anurajms/meta_analysis huggingface dataset:
primary outcome:
Positive pressure therapy for Ménière’s disease
Improvement in vertigoMeasured as a dichotomous outcome (improved/not improved), according to self‐report, or according to a change of a specified score (as described by the study authors) on a vertigo rating scale.Change in vertigoMeasured as a continuous outcome, to identify the extent of change in vertigo symptoms.Serious adverse eventsIncluding any event that causes death, is life‐threatening, requires hospitalisation, results in disability or permanent damage, or in congenital abnormality. Measured as the number of participants who experience at least one serious adverse event during the follow‐up period.
primary outcome:
Tranexamic acid for the reduction of bleeding during functional endoscopic sinus surgery
Surgical field bleeding score (e.g. Wormald or Boezaart grading system for bleeding during endoscopic sinus surgery. Where both were reported we chose the Boezaart grading system).Intraoperative blood loss measured at the end of surgery (mL).Significant adverse effects: of relevance are seizures and thromboembolism within 12 weeks of surgery.
primary outcome:
Antihistamines for motion sickness
Proportion of susceptible participants who did not experience any motion sickness symptoms (based on subjective reporting of nausea and/or vomiting or the use of a validated scale).Proportion of susceptible participants who experienced a reduction or resolution of existing motion sickness symptoms (based on subjective reporting of nausea and/or vomiting or the use of a validated scale).
primary outcome:
Interventions for the prevention of persistent post‐COVID‐19 olfactory dysfunction
Presence of normal olfactory function:as assessed by the participants (e.g. self‐rated complete recovery);as assessed using psychophysical testing, using Sniffin' Sticks, University of Pennsylvania Smell Identification Test (UPSIT) or another validated test.Serious adverse effects (as defined by the trialists).Change in sense of smell:as assessed by the participants (e.g. using a visual analogue score);as assessed using psychophysical testing, using Sniffin' Sticks, UPSIT or another validated test.
primary outcome:
Interventions for the treatment of persistent post‐COVID‐19 olfactory dysfunction
Recovery of sense of smell:as assessed by the participants;as assessed with psychophysical testing, using Sniffin' Sticks, University of Pennsylvania Smell Identification Test (UPSIT) or another validated test.Disease‐related quality of life, as assessed by the Olfactory Disorders Questionnaire, or another validated questionnaire (which specifically relates to olfactory dysfunction).Serious adverse effects (as defined by the trialists).
primary outcome:
Intratympanic corticosteroids for sudden sensorineural hearing loss
Change in hearing threshold with pure tone audiometry (pure tone average (PTA)).
primary outcome:
Medical interventions for chronic rhinosinusitis in cystic fibrosis
QoL measured by questionnaires (e.g. Rhinosinusitis Outcome Measure‐31 (Tipirneni 2017) and Sinonasal Outcome Test‐22 (SNOT‐22) (Tipirneni 2017) for adults; Sinonasal‐5 for children (Tipirneni 2017))Refractory to treatment ‐ defined by persistent symptoms during intervention or recurrence of symptoms soon after stopping the intervention, requiring higher dose or concentration or more potent intervention to obtain any or sustained benefit as measured by Chronic Sinusitis Survey or visual analogue scaleTreatment‐related adverse eventsmild (an adverse event that does not require treatment, does not require the medication to be stopped, e.g. nausea)moderate (an adverse event that needs treatment, does not require the medication to be stopped; or needs the treatment to be stopped for a short duration, e.g. intractable vomiting)severe (an adverse event that is life‐threatening and requires the medication to be stopped permanently, e.g. allergy to an antibiotic)
primary outcome:
Biologics for chronic rhinosinusitis
Health‐related quality of life, using validated disease‐specific health‐related quality of life scores, such as the Sino‐Nasal Outcome Test‐22 (SNOT‐22), Rhinosinusitis Outcome Measures‐31 (RSOM‐31) and SNOT‐20.Disease severity, as measured by validated patient‐reported symptom score (such as the Chronic Sinusitis Survey (CSS) questionnaire and visual analogue scales). Where this was unavailable, we considered including data measuring the severity of individual symptoms (see below).Serious adverse events (SAEs), measured by the number of participants affected. A serious adverse event is defined as "Death, a life‐threatening adverse event, inpatient hospitalisation or prolongation of existing hospitalisation, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life‐threatening, or require hospitalisation may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition" (FDA 2018).
primary outcome:
Efficacy and safety of rapid tests to guide antibiotic prescriptions for sore throat
Number of participants provided with an antibiotic prescription.Number of participants with an antibiotic dispensed.
primary outcome:
Cognitive behavioural therapy for tinnitus
Impact of tinnitus on quality of life as measured by validated tinnitus‐specific multi‐item questionnaires identified in a systematic review of outcome instruments used in studies of interventions for tinnitus (Hall 2016). These included:Tinnitus Functional Index;Tinnitus Handicap Inventory;Tinnitus Handicap Questionnaire;Tinnitus Questionnaire;Tinnitus Reaction Questionnaire;Tinnitus Disability Index;Tinnitus Severity Scale.Serious adverse effects: self‐harm, suicide, suicide attempt, suicidal crisis, severe symptom exacerbation.
primary outcome:
Tranexamic acid for patients with nasal haemorrhage (epistaxis)
Control of epistaxis: re‐bleeding, as measured by the proportion of patients re‐bleeding within a period of up to 10 days (minimum five days).Significant adverse effects: seizures, thromboembolic events.
primary outcome:
Sound therapy (using amplification devices and/or sound generators) for tinnitus
Tinnitus symptom severity (such as the impact of tinnitus on quality of life, activities of daily living and sleep), as measured by the global score on a multi‐item tinnitus questionnaire (Table 1). These included:Tinnitus Questionnaire (Hallam 1996; Hiller 1992);Tinnitus Functional Index (TFI) (Meikle 2012);Tinnitus Handicap Inventory (THI) (Newman 1996);Tinnitus Handicap Questionnaire (Kuk 1990);Tinnitus Reaction Questionnaire (Wilson 1991);Tinnitus Severity Scale (Sweetow 1990).Significant adverse effect: increase in self‐reported tinnitus loudness.
primary outcome:
Antibiotics for acute rhinosinusitis in adults
Cure in people with:clinically diagnosed rhinosinusitis;rhinosinusitis confirmed by imaging.
primary outcome:
Perioperative local anaesthesia for reducing pain following septal surgery
Postoperative pain intensity at 12, 24 and 48 hours measured by:visual analogue scale (VAS);other pain outcome tools including numerical rating scales and verbal rating scales.
primary outcome:
Bilateral versus unilateral hearing aids for bilateral hearing impairment in adults
Patient preference for bilateral versus unilateral aids.Hearing‐specific health‐related quality of life (e.g. Hearing Handicap Inventory for the Elderly (HHIE), Hearing Handicap Inventory for Adults (HHIA), Auditory Disability Preference ‐ Visual Analogue Scale (ADPI‐VAS), Quantified Denver Scale of communication (QDS).Adverse effects (pain or discomfort in the ear, initiation or exacerbation of middle or outer ear infection).
primary outcome:
Influenza vaccines for preventing acute otitis media in infants and children
Number of children having at least one episode of AOM during the follow‐up period.Number of episodes of AOM recorded during the follow‐up period.
primary outcome:
Hearing aids for mild to moderate hearing loss in adults
Hearing‐specific health‐related quality of life, where participation was the key domain. This was measured using self‐report questionnaires. Where multiple questionnaires were used in a study, we proposed a ranked hierarchy of instruments whereby we identified the primary outcome based on the following in order of importance:Hearing Handicap Inventory for the Elderly (HHIE; Ventry 1982) or HHI for Adults (HHIA; Newman 1990), if the HHIE was not used;Quantified Denver Scale of Communication (QDS; Tuley 1990);Auditory Disability Preference ‐ Visual Analogue Scale (ADPI‐VAS; Joore 2002); andany questionnaire not specified above that was relevant to hearing‐specific health‐related quality of life.Adverse effect: pain. As reported by the patient as pain, discomfort, tenderness or skin irritation, or reported as occurrence of ear infection as a consequence of hearing aid fitting.
primary outcome:
Heated, humidified air for the common cold
Reduction in the clinical severity of the common cold (i.e. a decrease in the symptom score index). This was measured based on symptoms of nasal blockage, sneezing, and nasal drainage, which were scored on a four‐point scale (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe).Number of participants with the subjective response: therapy did not help.
primary outcome:
Coblation versus other surgical techniques for tonsillectomy
Postoperative pain as measured using a validated pain scale at 1, 3 and 7 days.Intraoperative blood loss (mL).Adverse effects: primary bleeding (within 24 hours postoperatively) and secondary bleeding (> 24 hours postoperatively).
primary outcome:
Needle aspiration versus incision and drainage for the treatment of peritonsillar abscess
Recurrence rate (proportion of patients needing repeat intervention)Adverse effects/events associated with the interventions
primary outcome:
Interventions for children with ear discharge occurring at least two weeks following grommet (ventilation tube) insertion
Proportion of children with resolution of ear discharge at short‐term follow‐up (less than two weeks).Adverse events likely to be related to the study medications (ototoxicity, gastrointestinal symptoms, skin rash).Serious complications related to middle ear infection, including acute mastoiditis and intracranial complications.
primary outcome:
Nasal decongestants in monotherapy for the common cold
Subjective symptom scores for nasal congestion (self‐reported scores of congestion).Overall patient well‐being score (self‐reported).
primary outcome:
Interventions to improve hearing aid use in adult auditory rehabilitation
The purpose of this review was to look at interventions that promote use of hearing aids once they have been fitted either by increasing the proportion of those fitted who become successful users or by increasing the amount of use per person. We recognise that for an individual use does not always equate to benefit but it is certainly a necessary starting point. At the most basic level it is not possible to benefit from a hearing aid if it is not in use for at least a proportion of the time.As hearing loss is a long‐term condition and hearing aids are usually intended as a long‐term intervention, we were interested in hearing aid use after a follow‐up period of at least a year. We also included short‐term (</ = 12 weeks) and medium‐term (> 12 to < 52 weeks) follow‐up, but we considered this lower quality evidence than if long‐term data were available for the same outcome.
primary outcome:
Betahistine for symptoms of vertigo
Proportion of patients with reduction in vertigo symptoms (considering together the intensity, frequency and duration those symptoms).Proportion of patients with adverse effects. Betahistine is thought to cause upper gastrointestinal adverse effects and we recorded these separately.
primary outcome:
Antibiotics for otitis media with effusion in children
Complete resolution of OME (complete treatment success) at two to three months post‐randomisation.Adverse effects, specifically diarrhoea, vomiting or skin rash.
primary outcome:
Short‐course oral steroids as an adjunct therapy for chronic rhinosinusitis
Health‐related quality of life, using disease‐specific health‐related quality of life scores, such as the Sino‐Nasal Outcome Test‐22 (SNOT‐22), Rhinosinusitis Outcome Measures‐31 (RSOM‐31) and SNOT‐20.Disease severity, as measured by patient‐reported symptom score (such as the Chronic Sinusitis Survey (CSS) questionnaire and visual analogue scales). In the absence of validated symptom score data, patient‐reported individual symptom scores were reported for the following symptoms: nasal obstruction/blockage/congestion, nasal discharge (rhinorrhoea), facial pressure/pain, loss of sense of smell (adults), cough (children).Significant adverse effect: mood or behavioural disturbances.
primary outcome:
Different types of intranasal steroids for chronic rhinosinusitis
Health‐related quality of life, using disease‐specific health‐related quality of life scores, such as the Sino‐Nasal Outcome Test‐22 (SNOT‐22), Rhinosinusitis Outcome Measures‐31 (RSOM‐31) and SNOT‐20.Disease severity, as measured by patient‐reported symptom score (such as the Chronic Sinusitis Survey (CSS) questionnaire and visual analogue scales). In the absence of validated symptom score data, we reported patient‐reported individual symptom scores for the following symptoms: nasal obstruction/blockage/congestion, nasal discharge (rhinorrhoea), facial pressure/pain, loss of sense of smell (adults) and cough (children).Significant adverse effect: epistaxis.
primary outcome:
Saline irrigation for chronic rhinosinusitis
Health‐related quality of life, using disease‐specific health‐related quality of life scores, such as the Sino‐Nasal Outcome Test‐22 (SNOT‐22), Rhinosinusitis Outcome Measures‐31 (RSOM‐31) and SNOT‐20.Disease severity, as measured by patient‐reported symptom score (such as the Chronic Sinusitis Survey (CSS) questionnaire and visual analogue scales). In the absence of validated symptom score data, we reported patient‐reported individual symptom scores for the following symptoms: nasal obstruction/blockage/congestion, nasal discharge (rhinorrhoea), facial pressure/pain, loss of sense of smell (adults), cough (children).Significant adverse effect: epistaxis.
primary outcome:
Intranasal steroids versus placebo or no intervention for chronic rhinosinusitis
Health‐related quality of life, using disease‐specific health‐related quality of life scores, such as the Sino‐Nasal Outcome Test‐22 (SNOT‐22), Rhinosinusitis Outcome Measures‐31 (RSOM‐31) and SNOT‐20.Disease severity, as measured by patient‐reported symptom score (such as the Chronic Sinusitis Survey (CSS) questionnaire and visual analogue scales).Significant adverse effect: epistaxis.
primary outcome:
Short‐course oral steroids alone for chronic rhinosinusitis
Health‐related quality of life, using disease‐specific health‐related quality of life scores, such as the Sino‐Nasal Outcome Test‐22 (SNOT‐22), Rhinosinusitis Outcome Measures‐31 (RSOM‐31) and SNOT‐20.Disease severity, as measured by patient‐reported symptom score (such as the Chronic Sinusitis Survey (CSS) questionnaire and visual analogue scales). In the absence of validated symptom score data, patient‐reported individual symptom scores were reported for the following symptoms: nasal obstruction/blockage/congestion, nasal discharge (rhinorrhoea), facial pressure/pain, loss of sense of smell (adults), cough (children).Significant adverse effect: mood or behavioural disturbances.
primary outcome:
Systemic and topical antibiotics for chronic rhinosinusitis
Health‐related quality of life, using disease‐specific health‐related quality of life scores, such as the Sino‐Nasal Outcome Test‐22 (SNOT‐22), Rhinosinusitis Outcome Measures‐31 (RSOM‐31) and SNOT‐20.Disease severity, as measured by patient‐reported symptom score (such as the Chronic Sinusitis Survey (CSS) questionnaire and visual analogue scales). In the absence of validated symptom score data, patient‐reported individual symptom scores were reported for the following symptoms: nasal obstruction/blockage/congestion, nasal discharge (rhinorrhoea), facial pressure/pain, loss of sense of smell (adults) and cough (children).Significant adverse effect: gastrointestinal disturbances include nausea and vomiting, diarrhoea and abdominal pain.
primary outcome:
Water precautions for prevention of infection in children with ventilation tubes (grommets)
Episodes of otorrhoeaAdverse effects
primary outcome:
Antihistamines for the common cold
The change in severity of overall symptoms of the common cold (for example, absent, mild, moderate, severe).The change in duration of overall symptoms of the common cold (for example, days to resolution).
primary outcome:
Corticosteroids for the common cold
Proportion of participants with resolution or improvement of symptoms (individual and global) within one month.Time lapse before resolution of symptoms.
primary outcome:
Non‐steroidal anti‐inflammatory drugs for the common cold
Global evaluation of efficacy in the treatment of common cold symptoms.Decrease in the number or duration of individual common cold symptoms. These symptoms were assessed by severity scale.
primary outcome:
Virtual reality training for improving the skills needed for performing surgery of the ear, nose or throat
Real world outcomes: intra‐ or postoperative error rates, discomfort or pain score of patients after surgery, and re‐admission rates.Technical skills in the operating theatre: psychomotor scores measuring physical co‐ordination providing precise movement, procedural scores measuring task accomplishment through a sequence of actions, and surgical anatomy scores measuring knowledge of specific anatomical structures.Non‐technical skills in the operating theatre: situational awareness skill scores, decision‐making skill scores, communication and teamwork skill scores, and leadership skill scores.
primary outcome:
Antibiotics for preventing recurrent sore throat
Incidence of sore throat recurrence, measured by the number of self reported episodes per year (patients were followed up for a minimum of 12 months post‐antibiotic therapy; we then planned to calculate the results as occurrence per year); and cumulative severity, measured in days of disability for incident cases.Adverse effects (including diarrhoea, thrush, rashes, nausea etc.).
primary outcome:
Topical nasal steroids for treating nasal polyposis in people with cystic fibrosis
Quality of life (QOL) (as measured by a validated QOL score i.e. CFQoL (Gee 2000), CFQ‐R (Quittner 2009))Nasal symptom score (as measured by a validated score i.e. SNOT (Hopkins 2009))
primary outcome:
Pharmacological agents for the prevention of vestibular migraine
Overall improvement in symptoms
primary outcome:
Steroid‐eluting sinus stents for improving symptoms in chronic rhinosinusitis patients undergoing functional endoscopic sinus surgery
Improvement in symptom scores (i.e. visual analogue scale (VAS) and Sino‐Nasal Outcome Test‐22 (SNOT‐22))
primary outcome:
Antibiotics for acute laryngitis in adults
Clinical improvementImprovement in recorded voice score assessed by an expert panel at presentation and after the period of time considered in each trial (usually one or two weeks, or both). As a standard, trials used the patient's normal voice, recorded weeks later.Symptom improvement at presentation (hoarseness/subjective voice score, pharyngitis, cough, sore throat and rhinorrhoea/nasal congestion) and after the period of time considered in each trial, as assessed by the investigators or the patient.
primary outcome:
Vestibular rehabilitation for unilateral peripheral vestibular dysfunction
Measure(s) of change in the specified symptomatology (for example, proportion with dizziness resolved, frequency or severity of dizziness). Symptomatic ratings must be reported and recorded pre‐ and post‐trial.Statistically significant differences between vestibular rehabilitation and other interventions (manoeuvres) in favour of 'other' (where 'other' were physical manoeuvres for benign paroxysmal positional vertigo (BPPV)) were found for the following.
primary outcome:
Stereotactic radiotherapy for vestibular schwannoma
Proportion of patients in whom the tumour has not grown and whose symptoms (hearing loss, facial function, tinnitus, balance disturbance) have not deteriorated a) at 12 months, b) at two years, c) in the long term.
primary outcome:
The Epley (canalith repositioning) manoeuvre for benign paroxysmal positional vertigo
Complete resolution of vertigo symptoms.
primary outcome:
Surgical versus medical interventions for chronic rhinosinusitis with nasal polyps
Disease severity, as measured by patient‐reported disease‐specific symptom scores. This includes rating of nasal obstruction and other sinonasal symptoms (using visual analogue scales or other methods).Health‐related quality of life, using disease‐specific health‐related quality of life scores, such as the Sino‐Nasal Outcome Test‐22 (SNOT‐22) (Table 1).Health‐related quality of life, using generic quality of life scores, such as the SF‐36.
primary outcome:
Over‐the‐counter (OTC) medications for acute cough in children and adults in community settings
All cough outcomes (such as frequency, severity, amount of sputum, improvement in cough symptoms using continuous and categorical data and different ways of measurement including cough sound pressure levels, cough counts, patient questionnaires, physician assessment, etc). We did not consider global patient or physician ratings of wellness or recovery as outcomes, unless these were directly related to cough symptoms.
primary outcome:
Surgical interventions for chronic rhinosinusitis with nasal polyps
Disease severity, as measured by patient‐reported disease‐specific symptom scores. This includes rating of nasal obstruction and other sinonasal symptoms (using visual analogue scales or other methods).Health‐related quality of life, using disease‐specific health‐related quality of life scores, such as the Sinonasal Outcome Test‐22 (SNOT‐22) (Table 1).Health‐related quality of life, using generic quality of life scores, such as the SF‐36.
primary outcome:
Tonsillectomy or adenotonsillectomy versus non‐surgical treatment for chronic/recurrent acute tonsillitis
Number and severity of episodes of tonsillitis or sore throatNumber of days with sore throatMorbidity and mortality of surgery (measures of morbidity include complications of surgery and number of days with postoperative pain)
primary outcome:
Amplification with hearing aids for patients with tinnitus and co‐existing hearing loss
Tinnitus severity or handicap, measured as a change between baseline (pre‐hearing aid fitting) and follow‐up compared to a control, using a tinnitus questionnaire listed in Table 1. This list will be updated on an ongoing basis whenever other questionnaires are validated.
primary outcome:
Once or twice daily versus three times daily amoxicillin with or without clavulanate for the treatment of acute otitis media
Clinical cure rate at the end of antibiotic therapy (days 7 to 15), in terms of resolution of otalgia, resolution of fever and bacteriological cure rate, if data are provided.Clinical cure rate at the end of therapy(Table 2; Analysis 1.1; Figure 3)Five trials involving 1601 participants compared one or two daily doses of amoxicillin, with or without clavulanate, with three daily doses. The risk ratio (RR) showed comparable results between groups (RR 1.03, 95% confidence interval (CI) 0.99 to 1.07).
primary outcome:
Nebulized epinephrine for croup in children
Change in clinical croup scores following treatment.
primary outcome:
Oral rinses, mouthwashes and sprays for improving recovery following tonsillectomy
Pain: reduction in severity.Pain: time to complete resolution.Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively.Bleeding: time to complete cessation.Bleeding: postoperative measures to reduce bleeding.
primary outcome:
Steroids for idiopathic sudden sensorineural hearing loss
We assessed the following outcomes:Outcomes were to be measured and assessed both within seven to 30 days (short‐term) and one to 12 months (long‐term) after treatment. As a meta‐analysis was not appropriate in this review due to the insufficient quality of the data, we performed a qualitative systemic review.
primary outcome:
Acetaminophen (paracetamol) for the common cold in adults
Subjective symptom score. Total scores are calculated by summing up all symptom scores. Each symptom score was graded on a severity visual analogue scale (VAS) of 0 to 3, 0 to 4, or 0 to 10 cm.Duration of common cold symptoms.
primary outcome:
Intranasal ipratropium bromide for the common cold
Change in severity of symptoms of rhinorrhoea and congestion assessed subjectively by validated scales; for example, visual analogue scales (VAS) (Stewart 1992).Global assessment of overall improvement from use of the intervention by a standardised questionnaire to participants at the end of the study. These could include the Global Rating of Change: respondents' evaluation of changes in one or more domains of health‐related quality of life indicating whether they are better, about the same or worse (Patrick 1993). Another method is the Global Measure, which involves an assessment of the overall quality of the health status of the patient at a given point in time (Guyatt 1991).
primary outcome:
Antibiotics for the common cold and acute purulent rhinitis
For the common cold: persisting symptoms.For acute purulent rhinitis: persistent purulent rhinitis.
primary outcome:
Acetylcysteine and carbocysteine for acute upper and lower respiratory tract infections in paediatric patients without chronic broncho‐pulmonary disease
Time to resolution of clinical symptoms, signs or both (where clinical symptoms and signs may include increased respiratory rate, use of accessory respiratory muscles, abnormal lung examination, cough, sputum production, fever or activity limitations).Proportions of patients with clinical symptoms, signs or both at a designated time.Global assessment of improvement by clinicians, patients or their parents at a designated time.
primary outcome:
Autoinflation for hearing loss associated with otitis media with effusion
Improvement in tympanogram (to type C1 or A tympanogram)Differences in hearing level on pure‐tone audiogram (average 10 dB improvement over the frequencies 250 Hz to 2000 Hz)Improvement measured as a composite of change in tympanogram and/or audiometry (post hoc)
primary outcome:
Interventions for the prevention of postoperative ear discharge after insertion of ventilation tubes (grommets) in children
Otoscopic observation of postoperative otorrhoea from one or both ears
primary outcome:
Surgery for Ménière's disease
Due to the natural history of Ménière's disease it is hard to say when a patient is cured. According to the Committee of Hearing and Equilibrium (Monsell 1995a) it is possible to define improvement subjectively. The patient counts their vertigo spells for six months before the intervention, then again for a further period of six months and at 18 to 24 months after the intervention. The quotient of the mean vertigo spells per month classifies the improvement of vertigo. When this quotient is zero, complete control of the vertigo has been achieved. As it is not clear whether this relief of vertigo is permanent, authors are encouraged to report results up to four years after the treatment.
primary outcome:
Clinical service organisation for adults with atrial fibrillation
All‐cause mortality.All‐cause hospitalisation (number of participants with at least one hospitalisation).
primary outcome:
Collaborative care approaches for people with severe mental illness
We changed the outcomes from those reported in the original review (Differences between protocol and review; Appendix 3). As this review has been funded as part of the Byng 2023 National Institute of Health Research (NIHR) grant, we were able to utilise a core outcome set for use in community‐based bipolar trials to guide our choice of outcomes (Retzer 2020). We were also able to utilise an additional stakeholder consultation to select outcomes that were important to those working with and living with SMI diagnoses. This stakeholder consultation was convened to capture the wider psychosis target population in Byng 2023 and the nature of the intervention. Quality of life (QoL) was selected by the research team and Lived Experience Advisory Panels (Plappert 2021) as the most important outcome domain for stakeholders. We added this to our primary outcomes along with mental state and psychiatric hospital admissions. In response to stakeholder feedback, we also added personal recovery as an outcome and we broadened our satisfaction outcome to encompass 'experience of care'. We also included process/delivery outcomes as secondary outcomes. These changes were made before we extracted data from our included studies.For valid scales please see Data extraction and management.Where possible, we divided outcomes into short‐term (less than six months), medium‐term (seven to 12 months) and long‐term (over 12 months). We endeavoured to prioritise the report of binary outcomes recording clear and clinically meaningful degrees of change ahead of continuous outcomes (e.g. global impression of much improved, or more than 50% improvement on a rating scale ‐ as defined within the trials). For outcomes such as 'clinically important change', 'any change' and 'relapse', we used the definition used by each of the trials.
primary outcome:
Admission avoidance hospital at home
Mortality.Admission to hospital.
primary outcome:
Primary‐level and community worker interventions for the prevention of mental disorders and the promotion of well‐being in low‐ and middle‐income countries
Diagnosis (or a proxy thereof, as assessed by scoring above a cut‐off for a screening tool) of mental disorders at study endpoint, determined according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) III (APA 1980), DSM‐III‐R (APA 1987), DSM‐IV‐TR (APA 2000), DSM‐V (APA 2013), International Classification of Diseases (ICD)‐10 (WHO 1992), or any other standardized criteria.Diagnosis (or a proxy thereof, as assessed by scoring above a cut‐off for a screening tool) of mental disorders at 1 to 6 months post‐intervention.Diagnosis (or a proxy thereof, as assessed by scoring above a cut‐off for a screening tool) of mental disorders at 7 to 24 months post‐intervention.Quality of life.Adverse events experienced during the intervention.
primary outcome:
Interventions to improve the appropriate use of polypharmacy for older people
Medication appropriateness (as measured by an implicit, i.e. judgement‐based, tool, e.g. MAI (Hanlon 1992) or a defined subset of criteria from a validated instrument) (Appendix 2).Potentially inappropriate medications (as defined by a validated explicit, i.e. criteria‐based, tool, e.g. STOPP criteria (Gallagher 2008; O'Mahony 2015), which could consist of the number of potentially inappropriate medications and/or the proportion of patients with one or more potentially inappropriate medication) (Appendix 2).Potential prescribing omissions (as defined by a validated explicit tool, e.g. START criteria (Gallagher 2008; O'Mahony 2015)), which could consist of the number of potential prescribing omissions and/or the proportion of patients with one or more potential prescribing omission.Hospital admissions (including all‐cause hospital admissions and unplanned hospital readmissions).
primary outcome:
Interventions for the uptake of evidence‐based recommendations in acute stroke settings
recommended diagnostic procedures or assessments;acute medical interventions;interventions to prevent complications;patient‐centred goal setting;early rehabilitation interventions;prescribing patterns for secondary prevention medications;referral patterns within the acute setting or to downstream services ;assessments for post‐acute rehabilitation;information provision;composite improvement outcomes spanning multiple categories.
primary outcome:
Acute assessment services for patient flow assistance in hospital emergency departments
Mortality at the time point closest to 30 daysLength of stay in the service (in minutes)Waiting time to see a doctor (in minutes)
primary outcome:
Pharmacological, non‐invasive brain stimulation and psychological interventions, and their combination, for treating depression after stroke
Meeting the criteria for depression at end of treatment, as defined by DSM or similar standard diagnostic criteria.Inadequate response to treatment defined as less than 50% reduction in depression scale scores at end of treatment.
primary outcome:
Case management for integrated care of older people with frailty in community settings
Mortality. We justified including mortality as a primary outcome because frailty is the leading cause of death in older people (Clegg 2013).Change in place of residence to a nursing or residential homeQuality of lifeSerious adverse effects (i.e. medical event or injury triggered by participating in the trial)
primary outcome:
Medication review in hospitalised patients to reduce morbidity and mortality
Mortality (all‐cause)
primary outcome:
Comprehensive Geriatric Assessment for community‐dwelling, high‐risk, frail, older people
Death.Nursing home admission (i.e. new admission to full‐time residential care during study follow‐up period).Unplanned hospital admission.Emergency department visits.Serious adverse events.
primary outcome:
Discharge planning from hospital
1. Hospital length of stay2. Unscheduled readmission to hospital3. Patient health status: mortality, functional status, psychological health4. Satisfaction of patients, caregivers and healthcare staff5. Healthcare resource use and costs
primary outcome:
Early warning systems and rapid response systems for the prevention of patient deterioration on acute adult hospital wards
Hospital mortality
primary outcome:
Routine provision of feedback from patient‐reported outcome measurements to healthcare providers and patients in clinical practice
patient‐reported outcomes: quality of life, general health perceptions, functioning, and symptoms, such as nausea, fatigue, and mental health‐related symptoms;adverse effects: distress following or related to PROM completion.
primary outcome:
Decision‐support tools via mobile devices to improve quality of care in primary healthcare settings
Providers' adherence to recommended practices, guidelines, or protocols (e.g. providing the service at the recommended time, referral as recommended, screening and prioritizing as recommended).Time between presentation and appropriate management, including time for referrals and service linkages.Patients' or clients' health behaviour.Patients' or clients' health status and well‐being, assessed through validated measures, if available.Patient or client acceptability and satisfaction with the intervention, assessed through validated measures, if available.Provider acceptability and satisfaction with the intervention, assessed through validated measures, if available.Resource use (e.g. human resources and time, training, supplies, and equipment).Unintended consequences that resulted in an adverse effect of the intervention (these could have included misreading or misinterpretation of the data; transmission of inaccurate data, e.g. incorrect underlying algorithms or clinical protocols; loss of verbal or non‐verbal communication cues; decreased direct engagement with patient; issues of privacy and disclosure; loss (including theft) or misuse of device (in cases in which health workers were given the phones or tablets); interrupted workflow due to infrastructural constraints for battery recharging and network coverage; impacts on equity; disruptions on the delivery of health services, unforeseen ill‐effects on patient outcomes).
primary outcome:
Telerehabilitation services for stroke
The primary outcome of interest was independence in activities of daily living assessed post‐intervention. In the review, this encompassed the self‐care, mobility and domestic life activity and participation domains derived from the International Classification of Functioning, Disability and Health (WHO 2010). Included assessment tools were those such as the Functional Independence Measure, the Barthel Index, Lawton Instrumental Activities of Daily Living, Frenchay Activities Index, and the Nottingham Extended Activities of Daily Living Index.
primary outcome:
Pharmacy‐based management for depression in adults
Depression symptom level: as measured using validated patient‐reported or clinician‐rated depression measures. Included studies used a range of outcome measures to describe symptom level including dichotomous outcomes (improvement in symptoms yes/no) and continuous outcomes (mean depression scores). We combined results from dichotomous outcome measures and results from continuous outcome measures in separate meta‐analyses (see Data synthesis).Acceptability of the intervention: based on the number of people discontinuing the intervention by leaving the study early.
primary outcome:
Manually‐generated reminders delivered on paper: effects on professional practice and patient outcomes
Dichotomous process adherence outcomes: the percentage of patients receiving a target process of care (e.g. prescription of a specific medication, documentation of performance of a specific task, such as referral to a consultant) or whose care was in compliance with a guideline recommendation;Continuous process outcomes: any continuous measure of how providers delivered care (e.g. duration of antibiotic therapy, time to respond to a critical lab value).Dichotomous clinical outcomes: patient‐important endpoints (such as death or development of a pulmonary embolism), as well as surrogate or intermediate endpoints, such as achievement of a target blood pressure or serum cholesterol level;Continuous clinical outcomes: various markers of disease or health status (e.g. mean blood pressure or cholesterol level).
primary outcome:
Telephone counselling for smoking cessation
Long‐term smoking cessation (i.e. at least six months after the start of intervention). We excluded trials with shorter follow‐up. We used the strictest definition of smoking cessation available in a trial and biochemically‐validated abstinence data whenever available.
primary outcome:
Follow‐up services for improving long‐term outcomes in intensive care unit (ICU) survivors
Health‐related quality of life (HRQoL)All cause mortalityDepression and anxiety
primary outcome:
Patient‐mediated interventions to improve professional practice
Adherence to recommended clinical practice or clinical practice guidelines by healthcare professionals.
primary outcome:
Impact of public release of performance data on the behaviour of healthcare consumers and providers
Changes in healthcare utilisation by consumersObjective measures of changing consumer behaviour, such as increased use of a specific healthcare providerChanges in healthcare decisions taken by healthcare providers (professionals and organisations)Objective measures of changing healthcare provider behaviour, such as changes to drug prescribingChanges in the healthcare utilisation decisions of purchasersObjective measures of changing purchaser behaviour, such as increased or decreased funding for servicesChanges in provider performanceObjective changes, such as reaching the correct diagnosis or time to treatmentIncluding measures that were made both public and others that were notChanges in patient outcomeObjective changes, such as mortality or patient‐reported outcome measuresChanges in staff moraleUsing a previously validated assessment tool
primary outcome:
Pharmacist services for non‐hospitalised patients
We included a broad range of outcome measures associated with health, service utilisation and healthcare‐related harm. We selected commonly‐used objective outcomes to facilitate comparison and meta‐analysis. Outcome measure selection was informed by guidelines and discussion with clinicians with expertise in specific conditions. For example, we sought national or international guidelines to identify the clinical outcomes most frequently used in disease management. Where no clear evidence was available to inform our decision‐making process, we consulted one or more clinicians to determine the most meaningful outcome measures used in everyday practice. For completeness, we have included trials which fulfilled the above inclusion criteria but which did not present data on the outcome measures of interest.
primary outcome:
Hospitalisation in short‐stay units for adults with internal medicine diseases and conditions
Mortality; proportion of participants that died at any time and of any causeSerious adverse events; proportion of participants with one or more serious adverse events as defined by the International Committee of Harmonisation‐Good Clinical Practice (ICH‐GCP): "any untoward medical occurrence that resulted in death, was life threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity" (ICH‐GCP 1997).
primary outcome:
Nurses as substitutes for doctors in primary care
We considered three types of outcomes for inclusion in this review: patient outcomes; process of care outcomes; and utilisation outcomes, including both volume and costs.
primary outcome:
Improving adherence to Standard Precautions for the control of health care‐associated infections
Adherence to Standard Precautions guidelines, as measured by rates of observed Standard Precautions practice (e.g. observed glove use) or a proxy indicator of adherence (e.g. increased application of policy; volume of glove use), or a combination of these. The definition of adherence could vary across studies. Investigators could assess adherence using different observational methods, or they could assess adherence at an individual or organisational level
primary outcome:
Comprehensive geriatric assessment for older people admitted to a surgical service
The primary outcomes were mortality and discharge to an increased level of care.We measured mortality to the end of follow‐up after treatment. We measured discharge to an increased level of care reported as participants being discharged to a setting where they would receive an increased level of care such as an assisted‐living or long‐term care facility, as opposed to returning to their pre‐admission place of residence.
primary outcome:
Patient reminder and recall interventions to improve immunization rates
Our primary outcome measure was receipt of immunizations. We selected this outcome measure over other possible outcomes because of certain limitations, for example: the total number of vaccines would vary based on country, age group, and other factors; the proportion of the population that received all vaccines would depend on the specific population, such as age group; and on‐time vaccination is restrictive and is not expected to support clinicians' efforts to optimize receipt of vaccinations.We accepted outcomes for individual vaccinations or standard combinations of recommended vaccinations, such as all recommended vaccinations by a specific date or age. If outcomes for a study were measured at multiple time points, we selected the outcomes designated as primary by the study authors. If unclear, we averaged outcomes over time periods.We excluded immunizations that were sought for purposes of traveling to a destination where the disease may be widespread, and immunization orders or visits that did not also measure immunization status.
primary outcome:
Providing physicians with feedback on medication adherence for people with chronic diseases taking long‐term medication
Medication adherence, regardless of its definition and its calculation method (e.g. percentage of 'days covered' by medication, percentage of non‐adherent patients, number of days before a refill of medication).
primary outcome:
Interventions to change the behaviour of health professionals and the organisation of care to promote weight reduction in children and adults with overweight or obesity
We included any objective measure of provider performance consistent with EPOC guidelines or participant outcomes (EPOC 2013). We also planned to report any available cost data.
primary outcome:
Comprehensive geriatric assessment for older adults admitted to hospital
Living at home (the inverse of death or institutionalisation combined; used to describe someone who is alive and in own home at follow‐up)
primary outcome:
Interprofessional collaboration to improve professional practice and healthcare outcomes
Patient health outcomes (objectively measured or self‐reported, using a validated instrument)mortalitymorbiditydisease incidencedisease durationcure ratesquality of life measuresfunctional statuscomplication ratepatient‐assessed quality of careClinical process or efficiency outcomesreadmission ratesadherence to recommended practices (by healthcare providers)continuity of careuse of healthcare resources (i.e. cost‐benefit analysis)participant satisfaction
primary outcome:
Home or foster home care versus institutional long‐term care for functionally dependent older people
We included the following outcome measures.
primary outcome:
Non‐medical prescribing versus medical prescribing for acute and chronic disease management in primary and secondary care
The studies included in the review reported a wide variety of outcome measures. We only included studies with objective measures of patient clinical outcomes. Non‐inferiority was regarded as a positive outcome where a non‐medical prescribing outcome was at least as good as the comparator. We excluded studies with only a qualitative component in order to maintain the clinical focus of the review.
primary outcome:
Tools developed and disseminated by guideline producers to promote the uptake of their guidelines
We included studies reporting the following outcome measures:
primary outcome:
Mobile clinics for women's and children's health
Health outcomes: participant outcomes were:health status and well‐being, including number of cases diagnosed, treated, or referred for treatment, including cases of STDs, high‐risk pregnancies, malnutrition among children and infectious diseases among children;health behaviour: any measure of the extent to which service users adhered to recommended care plans. For example, for women, whether they attended for the recommended number of antenatal visits, and for children, whether they completed the vaccination schedule at the designated time;utilisation, coverage, or access: we used coverage and service utilisation as proxies for the impact of health services on the health of women and children. Measures included:contraceptive prevalence;vaccination coverage among children;use of other services provided by mobile clinics (e.g. osteoporosis screening, antenatal care, postnatal care, screening for STDs, screening for breast and cervical cancer, HIV counselling, regular weight monitoring of children etc.);resource use, including:cost‐effectiveness of services offered by the mobile clinics in comparison to static clinics.
primary outcome:
Integrated management of childhood illness (IMCI) strategy for children under five
As one study also reported on other newborn care practices, which we did not anticipate, we describe these results under "coverage." In addition, in the protocol, we stated that we would assess morbidity episodes as secondary outcomes. As it is unlikely that IMCI would influence the incidence of disease, and studies did not report on this, we have not commented further on this outcome.