Home Health An umbrella assessment of effectiveness and efficacy trials for app-based well being interventions – npj Digital Medicine

An umbrella assessment of effectiveness and efficacy trials for app-based well being interventions – npj Digital Medicine

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An umbrella assessment of effectiveness and efficacy trials for app-based well being interventions – npj Digital Medicine

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Study choice

The research choice course of in keeping with PRISMA necessities14 is summarized in Fig. 1. The database search yielded a complete of 1895 data, with further 2513 data recognized by way of ahead and backward quotation looking out of data from the preliminary search deemed eligible after full textual content screening by the primary writer. After de-duplication, 4253 articles have been screened by title and summary. Of these, 3892 data have been excluded, and 361 data have been included for full textual content screening. The last variety of included articles was 48. Inter-rater reliability (IRR) for title-/summary screening and full-text screening was κ = 0.3469 and κ = 0.9326, respectively. A listing of the 313 research excluded after full-text screening with exclusion causes for every research could be present in Supplementary Table 1.

Fig. 1: PRISMA movement chart of retrieved, screened and included articles.
figure 1

Flow chart illustrating the method of research identification for the current umbrella assessment with database searches (final up to date on August 28, 2023), deduplication, title and summary screening in addition to full-text screening, resulting in a last inclusion choice for n = 48 systematic evaluations.

Review traits

Included evaluations have been revealed between 2013 and 2023, with the best variety of evaluations revealed in 2020 (n = 10) and the primary three quarters of 2023 (n = 9) (see Fig. 2).

Fig. 2: Number of included evaluations by publication yr.
figure 2

Vertical bar chart illustrating the variety of included systematic evaluations (n = 48 in whole) on the y-axis stratified by yr of publication on the x-axis.

All included evaluations thought of articles with out geographic restrictions, besides one specializing in China15. The variety of RCT research included in a assessment ranged from two to 36. Out of the 48 included evaluations, 3515,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49 performed knowledge pooling and meta-analyses whereas 13 evaluations50,51,52,53,54,55,56,57,58,59,60,61,62 supplied a story synthesis with out meta-analysis. Median follow-up durations ranged from 1 to 10 months, with no respective data reported in six evaluations15,31,32,33,50,53. A abstract of assessment traits is proven in Supplementary Table 2.

Methodological high quality

Figure 3 summarizes the frequency of every AMSTAR2 score for every area throughout evaluations. Supplementary Fig. 1 moreover presents the domain-specific methodological high quality scores for every assessment.

Fig. 3: Frequency of danger of bias for every area.
figure 3

Horizontal stacked bar chart illustrating on the x-axis the share of the n = 48 (100%) included systematic evaluations which was rated as both low danger of bias (inexperienced), exhibiting some considerations with regard to bias (yellow) or excessive danger of bias (purple), for every of the 16 AMSTAR objects (listed on the y-axis), respectively. White bar stacks symbolize the share of systematic evaluations with out meta-analysis, to which AMSTAR2 objects 11, 12, and 15 weren’t relevant (“NA”). The acronym PICO within the first AMSTAR2 merchandise stands for Population, Intervention, Comparator, Outcome.

Sixteen evaluations said that that they had registered or in any other case revealed a assessment protocol17,19,25,34,35,38,40,41,42,47,48,51,54,56,60,62. After checking these protocols, 13 have been rated as incomplete as they missed data on the search phrases defining the search technique (merchandise 2)17,19,34,38,40,41,47,48,51,54,56,60,62. All evaluations searched a minimum of two databases and supplied their full search technique within the last report, however 25 evaluations16,17,19,21,22,27,28,29,33,38,39,41,43,45,47,48,49,50,52,53,54,55,58,59,61 did not justify publication restrictions, for instance relating to language, entailing a “no” on merchandise 4. Six evaluations supplied a listing of research excluded at full-text screening stage (merchandise 7)26,37,42,48,56,57. Overall, a passable evaluation instrument for danger of bias was used (merchandise 9). Three evaluations reported conflicts of curiosity (merchandise 16)16,42,49. We rated one assessment as reasonable high quality56. IRR for high quality evaluation throughout all objects and evaluations was κ = 0.6671. Item-specific IRRs could be present in Supplementary Table 3.

Extraction outcomes

Included RCTs coated populations from all continents, with a majority of research performed in high- or middle-income nations such because the United States, China, Australia, United Kingdom, Spain, Norway and Japan. Seven evaluations33,38,45,46,48,49,50 didn’t report nations of included research.

An overview of coated well being indications is displayed in Supplementary Fig. 2 and, in additional aggregated illness teams, Fig. 4. Most evaluations focused particular indications, together with sort 2 diabetes (T2DM) (n = 5)19,20,22,23,26, hypertension (n = 4)15,27,31,38, melancholy (n = 3)33,53,61, chubby/weight problems (n = 3)40,41,52, continual obstructive pulmonary illness (COPD) (n = 2)35,39, urinary incontinence (n = 2)56,62, bronchial asthma (n = 1)57, autism spectrum problems (n = 1)32, post-traumatic stress dysfunction (PTSD) (n = 1)59, sort 1 diabetes (n = 1)47, Parkinson’s illness (n = 1)45, knee arthroplasty (n = 1)46 and decrease again ache (n = 1)51. Twenty-two evaluations coated a number of situations inside their scope, reminiscent of diabetes of varied sorts (n = 7)18,21,24,25,36,37,50, continual non-communicable ailments (n = 2)55,58, nervousness and melancholy (n = 2)43,49, situations requiring rehabilitation (n = 2)42,44, pediatric ailments (n = 1)54, ailments requiring remedy (n = 2)17,34, cardiovascular ailments (n = 2)16,30, ache situations (n = 2)48,60, psychological diseases (n = 1)28, or a mix of diabetes and hypertension (n = 1)29.

Fig. 4: Frequency of aggregated illness indications addressed within the included systematic evaluations.
figure 4

Vertical bar chart illustrating the variety of included systematic evaluations (on the y-axis) overlaying every of the 11 aggregated teams of well being situations (on the x-axis) which we recognized throughout the n = 48 included systematic evaluations. The whole variety of systematic evaluations included within the graph exceeds the variety of included systematic evaluations as some systematic evaluations cowl multiple group of well being situations. Cardiovascular situations embrace hypertension, stroke, weight problems, atrial fibrillation, coronary heart failure, myocardial infarction, coronary coronary heart illness, hypercholesterolemia, prediabetes and heart problems. Diabetes mellitus consists of sort 2 diabetes, sort 1 diabetes, diabetes, and gestational diabetes. Musculoskeletal situations embrace fibromyalgic syndrome, musculoskeletal problems, continual pelvic ache, continual musculoskeletal ache, a number of sclerosis, continual low again ache, continual neck ache, non-specific decrease again ache, unspecified continual ache, continual ache or fibromyalgia, Parkinson, and neurological problems. Mental well being situations embrace melancholy, nervousness, bipolar dysfunction, autism, post-traumatic stress dysfunction, consideration deficit hyperactivity dysfunction, and schizophrenia. Respiratory situations embrace bronchial asthma, continual obstructive pulmonary illness, lung transplant, allergic rhinitis, and continual lung illness. Autoimmune situations embrace autoimmune deficiency syndrome and psoriasis. Orthopedic situations embrace osteoarthritis, spina bifida, and post-operative knee aristoplasty. Urinary Tract Disorders embrace urinary incontinence and interstitial cystitis. Heterogenous ailments embrace unspecified continual ailments and multimorbidity. Cancer consists of chemotherapy associated to most cancers toxicity. Gastrointestinal situations embrace irritable bowel syndrome. For a extra detailed illustration of frequencies for all 49 ungrouped particular person well being situations, see Supplementary Fig. 2.

Information on pooled pattern measurement was supplied by all besides three evaluations31,45,46 and ranged from 282 to 7669 sufferers. Further data on extracted inhabitants traits could be present in Supplementary Tables 4 and 5.

The well being apps carried out a big selection of capabilities together with signs monitoring and assessments, remedy reminders, real-time biofeedback, personalised applications and schooling, tailored motivational messages or cues and suggestions, social assist, communication with healthcare professionals, purpose setting, knowledge storage, and visualization.

A abstract of reported app traits and functionalities is documented in Supplementary Table 4.

Comparator situations have been described in 43 out of the 48 evaluations. Some evaluations included regular care comparators solely, others diverse between regular care or different management apps, to lighter technological options, textual content messages, paper-based monitoring diaries, in-person and normal schooling, and no therapy. A abstract of reported comparators is proven in Supplementary Table 4.

Eleven evaluations reported outcomes on T2DM sufferers. Five centered on T2DM alone19,20,22,23,26, whereas six included broader populations however performed (subgroup) analyses particularly on T2DM21,24,25,36,37,58. All eleven evaluations besides one19 assessed glycemic management, operationalized as change in glycated hemoglobin (HbA1c) discount, as primary or secondary consequence. Further outcomes comprised adjustments in physique weight, waist circumference or physique mass index19,20,22,23, fats mass or proportion of physique fats19, lipids, blood strain, life-style adjustments, remedy use20,22,23, psychological signs and high quality of life (QoL)23. All research that centered on different kinds of diabetes (e.g., sort 1 diabetes, blended sorts, prediabetes, gestational diabetes)18,36,37,47,50 centered on HbA1c adjustments as primary consequence, whereas only some included adversarial occasions37,54 and QoL54. Another consequence reported for diabetic populations was remedy adherence, but it surely was reported in samples that didn’t completely embrace diabetes sufferers (sufferers with pharmaceuticals16, continual illness sufferers34,54).

Reviews together with sufferers with hypertension centered on evaluating the influence of well being app interventions on remedy adherence27,31,38, systolic and diastolic blood strain15,27,38, and well being behaviors27,38. Three evaluations16,17,34 reported on remedy adherence, and two evaluations16,29 on systolic and diastolic blood strain, lipids and anthropometric outcomes in samples that didn’t completely embrace hypertensive sufferers.

Reviews specializing in sufferers with melancholy measured enhancements of depressive signs33,53,61, and vanity and QoL53,61. Two evaluations moreover reported outcomes for remedy adherence17,61, one61 on psychiatric admissions, remedy adherence and negative effects, resilience, attitudes, sleep disturbances and additional psychological and behavioral outcomes61. Further evaluations reported on depressive28,43,49, mania and psychotic signs in addition to adversarial occasions28 and nervousness signs43,49 in samples that did embrace melancholy sufferers, nevertheless not completely. Outcomes evaluated in different psychological well being indications included signs associated to PTSD59, optimistic and destructive psychotic signs together with hallucinations or delusions and absence of expertise (in schizophrenia), mania and melancholy signs (bipolar dysfunction)28, and autism-related outcomes primarily based on the Mullen Scales of Early Learning, MacCarthur-Bates Communication Development Inventory and Communication and Symbolic Behavior Scales32.

Reviews specializing in chubby and weight problems used the next outcomes: weight reduction40,41,52, waist circumference, blood strain, lipids, HbA1c, vitality consumption40,41, bodily exercise, physique fats, BMI40, motivation and adherence52.

Outcomes reported in different indications could be present in Supplementary Tables 4 and 6.

Figure 5 illustrates the kinds of outcomes reported within the systematic evaluations by aggregated teams of investigated well being situations. More particulars on the uncategorized outcomes could be present in Supplementary Tables 4 and 6.

Fig. 5: Distribution of consequence sorts reported by categorized illness indications.
figure 5

Vertical stacked bar chart illustrating the proportion of behavioral (purple stacks), healthcare useful resource utilization (rose stacks), laboratory/anthropometric (inexperienced stacks), and affected person reported (blue stacks) outcomes on the y-axis by aggregated teams of well being situations (on the x-axis) coated within the whole of n = 48 included systematic evaluations. Behavioral outcomes comprised behaviors reminiscent of remedy adherence and bodily exercise. Healthcare useful resource utilization comprised outcomes reminiscent of hospitalizations, and physician visits. Laboratory/anthropometric outcomes included scientific or physique measurements. Patient-reported outcomes comprised subjectively reported outcomes reminiscent of high quality of life or symptom enchancment.

Twenty-three out of 35 meta-analyses performed subgroup analyses18,19,20,21,23,24,25,26,27,28,29,33,34,36,37,40,41,43,47,48,49,53,57. Investigated subgroups have been outlined by quantity, sorts and intensities of app options, differentiation between standalone or built-in interventions, baseline demographic or disease-related participant traits, follow-up length, intervention length, research high quality, sort of comparator, pattern measurement, attrition, analytic approaches, and consequence evaluation strategies. Summaries of the subgroups investigated are in Supplementary Table 7.

Overall, 41 out of the 48 evaluations concluded that app-based well being interventions have been efficient in bettering well being outcomes. The seven systematic evaluations which didn’t conclude that app-based well being interventions have been efficient reported inconclusive outcomes as some research confirmed effectiveness and others didn’t35,51,53,54,57,61, or reported clinically irrelevant enhancements41. Reported synthesized outcomes, kinds of impact estimates, and variety of underlying particular person research have been heterogeneous. A whole overview of extracted outcomes and summaries of writer’s conclusions is proven in Supplementary Table 6. For instance, for remedy adherence, meta-analysed impact estimates reported in 6 systematic evaluations ranged between 0.38 and 0.8 standardized imply distinction, with 2−14 research summarized, 6 out of 6 meta-analysed level estimates suggesting a rise in remedy adherence, and 6 out of 6 meta-analytic outcomes suggesting statistically vital results. Three evaluations moreover expressed impact estimates for remedy adherence by way of Odds Ratios or imply variations. For HbA1c, meta-analysed impact estimates from 13 systematic evaluations ranged between 0.06% and −0.6% (weighted) imply distinction, with 2−24 research summarized, 27 out of 28 meta-analysed level estimates suggesting a discount in % HbA1c, and 18 out of 28 meta-analytic outcomes suggesting statistically vital results. For systolic blood strain (SBP), meta-analysed impact estimates from 9 systematic evaluations ranged between 0.1 and −8.12 mmHg (weighted) imply distinction, with 2−13 research summarized, 8 out of 10 meta-analysed level estimates suggesting a discount in SBP, and 4 out of 10 meta-analytic outcomes suggesting statistically vital results. Two evaluations moreover expressed impact estimates for SBP by way of Odds Ratios or imply variations. In two evaluations with meta-analysed outcomes on SBP the result unit was unclear.

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