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Research Article | Volume 2 Issue 1 (Jan-June, 2021) | Pages 1 - 7
Number Needed To Treat Statistic Reporting Frequency in Systematic Review and Clinical Trial Abstracts On the Physiotherapy Evidence Database (PEDro)
1
64 Deborah Hilton Statistics Online, Melbourne, Australia
Under a Creative Commons license
Open Access
Received
April 12, 2021
Revised
June 3, 2021
Accepted
June 16, 2021
Published
June 30, 2021
Abstract

Hilton and colleagues in 2006 published a manuscript on the number needed to treat (NNT) describing how to convert more commonly reported statistics (dichotomous outcomes) into the NNT (the mathematical inverse of the absolute risk reduction), utilising the PEDro downloadable spreadsheet and nine manuscripts on the physiotherapy evidence database (PEDro) (varied clinical disciplines). It is easily interpretable, explicit and describes how many patients need to be treated with the new intervention in order for one additional patient to have the desired outcome compared with the number expected to have that outcome under the standard treatment or placebo. Subsequently in order to comprehend how often there is reporting of NNT in systematic reviews and clinical trials a PEDro search was conducted in order to ascertain how many systematic reviews and clinical trials report NNT. A simple search; search words ‘number needed to treat’ identified 248 records. 176 records (71% of the total) reported NNT in the abstract. The remainder either didn’t report NNT in the abstract (5.5%) or it stated that copyright release for the abstract had not been granted (23.5%) so verification wasn’t possible. The 176 records were then placed into arbitrarily chosen clinical specialty categories.

Keywords
INTRODUCTION

Physiotherapy involves the interaction between physiotherapist, patients/clients, the health care team, families and caregivers, and communities in order for movement potential to be assessed and goals to be decided upon, using physiotherapist’s unique knowledge and skills.  The basis for this process should rest on evidence-based physiotherapy/evidence-based practice (EBP), which constitutes a combination of research, clinical experience, patient/client opinions as well as cost-benefit considerations [1]. 

 

There is a wealth of research and scientific information worldwide and Glasziou [2] in a manuscript titled ‘Managing the evidence flood’ states ‘the first issue is recognition that there is an inescapable and growing information problem’ [2].   The author states there must be effort allocated to better organizing, filtering, and using the research so that what is done doesn’t diverge from what is known. 

 

If you consider physiotherapy per, say, the following website provides relevant specific quality information. The Physiotherapy Evidence Database (PEDro), is a global site that has been providing physiotherapists with free access to evidence based clinical physiotherapy research for 21 years (PEDro). When the site was accessed in 2021, it stated that there was access to over 49,000 randomized controlled trials, systematic reviews and evidence-based clinical practice guidelines relevant to physiotherapy on the site, and that users included people from over 200 countries across the globe.   The information may be accessed by students, researchers, educators, clinicians and policy makers.  The trials are assessed for their quality using the PEDro scale.

 

Once information is located, the next step is interpretation to understand the results meaningfully.  The abstract statistical details can be detailed and interpretation maybe difficult and confusing for some readers whom may not have a thorough or good understanding of statistical terminology.  If a clinician is wanting to convey the main results of a clinical trial to a patient undergoing the same procedure or intervention as what is in the published clinical trial or meta-analysis, they need to do this in a way so that the patient can understand the likelihood that treatment will benefit, harm or be ineffective (i.e., have no effect).   

 

Hilton after publishing the manuscript on number needed to treat in 2006 [4,6], provided this manuscript to a number of clinical physiotherapists in Victoria.  One comment from one physiotherapist she received was basically to the effect of when I tell patients how likely they are to have benefit I tell them it is like a piece of string in that your likelihood of being helped is anywhere along 

 

 

Figure 1: Person walking along a slackline (or a piece of string).

 

that piece of string and it differs depending upon the patient and various other factors.  Other factors that may be associated with treatment or outcome could include complications, re-injury, compliance with exercise regime, attendance at sessions etc. While that physiotherapist, may sometimes convey likelihood to patients using the piece of string example (see figure 1), (with this analogy being relevant to continuous outcomes) and maybe other physiotherapists also use this analogy, some other physiotherapists and patients may prefer a more precise estimation when compared to the string analogy.

 

For a thorough understanding and if the readers want to obtain comprehensive background information on interpretating and estimating treatment effects from that reported in clinical research, they should refer to the manuscripts by author Herbert who explains in detail very well the concepts and definitions of both continuous and/or dichotomous outcomes [5,6]. 

 

For a detailed comprehensive overview of slacklining which is the neuromechanical action of balance retention on a tightened band, refer to the manuscripts by Gabel and colleagues [7,8].  The authors of these papers describe the evolution being from rope-walking and even though slacklining has an extensive history, there is only limited and recent published research.  Used for specific patient and situational purposes, commenced within a framework of evidence-based practice to ensure a multi-tiered application for movement, balance and stability.

 

Personal preferences can include costs, time commitments and location all of which may influence a patient’s decision.  It is possible that some patients have limited funds, hence they may want to make sure that they invest in treatment with a high likelihood of benefit. It is important to convey to patients whether treatment is likely to work, how likely is it to work, and what alternatives may work if these are at all known and this indeed may include alternative treatments or lifestyle interventions that may or may not be listed on PEDro. 

 

One classic example is knee osteoarthritis. Three systematic reviews located on this topic detail either orthopaedic manual therapy [9] aerobic walking and quadriceps strengthening exercises [10]. While the other assesses weight reduction in obese patients [11].   These manuscripts will be utilised as examples to show how to interpret various outcomes reported on continuous scales.   

 

The first systematic review and meta-analysis by Anwer et al, on the effects of orthopaedic manual therapy (OMT) in knee osteoarthritis utilized a visual analogue scale, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, WOMAC function score, WOMAC global score, and stairs ascending-descending time [9]. Two outcome measures that are easy to understand that were also statistically significant include; the reduction of VAS score in OMT compared with exercise therapy group (SDM -0.78; 95% CI -1.42 to -0.17; p = 0.013) and the reduction of stairs ascending-descending time in OMT compared with the exercise therapy group (SDM -0.88; 95% CI -1.48 to -0.29; p = 0.004). VAS and time are measures that should be easily understood by the general public. This review indicated OMT compared with exercise therapy alone has benefits in decreasing pain, improving function, and physical ability for people with knee osteoarthritis.     

 

The 2nd systematic review by authors Roddy et al, on the topic of aerobic walking or strengthening exercise for osteoarthritis of the knee, identified 35 RCTs, 13 of which met inclusion criteria and provided data suitable for further analysis [10]. Pooled effect sizes for pain were 0.52 for aerobic walking and 0.39 for quadriceps strengthening. For self-reported disability, pooled effect sizes were 0.46 for aerobic walking and 0.32 for quadriceps strengthening. The conclusion was that both are effective for reducing pain and disability from knee osteoarthritis and that no difference between them was found on indirect comparison. 

 

The 3rd a systematic review and meta-analysis by Christensen and colleagues was on the topic of weight reduction in obese patients diagnosed with knee osteoarthritis [11].  Among 35 potential trials identified, four RCTs including five intervention/control groups met our inclusion criteria which resulted in data for 454 patients. Pooled effect size for pain and physical disability was 0.20 (95% CI 0 to 0.39) and 0.23 (0.04 to 0.42) at a weight reduction of 6.1 kg (4.7 to 7.6 kg). Disability could be significantly improved when weight was decreased more than 5.1% as shown by meta-regression analysis. 

 

If you consider these three examples, all being systematic reviews on the topic of knee arthritis it is useful to compare alternative treatments.  Considering the hypothetical example of an overweight or obese patient with knee arthritis whom were conveyed this information from these three systematic reviews on the likelihood of benefit from orthopaedic manual therapy, aerobic walking or strengthening exercise and / or weight reduction using the outcome and effect measures reported. They then may have to decide which alternative treatment is best for them based upon these measures reported. Otherwise, they may just consider the summary conclusions of all three systematic reviews, which is that all are effective and then hence proceed to base their decision on personal preferences, cost, location and time commitments if they choose to just start one intervention.  However, this example shows that health professionals need to provide patients with information and there maybe alternatives to hands on treatment that include lifestyle interventions, but, if possible, some measure of likelihood of benefit should be given when conveying information to patients whether this be time, VAS and/or other measures of effect.   Some people may prefer the lifestyle interventions, as opposed to on hands physiotherapy treatment for pain and disability in particular if the likelihood of benefit from on hands treatment was similar to that of a lifestyle intervention, if you also take into account other considerations such as cost, time and location.   Personal preferences vary but what is important is that staff and patients are armed with facts and information.   

 

These examples above give outcome and effect measure estimates of likely benefit as the outcomes specified as examples are on a continuous scale.  Various other manuscripts may include treatment and control groups whereby outcome measures are dichotomous. If you consider the slackline figure or piece of string diagram above, a dichotomous outcome analogy would be either the person makes it to the other side uninjured and alive, or they fall off the slackline and fracture some bones or die. A dichotomous event being success or failure walking along the slackline. Hilton and colleagues included a table in the manuscript which detailed a number of studies which were identified from the PEDro database, whereby the author calculated number needed to treat [4]. The number   needed   to   treat   statistic (NNT); the mathematical inverse   of   the   absolute risk reduction (ARR) is explicit, easily interpretable & usually reported as a whole number.  It conveys how many patients need to be treated with the new intervention in order for one additional patient to have the desired outcome, compared with the number expected to have that outcome under standard treatment or placebo. [4]. 

 

One manuscript that was utilized in these calculations was that by author Bennell and colleagues [12] where patients with the target disorder of knee joint osteoarthritis were included.  The intervention comprised; knee taping, exercises, mobilization, massage, home exercises and a taping instruction sheet. The control group had sham ultrasound and light application of non-therapeutic gel.  The event or outcome measured was global improvement in pain and results were that 49% of control group subjects and 77% of experimental group subjects had this outcome/event.   Hilton utilized the event rates reported in the manuscript by Bennell and colleagues and calculated a NNT of 4 [2-10].  This means that 4 people need to be treated with the intervention in order for one to have a beneficial outcome in this case global improvement in pain. 

 

Whether clinicians and their patients find this terminology beneficial and easier to understand, is something that can only be determined as a result of people using this terminology and if feedback is given from patients whom may say thank you, that is easily understandable in terms of how likely I am to improve.  Whether this is easier to understand compared to other terminology that may convey likelihood of recovery or benefit, can only be determined from patient feedback and as a result of clinicians using this terminology in routine clinical care in order to assess its acceptability over time from a range of patients with differing medical conditions, understanding levels, ages and cultural backgrounds.  Some people may relate more to a number or effect measure that is precise, as opposed to telling patients their likelihood of improvement is anywhere along a piece of string as it varies for different people.  Should you have a study with dichotomous outcomes, where by NNT can be calculated, this may be easier to understand then the other measures of effect given as examples. However, in order to assess this, the terminology needs to be utilized in routine clinical care. You must also be mindful of the fact, outcome measure information and conveying these details differs depending upon whether it is a continuous or dichotomous outcome [4,5,13].

 

Table I: Statistical definitions including number needed to treat 

StatisticAbbreviationDefinition
Control event rate 

CER

 

The event rate (proportion or percentage of patients with the event) in the control or placebo group.
Experimental event rateEERThe event rate (proportion or percentage of patients with the event) in the experimental or treatment group. 
Relative RiskRR= EER/CER.
Relative Risk ReductionRRR

= ((CER) – (EER))/ CER, or (1-(EER/CER))

x 100 to express as a percentage. 

Absolute risk reductionARR

= (CER – EER), where the event is an adverse outcome. (if not already expressed as a percentage multiply x 100 to express as a percentage).

= (EER – CER), where the event is a beneficial outcome. (if not already expressed as a percentage multiply x 100 to express as a percentage).

Number needed to treatNNT

= 1/ARR

Where event rates are expressed as percentages and not proportions, then NNT = 100/ARR. 

Number needed to harmNNH1/ARR where the ARR is negative, when the risk of an adverse outcome is higher in the experimental group. 

 

MATERIALS AND METHODS

A PEDro search was conducted using the search words; ‘number needed to treat’ and selecting ‘match all search terms’ which is an option at the end of the search page as opposed to match any search term. This search identified 248 records. https://pedro.org.au (PEDro).  176 records (71% of the total) reported NNT in the abstract.  The remainder either didn’t report NNT in the abstract (5.5%) or it stated that copyright release for the abstract had not been granted (23.5%) so verification wasn’t possible.    The 5.5% of records where NNT wasn’t reported in the abstract yet they were retrieved by the search, mostly had the word number somewhere in the abstract. 

RESULTS

These results have been presented as an abstract and e-poster with voice recording at the World Physiotherapy Congress 2021 Online [27].  Table 2 below shows the breakdown of therapeutic discipline of the 176 records where NNT was reported in the abstract.  These categories were arbitrarily chosen by the author of this manuscript, and the categorization was complex and difficult.  24 (13.64%) of the studies could have been placed in another category which wasn’t included being neonates/ pediatrics/ adolescents. However, given that all of these 24 studies were placed already in either Cardio / Respiratory, Musculoskeletal, General Exercise, General and / or Chronic Pain, Women’s Health, Neurological or adhoc, a category incorporating baby/child/adolescent health was not created.   

 

In addition, the categorization in many cases is arbitrary and subjective as in fact there were many instances of where a study could have been placed in either one category or another category.  Several examples are shown below whereby you can see by the titles that they could have been placed in one or two or even three categories. There were others though in addition to those listed below.  The title ‘Exercise for rheumatoid arthritis of the hand’ was put into the Rheumatic / Inflammatory category yet in fact it could have been placed into the general exercise category also. The manuscript title; Exercise therapy for schizophrenia was placed into the Mental Health category, yet in fact it also could have been placed into the category of general exercise. The manuscript titled; A meta-analysis of mental health treatments and cardiac rehabilitation for improving clinical outcomes and depression among patients with coronary heart disease, was placed into the Cardio / Respiratory category, yet could have also been put into the mental health category. The manuscript titled; Physical conditioning programs for workers with back and neck pain: a Cochrane Systematic Review, was placed into the Musculoskeletal category, yet indeed alternatively could have been placed into the general exercise category.  These are just some examples of those manuscripts below but there were others in addition that are not listed.  In essence this means that due to the arbitrary categorization in some cases, these numbers and percentages listed in the table could fluctuate so it has to be interpretated with that in mind. It has to be taken 

 

Table 2: Arbitrarily chosen categories of Therapeutic Discipline.

Therapeutic Discipline Number of abstracts (total abstracts n = 176) Percentage of abstracts (total abstracts n = 176)
Musculoskeletal4827
Cardio / Respiratory4224
Rheumatic / Inflammatory42
General and / or Chronic Pain127
Women’s Health137.5
Men’s Health21
Neurological106
Mental Health127
General Exercise2011
Adhoc 137.5 

 

with 'a grain of salt', a saying which means to accept it while maintaining a degree of scepticism about its truth. These table results may not be totally true or accurate as another person completing the categorization may interpret the title differently and place it in an alternate category. Should the reader require further details of these titles listed below they can search the PEDro website with the title to obtain author and other publication details. 

 

  • A meta-analysis of mental health treatments and cardiac rehabilitation for improving clinical outcomes and depression among patients with coronary heart disease

  • Effects of exercise on depression in adults with arthritis: a systematic review with meta-analysis of randomized controlled trials

  • Physical conditioning programs for workers with back and neck pain: a Cochrane Systematic Review. 

  • Effectiveness of a 12-week physical exercise program on lower-limb malalignment in school-age rugby: A randomized clinical trial

  • Exercise for rheumatoid arthritis of the hand (Cochrane review) (with consumer summary)

  • Acupuncture for neuropathic pain in adults (Cochrane review) (with consumer summary)

  • Acupuncture for the prevention of episodic migraine (Cochrane review) (with consumer summary)

  • Psychological therapies (internet-delivered) for the management of chronic pain in adults (Cochrane review)

  • Exercise therapy for schizophrenia (Cochrane review) (with consumer summary)

  • Community-deliverable exercise and anxiety in adults with arthritis and other rheumatic diseases: a systematic review with meta-analysis of randomised controlled trials (with consumer summary)

  • Effects on shoulder pain and disability of teaching patients with shoulder pain a home-based exercise program: a randomized controlled trial

  • Systematic review of randomised controlled trials of psychological therapy for chronic pain in children and adolescents, with a subset meta-analysis of pain relief

DISCUSSION

The World Physiotherapy policy statement on evidence-based practice states that physiotherapists have an accountability to use systematic research evidence to guide practice and to ensure that patient’s/client’s treatment is therefore based upon best available documented evidence [15]. This research and scientific knowledge should be integrated with clinical experience, knowledge of disease pathophysiology, patient preferences, choices and views, while also considering the cultural context, beliefs and values of the locality.   It should also be understood that probabilities can change and there are uncertainties.   

 

The policy document states that physical therapists should be able to critically evaluate, raise questions as a result of practice, assess and critically appraise the evidence and assess the outcomes of how they implement and utilize this evidence.   

 

If dichotomous outcomes are reported but NNT is not calculated, then there are various calculators available whereby NNT can be calculated by the reader.  Several of these include those listed below, however if you google search, you will find others also available online as shareware. 

 

  • PEDro confidence interval calculator (PEDro confidence interval calculator)

https://pedro.org.au/english/resources/confidence-interval-calculator/

  • GraphPad software (GraphPad software)                           

http://www.graphpad.com/quickcalcs/NNT1.cfm

  • ClinCalc.com (ClinCalc.com)

https://clincalc.com/stats/nnt.aspx

 

In addition, for a complex overview of the number needed to treat in pairwise and network meta-analysis and its graphical representation, refer to the manuscript by Veroniki and colleagues [19]. 

 

Aside from the explosion of statistical information generally available for professionals or the public which may or may not include statistics such as NNT, there is also an avalanche of information generally in documents, official reports and government publications that may relate to conditions such as arthritis.  The technological revolution and modern times have resulted in society being inundated with information possibilities on the world wide web. 

 

Physiotherapists must also have some understanding and knowledge of the literature relating to population health and prevention as it relates to general exercise physical activity programs or measures.   Specific ailments such as arthritis have a high prevalence in society. In fact, it is reported that one in eleven Australians (9%) have osteoarthritis, approximately 2.1 million people in 2014-5 [20,21].  Research summaries also report that age, being overweight or obese, occupation and genetic factors are known to increase risk of back pain and other back musculoskeletal conditions as well as increasing the risk of arthritis [22]. 

 

According to the Arthritis Foundation, whom mention statistics compiled by the Centres for Disease Control and Prevention, 47% of people with diabetes have arthritis, as well as 31% of those who are obese (Arthritis Foundation). In addition, nearly half of all adults with heart disease also have arthritis. 

 

Physical activity can be difficult for those with arthritis, who are overweight or obese. It’s a vicious cycle: If you have pain, you don’t exercise and this may result in your joints hurting more. Also, being overweight and not physically active, may increase joint pain, or the reverse maybe the case if you have joint pain, you become less active and your body weight may increase. Regardless of the ordering of events, the benefits for general physical activity programs are evident. 

 

According to a report compiled by Vic Health, titled physical activity and sedentary behaviour (evidence summary), physical inactivity is responsible for more than 5 million deaths globally / year [26,25]. Reducing the prevalence of inactivity in Australian adults by 10% would result in a 15% reduction in deaths / year attributable to physical inactivity and it would reduce disability adjusted life years lost by 14% [24]. 

 

Since war times, the physiotherapy profession has become a predominant group of allied health providers (Nicholls. DA). A manuscript titled; ‘Looking back at 100 years of physiotherapy education in Australia’, states that in Australia, physiotherapy originated from the United Kingdom (UK) as in 1894, an Association was created by members of its precursor discipline — massage therapy [27].   Sometime after, the focus has been on orthodox physical rehabilitation and the biomechanics of normal and abnormal movement [26]. 

 

Physiotherapy is arriving at a critical point in its history [26]. Current times include ageing populations of increasingly chronically ill people in the community, with people doubting biomedicine and a rapidly evolving economy means there are risks to the status of the profession as it is known.   

 

Prevention and population health initiatives are paramount. The wealth of information available and evolving technology is another area that results in possibilities and potential with the coronavirus epidemic resulting in more and more people being forced or considering telehealth as an option.  Whether or not this continues once the pandemic subsides will be interesting to see. This again is another area aside from statistical calculations, or the availability and quantity of information on the web in terms of statistical reports and documents, but a future avenue is to utilize the versatility and complexity of modern communication being the Internet in telehealth options. Already there are physiotherapy researchers looking at telephone or telehealth options. 

 

Cottrell and Russell report on the topic of telehealth for musculoskeletal physiotherapy [29].  The authors state that access to traditional in-person healthcare can be difficult for some people and in addition they note that the implications of the coronavirus pandemic has resulted in the fast adoption of telehealth, overcoming some of barriers that are perceived. 

 

Hinman RS and colleagues [30] conducted a study titled; ‘Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial’ [30].     They reported that physiotherapist-led exercise advice and support delivered by telephone modestly improved physical function but not the co-primary outcome of knee pain at 6 months for participants with knee osteoarthritis. 

 

A manuscript titled; Effectiveness of telephone-based interventions for managing osteoarthritis and spinal pain: a systematic review and meta-analysis was published in 2018 [31]. The authors searched seven electronic databases from inception to May 2018.  This included 23 studies with 56 trial arms and 4,994 participants.  The results showed modest confidence that telephone-based interventions reduce the degree of the level of pain and disability for patients with osteoarthritis and spinal pain compared to usual care, but telephone plus face-to-face interventions were no more effective than usual care or face-to-face interventions alone.

 

In fact, the PEDro has a page titled; Evidence to guide telehealth physiotherapy.  This page includes 17 systematic reviews on the topic (Physiotherapy Evidence Database (PEDro).    One of the listings on this site was by Cottrell and colleagues which was a systematic review, on the topic of real-time telerehabilitation for the treatment of musculoskeletal conditions [33]. The conclusions were that compared to conventional methods of healthcare delivery telerehabilitation for the improvement of physical function and pain in a variety of musculoskeletal conditions appeared to be effective and comparable. 

 

As a closing thought, to be armed with information and statistics is important, but it is also important to listen to people.  Herbert and colleagues in a book chapter titled; What do I need to know? in the book; Practical Evidence-Based Physiotherapy mentions a well-known saying; ‘the beginning of all wisdom lies not in the answer, but in the question’ [32]. A question needs to be formulated.  If you want to know how the patient’s condition is affecting their daily life, it is best to obtain this information by asking questions.  High-quality clinical research information can then provide information needs. This author in chapter 10 mentions that historically outcome measurement was not a feature of routine clinical practice.  Previously information was collected incidentally from the impressions of outcomes clinically or otherwise on the basis of patient comments    either    satisfaction   or   dissatisfaction [35]. 

 

Nowadays, statistics and information are vitally important and must be used to facilitate and inform treatment, but as per the famous quote in Shakespeare’s Macbeth – it is not the be all end all.  Exercise compliance and training regimes in Kenyan runners are generally good as running is generally ingrained in their culture, a matter of necessity in some cases for travel, and too much information or technology may just impede or be a barricade to physical activity.  While this doesn’t pertain to specific injuries as such, it is an interesting phenomenon. 

 

Not everything that can be counted counts, and not everything that counts can be counted’. Albert Einstein, Physicist. ‘Facts are stubborn things, but statistics are pliable’ Mark Twain.

CONCLUSION

The number needed to treat as shown by this analysis is quite often reported in clinical trials and systematic reviews.  It is also used across a range of clinical specialties.   This calculation and reporting of number needed to treat facilitates the usage of this statistic by physiotherapists.

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