J Manipulative Physiol Ther. 2019 (Mar; 42 (3): 167–176 ~ FULL TEXT
Joyce E. Miller, DC, PhD, Heather A. Hanson, DC, MSc, Mandy Hiew, BA, Derek S. Lo Tiap Kwong, BA, Zicheng Mok, BA, Yun-Han Tee, BA
Outpatient Teaching Clinic,
AECC University College,
Bournemouth, Dorset, UK.
OBJECTIVE: The purpose of this study was to investigate the report by mothers of their infants' condition before and after a trial of care provided by registered chiropractic clinicians in addition to ratings of satisfaction, cost of care, and reports of any adverse events or side effects. A second purpose was to report the demographic profile of infants who presented for care to 16 chiropractic clinics in the United Kingdom.
METHODS: This observational study prospectively collected reports by mothers of their infants' demographic profiles and outcomes across several domains of infant behavior and their own mental state using the United Kingdom Infant Questionnaire. Participating registered chiropractors were recruited through the Royal College of Chiropractors annual meeting in January 2016, and 15 clinics and the Anglo-European College of Chiropractic University College teaching clinic volunteered to participate.
RESULTS: In all, 2001 mothers completed intake questionnaires and 1092 completed follow-up forms. Statistically significant (P < .05) improvements were reported across all aspects of infant behavior studied, including feeding problems, sleep issues, excessive crying, problems with supine sleep position, infant pain, restricted cervical range of motion, and time performing prone positioning. Maternal ratings of depression, anxiety, and satisfaction with motherhood also demonstrated statistically significant improvement (P < .05). In total, 82% (n = 797) reported definite improvement of their infants on a global impression of change scale. As well, 95% (n = 475) reported feeling that the care was cost-effective, and 90.9% (n = 712) rated their satisfaction 8 or higher on an 11–point scale. Minor self-limiting side effects were reported (5.8%, n = 42/727) but no adverse events.
CONCLUSION: In this study, mothers reported that chiropractic care for their infants was effective, safe, and cost-effective. Although the observational design makes it impossible to determine efficacy, the study's findings indicate that, on average, the changes observed by mothers were positive and may be clinically relevant.
Key Indexing Terms: Infant, Chiropractic, Complementary Therapies
From the FULL TEXT Article:
An important development in health care in the past decade has been the increasing interest in patient-centered care emphasizing the patient’s own perspective on their illness and treatment. Patient-reported outcome measures are designed to assess a patient’s subjective impressions of their health with respect to symptoms, function, and health-related constructs such as health-related quality of life. [1, 2] The World Health Organization points out that involvement of the patient in their own health care is a social, economic, and technical necessity.  Although patient-reported outcome measures are important, using them for the pediatric patient is challenging whether they could be helpful to improve doctor–patient or doctor–parent communication and shared decision-making. 
Patient-reported outcome measures are commonly used as tools for monitoring and quantifying a patient’s progress while undergoing treatment [5–7] and as outcomes in clinical trials.  Routine collection of patient-reported outcomes (PROs) has been suggested as a method of collecting large amounts of data to capture information about what occurs in routine clinical practice.  These large amounts of data may be used to measure quality of care and evaluate comparative effectiveness of treatments. [1, 2] Routine collection of PROs in chiropractic practice has been demonstrated to be feasible for adult patients [9, 10] and children,  allowing for collection of so-called big data. A similar approach involving routine collection of PROs for infants undergoing chiropractic care would seem a worthwhile endeavor in attempting to address the lack of research in this area.  Infants are common users of chiropractic care. [13–15] In such a vulnerable population, it seems crucial that research be conducted to determine the effect of treatment on the patient’s clinical condition and to measure safety and parental satisfaction. The chiropractic profession has been criticized for a lack of high-quality evidence to support the care of this population. [16–19]
To satisfy the demand for a parent-reported outcome measure, the United Kingdom Infant Questionnaire (UKIQ) was developed, based on maternal views of what is important in an infant’s health, and has been tested for reliability and validity.  Evidence suggests that mothers are reliable reporters of their infant’s behavior and therefore in the best position to provide insight into their child’s clinical situation. [21–23] The UKIQ collects both demographic information about the infant and maternal impressions across several domains of their infant’s behavior, including sleep, feeding, crying, inability to maintain a supine sleep position (a risk factor for sudden infant death syndrome), range of motion of the cervical spine, and use of prone positioning. 
Difficulty in these areas represents threats to the health of the infant and public health because they are considered risk factors for early cessation of breastfeeding  and impaired infant–parental bonding  and parental abuse  in the short term, and behavioral issues, developmental delay, [27–29] and continued sleep difficulties in the long term.  Mothers were also asked about their own mental state in relation to their child’s condition and experience of motherhood because maternal mental condition has been found to be key to the child’s health. 
The purpose of this study was to investigate the report by mothers about their infant’s condition before and after a trial of care provided by registered chiropractic clinicians in addition to maternal ratings of satisfaction, cost-effectiveness, and reports of any adverse events or side effects over the treatment period. A second purpose was to report the demographic profile of infants who presented for care to 16 chiropractic clinics in the United Kingdom.
This is the first known large survey of baseline and follow-up characteristics of infant patients presented to chiropractic practices. More appropriate research designs are required to investigate actual efficacy of registered chiropractors’ care of infants. This study can only illuminate maternal reports of their perceptions of effect of care. Nevertheless, studies investigating efficacy might neglect to consider whether care results in clinically significant change, and it seems likely that parents themselves are in the best position to make this assessment. A recent systematic review indeed questioned whether the small benefits observed in studies of efficacy of manual therapy for crying and distressed infants translated into meaningful changes for parents.  Research of this nature is perhaps best suited to addressing this very relevant question. Mothers repeatedly have been found to be excellent reporters of their infant’s state of health, [21–23] and mothers, by and large, reported good recovery from the initial complaints in this study. The greatest reductions in maternal ratings were reported in the scale of the feeding problem of the infant and in the mother’s own anxiety level. It makes sense that these may go hand in hand because previous studies have found the maternal psychological experience is entwined with breastfeeding issues [33, 34] and inconsolable infant crying. 
Anxiety and depression have been widely researched and found to be prevalent and serious problems both ante- and postnatally and often linked to the feeding, crying, and sleeping issues of the newborn. [36–38] Providers of infant care are increasingly aware of both the prevalence and effects of postpartum depression on the family unit.  Research has shown that screening for depression improves clinical outcomes and that postpartum depression is exceedingly common, affecting an estimated 14% to 25% of mothers. 
Previous studies have shown that mothers report lower scores on validated anxiety and depression indices and better quality of life after their infant has received a course of treatment at a chiropractic clinic. [41, 42] It seems logical that being given an explanation for the etiology of the infant’s problem and observing a reduction in symptoms could be helpful in easing maternal distress. It has been reported elsewhere that mothers want specific contextualized help for their child and not simple reassurance that their condition is not a life-threatening concern. 
In all categories, change was observed in a direction that can be interpreted as a clinically favorable result. The concept of clinical significance of care can be difficult to determine.  Other studies have found that a shift of 35% or more in ratings of improvement is most likely clinically significant.  It is pertinent to suggest that mothers thought the care was beneficial owing to the consistently high ratings of satisfaction, improvement, and cost-effectiveness.
This study’s findings resembled those of previous research demonstrating that the effect of manual therapy for infants occurs within 2 weeks [46–50] and in 1 study after 1.1 treatments, with complete recovery after an average of 4 sessions.  This study was very similar, with a mode of 3 treatments and an average of 4 before release from care. A quick response to care has been suggested to be beneficial in alleviating distress and anxiety in parents.  The same early effect of treatment has been found in adults, although the mean number of treatments was higher (5.4) with a wider range (1–20 treatments in a 90–day span).  In cases where the natural history of the disorder is known, as in excessive crying that has been found to recover after 12 weeks  and up to 26 weeks, [51, 52] there is little question that the care was an improvement over the natural history.
The results reflected statistically significant improvements in complaints of infants such as crying, sleep, pain, breastfeeding, and inability to meet the guidelines for supine sleep. The shared etiology of these problems was musculoskeletal irritability and imbalance, which is common at all ages, but in infants can result from a difficult birth. [42, 47, 50] Manual therapy provided by chiropractors has been found effective in treating the musculoskeletal imbalances of infants, [46, 48] with modified treatments appropriate for the size and age of the child. [46, 53] There is also scientific background that manual touch therapy was found effective to reduce signs of pain in premature neonates using sophisticated brain studies. 
Like other studies, mothers reported very high levels of satisfaction with care, even if the baby did not totally recover.  Satisfaction ratings are complex and therefore should be interpreted with caution because they could be explained by many other confounding factors,  not least because the family appreciates the time and attention given to them and their baby. A factor more meaningful than satisfaction may be the positive report of cost-effectiveness. This concept has been found to be a part of patient-centered care and defined as clinical benefit for the amount of money spent.  Because this care took place in the UK where National Health Service care is free of charge and chiropractic treatment is not, it is interesting that mothers will still seek additional care, even with the additional financial burden. Zuzak et al  found that parents throughout Europe seek complementary or integrated therapies for children, with manual therapy the most commonly chosen. [15, 59]
The information collected was from the mothers’ impressions of care. No efficacy from care can be assigned from this study owing to lack of randomization or controls. However, the strength of this type of study lies in that the data came directly from the mothers and not from the caregivers, who have traditionally been the ones to determine whether a patient has benefited from care. The nature of these common complaints of infancy does not make them conducive to study using a double-blind, randomized design. Many infants may have experienced a combination of complaints.  Treatment often requires an approach customized to the individual patient, and few parents are willing to be blinded to the treatment received by their infant or whether treatment has been received. As such, this type of study presents real-world data as evidence,  which provides external validity not found in randomized controlled trials and thus is more applicable to heterogenous general patient populations than higher-level studies. 
The sample size was relatively large, and the response rate at over 50% was reasonable. A follow-up rate of 41% was reported in a successful routine PROs survey in the NHS Health and Social Care Information Centre. [7, 63] In research being conducted in a routine clinical setting, it may be unrealistic to expect higher follow-up rates. Follow-up is given as part of the normal patient management process, and this means that some patients will not have received the opportunity to complete a follow-up form owing to discontinuation from care before discharge, referral to another health professional at intake, or care being deemed unnecessary at intake. Others simply will not have progressed to a point in care where follow-up is appropriate and will therefore have completed only the intake at the close of the study period. This may be a downside of accessing real-world clinical evidence.
Data were collected anonymously, making it impossible to collect follow-up data from those who dropped out from treatment or pursue any further follow-up efforts if follow-up had not been completed. It could be expected that those who did not complete the follow-up may be precisely the mothers who are unhappy with care or did not complete treatment, and this is a weakness of this study because it is impossible to know what their potential responses would be. It might be worthwhile to consider including a more extensive follow-up process for future research to capture the impressions of these mothers, but this would bring with it the disadvantage of requiring collection of more personal information at intake, which is not common practice in this type of data collection. Specifically, future research might track which infants discontinued care, were referred for other medical care, or were not treated because care was deemed unnecessary. With these data, comparisons of ratings could be made between mothers who discontinued care and those who completed care. The absence of such data is a shortcoming of this study because no such comparison is possible.
In addition, the entire study consisted of a population attending chiropractic clinics, and this group has been shown to differ from the broader population. [64, 65] Although this study included 15 private chiropractic offices, data were also obtained from the AECC University College teaching clinic, and this may provide a skewed sample. [65, 66] These factors may limit the generalizability of the results to the general population of mothers and infants with complaints, even though this type of study is designed for improved external validity.
A lack of validated and pragmatic outcome measures designed specifically for the infant population has been considered an impediment to conducting high-quality research in well-baby infant quality of life care, but the UKIQ may be capable of addressing this barrier. Its feasibility for use in chiropractic practice has been demonstrated for both paper and electronic versions of the tool,  and an electronic version has been found technically capable of large-scale data collection in chiropractic practice. 
Whether the patient improves or not is fundamental to clinical practice. Parent report of outcomes allows the mother to determine whether the change, if any, that occurred during a course of care should be classed as improvement or not. This facilitates patient-centered care and provides valuable information for the clinician and when the sample size is large and applicable to a wider population, to health care decision-makers, as well. Although this study’s design was not capable of determining efficacy, its findings may provide insight into whether mothers perceive this care to be of value to their infant. This research reflected only the mother’s point of view, and higher levels of research such as randomized controlled trials are required to determine true efficacy of this type of care for infants.
This was the first study of its kind to investigate prospectively collected data provided by mothers regarding presentation and outcomes from treatment from a large cohort of infants presented for chiropractic care. The infant’s care was reported by the mothers who completed follow-up as effective, safe, and cost-effective.
The findings of this study indicate that, on average, mothers report improvement in common complaints of infancy (crying, problematic feeding, sleeping, and pain) after chiropractic treatment along with improvements in their own mental state.
High maternal ratings for satisfaction and cost-effectiveness also were noted, and together these findings seem to indicate that on average, mothers note clinically important changes after chiropractic treatment of their infant.
This is the first large prospective study reporting parental report of effectiveness of routine chiropractic care for infants.
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