This article is dependent on random sampling of non-randomly ordered lists. Despite this it fails to even mention what random sampling method was selected nor what software was used to implement this method. The list of "randomly" selected signatories generated by this unnamed method is not given in the article itself, however the data availability statement refers to a "public, open access repository" although the repository is not named and no link is given, so perhaps this is available somewhere?
No sample size calculation is given, and the selection of 30 is not justified within the method or discussion in any way.
This paper frankly fails to meet minimum standards in describing how the research was actually conducted.
It is unclear to me what merits of the paper led to its selection for publication, although this lack of clarity is partially driven by the failure of BMJ Open to publish any reviews in violation of their stated policies.
In many ways, the Building Blocks (BB2-6) study reported recently in BMJ Open is conducted impressively.1 The depth of analysis of social-service and child-protective-system involvement of families enrolled in Usual Care (UC) and Family-Nurse Partnership (FNP - as the program is called in the UK) is remarkably thorough. I was disappointed, however, to find that the report did not address a number of critical issues as thoroughly as needed to better interpret its findings.
The most fundamental challenge with this trial is that it was “open-label.” Treatment assignment was not masked to UC providers, including Midwives and Health Visitors (HV) charged with serving the same population as FNP nurses - and with similar goals. This type of design has been criticized because it can lead to “Compensatory Equalization.” 2 I understand why this design was chosen, but am concerned that it compromised the estimate of real FNP effects. Its consequences need to be examined in greater depth.
In the 18 trial sites, FNP nurses assumed the role of Health Visitors,3 which would allow usual HV’s to serve others on their caseloads more intensively, a condition possibly amplified if they felt, quite naturally, that their service might be devalued if maternal and child health were improved more with visits by FNP nurses. To what degree did this knowledge modify their delivery of UC? The authors have examined this issue, but more can be done.
Note that the number of visit...
In many ways, the Building Blocks (BB2-6) study reported recently in BMJ Open is conducted impressively.1 The depth of analysis of social-service and child-protective-system involvement of families enrolled in Usual Care (UC) and Family-Nurse Partnership (FNP - as the program is called in the UK) is remarkably thorough. I was disappointed, however, to find that the report did not address a number of critical issues as thoroughly as needed to better interpret its findings.
The most fundamental challenge with this trial is that it was “open-label.” Treatment assignment was not masked to UC providers, including Midwives and Health Visitors (HV) charged with serving the same population as FNP nurses - and with similar goals. This type of design has been criticized because it can lead to “Compensatory Equalization.” 2 I understand why this design was chosen, but am concerned that it compromised the estimate of real FNP effects. Its consequences need to be examined in greater depth.
In the 18 trial sites, FNP nurses assumed the role of Health Visitors,3 which would allow usual HV’s to serve others on their caseloads more intensively, a condition possibly amplified if they felt, quite naturally, that their service might be devalued if maternal and child health were improved more with visits by FNP nurses. To what degree did this knowledge modify their delivery of UC? The authors have examined this issue, but more can be done.
Note that the number of visits completed by HV’s to UC families, based upon maternal report, differs between the original publication (with a mean of 16.25 visits completed through child-age 18 months),4 compared to 5.01 home-visits and 6.31 visits during clinic encounters reported in the current report,1 and an earlier one.5 These discrepancies are not explained.
Moreover, the authors have not reported the frequency of visits completed for families identified as being at heightened-need at trial registration. It is entirely possible (likely even) that HV’s (and Midwives) paid even more visits and attention to families with greater needs -- in spite of the authors’ assertion that high caseloads (400-500 families per HV) would minimize the impact of this shift in caseload due to FNP-nurses’ assuming the HV role.1
Prior work has found that the benefits of FNP are most pronounced among those with greater needs. 6 The relative absence of corresponding effect moderation in the Building Blocks trial may reflect Midwives and HV’s giving even greater attention to those experiencing concentrated adversities, such as prenatal smoking, being very young, NEET (Not in Education, Employment or Training), and so forth. Knowing the degree to which Midwives and HV’s gave greater attention to those with greater needs in this trial is essential for its interpretation. If Midwives and HV’s gave greater attention to those in the UC group than usual, and especially more visits to those experiencing concentrated adversities, it is likely that the estimates of FNP effects reported are lower than what FNP actually produces compared to usual UC.
My second issue is with the investigators’ choice of “Child in Need” as the primary outcome. It does not appreciate FNP nurses’ ethical, clinical, and legal mandate to make sure that children are protected through linkages with the system. Intensive involvement with families during pregnancy and early months of the child’s life puts FNP nurses in a strong position to evaluate need at this critical stage in human development; referrals to the child welfare and healthcare systems are designed to ensure children’s protection, often when the family needs extra support during hard times. Note, for example, that FNP-visited families had higher rates of safeguarding procedures noted in the primary care record (13.6%) than their Usual-Care counterparts (8.0%) (p=.005) in the BB-02 report.4 Moreover, FNP-visited parents are encouraged to have their children’s injuries, even if relatively minor, evaluated through the healthcare system to rule out more serious underlying conditions. The authors have begun to examine such surveillance bias, but could do more following the types of analyses that addressed this issue in the Elmira, NY NFP trial.7
An objective outcome of unquestionable clinical and public health importance that the investigators have in their database, on the other hand, and related to dysfunctional care, is the number of days very young, pre-ambulatory children (0-24 months of age) were hospitalized for injuries or ingestions. Days-hospitalized for injuries and ingestions was reduced for NFP-visited families in the first two years of the child’s life in the US Memphis, TN trial of NFP.8 More days hospitalized for trauma is a reflection of severity.9 The analysis of corresponding data in the Building Blocks trial, so far, has not dug into critical issues affecting the operationalization and interpretation of this outcome. It appears that this outcome was operationalized differently in the original report4 compared to the current one.1 Some children taken to A&E may be admitted to hospital as a safety precaution when the system is overloaded and they cannot be evaluated quickly. Such short overnight stays are rarely for serious conditions and under normal conditions could be managed through A&E.
I was surprised that the investigators appeared to retain these overnight “admissions” in their current report (detailed in the supplementary materials, n=42/760 FNP-visited versus n=63/757 UC children in the 0-24 month-age range)1 while they appear not to have retained them in the original report (n=35/722 for FNP versus n=49/745 in UC.4 Overnight “admissions” are minor compared to more serious or life-threatening injuries/ingestions requiring multiple-day admissions. These discrepancies between the two reports should be clarified.
Re-analysis of number of days hospitalized for injuries and ingestions after removing these very short over-night admissions will provide a more objective assessment of the degree to which FNP prevented an outcome of clear public-health and clinical importance often connected to dysfunctional care and prevented by this program.
As investigators concerned with the prevention of health and developmental problems, it is crucial that we gain greater clarity about which objective outcomes of clear clinical and public-health importance are affected in replicated, well-designed randomized clinical trials.
References
1. Robling M, Lugg-Widger F, Cannings-John R, et al. A nurse-led home-visitation programme for first-time mothers in reducing maltreatment and improving child health and development (BB: 2-6): longer-term outcomes from a randomised cohort using data-linkage. BMJ Open. 2022; 12:e049960.
2. Campbell DT, Cook TD. Quasi-experimentation. Chicago, IL: Rand Mc-Nally. 1979;
3. Owen-Jones E, Bekkers M-J, Butler CC, et al. The effectiveness and cost-effectiveness of the Family Nurse Partnership home visiting programme for first time teenage mothers in England: a protocol for the Building Blocks randomised controlled trial. BMC Pediatr. 2013;13(1):1-13.
4. Robling M, Bekkers M-J, Bell K, et al. Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial. The Lancet. 2016;387(10014):146-155.
5. Robling M, Cannings-John R, Channon S, et al. What is usual care for teenagers expecting their first child in England? A process evaluation using key informant mapping and participant survey as part of the Building Blocks randomised controlled trial of specialist home visiting. BMJ open. 2018;8(5):e020152.
6. Olds DL. Prenatal and infancy home visiting by nurses: From randomized trials to community replication. Prevention Science. 2002;3(3):153-172.
7. Olds D, Henderson CR, Kitzman H, Cole R. Effects of prenatal and infancy nurse home visitation on surveillance of child maltreatment. Pediatrics. 1995;95(3):365-372.
8. Kitzman H, Olds DL, Henderson CR, et al. Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing: a randomized controlled trial. JAMA. 1997;278(8):644-652.
9. Naqvi G, Johansson G, Yip G, Rehm A, Carrothers A, Stöhr K. Mechanisms, patterns and outcomes of paediatric polytrauma in a UK major trauma centre. The Annals of The Royal College of Surgeons of England. 2017;99(1):39-45.
This paper has several ethical, conceptual, statistical, and presentational issues. From an ethical standpoint, it is somewhat surprising that the author declares no human subjects are involved. Bibliometric data is widely established as public data, and some IRBs hold the same is true of data gathered from public accounts on Twitter (here, follower counts). However, the author explicitly investigates whether named individuals choose to use Twitter by searching for a linked account through google. Decisions about whether or not to use Twitter are reasonably private. There is no reason to believe someone who has chosen not to use Twitter has consented to their presence in a study on social media use. For these reasons review by an IRB seems warranted.
Other ethical challenges may arise from a failure to disclose the author's well-documented history of interaction (co-authorship, affiliations, debate, etc..) with the named signatories—positive and negative. An IRB may have taken those relationships into consideration when deciding (for instance) whether it was appropriate to explicitly name scientists. Alternatively, reviewers and readers alike may have found these important context when interpreting the paper as a whole.
Conceptually, the author acknowledges the limitation that: “Both citation indices and Twitter followers have limitations in face validity and construct validity as measures of impact.” Yet the paper’s conclusions are based entirely...
This paper has several ethical, conceptual, statistical, and presentational issues. From an ethical standpoint, it is somewhat surprising that the author declares no human subjects are involved. Bibliometric data is widely established as public data, and some IRBs hold the same is true of data gathered from public accounts on Twitter (here, follower counts). However, the author explicitly investigates whether named individuals choose to use Twitter by searching for a linked account through google. Decisions about whether or not to use Twitter are reasonably private. There is no reason to believe someone who has chosen not to use Twitter has consented to their presence in a study on social media use. For these reasons review by an IRB seems warranted.
Other ethical challenges may arise from a failure to disclose the author's well-documented history of interaction (co-authorship, affiliations, debate, etc..) with the named signatories—positive and negative. An IRB may have taken those relationships into consideration when deciding (for instance) whether it was appropriate to explicitly name scientists. Alternatively, reviewers and readers alike may have found these important context when interpreting the paper as a whole.
Conceptually, the author acknowledges the limitation that: “Both citation indices and Twitter followers have limitations in face validity and construct validity as measures of impact.” Yet the paper’s conclusions are based entirely on the validity of these measures. Further, the K-index calculated is not widely regarded as a serious metric, with issues in the current use case such as being infinite for those that do not use Twitter.
Statistically, the paper presents p-values absent a description of which statistical tests were used or relevant effect sizes and uncertainty. As the author relied on zero-imputation of missing data (Twitter accounts that were not found on a google search) clarity is necessary to evaluate the paper. As many of the papers' claims are built on these statistical tests, the reader is unable to evaluate whether they were appropriate and the findings overall.
Presentationally, the author claims all of the data used in the manuscript are available in a “public, open-access repository” but does not link to the repository itself. Much of the data are contained in the tables, yet not all of the data are. This appears to be the case for the larger list of signatories, making it difficult to assess the randomness of the “random sample”. Finally, BMJ Open’s policy is to make peer review public, which has not happened in this instance. Given the issues stated above (and others omitted for brevity), publishing the reviewer’s reports and names would be critical to contextualize this research in the broader context of the literature.
Though not patently exhibited or openly expressed, the family of each of these healthcare workers exerts a strong influence on the day-to-day mental health status of their family member. Appreciation needs to be focused on the corollary too. The mental health of all the family members play a role.
We applaud the authors for publishing their trial protocol for this important subject of empirical antibiotic approaches in uncomplicated LUTIs in women.
It is alarming that in the community settings, women presenting with LUTs more than half of the E.coli isolates and more than a third of K. pneumoniae isolates are were resistant to third generation cephalosporins ( i.e.ESBL-producing microorganisms) (1). It therefore makes sense to use Fosfomycin as empirical treatments when >20% of isolates are multi-drug resistant microorganisms (2), What is not clear is why GPs in Spain prefer to use short-course therapies over single-dose therapy which is not in line with the Spanish national guidelines. We believe that better compliance could be achieved in addition to desirable outcomes with this strategic approach although as the authours mention there may potentially be more relapses. It would be useful to explore what the reasoning is behind this preference. Perhaps, they have concerns regarding the pharmacokinetic and spectrum of activity of Fosfomycin (3) that might not achieve the desired clearance of microorganisms? This has clearly been described elsewhere including a comprehensive metanalysis on the successful outcomes of single dose Fosfomycin (4-6). Indeed, we read with interest that you hypothesise that short-course treatments will be more effective than the recommended 3 g single dose of Fosfomycin, resembling what clinicians usually do in routine practice....
We applaud the authors for publishing their trial protocol for this important subject of empirical antibiotic approaches in uncomplicated LUTIs in women.
It is alarming that in the community settings, women presenting with LUTs more than half of the E.coli isolates and more than a third of K. pneumoniae isolates are were resistant to third generation cephalosporins ( i.e.ESBL-producing microorganisms) (1). It therefore makes sense to use Fosfomycin as empirical treatments when >20% of isolates are multi-drug resistant microorganisms (2), What is not clear is why GPs in Spain prefer to use short-course therapies over single-dose therapy which is not in line with the Spanish national guidelines. We believe that better compliance could be achieved in addition to desirable outcomes with this strategic approach although as the authours mention there may potentially be more relapses. It would be useful to explore what the reasoning is behind this preference. Perhaps, they have concerns regarding the pharmacokinetic and spectrum of activity of Fosfomycin (3) that might not achieve the desired clearance of microorganisms? This has clearly been described elsewhere including a comprehensive metanalysis on the successful outcomes of single dose Fosfomycin (4-6). Indeed, we read with interest that you hypothesise that short-course treatments will be more effective than the recommended 3 g single dose of Fosfomycin, resembling what clinicians usually do in routine practice. Exploring physician attitudes and reasons would be a useful addition to the SCOUT study
The objectives are comprehensive including measurement of bacteriological eradication, relapse, complications, and adverse events as well as cost effectiveness and QoL. An additional consideration should include patient satisfaction and preference as well as compliance which we hope will be captured in the QoL questionnaire. This will be useful if it complements the findings of LUTS clearance.
However, to add balance to the argument, we expressed concerns regarding the risk of Fosfomycin resistance once its use will be routine and more extensive, furthermore this antibiotic needs also to be salvaged for its potential use intravenously as third line treatment for serious sepsis due to multi-drug resistant organisms (7).
There is no doubt that the SCOUT study will answer important questions including local prevalence of resistance organisms, emergence of resistance as a result of the single dose approach treatment, and empirical antibiotic stewardship approaches in uncomplicated LUTIs in women
References
1. European Centre for Disease Prevention and Control (ECDC). . Antimicrobial resistance surveillance in Europe 2020.Annual report of the European antimicrobial resistance surveillance network (EARS-Net). Stockholm: ECDC, 2020.
2. Guay DRP. Contemporary management of uncomplicated urinary tract infections. Drugs 2008;68:1169–205
3. S Patel et al. Fosfomycin tromethamine. A review of its antibacterial activity, pharmacokinetic properties and therapeutic efficacy as a single-dose oral treatment for acute uncomplicated lower urinary tract infections. Drugs. 1997 Apr;53(4):637-56
4. G,E Stein. Comparison of single-dose fosfomycin and a 7-day course of nitrofurantoin in female patients with uncomplicated urinary tract infection. Clin Ther. 1999 Nov;21(11):1864-72.
5. Angela Huttner et al Effect of 5-Day Nitrofurantoin vs Single-Dose Fosfomycin on Clinical Resolution of Uncomplicated Lower Urinary Tract Infection in Women: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1781-1789.
6. Tianqi Wang et al. Comparison of single-dose fosfomycin tromethamine and other antibiotics for lower uncomplicated urinary tract infection in women and asymptomatic bacteriuria in pregnant women: A systematic review and meta-analysis. Meta-Analysis Int J Antimicrob Agents. 2020 Jul;56(1):106018.
7. Al-Wali W.,Hughes C. Fosfomycin should not be first line treatment for uncomplicated urinary tract infection.BMJ 2016;352:i413
The activity pacing framework was developed to address a clinical need to provide a comprehensive guide for healthcare professionals on instructing activity pacing to a range of patients who commonly seek assistance in the management of symptoms of chronic pain and fatigue. As a research team with clinical and academic backgrounds, we see many patients seeking healthcare services presenting with overlapping symptoms and co-existence of conditions of chronic pain and fatigue, including chronic low back pain, chronic widespread pain, fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). In the current study, co-morbidity of chronic conditions was evident. At baseline, 65 participants (61.3%) reported two or more conditions of chronic pain or fatigue. Observing specifically the subgroup of participants with ME/CFS, 11 of the 12 patients with ME/CFS reported least one other co-morbidity of either low back pain, chronic widespread pain, fibromyalgia or another condition. Ten of these 12 patients reported ME/CFS to be their main condition. This clinical presentation of overlapping symptoms and co-existence of chronic pain and fatigue is recognised in the research literature [1, 2]. As such, our work into activity pacing has had an inclusive approach for patients with a range of symptoms, and for healthcare professionals working across varying services.
In reference to our earlier work to develop an activity pacing questionnaire, Michiel Tack has q...
The activity pacing framework was developed to address a clinical need to provide a comprehensive guide for healthcare professionals on instructing activity pacing to a range of patients who commonly seek assistance in the management of symptoms of chronic pain and fatigue. As a research team with clinical and academic backgrounds, we see many patients seeking healthcare services presenting with overlapping symptoms and co-existence of conditions of chronic pain and fatigue, including chronic low back pain, chronic widespread pain, fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). In the current study, co-morbidity of chronic conditions was evident. At baseline, 65 participants (61.3%) reported two or more conditions of chronic pain or fatigue. Observing specifically the subgroup of participants with ME/CFS, 11 of the 12 patients with ME/CFS reported least one other co-morbidity of either low back pain, chronic widespread pain, fibromyalgia or another condition. Ten of these 12 patients reported ME/CFS to be their main condition. This clinical presentation of overlapping symptoms and co-existence of chronic pain and fatigue is recognised in the research literature [1, 2]. As such, our work into activity pacing has had an inclusive approach for patients with a range of symptoms, and for healthcare professionals working across varying services.
In reference to our earlier work to develop an activity pacing questionnaire, Michiel Tack has quoted that a small number of participants acknowledged challenges of developing a generic questionnaire for both chronic pain and fatigue. For this reason, we have engaged with diverse samples throughout the stages of our work. Interestingly, during the development of this subsequent work to develop an activity pacing framework as a guide for healthcare professionals, during the online survey across 92 healthcare professionals, the “development of a framework that is applicable to both chronic pain and fatigue was welcomed more than rebuked among participants” [3, page 9].
The facets of activity pacing for managing symptoms of both chronic pain and fatigue have been considered at every stage of development of the activity pacing framework. Components of energy conservation for ME/CFS as stated by Michiel Tack, including “balancing activity and rest, delegating tasks, setting priorities” are included within the activity pacing framework. However, the underlying principle of the activity pacing framework aligns with an operant approach involving quota-contingency towards setting targets according to an amount or a valued activity rather than towards symptom-contingency. The decision to align the activity pacing framework towards an operant approach rather than energy conservation was made based on existing research literature, together with the multi-staged development process.
Stage I of this development process involved encompassing a wide range of opinions in an online survey. We identified 115 Pain Services and 53 ME/CFS Services within English National Health Service (NHS) Trusts to invite to participate. This resulted in a sample of 92 healthcare professionals across 48 trusts [3]. Following this, the first draft of the activity pacing framework was discussed in a Nominal Group Technique (consensus meeting) involving healthcare professionals and patients, including those with ME/CFS [4]. The views of those with ME/CFS or working in this field have been consulted at each stage of our work. The authors appreciate that due to the lower prevalence of ME/CFS compared with chronic pain, and the smaller number of ME/CFS Services compared with Pain Services, those with/working with ME/CFS do represent a smaller group in our work. However, we found that “Across pain and fatigue services alike, participants commented that they instructed pacing similarly, as a quota-contingent strategy that addressed avoidance behaviours and encouraged graded activity” [3, page 5].
Regarding the updated National Institute for Health and Care Excellence (NICE) guideline for ME/CFS (NG206) [5], it is curious that there is no mention of activity pacing, despite the evidence review including studies implementing energy conservation and adaptive pacing therapy approaches to activity pacing. Of note, the current feasibility study [7] was designed and undertaken prior to the publication of the NICE guidelines (NG206) and the results were published after the NICE guidelines. Therefore this feasibility study and the NICE guidelines (NG206) were developed independently of each other. Interestingly, a randomised controlled trial (RCT) has compared the energy conservation and the operant learning approaches to activity pacing [6]. Racine et al. [6] concluded that the operant approach may be more beneficial due to greater reductions in depression and significant reductions in avoidance behaviour (the latter not being significantly associated with the energy conservation approach). This RCT occurred in a sample of participants with fibromyalgia [6]. Future research could assess if the same pattern of results is replicated among other samples of participants, including those with ME/CFS.
Michiel Tack cited that the NICE guideline (NG206) cautions against “any program … that uses fixed incremental increases in physical activity or exercise, for example, graded exercise therapy.” We are uncertain of any healthcare professionals working in the field of chronic pain or fatigue who would implement a fixed incremental increase to physical activity without listening to/observing patients. Nor does the activity pacing framework refer to “fixed incremental increases” in any type of activity. The activity pacing framework does include the potential for gradual increases in activity. However, this may not be a component of activity pacing that is suitable or needed for all patients. Furthermore, during the development of the activity pacing framework, there was resounding endorsement towards activity pacing having a flexible approach. Healthcare professionals reported earlier definitions of activity pacing to be overly-prescriptive and punitive. Therefore, novel to the activity pacing framework is the emphasis on facets of flexibility and active decision-making to facilitate patients re-gaining a sense of choice and control. Please also note that although a gradual increase in activities is included in this framework and this framework can assist graded exercise/activity, it is not a framework on graded exercise. This is a framework for activity pacing. As such, the framework includes the multiple dimensions of activity pacing, including adjusting activities, planning activities, having consistent activity levels and acceptance of symptoms/abilities. For some patients, activity pacing will involve reducing their activities, for others, it will involve having more consistent levels of activities, while for others there will be opportunities to gradually increase their activities. These facets are tailored to individuals’ baseline abilities, needs and behaviours (for example, avoidance, underactivity-overactivity cycling or excessive persistence).
Of particular concern, is the suggestion by Michiel Tack that this approach to activity pacing may cause harm. To purposefully explore whether the activity pacing framework was feasible for patients with ME/CFS, we observed the changes in activity pacing and symptoms for the subgroup of patients who reported ME/CFS. Due to the small subgroup sample size, statistical analyses were not used and the information in the manuscript was limited to reporting that, for the subgroup of participants with ME/CFS “improvements were seen between T1-T2 and T1-T3 across all APQ-28 subthemes and symptoms” [7, page 7]. Therefore, patients with ME/CFS showed improvements in activity pacing, pain, depression, anxiety, physical fatigue, mental fatigue, avoidance, self-efficacy, physical function, mental function and quality of life, as measured in their self-reported questionnaires. As stated in this paper, this study was not a clinical trial and so the effects of activity pacing have not been inferred for those with either chronic fatigue or chronic pain.
Finally, the aim of the activity pacing framework does not seek to cure chronic pain or chronic fatigue. However, it does include the potential for reversibility of the some of the secondary effects of long-term symptoms. In this way, patients may feel enabled to not only “cope with” their condition, but to also live well.
References
1. Aggarwal VR, McBeth J, Zakrzewska JM, et al. The epidemiology of chronic syndromes that are frequently unexplained: do they have common associated factors? Int J Epidemiol 2006;35:468-76.
2. Meeus M, Nijs J and Meirleir KD. Chronic musculoskeletal pain in patients with the chronic fatigue syndrome: a systematic review. Eur J Pain 2007;11:377-86.
3. Antcliff D, Keenan AM, Keeley P, et al. Survey of activity pacing across healthcare professionals informs a new activity pacing framework for chronic pain/fatigue. Musculoskeletal Care 2019;17:335-345.
4. Antcliff D, Keenan AM, Keeley P, et al. Engaging stakeholders to refine an activity pacing framework for chronic pain/fatigue: A nominal group technique. Musculoskeletal Care 2019;17:354-362.
5. National Institute for Health and Care Excellence (NICE). Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. NICE Guideline 206 London 2021.
6. Racine M, Jensen MP, Harth M, et al. Operant Learning Versus Energy Conservation Activity Pacing Treatments in a Sample of Patients With Fibromyalgia Syndrome: A Pilot Randomized Controlled Trial. J Pain 2019;20:420-439.
7. Antcliff D, Keenan AM, Keeley P, et al. Testing a newly developed activity pacing framework for chronic pain/fatigue: a feasibility study. BMJ Open 2021;11:e045398.
Abrahami et al. examined proton pump inhibitor (PPI) and histamine-2 receptor antagonist (H2RA) prescribing patterns over a long period in primary care in the UK (1). From 1990 to 2018, PPI prevalence increased from 0.2% to 14.2%, while H2RA prevalence were under 3.4%. The authors described that PPIs were associated with a number of adverse effects not attributed to H2RAs, and recommended H2RAs as a valuable treatment as acid suppressants. I have a comment about the study with special reference to dementia risk.
Prescribing acid suppressants is more prevalent in the elderly. Wang et al. conducted a meta-analysis to investigate the risk of acid suppressants on dementia (2). The pooled adjusted hazard ratios (95% confidence intervals) of PPI users and H2RA users for the development of dementia were 0.98 (0.85-1.13) and 1.20 (0.98-1.47), respectively. Although there is no significant association regarding the effect of acid suppressants on the development of dementia, H2RA presented a trend of increased risk for dementia. There are medical reasons of prescribing PPIs instead of H2RAs, and evidence should be presented for concluding the higher adverse effects of PPIs than H2RAs.
References
1. Abrahami D, McDonald EG, Schnitzer M, et al. Trends in acid suppressant drug prescriptions in primary care in the UK: a population-based cross-sectional study. BMJ Open 2020;10(12):e041529.
2. Wang H, Tian L, Yan X. No association between acid suppressant use and...
Abrahami et al. examined proton pump inhibitor (PPI) and histamine-2 receptor antagonist (H2RA) prescribing patterns over a long period in primary care in the UK (1). From 1990 to 2018, PPI prevalence increased from 0.2% to 14.2%, while H2RA prevalence were under 3.4%. The authors described that PPIs were associated with a number of adverse effects not attributed to H2RAs, and recommended H2RAs as a valuable treatment as acid suppressants. I have a comment about the study with special reference to dementia risk.
Prescribing acid suppressants is more prevalent in the elderly. Wang et al. conducted a meta-analysis to investigate the risk of acid suppressants on dementia (2). The pooled adjusted hazard ratios (95% confidence intervals) of PPI users and H2RA users for the development of dementia were 0.98 (0.85-1.13) and 1.20 (0.98-1.47), respectively. Although there is no significant association regarding the effect of acid suppressants on the development of dementia, H2RA presented a trend of increased risk for dementia. There are medical reasons of prescribing PPIs instead of H2RAs, and evidence should be presented for concluding the higher adverse effects of PPIs than H2RAs.
References
1. Abrahami D, McDonald EG, Schnitzer M, et al. Trends in acid suppressant drug prescriptions in primary care in the UK: a population-based cross-sectional study. BMJ Open 2020;10(12):e041529.
2. Wang H, Tian L, Yan X. No association between acid suppressant use and risk of dementia: an updated meta-analysis. Eur J Clin Pharmacol 2021 Nov 22. https://doi.org/10.1007/s00228-021-03248-0
I want to thank Dr Successful for helping me with his herbal medicine to get rid of my copd completely, i have been living with the disease for the past 2yrs. Right now am Copd Chronic obstructive Pulmonary disease negative after using the herbal medicine Dr Successful sent to me. I give thanks to God and healed completely you are the best Traditional doc in the world contact Dm https://web.facebook.com/Drsuccessful-109263294750359 He you can as well dm him on https://www.facebook.com/Priestsuccessful or https://wa.me/qr/UFTMANFGSLY4E1 you can also talk with him on drsuccesfulcuringhome@gmail.com also have powerful herbs remedies his herbal medications prevent and cure Cancer, Diabetes, High-Blood Pressure, Kidney Diseases, Prostate, Gall Stone, Myoma, Cyst, Paralysis, Stroke, Leukemia, Dengue, Anemia, Primary Complex, Gout, Arthritis, Migraine, Sleep Disorder, Dysmenorrhea, Goiter, Heart Problem, Hepatitis, Psoriasis, Vertigo, Low Sperm Count,Sexual Impotence, parasite and other serious problems.
The version of pacing proposed by Antcliff and colleagues for patients with chronic pain and fatigue contradicts how the term is applied in the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) community.
Jamieson-Lega et al. previously noted that pacing represents “a variety of differing and, at times, contradictory concepts.” (1) Broadly, two main traditions exist. One has a history in operant conditioning and is mostly used in the treatment of chronic pain. It consists of a preplanned strategy that is time- or quota-contingent with the aim of breaking the association between resting behavior and symptoms. It involves dividing tasks into manageable parts, doing things slowly but steadily, and building a consistent routine to achieve a target, often an increase in (physical) activity. (2) The other main tradition is energy conservation management as used in patients with neurological conditions such as multiple sclerosis. Here, pacing can be symptom contingent as it is mainly aimed at avoiding overexertion and relapses while engaging in meaningful activities. It involves balancing activity and rest, delegating tasks, setting priorities, and using assistive devices. (3)
The “activity pacing framework” developed by Antcliff and colleagues is in line with the first tradition but ignores the second. It follows principles of quota-contingency and focuses on gradually increasing activity levels. It is presented as a rehabilitative intervention provided b...
The version of pacing proposed by Antcliff and colleagues for patients with chronic pain and fatigue contradicts how the term is applied in the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) community.
Jamieson-Lega et al. previously noted that pacing represents “a variety of differing and, at times, contradictory concepts.” (1) Broadly, two main traditions exist. One has a history in operant conditioning and is mostly used in the treatment of chronic pain. It consists of a preplanned strategy that is time- or quota-contingent with the aim of breaking the association between resting behavior and symptoms. It involves dividing tasks into manageable parts, doing things slowly but steadily, and building a consistent routine to achieve a target, often an increase in (physical) activity. (2) The other main tradition is energy conservation management as used in patients with neurological conditions such as multiple sclerosis. Here, pacing can be symptom contingent as it is mainly aimed at avoiding overexertion and relapses while engaging in meaningful activities. It involves balancing activity and rest, delegating tasks, setting priorities, and using assistive devices. (3)
The “activity pacing framework” developed by Antcliff and colleagues is in line with the first tradition but ignores the second. It follows principles of quota-contingency and focuses on gradually increasing activity levels. It is presented as a rehabilitative intervention provided by healthcare professionals with the aim of improving physical and cognitive function. Indeed, Antcliff and colleagues explain that “the activity pacing framework includes the potential for reversibility of some of the consequences of chronic pain/fatigue, such as the potential to reduce levels of disability.” In contrast, pacing as used in the ME/CFS community follows the second tradition. It is a self-management strategy, often initiated by the patient, and symptom contingent. It aims to avoid flare-ups and relapses while remaining as active as possible. (4) The goal is to help patients cope with their illness rather than treat or cure it.
Both interpretations of pacing contradict each other, and it is unclear why, given these differences, Antcliff and colleagues have created a unified framework for patients with chronic pain, fatigue, and ME/CFS. No justification has been provided why the definition of pacing needs to be standardized across different health conditions or why the treatment of ME/CFS and other conditions should be similar. During the development of the activity pacing questionnaire by Antcliff and colleagues, some panelists already suggested that “it might be difficult to develop a generic questionnaire for both chronic pain and fatigue.” One clinician noted “a tension between pacing to manage/reduce symptoms, and pacing in order to optimise function.”(5)
This tension was mainly resolved by ignoring the second interpretation of pacing. Because ME/CFS patients and therapists are fewer in number than those of chronic pain conditions, the predictable result of a standardized framework has been that the views of the ME/CFS community were overlooked. Indeed, they represented only a small minority of the patients Antcliff and colleagues consulted in developing their activity pacing framework. (6)
This will not only result in confusion but may also lead to patients being harmed. ME/CFS has been characterized as an “exercise intolerance disease”. (7) A distinctive feature of the illness is that patients experience a marked symptom exacerbation when they exceed their energy limit. In the literature, this is referred to as post-exertional malaise (PEM). Although encouraging patients to gradually increase their activities has been a popular approach to treat ME/CFS, it has also been highly controversial. In multiple surveys, ME/CFS patients reported that their health deteriorated rather than improved following graded exercise. (8) As a result, quota-contingent increases in activity levels are no longer advised for ME/CFS. The new NICE guidance for ME/CFS, for example, actively cautions against “any program … that uses fixed incremental increases in physical activity or exercise, for example, graded exercise therapy.” (9) This advice is in direct contradiction to the pacing framework Antcliff and colleagues are offering ME/CFS patients.
The authors have been developing this approach for multiple years but have consistently avoided this issue in their publications, despite attempts from colleagues in the ME/CFS field to highlight potential difficulties. (10) I hope that Antcliff and colleagues will now respond to these concerns.
References
1. Jamieson-Lega K, Berry R, Brown CA. Pacing: A concept analysis of a chronic pain intervention. Pain Res Manag J Can Pain Soc. 2013;18(4):207–13.
2. Nielson WR, Jensen MP, Karsdorp PA, Vlaeyen JWS. Activity pacing in chronic pain: concepts, evidence, and future directions. Clin J Pain. 2013 May;29(5):461–8.
3. Blikman LJ, Huisstede BM, Kooijmans H, Stam HJ, Bussmann JB, van Meeteren J. Effectiveness of energy conservation treatment in reducing fatigue in multiple sclerosis: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2013 Jul;94(7):1360–76.
4. Goudsmit EM, Nijs J, Jason LA, Wallman KE. Pacing as a strategy to improve energy management in myalgic encephalomyelitis/chronic fatigue syndrome: a consensus document. Disabil Rehabil. 2012;34(13):1140–7.
5. Antcliff DC. The Development of an Activity Pacing Questionnaire for Chronic Pain and/or Fatigue. A thesis submitted to the University of Manchester for the degree of PhD in the Faculty of Medical and Human Sciences. [Internet]. 2014. Available from: https://www.escholar.manchester.ac.uk/api/datastream?publicationPid=uk-a...
6. Antcliff D, Keenan A-M, Keeley P, Woby S, McGowan L. “Pacing does help you get your life back”: The acceptability of a newly developed activity pacing framework for chronic pain/fatigue. Musculoskeletal Care. 2021 May 6;
7. Institute of Medicine. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness [Internet]. Washington (DC): National Academies Press (US); 2015. Available from: http://www.ncbi.nlm.nih.gov/books/NBK274235/
8. Geraghty K, Hann M, Kurtev S. Myalgic encephalomyelitis/chronic fatigue syndrome patients’ reports of symptom changes following cognitive behavioural therapy, graded exercise therapy and pacing treatments: Analysis of a primary survey compared with secondary surveys. J Health Psychol. 2019 Sep;24(10):1318–33.
9. National Institute for Health and Care Excellence (NICE). Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management (NG206). [Internet]. 2021. Available from: https://www.nice.org.uk/guidance/ng206/resources/myalgic-encephalomyelit...
10. https://twitter.com/MichelleBull4/status/1198306722722582529
The conclusion states "The considerable number of included papers reporting a statistically insignificant result decreases the usual concern over publication bias". I disagree with this. Firstly, the number of p-values labeled "non significant" in Table 3 was 15 out of 48 (31%), which I would not call "considerable". More importantly, if nudges are not effective then there should be many negative studies, so there still could be a large publication bias. Searching for registered studies that used a nudge but were never published would give some evidence of potential publication bias.
This article is dependent on random sampling of non-randomly ordered lists. Despite this it fails to even mention what random sampling method was selected nor what software was used to implement this method. The list of "randomly" selected signatories generated by this unnamed method is not given in the article itself, however the data availability statement refers to a "public, open access repository" although the repository is not named and no link is given, so perhaps this is available somewhere?
No sample size calculation is given, and the selection of 30 is not justified within the method or discussion in any way.
This paper frankly fails to meet minimum standards in describing how the research was actually conducted.
It is unclear to me what merits of the paper led to its selection for publication, although this lack of clarity is partially driven by the failure of BMJ Open to publish any reviews in violation of their stated policies.
In many ways, the Building Blocks (BB2-6) study reported recently in BMJ Open is conducted impressively.1 The depth of analysis of social-service and child-protective-system involvement of families enrolled in Usual Care (UC) and Family-Nurse Partnership (FNP - as the program is called in the UK) is remarkably thorough. I was disappointed, however, to find that the report did not address a number of critical issues as thoroughly as needed to better interpret its findings.
Show MoreThe most fundamental challenge with this trial is that it was “open-label.” Treatment assignment was not masked to UC providers, including Midwives and Health Visitors (HV) charged with serving the same population as FNP nurses - and with similar goals. This type of design has been criticized because it can lead to “Compensatory Equalization.” 2 I understand why this design was chosen, but am concerned that it compromised the estimate of real FNP effects. Its consequences need to be examined in greater depth.
In the 18 trial sites, FNP nurses assumed the role of Health Visitors,3 which would allow usual HV’s to serve others on their caseloads more intensively, a condition possibly amplified if they felt, quite naturally, that their service might be devalued if maternal and child health were improved more with visits by FNP nurses. To what degree did this knowledge modify their delivery of UC? The authors have examined this issue, but more can be done.
Note that the number of visit...
This paper has several ethical, conceptual, statistical, and presentational issues. From an ethical standpoint, it is somewhat surprising that the author declares no human subjects are involved. Bibliometric data is widely established as public data, and some IRBs hold the same is true of data gathered from public accounts on Twitter (here, follower counts). However, the author explicitly investigates whether named individuals choose to use Twitter by searching for a linked account through google. Decisions about whether or not to use Twitter are reasonably private. There is no reason to believe someone who has chosen not to use Twitter has consented to their presence in a study on social media use. For these reasons review by an IRB seems warranted.
Other ethical challenges may arise from a failure to disclose the author's well-documented history of interaction (co-authorship, affiliations, debate, etc..) with the named signatories—positive and negative. An IRB may have taken those relationships into consideration when deciding (for instance) whether it was appropriate to explicitly name scientists. Alternatively, reviewers and readers alike may have found these important context when interpreting the paper as a whole.
Conceptually, the author acknowledges the limitation that: “Both citation indices and Twitter followers have limitations in face validity and construct validity as measures of impact.” Yet the paper’s conclusions are based entirely...
Show MoreThough not patently exhibited or openly expressed, the family of each of these healthcare workers exerts a strong influence on the day-to-day mental health status of their family member. Appreciation needs to be focused on the corollary too. The mental health of all the family members play a role.
The silent pillars need plenty of support!
We applaud the authors for publishing their trial protocol for this important subject of empirical antibiotic approaches in uncomplicated LUTIs in women.
It is alarming that in the community settings, women presenting with LUTs more than half of the E.coli isolates and more than a third of K. pneumoniae isolates are were resistant to third generation cephalosporins ( i.e.ESBL-producing microorganisms) (1). It therefore makes sense to use Fosfomycin as empirical treatments when >20% of isolates are multi-drug resistant microorganisms (2), What is not clear is why GPs in Spain prefer to use short-course therapies over single-dose therapy which is not in line with the Spanish national guidelines. We believe that better compliance could be achieved in addition to desirable outcomes with this strategic approach although as the authours mention there may potentially be more relapses. It would be useful to explore what the reasoning is behind this preference. Perhaps, they have concerns regarding the pharmacokinetic and spectrum of activity of Fosfomycin (3) that might not achieve the desired clearance of microorganisms? This has clearly been described elsewhere including a comprehensive metanalysis on the successful outcomes of single dose Fosfomycin (4-6). Indeed, we read with interest that you hypothesise that short-course treatments will be more effective than the recommended 3 g single dose of Fosfomycin, resembling what clinicians usually do in routine practice....
Show MoreThe activity pacing framework was developed to address a clinical need to provide a comprehensive guide for healthcare professionals on instructing activity pacing to a range of patients who commonly seek assistance in the management of symptoms of chronic pain and fatigue. As a research team with clinical and academic backgrounds, we see many patients seeking healthcare services presenting with overlapping symptoms and co-existence of conditions of chronic pain and fatigue, including chronic low back pain, chronic widespread pain, fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). In the current study, co-morbidity of chronic conditions was evident. At baseline, 65 participants (61.3%) reported two or more conditions of chronic pain or fatigue. Observing specifically the subgroup of participants with ME/CFS, 11 of the 12 patients with ME/CFS reported least one other co-morbidity of either low back pain, chronic widespread pain, fibromyalgia or another condition. Ten of these 12 patients reported ME/CFS to be their main condition. This clinical presentation of overlapping symptoms and co-existence of chronic pain and fatigue is recognised in the research literature [1, 2]. As such, our work into activity pacing has had an inclusive approach for patients with a range of symptoms, and for healthcare professionals working across varying services.
In reference to our earlier work to develop an activity pacing questionnaire, Michiel Tack has q...
Show MoreAbrahami et al. examined proton pump inhibitor (PPI) and histamine-2 receptor antagonist (H2RA) prescribing patterns over a long period in primary care in the UK (1). From 1990 to 2018, PPI prevalence increased from 0.2% to 14.2%, while H2RA prevalence were under 3.4%. The authors described that PPIs were associated with a number of adverse effects not attributed to H2RAs, and recommended H2RAs as a valuable treatment as acid suppressants. I have a comment about the study with special reference to dementia risk.
Prescribing acid suppressants is more prevalent in the elderly. Wang et al. conducted a meta-analysis to investigate the risk of acid suppressants on dementia (2). The pooled adjusted hazard ratios (95% confidence intervals) of PPI users and H2RA users for the development of dementia were 0.98 (0.85-1.13) and 1.20 (0.98-1.47), respectively. Although there is no significant association regarding the effect of acid suppressants on the development of dementia, H2RA presented a trend of increased risk for dementia. There are medical reasons of prescribing PPIs instead of H2RAs, and evidence should be presented for concluding the higher adverse effects of PPIs than H2RAs.
References
Show More1. Abrahami D, McDonald EG, Schnitzer M, et al. Trends in acid suppressant drug prescriptions in primary care in the UK: a population-based cross-sectional study. BMJ Open 2020;10(12):e041529.
2. Wang H, Tian L, Yan X. No association between acid suppressant use and...
I want to thank Dr Successful for helping me with his herbal medicine to get rid of my copd completely, i have been living with the disease for the past 2yrs. Right now am Copd Chronic obstructive Pulmonary disease negative after using the herbal medicine Dr Successful sent to me. I give thanks to God and healed completely you are the best Traditional doc in the world contact Dm https://web.facebook.com/Drsuccessful-109263294750359 He you can as well dm him on https://www.facebook.com/Priestsuccessful or https://wa.me/qr/UFTMANFGSLY4E1 you can also talk with him on drsuccesfulcuringhome@gmail.com also have powerful herbs remedies his herbal medications prevent and cure Cancer, Diabetes, High-Blood Pressure, Kidney Diseases, Prostate, Gall Stone, Myoma, Cyst, Paralysis, Stroke, Leukemia, Dengue, Anemia, Primary Complex, Gout, Arthritis, Migraine, Sleep Disorder, Dysmenorrhea, Goiter, Heart Problem, Hepatitis, Psoriasis, Vertigo, Low Sperm Count,Sexual Impotence, parasite and other serious problems.
The version of pacing proposed by Antcliff and colleagues for patients with chronic pain and fatigue contradicts how the term is applied in the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) community.
Jamieson-Lega et al. previously noted that pacing represents “a variety of differing and, at times, contradictory concepts.” (1) Broadly, two main traditions exist. One has a history in operant conditioning and is mostly used in the treatment of chronic pain. It consists of a preplanned strategy that is time- or quota-contingent with the aim of breaking the association between resting behavior and symptoms. It involves dividing tasks into manageable parts, doing things slowly but steadily, and building a consistent routine to achieve a target, often an increase in (physical) activity. (2) The other main tradition is energy conservation management as used in patients with neurological conditions such as multiple sclerosis. Here, pacing can be symptom contingent as it is mainly aimed at avoiding overexertion and relapses while engaging in meaningful activities. It involves balancing activity and rest, delegating tasks, setting priorities, and using assistive devices. (3)
The “activity pacing framework” developed by Antcliff and colleagues is in line with the first tradition but ignores the second. It follows principles of quota-contingency and focuses on gradually increasing activity levels. It is presented as a rehabilitative intervention provided b...
Show MoreThe conclusion states "The considerable number of included papers reporting a statistically insignificant result decreases the usual concern over publication bias". I disagree with this. Firstly, the number of p-values labeled "non significant" in Table 3 was 15 out of 48 (31%), which I would not call "considerable". More importantly, if nudges are not effective then there should be many negative studies, so there still could be a large publication bias. Searching for registered studies that used a nudge but were never published would give some evidence of potential publication bias.
Pages