PLUTO PiLoting a Universal Tonsillectomy Outcomes questionnaire study

Abstract

Purpose

Sleep disordered breathing (SDB) and recurrent sore throats (RST) are two common childhood problems, often associated with adenotonsillar hypertrophy. Untreated SDB and RST can have severe consequences, which may impact a child’s quality of life (QoL). These conditions are commonly treated with tonsillectomy with or without adenoidectomy (TA).

There is debate regarding indications for surgery. This has been triggered by both diagnostic resource constraints and concerns about potential under-treatment of RST and mild forms of SDB. Recent research has also highlighted the incongruity between parental and clinician views of TA outcomes.

In order to address this, qualitative methods of analysis have informed development of QoL tools. This provides a less restrictive and more patient/parent based assessment of illness and has resulted in the creation of questionnaires such as the Paediatric Sleep Questionnaire (PSQ) and the 14 item Paediatric Throat Disorders Outcomes test (PTDO). However, there are no short, condition specific, questionnaires that assess SDB and RST separately and that are “country neutral” in their wording.

This study aims to progress development of two universally applicable SDB and RST specific QoL questionnaires.

Methodology

Children aged 4 – 16 years with SDB and/or RST were identified in our clinics, with 69 participants entering the study. Pre-and post-interventional questionnaires containing our proposed SDB and RST questionnaires and previously validated questionnaires (including the PSQ and the PTDO) were completed by parents twice, three months apart. Level II polysomnography objectively measured SDB severity. The reliability, validity, sensitivity to change and ease of response of our proposed questionnaires were analysed to allow item reduction.

Results

Both proposed SDB and RST questionnaires demonstrated satisfactory construct validity with moderate to strong correlations with previously validated adenotonsillar disease specific questionnaires (r= 0.66 – 0.88). A highly significant sensitivity to change was also noted in both questionnaires, with a mean difference between the treated and not treated cohort of -1.8 and -2.3, p<0.001 respectively. The proposed SDB and RST questionnaires showed excellent test – retest reliability (rs= 0.84, 0.86 respectively) and internal consistency (α= 0.90, 0.94 respectively). The suitability and ease of response of both questionnaires were highly satisfactory, with acceptable difficulty means ranging from 3.0 – 3.8.

The reduced ten – item questionnaires also demonstrated excellent validity, with both the SDB and RST questionnaires showing a significant ability to differentiate between children clinically diagnosed with only SDB or RST (differences of 0.6, p=0.054 and -1.5, p< 0.001 respectively). Moderate to strong correlations with previously validated adenotonsillar disease specific questionnaires were also reported (r= 0.64 – 0.87). These questionnaires are highly sensitive to change, with a mean difference between the treated and not treated cohort of -2.1 (95% CI -2.6, -1.6) and -2.7 (95% CI -3.1, -2.3). A good test – retest reliability (rs= 0.84, 0.87 respectively) and internal consistency (α= 0.88, 0.94 respectively) was also noted in both the SDB and RST questionnaires.

Conclusion

Our proposed SDB and RST specific questionnaires are parent reported QoL instruments which have demonstrated a satisfactory and consistent ability to measure the impact of these conditions on children’s QoL.