidence of positive outcomes and this needs to be part of the consideration around which programmes are delivered...
Despite the inconclusive results from the RCT, a number of authorities continued to report positive outcomes for parents and children. Other Flying Start partnerships were also considering introducing the FLNP due to the emphasis in the programme on relationship building and its appropriateness for families with poor literacy skills, making it more accessible than other programmes...
Practitioners continue to use the FLNP because they can see the positive impact for parents and families, it is accessible and appropriate for the parents in their localities and it is cost effective to run.."
While recognising that the trial encountered these implementation issues we acknowledge that the findings have raised important questions and Family Links is embarking on further review and research to explore the implementation questions that the research raises. We are giving further consideration to the programme's theoretical underpinning and the fidelity of practitioners and how this interfaces with outcomes and outcome measures. We intend to use the most rigorous research methods possible, working with the research community to tackle some of these challenges. Family Links is appointing an in-house researcher to improve quality control monitoring and contribute to programme evaluation. It is now standard practice for everyone trained in the Nurturing Programme to take part in a Refresher day 12 months after the initial training; this is included in the initial training cost.
Family Links is keen to ensure that the Nurturing Programme's content reflects a realistic understanding of what it can (and cannot) be expected to achieve. As a first step we have commissioned the Colebrooke Centre for Evidence and Implementation to help us explore and develop the theory of change that underpins the programme. We will then consider how its impact can most usefully be measured and assessed. We are hopeful that the innovative approach being taken will hold useful implications for family support organisations besides our own.
The Nurturing Programme seeks to promote mental wellbeing among parents and children as well as behaviour management (increasing life- course resilience to mental health problems such as anxiety and depression). As noted by Simkiss and colleagues this means it does more to address aims of the Government's 'No Health without Mental Health' strategy than behaviour management programmes alone. Through continuing development and research, Family Links is determined to ensure that the Nurturing Programme's potential is fully realised.
References: 1. Harriet Hiscock, Jordana K Bayer, Obioha C Ukoumunne, Susan Rogers, and Melissa Wake. Universal parenting programme to prevent early childhood behavioural problems: cluster randomised trial. BMJ. 2008 February 9; 336(7639): 318-321. 2. Losel F, Beelmann A, Stemmler M, Jaursch S: Pr?vention von Problemen des Sozialverhaltens im Vorschulalter. [Prevention of social behavior problems at preschool age: Evaluation of the parent and child training program package EFFEKT]. Zeitschrift fur Klinische Psychologie und Psychotherapie 2006, 35:127-139. 3. Little M, Berry V, Morpeth L, Blower S, Axford N, Taylor R, Bywater T, Lehtonen M, Tobin K. The Impact of Three Evidence-Based Programmes Delivered in Public Systems in Birmingham, UK. International Journal of Conflict and Violence 2012;6 No 2 4. Sally Kendall, Julia Moller. Review of parenting support for Flying Start. Social research Number: 31/2013
Annette Mountford, CEO Family Links
Conflict of Interest:
Licensed provider of the Family Links Nurturing Programme within the UK.
Re:Data from HSCIC: if the article needed correction of the underlying data, should the authors review the conclusions reached?
We appreciate the interest in the paper and the further criticisms.
In the London SHA there were 1,504 practices in 2010/11, not 463 (plus we never reported such a number). 24 of these were using SystmOne, giving it a market share of approximately 1.6%.
We can't find evidence of the data corruption you suggest. As explained before, the correction related to a table label and was purely of a descriptive nature: not affecting the results and, consequently, not affecting the conclusions.
We made every effort to clarify this in previous replies.
Conflict of Interest: